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نشرة الممارس الصحي نشرة معلومات المريض بالعربية نشرة معلومات المريض بالانجليزية صور الدواء بيانات الدواء
  SFDA PIL (Patient Information Leaflet (PIL) are under review by Saudi Food and Drug Authority)

Ciprobay 250 contains the active substance ciprofloxacin. Ciprofloxacin is an antibiotic belonging to the fluoroquinolone family. Ciprofloxacin works by killing bacteria that cause infections. It only works with specific strains of bacteria.

 

Adults

Ciprobay 250 is used in adults to treat the following bacterial infections:

·                respiratory tract infections

·                long lasting or recurring ear or sinus infections

·                urinary tract infections

·                genital tract infections in men and women

·                gastro-intestinal tract infections and intra-abdominal infections

·                skin and soft tissue infections

·                bone and joint infections

·                to prevent infections due to the bacterium Neisseria meningitidis

·                anthrax inhalation exposure

 

Ciprofloxacin may be used in the management of patients with low white blood cell counts (neutropenia) who have a fever that is suspected to be due to a bacterial infection.

 

If you have a severe infection or one that is caused by more than one type of bacterium, you may be given additional antibiotic treatment in addition to Ciprobay 250.

 

Children and adolescents

Ciprobay 250 is used in children and adolescents, under specialist medical supervision, to treat the following bacterial infections:

·                lung and bronchial infections in children and adolescents suffering from cystic fibrosis

·                complicated urinary tract infections, including infections that have reached the kidneys (pyelonephritis)

·                anthrax inhalation exposure

 

Ciprobay 250 may also be used to treat other specific severe infections in children and adolescents when your doctor considered this necessary.


Do not take Ciprobay 250:

·                if you are allergic to the active substance, to other quinolone drugs or to any of the other ingredients of this medicine (listed in Section 6)

·                if you are taking tizanidine (see Section 2: Other medicines and Ciprobay 250)

 

Warnings and precautions

 

Before taking this medicine

You should not take fluoroquinolone/quinolone antibacterial medicines, including Ciprobay 250, if you have experienced any serious adverse reaction in the past when taking a quinolone or fluoroquinolone. In this situation, you should inform your doctor as soon as possible.

 

Talk to your doctor before taking Ciprobay 250

·                if you have ever had kidney problems because your treatment may need to be adjusted.

·                if you suffer from epilepsy or other neurological conditions.

·                if you have a history of tendon problems during previous treatment with antibiotics such as Ciprobay 250.

·                if you are diabetic because you may experience a risk of hypoglycaemia with ciprofloxacin.

·                if you have myasthenia gravis (a type of muscle weakness) because symptoms can be exacerbated.

·                if you have been diagnosed with an enlargement or “bulge” of a large blood vessel (aortic aneurysm or large vessel peripheral aneurysm).

·                if you have experienced a previous episode of aortic dissection (a tear in the aorta wall).

·                if you have been diagnosed with leaking heart valves (heart valve regurgitation).

·                if you have a family history of aortic aneurysm or aortic dissection or congenital heart valve disease, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome or Ehlers-Danlos syndrome, Turner syndrome, Sjögren’s syndrome [an inflammatory autoimmune disease], or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet´s disease, high blood pressure, or known atherosclerosis, rheumatoid arthritis [a disease of the joints] or endocarditis [an infection of the heart]).

·                if you have heart problems. Caution should be taken when using Ciprofloxacin, if you were born with or have family history of prolonged QT interval (seen on ECG, electrical recording of the heart), have salt imbalance in the blood (especially low level of potassium or magnesium in the blood), have a very slow heart rhythm (called ‘bradycardia’), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), you are female or elderly or you are taking other medicines that result in abnormal ECG changes (see section 2: Other medicines and Ciprobay 250).

·                if you or a member of your family is known to have a deficiency in glucose-6-phosphate dehydrogenase (G6PD), since you may experience a risk of anemia with ciprofloxacin.

 

For the treatment of some genital tract infections, your doctor can prescribe another antibiotic in addition to ciprofloxacin. If there is no improvement in symptoms after 3 days of treatment, please consult your doctor.

 

While taking Ciprobay 250

Tell your doctor immediately, if any of the following occurs while taking Ciprobay 250. Your doctor will decide whether treatment with Ciprobay 250 needs to be stopped.

 

·                Severe, sudden allergic reaction (an anaphylactic reaction/shock, angio-oedema). Even with the first dose, there is a small chance that you may experience a severe allergic reaction with the following symptoms: tightness in the chest, feeling dizzy, sick or faint, or experiencing dizziness when standing up. If this happens, stop taking Ciprobay 250 and contact your doctor immediately.

 

·                Prolonged, disabling and potentially irreversible serious side effects. Fluoroquinolone/ quinolone antibacterial medicines, including Ciprobay 250, have been associated with very rare but serious side effects, some of them being long lasting (continuing months or years), disabling or potentially irreversible. This includes tendon, muscle and joint pain of the upper and lower limbs, difficulty in walking, abnormal sensations such as pins and needles, tingling, tickling, numbness or burning (paraesthesia), sensory disorders including impairment of vision, taste and smell, and hearing, depression, memory impairment, severe fatigue, and severe sleep disorders.

If you experience any of these side effects after taking Ciprobay 250, contact your doctor immediately prior to continuing treatment. You and your doctor will decide on continuing the treatment considering also an antibiotic from another class.

 

·                Pain and swelling in the joints and inflammation or rupture of tendons may occur rarely. Your risk is increased if you are elderly (above 60 years of age), have received an organ transplant, have kidney problems or if you are being treated with corticosteroids.
Inflammation and ruptures of tendons may occur within the first 48 hours of treatment and even up to several months after stopping of Ciprobay 250 therapy. At the first sign of pain or inflammation of a tendon (for example in your ankle, wrist, elbow, shoulder or knee), stop taking Ciprobay 250, contact your doctor and rest the painful area. Avoid any unnecessary exercise, as this might increase the risk of a tendon rupture.

 

·                If you feel sudden, severe pain in your abdomen, chest or back, which can be symptoms of aortic aneurysm and dissection, go immediately to an emergency room. Your risk may be increased if you are being treated with systemic corticosteroids.

 

·                If you start experiencing a rapid onset of shortness of breath, especially when you lie down flat in your bed, or you notice swelling of your ankles, feet or abdomen, or a new onset of heart palpitations (sensation of rapid or irregular heartbeat), you should inform a doctor immediately.

 

·                If you suffer from epilepsy or other neurological conditions such as cerebral ischemia or stroke, you may experience side effects associated with the central nervous system. If seizure happens, stop taking Ciprobay 250 and contact your doctor immediately.

 

·                You may rarely experience symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness and/or weakness especially in the feet and legs or hands and arms. If this happens, stop taking Ciprobay 250 and inform your doctor immediately in order to prevent the development of potentially irreversible condition.

 

·                You may experience psychiatric reactions even when taking quinolone antibiotics, including Ciprobay 250, for the first time. If you suffer from depression or psychosis, your symptoms may become worse under treatment with Ciprobay 250. In rare cases, depression or psychosis can progress to suicidal thoughts and self-injurious behaviors such as suicide attempts, or completed suicide (see section 4: Possible side effects). If depression, psychosis, suicide-related thoughts or behavior occur, contact your doctor immediately.

 

·                Quinolone antibiotics may cause an increase of your blood sugar levels above normal levels (hyperglycaemia), or lowering of your blood sugar levels below normal levels, potentially leading to loss of consciousness (hypoglycaemic coma) in severe cases (see section 4). This is important for people who have diabetes. If you suffer from diabetes, your blood sugar should be carefully monitored.

 

·                Diarrhoea may develop while you are taking antibiotics, including Ciprobay 250, or even several weeks after you have stopped taking them. If it becomes severe or persistent or you notice that your stool contains blood or mucus, stop taking Ciprobay 250 and contact your doctor immediately, as this can be life-threatening. Do not take medicines that stop or slow down bowel movements.

 

·                If your eyesight becomes impaired or if your eyes seem to be otherwise affected, consult an eye specialist immediately.

 

·                Your skin becomes more sensitive to sunlight or ultraviolet (UV) light when taking Ciprobay 250. Avoid exposure to strong sunlight, or artificial UV light such as sunbeds.

 

·                Tell the doctor or laboratory staff that you are taking Ciprobay 250 if you have to provide a blood or urine sample.

 

·                If you suffer from kidney problems, tell the doctor because your dose may need to be adjusted.

 

·                Ciprobay 250 may cause liver damage. If you notice any symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or tenderness of the stomach, contact your doctor immediately.

 

·                Ciprobay 250 may cause a reduction in the number of white blood cells and your resistance to infection may be decreased. If you experience an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems you should see your doctor immediately. A blood test will be taken to check possible reduction of white blood cells (agranulocytosis). It is important to inform your doctor about your medicine.

 

Other medicines and Ciprobay 250

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

 

Do not take Ciprobay 250 together with tizanidine, because this may cause side effects such as low blood pressure and sleepiness (see Section 2: Do not take Ciprobay 250).

 

The following medicines are known to interact with Ciprobay 250 in your body. Taking Ciprobay 250 together with these medicines can influence the therapeutic effect of those medicines. It can also increase the probability of experiencing side effects.

 

Tell your doctor if you are taking:

·                Vitamin K antagonists (e.g. warfarin, acenocoumarol, phenprocoumon or fluindione) or other oral anti-coagulants (to thin the blood)

·                probenecid (for gout)

·                methotrexate (for certain types of cancer, psoriasis, rheumatoid arthritis)

·                theophylline (for breathing problems)

·                tizanidine (for muscle spasticity in multiple sclerosis)

·                olanzapine (an antipsychotic)

·                clozapine (an antipsychotic)

·                ropinirole (for Parkinson’s disease)

·                phenytoin (for epilepsy)

·                metoclopramide (for nausea and vomiting)

·                cyclosporin (for skin conditions, rheumatoid arthritis and in organ transplantation)

·                other medicines that can alter your heart rhythm: medicines that belong to the group of anti-arrhythmics (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (that belong to the group of macrolides), some antipsychotics

·                zolpidem (for sleep disorders)

 

Ciprobay 250 may increase the levels of the following medicines in your blood:

·                pentoxifylline (for circulatory disorders)

·                caffeine

·                duloxetine (for depression, diabetic nerve damage or incontinence)

·                lidocaine (for heart conditions or anesthetic use)

·                sildenafil (e.g. for erectile dysfunction)

·                agomelatine (for depression)

 

Some medicines reduce the effect of Ciprobay 250. Tell your doctor if you take or wish to take:

·                antacids

·                omeprazole

·                mineral supplements

·                sucralfate

·                a polymeric phosphate binder (e.g. sevelamer or lanthanum carbonate)

·                medicines or supplements containing calcium, magnesium, aluminium or iron

 

If these preparations are essential, take Ciprobay 250 about two hours before or no sooner than four hours after them.

 

Ciprobay 250 with food and drink

Unless you take Ciprobay 250 during meals, do not eat or drink any dairy products (such as milk or yoghurt) or drinks with added calcium when you take the tablets, as they may affect the absorption of the active substance.

 

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

 

It is preferable to avoid the use of Ciprobay 250 during pregnancy.

 

Do not take Ciprobay 250 during breast-feeding because ciprofloxacin is excreted in breast milk and can be harmful for your child.

 

Driving and using machines

Ciprobay 250 may make you feel less alert. Some neurological adverse events can occur. Therefore, make sure you know how you react to Ciprobay 250 before driving a vehicle or operating machinery. If in doubt, talk to your doctor.


Your doctor will explain to you exactly how much Ciprobay 250 you will have to take as well as how often and for how long. This will depend on the type of infection you have and how bad it is.

 

Tell your doctor if you suffer from kidney problems because your dose may need to be adjusted.

 

The treatment usually lasts from 5 to 21 days, but may take longer for severe infections. Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure how many tablets to take and how to take Ciprobay 250.

 

a.       Swallow the tablets with plenty of fluid. Do not chew the tablets because they do not taste nice.

b.       Do try to take the tablets at around the same time every day.

c.       You can take the tablets at mealtimes or between meals. Any calcium you take as part of a meal will not seriously affect uptake. However, do not take Ciprobay 250 tablets with dairy products such as milk or yoghurt or with fortified fruit juices (e.g. calcium-fortified orange juice).

 

Remember to drink plenty of fluids while you are taking this medicine.

 

If you take more Ciprobay 250 than you should

If you take more than the prescribed dose, get medical help immediately. If possible, take your tablets or the box with you to show the doctor.

 

If you forget to take Ciprobay 250

If you forget to take Ciprobay and it is:

·                6 hours or more until your next scheduled dose, take your missed dose right away. Then take the next dose at your regular time.

·                less than 6 hours until your next scheduled dose, do not take the missed dose. Take the next dose at your regular time.

Do not take a double dose to make up for a forgotten dose. Be sure to complete your course of treatment.

 

If you stop taking Ciprobay 250

It is important that you finish the course of treatment even if you begin to feel better after a few days. If you stop taking this medicine too soon, your infection may not be completely cured and the symptoms of the infection may return or get worse. You might also develop resistance to the antibiotic.

 

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

Advice/medical education

Antibiotics are used to cure bacterial infections. They are ineffective against viral infections.

If your doctor has prescribed antibiotics, you need them precisely for your current illness.

Despite antibiotics, some bacteria may survive or grow. This phenomenon is called resistance: some antibiotic treatments become ineffective.

Misuse of antibiotics increases resistance. You may even help bacteria become resistant and therefore delay your cure or decrease antibiotic efficacy if you do not respect appropriate:

-            dosages

-            schedules

-            duration of treatment

 

Consequently, to preserve the efficacy of this drug:

1 - Use antibiotics only when prescribed.

2 - Strictly follow the prescription.

3 - Do not re-use an antibiotic without medical prescription, even if you want to treat a similar illness.

4 - Never give your antibiotic to another person; maybe it is not adapted to her/his illness.

5 - After completion of treatment, return all unused drugs to your chemist’s shop to ensure they will be disposed of correctly.


Like all medicines, this medicine can cause side effects, although not everybody gets them.

 

The following section contains the most serious side effects that you can recognize yourself:

 

Stop taking Ciprobay 250 and contact your doctor immediately in order to consider another antibiotic treatment if you notice any of the following serious side effects:

 

Rare (may affect up to 1 in 1,000 people)

-                 Seizure (see Section 2: Warnings and precautions)

 

Very rare (may affect up to 1 in 10,000 people)

-                 Severe, sudden allergic reaction with symptoms such as tightness in the chest, feeling dizzy, sick or faint, or experience dizziness when standing up (anaphylactic reaction/shock) (see Section 2: Warnings and precautions)

-                 Muscle weakness, inflammation of the tendons which could lead to rupture of the tendon, particularly affecting the large tendon at the back of the ankle (Achilles tendon) (see Section 2: Warnings and precautions)

-                 A serious life-threatening skin rash, usually in the form of blisters or ulcers in the mouth, throat, nose, eyes and other mucous membranes such as genitals which may progress to widespread blistering or peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis).

 

Not known (frequency cannot be estimated from the available data)

-                 Unusual feelings of pain, burning tingling, numbness or muscle weakness in the extremities (neuropathy) (see Section 2: Warnings and precautions)

-                 A drug reaction that causes rash, fever, inflammation of internal organs, hematologic abnormalities and systemic illness (DRESS Drug Reaction with Eosinophilia and Systemic Symptoms, AGEP Acute Generalised Exanthematous Pustulosis).

 

Other side effects which have been observed during treatment with Ciprobay 250 are listed below by how likely they are:

 

Common (may affect up to 1 in 10 people)

-                 nausea, diarrhoea

-                 joint pain and joint inflammation in children

 

Uncommon (may affect up to 1 in 100 people)

-                 joint pain in adults

-                 fungal superinfections

-                 a high concentration of eosinophils, a type of white blood cell

-                 decreased appetite

-                 hyperactivity or agitation

-                 headache, dizziness, sleeping problems, or taste disorders

-                 vomiting, abdominal pain, digestive problems such as stomach upset (indigestion/heartburn), or wind

-                 increased amounts of certain substances in the blood (transaminases and/or bilirubin)

-                 rash, itching, or hives

-                 poor kidney function

-                 pains in your muscles and bones, feeling unwell (asthenia), or fever

-                 increase in blood alkaline phosphatase (a certain substance in the blood)

 

Rare (may affect up to 1 in 1,000 people)

-                 muscle pain, inflammation of the joints, increased muscle tone and cramping

-                 inflammation of the bowel (colitis) linked to antibiotic use (can be fatal in very rare cases) (see Section 2: Warnings and precautions)

-                 changes to the blood count (leukopenia, leukocytosis, neutropenia, anaemia), increased or decreased amounts of a blood clotting factor (thrombocytes)

-                 allergic reaction, swelling (oedema), or rapid swelling of the skin and mucous membranes (angio-oedema) (see Section 2: Warnings and precautions)

-                 increased blood sugar (hyperglycaemia)

-                 decreased blood sugar (hypoglycaemia) (see Section 2: Warnings and precautions)

-                 confusion, disorientation, anxiety reactions, strange dreams, depression (potentially leading to thoughts of suicide, suicide attempts, or completed suicide) (see Section 2: Warnings and precautions), or hallucinations

-                 pins and needles, unusual sensitivity to stimuli of the senses, decreased skin sensitivity, tremors, or giddiness

-                 eyesight problems incl. double vision (see Section 2: Warnings and precautions)

-                 tinnitus, loss of hearing, impaired hearing

-                 rapid heartbeat (tachycardia)

-                 expansion of blood vessels (vasodilation), low blood pressure, or fainting

-                 shortness of breath, including asthmatic symptoms

-                 liver disorders, jaundice (cholestatic icterus), or hepatitis

-                 sensitivity to light (see Section 2: Warnings and precautions)

-                 kidney failure, blood or crystals in the urine, urinary tract inflammation

-                 fluid retention or excessive sweating

-                 increased levels of the enzyme amylase

 

Very rare (may affect up to 1 in 10,000 people)

-                 a special type of reduced red blood cell count (haemolytic anaemia); a dangerous drop in a type of white blood cells (agranulocytosis) (see Section 2: Warnings and precautions); a drop in the number of red and white blood cells and platelets (pancytopenia), which may be fatal; and bone marrow depression, which may also be fatal

-                 allergic reaction called serum sickness-like reaction (see Section 2: Warnings and precautions)

-                 mental disturbances (psychotic reactions potentially leading to thoughts of suicide, suicide attempts, or completed suicide) (see Section 2: Warnings and precautions)

-                 migraine, disturbed coordination, unsteady walk (gait disturbance), disorder of sense of smell (olfactory disorders), pressure on the brain (intracranial pressure and pseudotumor cerebri)

-                 visual colour distortions

-                 inflammation of the wall of the blood vessels (vasculitis)

-                 pancreatitis

-                 death of liver cells (liver necrosis) very rarely leading to life-threatening liver failure (see Section 2: Warnings and precautions)

-                 small, pin-point bleeding under the skin (petechiae); various skin eruptions or rashes

-                 worsening of the symptoms of myasthenia gravis (see Section 2: Warnings and precautions)

 

Not known (frequency cannot be estimated from the available data)

-                 syndrome associated with impaired water excretion and low levels of sodium (SIADH)

-                 feeling highly excited (mania) or feeling great optimism and overactivity (hypomania)

-                 abnormal fast heart rhythm, life-threatening irregular heart rhythm, alteration of the heart rhythm (called ‘prolongation of QT interval’, seen on ECG, electrical activity of the heart)

-                 influence on blood clotting (in patients treated with Vitamin K antagonists)

-                 loss of consciousness due to severe decrease in blood sugar levels (hypoglycaemic coma). See section 2

 

Very rare cases of long lasting (up to months or years) or permanent adverse drug reactions, such as tendon inflammations, tendon rupture, joint pain, pain in the limbs,  difficulty in walking, abnormal sensations such as pins and needles, tingling, tickling, burning, numbness or pain (neuropathy), depression, fatigue, sleep disorders, memory impairment, as well as impairment of hearing, vision, and taste and smell have been associated with administration of quinolone and fluoroquinolone antibiotics, in some cases irrespective of pre-existing risk factors.

 

Cases of an enlargement and weakening of the aortic wall or a tear in the aortic wall (aneurysms and dissections), which may rupture and may be fatal, and of leaking heart valves have been reported in patients receiving fluoroquinolones. See also section 2.

 

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects, you can help provide more information on the safety of this medicine.

To report any side effect(s):

The National Pharmacovigilance Centre (NPC).

SFDA Call Center: 19999

E-mail: npc.drug@sfda.gov.sa

Website: https://ade.sfda.gov.sa


Keep this medicine out of the sight and reach of children.

 

Do not use this medicine after the expiry date, which is stated on the blister and carton after “EXP”: The expiry date refers to the last day of that month.

 

Not to be stored above 30°C.

 

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.


The active substance is ciprofloxacin.

 

Each film-coated tablet contains 250 mg ciprofloxacin (as hydrochloride).

 

The other ingredients are:

Tablet core: cellulose microcrystalline, crospovidone, magnesium stearate, maize starch, silica colloidal anhydrous.

Film-coat: hypromellose, macrogol 4000, titanium dioxide (E171)

 


Ciprobay 250 tablets: round, nearly white to slightly yellowish film-coated tablets marked with «CIP score 250» on one side and a Bayer cross on the other side. The tablets can be divided into equal doses. Pack size: 10 film-coated tablets

Manufacturer

Bayer HealthCare Manufacturing S.r.l.

Via delle Groane, 126

20024 Garbagnate Milanese, Italy.

 

Marketing Authorisation Holder

Bayer AG

Kaiser-Wilhelm-Allee 1

51368 Leverkusen, Germany.

 

Secondary Packed by:

DEEF Pharmaceutical Ind. Co.,

Saudi Arabia - Al Qassim


August 2021
  نشرة الدواء تحت مراجعة الهيئة العامة للغذاء والدواء (اقرأ هذه النشرة بعناية قبل البدء في استخدام هذا المنتج لأنه يحتوي على معلومات مهمة لك)

يحتوي سيبروباى 250 على المادة الفعالة سيبروفلوكساسين. سيبروفلوكساسين مضاد حيوي ينتمي إلى مجموعة الفلوروكينولون. سيبروفلوكساسين يعمل عن طريق قتل البكتيريا المسببة للعدوى.

يعمل فقط مع سلالات بكتيريا محددة.

البالغين:

سيبروباى 250 يستخدم فى البالغين لعلاج العدوى البكتيريه الاتية:

·      عدوى الجهاز التنفسي

·      عدوى الأذن أو الجيوب الأنفية المستمرة لفترة طويلة أو المتكررة

·      عدوى المسالك البولية

·      عدوى المسالك التناسلية عند الرجال و النساء

·      عدوى الجهاز المعدي المعوي (الجهاز الهضمي) و العدوى داخل البطن

·      عدوى الجلد و الأنسجة الرخوة

·      عدوى العظم و المفاصل

·      لمنع حدوث العدوى المسببة بالجرثومة المستخفيةُ السحائية النيسرِية (الالتهاب السحائي)

·      التعرض لاستنشاق جرثومة الجمرة الخبيثة

يمكن استخدام سيبروفلوكساسين لعلاج المرضى الذين لديهم عدد خلايا الدم البيضاء منخفض (نقص العدلات أو الكريات البيضاء المتعادلة) و لديهم ارتفاع في درجة حرارة الجسم التي يشتبه في أن تكون بسبب عدوى بكتيرية.

إذا كان لديك عدوى شديدة أو تلك التي حدثت بأكثر من نوع من الجراثيم، ربما في هذه الحالة يعطى لك بالإضافة الى سيبروباى 250 مضاد حيوي إضافي للعلاج.

الأطفال و المراهقين

يستخدم سيبروباى 250 في الأطفال و المراهقين، تحت رعاية الاخصائي الطبي، لعلاج العدوى البكتيرية الاتية:

·      عدوى الرئة و الشعب الهوائية في الأطفال و المراهقين الذين يعانون من تليف كيسي

·      عدوى المسالك البولية الصعبة، تشمل العدوى التي امتدت الى الكلي (التهاب الحويضة و الكلى)

·      التعرض لاستنشاق جرثومة الجمرة الخبيثة

قد يستخدم أيضاً سيبروباى 250 في الأطفال و المراهقين لعلاج عدوى اخرى شديدة محددة عندما يعتبر الطبيب هذا ضرورياً.

لا يجب ان تتناول سيبروباى 250 اذا كنت:

·      لديك حساسية للمادة الفعالة، لأدوية أخرى من أدوية الكينولون أو لأية من المكونات الأخرى في هذا الدواء (المذكورة في الجزء 6)

·      إذا كنت تتناول تيزانيدين (انظر الجزء 2: أدوية أخرى و سيبروباى 250)

 

تحذيرات و احتياطات

قبل استخدام هذا الدواء

يجب أن لا تستخدم أدوية مضادة للبكتيريا من مجموعة الفلوروكينولون/كينولون، إذا عانيت في الماضي من أي تفاعلات سلبية خطيرة عند استخدامك كينولون أو فلوروكينولون. في هذه الحالة يجب إبلاغ الطبيب المعالج في أسرع وقت ممكن.

 

قبل أن تتناول سيبروباى 250 أبلغ طبيبك:

·      إذا كان لديك في أي وقت مشاكل في الكلى لأن في هذه الحالة قد يحتاج العلاج الى تعديل.

·      إذا كنت تعاني من صرع أو أية حالات عصبية أخرى.

·      إذا كان لديك تاريخ مرضي سابق لمشاكل في الاوتار اثناء علاج سابق بمضاد حيوي مثل سيبروباى 250.

·      إذا كنت تعاني من داء السكري لأنك يمكن أن تعاني من مخاطرة انخفاض مستوى الجلوكوز في الدم مع سيبروفلوكساسين.

·      إذا كان لديك ضعف عضلي وخيم ميثينياجرافيس (نوع من الضعف العضلي) لأن الأعراض يمكن أن تتفاقم.

·      إذا تم تشخيصك بتضخم أو «انتفاخ» في الأوعية الدموية الكبيرة (تمدد الأوعية الأورطي أو تمدد الأوعية الدموية المحيطية الكبيرة).

·      إذا كنت قد عانيت من الإصابة بتمزق جدار شريان الأبهر (الشريان الاورطي).

·      إذا تم تشخيصك بارتجاع صمام القلب.

·      إذا كان لديك تاريخ عائلي مرضي لتمدد الشريان الأورطي أو تمزق لجدار الشريان الأورطي أو مرض صمام القلب الخلقي، أو عوامل مخاطرة أخرى أو لديك الحالات المهيئة للمرض (مثل اضطرابات النسيج الضام كمتلازمة مارفان أو متلازمة إهلرز-دانلوس ، أو متلازمة تيرنر ، أو متلازمة شوغرن [مرض المناعة الذاتية الالتهابية]، أو اضطرابات الأوعية الدموية مثل التهاب الشرايين تاكاياسو، التهاب الشريان ذو الخلايا العملاقة، مرض بهجت، ارتفاع ضغط الدم، أو تصلب الشرايين المعروف، والتهاب المفاصل الروماتويدي [مرض المفاصل] أو التهاب الشغاف [عدوى القلب]).

·      إذا كان لديك مشاكل في القلب. ينبغي اتخاذ الحذر عند استخدام سيبروفلوكساسين، إذا كنت قد ولدت مع أو لديك تاريخ مرضي عائلي من استطالة الفاصل الزمني QT (الذي يتم ملاحظته في الرسم الكهربائي للقلب ECG، التسجيل الكهربائي للقلب)، لديك عدم توازن الاملاح في الدم (خاصة انخفاض مستوى البوتاسيوم أو المغنيسيوم في الدم)، لديك إيقاع ضربات القلب بطيئة جداً (وتسمى ‹بطء القلب›)، لديك قلب ضعيف (قصور في القلب)، لديك تاريخ مرضي من الأزمات القلبية (احتشاء عضلة القلب)، أنك أنثى أو من المسنين أو تتناول أدوية أخرى تؤدي إلى تغييرات غير طبيعية للرسم الكهربائي للقلب ECG (انظر الجزء 2: أدوية أخرى و سيبروباى 250).

·      إذا كان لديك او كان احد افراد عائلتك معروف ان لديه نقص في انزيم الجلوكوز – 6 - فوسفات نازع الهيدروجين (G6PD)، حيث انه من الممكن أن تعانى من مخاطر الانيميا مع سيبروفلوكساسين.

لعلاج بعض عدوى المسالك التناسلية، يمكن لطبيبك أن يصف لك مضاد حيوي آخر بالإضافة إلى سيبروفلوكساسين. إذا لم تتحسن الأعراض المرضية بعد مضي 3 أيام من العلاج، الرجاء إبلاغ طبيبك.

 

أثناء تناول سيبروباى 250

أبلغ الطبيب المعالج فوراً، إذا حدثت لك أية من الحالات الآتية أثناء تناول سيبروباى 250. سوف يقرر طبيبك إذا كان هناك احتياج لوقف العلاج بسيبروباى 250.

·      تفاعلات حساسية شديدة، مفاجئة (تفاعل / صدمة حساسية، وذمة الأوعية). حتى مع أول جرعة، هناك إمكانية صغيرة من أن تعاني من تفاعلات حساسية شديدة تشمل الأعراض الآتية: ضيق في الصدر(التنفس)، شعور بدوار، غثيان أو اغماء، أو المعانة من دوخة عند الوقوف. إذا حدث ذلك لك، توقف عن تناول سيبروباى 250 و اتصل بطبيبك فوراً.

·      الآثار الجانبية الخطيرة التي تستمر لفترة طويلة، مُعيقة ويحتمل أنها لا ترتد لحالتها الطبيعية. الأدوية المرتبطة بالفلوروكينولون / الكينولون، بما في ذلك سيبروباي، قد ارتبطت بآثار جانبية نادرة للغاية ولكنها خطيرة، وبعضها يستمر لفترة طويلة من الزمن (شهور أو سنوات متواصلة)، مُعيقة أو يحتمل أنها لا ترتد لحالتها الطبيعية. يشمل ذلك الأوتار، ألم للعضلات ولمفاصل الأطراف العلوية والسفلية، صعوبة المشي، أحاسيس غير طبيعية مثل الدبابيس والإبر، وخز، دغدغة، خدر أو تحرُّق في الجلد (المذل)، والاضطرابات الحسية بما في ذلك ضعف الرؤية، التذوق والشم، والسمع، الاكتئاب، اضطرابات الذاكرة، التعب الشديد، واضطرابات النوم الشديدة. إذا واجهت أي من هذه الآثار الجانبية بعد تناول سيبروباي، فاتصل بطبيبك المعالج مباشرةً قبل مواصلة العلاج. سوف تقرر أنت وطبيبك مواصلة العلاج مع الأخذ في الاعتبار أيضاً لمضاد حيوي من مجموعة أخرى.

·      نادراً ما يحدث ألم وتورم في المفاصل والتهاب أو تمزق للأوتار. المخاطرة تزداد إذا كنت مسناً (فوق 60 عاماً)، أو إذا أجريت عملية زراعة أعضاء، أو كنت تعاني من مشاكل في الكلى أو إذا كنت تعالج بالكورتيكوستيرويد. قد يحدث التهاب وتمزق للأوتار خلال أول 48 ساعة من العلاج وحتى بعد عدة أشهر من توقف العلاج باستخدام سيبروباي. عند حدوث أول علامة ألم أو التهاب في وتر من الأوتار (على سبيل المثال في الكاحل، الرسغ، الكوع أو الركبة)، توقف عن تناول سيبروباي، اتصل بطبيبك المعالج وإراحة المنطقة المؤلمة. يجب تجنب أي إجهاد جسماني غير ضروري لأن هذا قد يؤدي إلى زيادة مخاطرة تمزق الوتر.

·      إذا شعرت بألم شديد مفاجئ في البطن أو الصدر أو الظهر ، والذي يمكن أن يكون من أعراض تمدد الوعاء الدموي الأبهري والتسلخ ، فانتقل فورًا إلى غرفة الطوارئ. قد تزداد مخاطرك إذا كنت تعالج بالكورتيكوستيرويدات.

إذا بدأت تعاني من بداية سريعة لضيق في التنفس ، خاصةً عند الاستلقاء على فراشك ، أو لاحظت تورمًا في الكاحلين أو القدمين أو البطن ، أو خفقان في القلب يحدث لأول مره (لإحساس بنبضات القلب السريعة أو غير المنتظمة) يجب إبلاغ الطبيب على الفور.

·      إذا كنت تعاني من نوبات صرع أو حالات عصبية أخرى مثل انخفاض تدفق الدم الى المخ أو سكتة دماغية، يمكن أن تعاني من آثار جانبية مرتبطة بالجهاز العصبي المركزي. اذا حدث نوبات، توقف عن تناول سيبروباى 250 و أتصل بطبيبك فوراً.

·      نادراً، قد تعاني من أعراض تلف الأعصاب (اعتلال عصبي) مثل ألم، تحرُّق في الجلد (المذل)، نخز، تنمل و / أو ضعف خاصة في القدمين والساقين أو في اليدين والذراعين. إذا حدث ذلك، توقف عن استخدام سيبروباي وأخبر طبيبك المعالج فوراً من أجل منع تطور الحالة التي يحتمل أنها لا ترتد لحالتها الطبيعية

·      قد تواجه ردود فعل نفسية حتى عند تناول مضادات الكينولون، بما في ذلك سيبروباي 250، لأول مرة. إذا كنت تعاني من اكتئاب أو ذهان، قد تصبح الاعراض أسوأ خلال فترة العلاج بتناول سيبروباى 250. في حالات نادرة، يمكن أن يتطور الاكتئاب أو الذهان إلى أفكار انتحارية وسلوكيات مؤذية للنفس مثل محاولات الانتحار أو الانتحار الكامل (انظر القسم 4: الآثار الجانبية المحتملة). في حالة حدوث اكتئاب أو ذهان أو أفكار أو سلوك متعلق بالانتحار، اتصل بطبيبك فوراً.

·      قد تسبب المضادات الحيوية من مجموعة الكينولون زيادة في نسبة السكر في دمك أعلى من المستويات الطبيعية (ارتفاع السكر في الدم)، أو انخفاض في نسبة السكر في دمك أقل من المستويات الطبيعية و يحتمل ان يؤدي إلى فقدان الوعي في الحالات الشديدة (غيبوبة سكر الدم) (انظر الجزء رقم 4). هذا مهم للأشخاص الذين يعانون من مرض السكري. إذا كنت تعاني من مرض الداء السكري، فيجب مراقبة نسبة السكر في دمك بعناية.

·      قد يحدث إسهال اثناء العلاج بالمضادات الحيوية، بما في ذلك سيبروباى 250، أو حتى بعد عدة أسابيع من التوقف عن تناول العلاج. اذا أصبح الإسهال شديداً أو مستمراً أو لاحظت وجود دم أو مخاط في البراز، يجب التوقف فوراً عن تناول سيبروباى 250، لأن هذا قد يكون مهدداً للحياة. لا تتناول الأدوية التي توقف أو تبطئ حركة الامعاء و أبلغ طبيبك فوراً.

·      إذا ضعف بصرك أو إذا بدأت عينيك تتأثر على خلاف ذلك، استشر طبيب متخصص في العيون فورا

·      يصبح جلدك أكثر حساسية لضوء الشمس أو للأشعة الفوق البنفسجية أثناء تناول سيبروباى 250. تجنب التعرض لضوء الشمس الشديد أو لضوء الأشعة فوق البنفسجية الصناعي مثل حمامات الشمس.

·      أخبر الطبيب أو أخصائي المختبر انك تتناول سيبروباى 250 أذا كان مطلوب منك إعطاء عينة دم أو بول.

·      إذا كنت تعاني من مشاكل في الكلى، أبلغ الطبيب لأنه يمكن أن تحتاج لتعديل الجرعة.

·      سيبروباى 250 يمكن ان يسبب ضرر في الكبد. اذا لاحظت أية أعراض مثل فقدان الشهية، يرقان (اصفرار الجلد)، بول غامق، حكة أو ألم في المعدة، اتصل بطبيبك فوراً.

·      سيبروباى 250 يمكن أن يسبب نقص في عدد خلايا الدم البيضاء و ربما تقل مقاومتك للعدوى. اذا عانيت من عدوى بأعراض مثل ارتفاع درجة حرارة الجسم تدهور خطير في الحالة الصحية العامة أو ارتفاع درجة حرارة الجسم بأعراض مشاكل عدوى موضعية مثل  التهاب الحلقِ التقرحي / البلعوم / الفم / أو مشاكل بولية (الكلى) يجب الذهاب لطبيبك فوراً. سيتم اجراء اختبار للدم لفحص احتمال النقص في عدد خلايا الدم البيضاء (نقص الكريات المحببة). من الضروري إبلاغ طبيبك عن الدواء الذى تتناوله.

 

تناول سيبروباى 250 مع الأدوية الاخرى

أبلغ طبيبك أو الصيدلي إذا كنت تتناول أدوية أخرى أو تناولت أدوية أخرى حديثاً، بما فى ذلك الأدوية التى  تصرف بدون وصفة طبية.

لا تتناول سيبروباى 250 ميليغرام في نفس الوقت مع تيزانيدين، حيث أن هّذا يمكن أن يسبب آثار جانبية مثل ضغط دم منخفض و نعاس (انظر الجزء 2: لا يجب ان تتناول سيبروباى 250 اذا كنت).

معروف عن الأدوية الآتية انها تتفاعل في الجسم مع سيبروباى 250. تناول سيبروباى 250 مع هذه الادوية يمكن أن يؤثر على التأثير العلاجي لهذه الأدوية. يمكن أيضاً أن يزيد من احتمال المعاناة من الآثار الجانبية:

 

أبلغ طبيبك إذا كنت تتناول:

·      مناهضات الفيتامين K (على سبيل المثال الورفارين، أسينوكومارول، فنبروكومون أو فلويندايون) أو مضادات أخرى للتجلط يتم تناولها عن طريق الفم (لجعل الدم خفيف القوام).

·      بروبنسيد (لعلاج النقرس)

·      ميثوتريكسات (لعلاج بعض أنواع السرطان، الصدفية، التهاب المفاصل الروماتويدى)

·      الثيوفيللين (لعلاج مشاكل التنفس)

·      تيزانيدين (لعلاج التشنجِ العضلي في التصلب المتعدد)

·      أولانزابين (مضاد الذهان)

·      كلوزابين (مضاد الذُّهان)

·      روبينيرول (لعلاج مرض باركينسون)

·      فينيتوين (لعلاج الصرع)

·      ميتو كلوبراميد (غثيان و قيء)

·      سيكلوسبورين (لحالات الجلد، التهاب المفاصل الروماتويدي)

·      أدوية أخرى يمكن أن تغير نظم القلب: أدوية تنتمي لمجموعة مضادات – اضطراب نظم القلب (على سبيل المثال كينيدين، هيدروكينيدين، ديزوبيراميد، أميودارون، سوتالول، دوفيتيليد، إبيوتيليد)، مضادات الاكتئاب الثلاثية الحلقات، بعض مضادات المكروبات (التي تنتمي لمجموعة الماكروليد)، بعض مضادات الذُّهان.

·      الزولبيديم (لاضطرابات النوم)

 

سيبروباى 250 يمكن أن يرفع مستويات الأدوية الآتية في الدم:

·      البنتوكسيفيللين (لعلاج اضطرابات الدورة الدموية)

·      الكافيين

·      ديولوكسيتين (لاكتئاب، ضرر الاعصاب بسبب الداء السكري أو سلس البول)

·      ليدوكاين (لحالات القلب أو استخدامات التخدير)

·      سيلدينافيل (على سبيل المثال خلل وظيفي للانتصاب)

·      أجوميلاتين (الاكتئاب)

 

بعض الأدوية تقلل من فاعلية سيبروباى 250. أبلغ طبيبك إذا كنت تتناول أو ترغب أن تتناول:

·      مضادات الحموضة

·      أوميبرازول

·      المكملات (الاضافات) المعدنية

·      سوكرالفيت

·      المركب الكيميائي البلمري المتحد مع الفوسفات (على سبيل المثال سفيلامر أو كربونات الانثانم)

·      الادوية أو المكملات (الاضافات) التي تحتوي علي كالسيوم، ماغنسيوم، ألومينيوم أو حديد

اذا كانت هذه المستحضرات أساسية، تناول سيبروباى 250 تقريباً قبل ساعتين أو ليس قبل أربعة ساعات من تناولهم.

 

تناول سيبروباى 250 مع الاطعمة و الأشربة

فيما عدا تناولك لسيبروباى 250 أثناء الاكل، لا تأكل أو تشرب أي من منتجات الألبان (مثل الحليب أو الزبادي) أو المشروبات المضاف اليها الكالسيوم أثناء تناول الاقراص ، لأنه قد يكون لهم آثر على امتصاص المادة الفعالة.

 

 

 

الحمل و الرضاعة الطبيعية

إذا كنت حاملا أو تقومين بالرضاعة الطبيعية، أو يشتبه أنك حامل أو كان لديك خطة لحدوث حمل أبلغي طبيبك أو الصيدلي بذلك للحصول على النصيحة قبل تناول هذا الدواء.

يفضل تجنب تناول سيبروباى 250 خلال فترة الحمل.

لا تتناولي سيبروباى 250 خلال فترة الرضاعة الطبيعية ، لأن سيبروفلوكساسين يمر من خلال حليب الأم و يمكن أن يكون ضار لطفلك.

 

القيادة و تشغيل الماكينات

قد يجعلك سيبروباى 250 تشعر انك أقل وعياً. قد تحدث بعض الحالات العصبية الغير ملائمة لهذا، تأكد من انك تعرف كيف يتفاعل جسمك مع سيبروباى 250 قبل قيادة السيارات و تشغيل الماكينات. اذا كان لديك شك في ذلك، أبلغ طبيبك.

 

https://localhost:44358/Dashboard

سوف يشرح لك طبيبك بالضبط ما هي كمية السيبروباى 250 التي سوف تتناولها و كذلك عدد مرات تكرارها و طول فترة تناولها. هذا سوف يعتمد على نوع العدوى و سوء الإصابة.

أبلغ طبيبك أذا كنت تعاني مشاكل في الكلي لأنه ربما تحتاج الى ضبط الجرعة.

يستمر العلاج عادة من 5 الى 21 يوم، لكن قد يكون أطول في العدوى الشديدة. تناول الأقراص تماماً كما وصفها لك طبيبك. راجع مع طبيبك أو الصيدلي إذا كنت لست واثقاً من عدد الاقراص الواجب تناولها أو كيفية تناول سيبروباى 250.

‌أ-          ابلع الاقراص مع كمية وفيرة من السائل. لا تمضغ الاقراص لأن لها طعم غير مستساغ.

‌ب-     حاول تناول الاقراص كل يوم عند نفس الوقت تقريباً.

‌ج-       يمكن تناول الاقراص في وقت الأكل أو بين الوجبات. اية كمية كالسيوم يتم تناولها كجزء من الوجبة لا تؤثر بشدة على الامتصاص. مع ذلك، لا تتناول أقراص سيبروباى 250 مع منتجات الالبان مثل اللبن الحليب أو الزبادي أو مع عصائر الفاكهة المزودة بالكالسيوم (على سبيل المثال عصير البرتقال المدعم بالكالسيوم).

تذكر بتناول كمية وفيرة من السوائل أثناء تناول هذا الدواء.

 

إذا تناولت سيبروباى 250 أكثر من المفروض:

اذا تناولت أكثر من الجرعة الموصوفة، اطلب المساعدة الطبية فوراً. إذا أمكن، خذ معك شريط الاقراص أو العلبة لتريها للطبيب.

 

إذا نسيت أن تتناول سيبروباى 250

إذا نسيت تناول سيبروباي و كان ذلك:

·      6 ساعات أو أكثر حتى موعد الجرعة التالية ، خذ الجرعة المنسية على الفور. ثم تناول الجرعة التالية في وقتك المعتاد.

·      أقل من 6 ساعات حتى موعد الجرعة التالية ، لا تتناول الجرعة المنسية. تناول الجرعة التالية في وقتك المعتاد.

لا تتناول جرعة مضاعفة لتعويض الجرعة المنسية. تأكد من إتمام خطة العلاج المقررة لك.

اذا توقفت عن تناول سيبروباى 250

انه لمن المهم أن تنهي خطة العلاج المقررة حتى اذا بدأت الشعور بالتحسن بعد بضعة ايام. اذا توقفت عن تناول هذا الدواء مبكراً جداً، قد تكون العدوى لم يكتمل شفائها و قد تعود أعراض العدوى أو تصبح أشد. قد تنشأ لديك أيضاً مناعة للمضاد الحيوي.

اذا كان لديك أية أسئلة أخرى حول تناول هذا الدواء، اسأل طبيبك أو الصيدلي.

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نصيحة / تعليم طبى

المضادات الحيوية تستخدم لعلاج العدوى البكتيرية. تكون غير فعالة لعلاج العدوى الفيروسية. إذا وصف لك الطبيب مضادات حيوية، فأنت تحتاج لهم بالتحديد لمرضك الحالي. بالرغم من المضادات الحيوية، بعض البكتيريا قد تحيا أو تنمو. هذه الظاهرة تسمى المقاومة: بعض المضادات الحيوية تصبح غير فعالة.

الاستخدام الخاطئ للمضادات الحيوية يزيد المقاومة. ربما حتى يساعد البكتيريا على أن تصبح مقاومة و بذلك يتأخر الشفاء أو يقلل فاعلية المضاد الحيوي أذا لم تتبع التعليمات بدقة:

·      الجرعات

·      البرامج المحددة للمواعيد

·      طول فترة العلاج

 

بناء على ذلك، من أجل الحفاظ على فاعلية هذا المنتج:

1.    استخدم المضادات الحيوية فقط إذا وصفها لك الطبيب.

2.    اتبع بدقة الوصفة الطبية.

3.    لا تعاود تناول المضاد الحيوي بدون وصفة طبية، حتى إذا كنت تريد علاج مرض مشابه.

4.    لا تعطى أبداً المضاد الحيوي الموصوف لك لأي شخص آخر، ربما لا يتناسب مع مرضه.

5.    بعد إتمام العلاج، أرجع كل الدواء الذي لم يتم تناوله للصيدلي للتأكد من التخلص السليم منه.

مثل كل الأدوية يمكن أن يسبب هذا الدواء آثار جانبية، مع أنه لا يصاب بها كل شخص.

يحتوي القسم الآتي على الآثار الجانبية الأكثر خطورة التي يمكن أن تدركها بنفسك:

توقف عن تناول سيبروباى 250 واتصل بطبيبك على الفور من أجل النظر في العلاج بمضادات حيوية أخرى، إذا لاحظت أي من الآثار الجانبية التالية:

 

نادراً: يمكن أن يصاب بها عدد من الأشخاص قد يصل إلى 1 من كل 1000 شخص

·      نوبات (انظر الجزء 2: تحذيرات و احتياطات)

 

نادراً جداً: يمكن أن يصاب بها عدد من الأشخاص قد يصل إلى 1 من كل 10000 شخص

·      حساسية شديدة و مفاجئة مع أعراض مثل ضيق في الصدر، شعور بالدوار والمرض أو الإغماء، أو شعور بالدوخة عند الوقوف (رد فعل تحسسي/صدمة) (انظر القسم 2: تحذيرات واحتياطات)

·      ضعف العضلات، التهاب الأوتار مما قد يؤدي إلى تمزق في وتر تؤثر بشكل خاص على الوتر الكبير في الجزء الخلفي من الكاحل (وتر العرقوب) (انظر القسم 2: تحذيرات واحتياطات)

·      طفح جلدي خطير مهدد للحياة، وعادة ما يكون على شكل بثور أو قروح في الفم والحلق والأنف والعينين وغيرها من الأغشية المخاطية مثل الأعضاء التناسلية التي قد تتزايد إلى تقرحات واسعة النطاق أو تقشر الجلد (متلازمة ستيفنز جونسون، انحلال البشرة السمي).

 

غير معروف: لا يمكن حساب التكرار من البيانات المتوفرة

·      شعور بألم غير عادي، حرقان وخز، وخدر أو ضعف العضلات في الأطراف (الاعتلال العصبي) (انظر القسم 2: تحذيرات واحتياطات)

·      رد فعل للدواء الذي يسبب طفح جلدي، حمى، التهاب الأعضاء الداخلية، تشوهات دموية وأمراض جهازية (رد الفعل للدواء مع فرط الكريات الحمضية والأعراض الجهازية، بثور طفحيه حادة عامة)

 

الآثار الجانبية الأخرى التي لوحظت خلال العلاج بسيبروباى 250 مدونة أدناه بنسبة تكرارها:

شائع: يمكن أن يصاب بها عدد من الأشخاص قد يصل إلى 1 من كل 10 أشخاص

·      غثيان، إسهال

·      الآم والتهاب المفاصل لدى الأطفال

 

غير شائع: يمكن أن يصاب بها عدد من الأشخاص قد يصل إلى 1 من كل 100 شخص

·      ألم المفاصل عند البالغين

·      عدوى فطرية إضافية

·      زيادة تركيز الايزينوفيل، نوع من خلايا الدم البيضاء

·      قلة الشهية

·      فرط النشاط الحركي أو هياج

·      صداع، دوخة، مشاكل النوم، أو اضطرابات حاسة التذوق

·      قيء، ألم في البطن، مشاكل في الهضم مثل اضطرابات المعدة (سوء الهضم / حرقان فم المعدة)، أو غازات

·      زيادة الكميات من بعض المواد في الدم، (إنزيمات ناقلة الأمين و/ أو البيليروبينِ)

·      طفح جلدي، حكة، أو قشعريرة

·      ضعف وظائف الكلى

·      ألم في العضلات والعظام، احساس بالتعب (وهن)، أو ارتفاع درجة حرارة الجسم

·      زيادة انزيم الفوسفات القلوي في الدم (مادة معينة في الدم)

 

نادراً: يمكن أن يصاب بها عدد من الأشخاص قد يصل إلى 1 من كل 1000 شخص

·      ألم العضلات، التهاب في المفاصل، زيادة توتر العضلات، أو انقباضات عضلية

·      التهاب في الامعاء (التهاب القولون) مرتبط بتناول مضاد حيوي (في حالات نادرة جداً يمكن ان يكون مميتا) (انظر الجزء 2: تحذيرات و احتياطات)

·      تغيرات في أعداد خلايا الدم (نقص الخلايا البيضاء، زيادة الخلايا البيضاء، نقص العدلات، فقر الدم)، الزيادة أو النقص في كميات عامل تجلط الدم (الصفائح الدموية)

·      تفاعل حساسية، انتفاخ (وذمة)، أو انتفاخ سريع للجلد و الاغشية المخاطية (وذمة وعائية) (انظر الجزء 2: تحذيرات و احتياطات)

·      ارتفاع الجلوكوز في الدم

·      انخفاض الجلوكوز في الدم (انظر الجزء 2: تحذيرات و احتياطات)

·      ارتباك، عدم اتزان، قلق تفاعلي، أحلام غريبة، اكتئاب، (مما قد يؤدي إلى الأفكار الانتحارية، محاولة الانتحار، أو الانتحار فعلياً) (انظر الجزء 2: تحذيرات و احتياطات)، أو هلوسة

·      احساس بوخز ابر و دبابيس في الجلد، حساسية غير طبيعية لمؤثرات الاحساس، انخفاض حساسية الجلد، رعشة أو دوار

·      مشاكل في الابصار تشمل رؤية مزدوجة (انظر الجزء 2: تحذيرات و احتياطات)

·      طنين، فقدان السمع، اضطراب السمع

·      ضربات قلب سريعة (تسارع نبضات القلب)

·      تمدد في الأوعية الدموية (توسع الأوعية)،  ضغط دم منخفض،  أو اغماء

·      صعوبة التنفس (ضيق النفس) تشمل اعراض الربو

·      اضطرابات الكبد، صفراء (يرقان الركود الصفراوي) او التهاب كبدي

·      حساسية للضوء (انظر الجزء 2: تحذيرات و احتياطات)

·      تلف الكلى، دم أو بلورات في البول، التهاب فى الجهاز البولي

·      احتباس السوائل داخل الجسم أو غزارة العرق

·      زيادة مستويات إنزيم الأميلاز

نادراً جداً: يمكن أن يصاب بها عدد من الأشخاص قد يصل إلى 1 من كل 10000 شخص

·      نوع معين لانخفاض عدد خلايا الدم الحمراء (أنيميا انحلالية)؛ انخفاض خطير لأعداد نوع من خلايا الدم البيضاء (نقص الكريات المحببة) (انظر الجزء 2: تحذيرات و احتياطات)؛ انخفاض في عدد خلايا الدم الحمراء و البيضاء و الصفائح الدموية (قلة الكريات الشاملة في الدم)، التي قد تكون مميتة، و انخفاض في النخاع العظمى الشوكي، الذى قد يكون أيضاً مميتاً.

·      تفاعلات حساسية تسمى تفاعل مرض المصل (انظر الجزء 2: تحذيرات و احتياطات)

·      اضطرابات ذهنية (تفاعلات ذهانيه مما قد تؤدي إلى الأفكار الانتحارية، محاولة الانتحار، أو الانتحار فعلياً) (انظر الجزء 2: تحذيرات و احتياطات)

·      صداع نصفى، اضطراب في التناسق، مشي غير منتظم (خلل في المشي) ، اضطرابات لحاسة الشم (اضطرابات شمية)، ضغط في الدماغ (ارتفاع الضغط داخل الجمجمة و ورم كاذب في المخ)

·      تشويه لرؤية الألوان

·      التهاب لجدار الأوعية الدموية (التهاب وعائي)

·      التهاب البنكرياس

·      موت خلايا الكبد (تنكرز الكبد) نادراً جداً يؤدى إلى فشل كبدي مهدد الحياة (انظر الجزء 2: تحذيرات و احتياطات).

·      نزف تحت الجلد صغير فى حجم رأس الدبوس (بيتيكيا)؛ هياج أو طفح جلدي متنوع

·      تفاقم أعراض مرض الوهن العضلي الوخيم (انظر الجزء 2: تحذيرات و احتياطات)

 

غير معروف: لا يمكن حساب التكرار من البيانات المتوفرة

·      متلازمة مرتبطة بإفراز ضعيف للمياه من الجسم وانخفاض مستويات الصوديوم.

·      الشعور بانفعال بشكل كبير (الهوس) أو الشعور بتفاؤل كبير ونشاط زائد (هوس خفيف)

·      إيقاع ضربات القلب غير طبيعية و سريعة، إيقاع ضربات القلب غير منتظمة مهددة للحياة، تغير في إيقاع ضربات القلب (يسمى «استطالة الفاصل الزمني QT»، يتم ملاحظته في الرسم الكهربائي للقلب ECG، التسجيل الكهربائي للقلب)

·      التأثير على تجلط الدم (لدى مرضى يتم معالجتهم بمضادات الفيتامين K)

·      فقدان الوعي بسبب الانخفاض الحاد في مستويات السكر في الدم (غيبوبة سكر الدم). انظر القسم 2

في بعض الحالات تحدث حالات نادرة جداً ارتبطت باستخدام مضادات حيوية من مجموعة الكينولون وكذلك باستخدام مضادات حيوية من مجموعة الفلوروكينولون، بغض النظر عن عوامل الخطر الموجودة قبل استخدام هذه المضادات الحيوية وهذه الحالات قد تدوم طويلاً (تصل إلى أشهر أو سنوات) أو ينتج عنها تفاعلات دوائية ضارة مستمرة (دائمة)، مثل التهاب الأوتار، تمزق الأوتار، آلام المفاصل، ألم في الأطراف، صعوبة في المشي، أحاسيس غير طبيعية مثل الدبابيس والإبر، الوخز، الدغدغة، تحرُّق في الجلد (المذل)، التنميل أو الألم (الاعتلال العصبي)، الاكتئاب، الإرهاق، اضطرابات النوم، ضعف الذاكرة، وكذلك ضعف السمع، الرؤية، والتذوق وضعف حاسة الشم.

تم الإبلاغ لدى المرضى الذين يتناولون الفلوروكينولونات عن حالات تضخم وضعف في جدار الأبهر أو تمزق في جدار الأبهر (تمدد الأوعية الدموية و تسلخها) ، والتي قد يؤدي الى تمزقها وقد تكون قاتلة ، وأيضا الى ارتجاع في صمام القلب مما يؤدي الى عدم اغلاقها بالكامل (انظر أيضًا القسم 2، التحذيرات والاحتياطات).

 

الإبلاغ عن الآثار الجانبية

إذا تم إصابتك بأية آثار جانبية، أبلغ طبيبك أو الصيدلي. هذا يشمل أية آثار جانبية غير مذكورة في هذه النشرة. من خلال الإبلاغ عن الآثار الجانبية يمكن أن تساعد على توفير مزيد من المعلومات حول سلامة هذا الدواء.

للإبلاغ عن الأعراض الجانبية:

المركز الوطني للتيقظ الدوائي

مركز اتصال الهيئة العامة للغذاء والدواء: 19999

البريد الالكتروني: npc.drug@sfda.gov.sa

الموقع الالكتروني: https://ade.sfda.gov.sa

 

لا تترك هذا الدواء في متناول أيدي أو بصر الأطفال.

لا تتناول هذا الدواء بعد تاريخ الانتهاء، المدون على الشريط و العلبة الكرتون بعد «EXP»: تاريخ الانتهاء هو آخر يوم في الشهر المشار اليه.

لا يحفظ في درجة حرارة أعلى من 30 درجة مئوية.

يجب عدم التخلص من أي أدوية من خلال الصرف الصحي أو من خلال النفايات المنزلية. اسأل الصيدلي عن كيفية التخلص من الأدوية التي لم تعد تحتاج اليها. سوف تساعد هذه التدابير على حماية البيئة.

المادة الفعالة هي: سيبروفلوكساسين.

يحتوي كل قرص مغلف على 250 ميليغرام سيبروفلوكساسين (كهيدروكلوريد).

المواد الأخرى هي:

لب القرص: سليلوز ذات بلورات مجهرية، كروسبوفيدون، استيارات المغنسيوم، نشاء الذرة، سليكا لا مائية غروية.

الكسوة الغشائية: هبرومللوز، ماكروجول 4000، ثاني اكسيد التيتانيوم (E171)

كيف يبدو سيبروباى 250 و ما هي محتويات العبوة

أقراص سيبروباى 250 : أقراص مغلفة، مستديرة الشكل، لونها ابيض الى ابيض مائل للصفرة ، الأقراص محززة و موسومة “CIP 250”  على جانب و على الجانب الآخر كلمة BAYER متعامدة.

يمكن تقسيم الأقراص إلى جرعات متساوية.

حجم العبوة:

10 أقراص مغلفة

المصنع

باير هيلثكير مانوفكتورينج إس أر أل

ڤيا ديل جروان، 126

20024 جارباجنيت ميلانيز، إيطاليا.

حامل تصريح التسويق:

باير ايه جي

قيصر-ويلهلم-آلي 1

51368 ليفركوزن، ألمانيا

التغليف الثانوي:

شركة ديف للصناعات الدوائية

المملكة العربية السعودية - القصيم

أغسطس 2021.
 Read this leaflet carefully before you start using this product as it contains important information for you

Ciprofloxacin Bayer and associated names 250 mg film-coated tablets [To be completed nationally]

Each film-coated tablet contains 250 mg ciprofloxacin (as hydrochloride). For the full list of excipients, see section 6.1.

Film-coated tablet Round, nearly white to slightly yellowish tablets marked with “CIP score 250” on one side and a Bayer cross on the reverse side. The tablets can be divided into equal doses.

Ciprofloxacin Bayer 250 mg film-coated tablets are indicated for the treatment of the following infections (see sections 4.4 and 5.1). Special attention should be paid to available information on resistance to ciprofloxacin before commencing therapy.

 

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

 

Adults

·                Lower respiratory tract infections due to Gram-negative bacteria

-        exacerbation of chronic obstructive pulmonary disease. In exacerbation of chronic obstructive pulmonary disease Ciprofloxacin Bayer should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections.

-        broncho-pulmonary infections in cystic fibrosis or in bronchiectasis

-        pneumonia

·                Chronic suppurative otitis media

·                Acute exacerbation of chronic sinusitis especially if these are caused by Gram-negative bacteria

·                Urinary tract infections

-        Uncomplicated acute cystitis. In uncomplicated acute cystitis Ciprofloxacin Bayer should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections.

-        Acute pyelonephritis

-        Complicated urinary tract infections

-        Bacterial prostatitis

·                Genital tract infections

-        gonococcal uretritis and cervicitis due to susceptible Neisseria gonorrhoeae

-        epididymo-orchitis including cases due to susceptible Neisseria gonorrhoeae

-        pelvic inflammatory disease including cases due to susceptible Neisseria gonorrhoeae

·                Infections of the gastro-intestinal tract (e.g. travellers’ diarrhoea)

·                Intra-abdominal infections

·                Infections of the skin and soft tissue caused by Gram-negative bacteria

·                Malignant external otitis

·                Infections of the bones and joints

·                Prophylaxis of invasive infections due to Neisseria meningitidis

·                Inhalation anthrax (post-exposure prophylaxis and curative treatment)

 

Ciprofloxacin may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection.

 

Children and adolescents

·                Broncho-pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis

·                Complicated urinary tract infections and acute pyelonephritis

·                Inhalation anthrax (post-exposure prophylaxis and curative treatment)

 

Ciprofloxacin may also be used to treat severe infections in children and adolescents when this is considered to be necessary.

 

Treatment should be initiated only by physicians who are experienced in the treatment of cystic fibrosis and/or severe infections in children and adolescents (see sections 4.4 and 5.1).


Posology

The dosage is determined by the indication, the severity and the site of the infection, the susceptibility to ciprofloxacin of the causative organism(s), the renal function of the patient and, in children and adolescents the body weight.

The duration of treatment depends on the severity of the illness and on the clinical and bacteriological course.

Treatment of infections due to certain bacteria (e.g. Pseudomonas aeruginosa, Acinetobacter or Staphylococci) may require higher ciprofloxacin doses and co-administration with other appropriate antibacterial agents.

 

Treatment of some infections (e.g. pelvic inflammatory disease, intra-abdominal infections, infections in neutropenic patients and infections of bones and joints) may require co-administration with other appropriate antibacterial agents depending on the pathogens involved.

 

Adults

 

Indications

Daily dose in mg

Total duration of treatment

(potentially including initial parenteral treatment with ciprofloxacin)

Infections of the lower respiratory tract

500 mg twice daily to 750 mg twice daily

7 to 14 days

Infections of the upper respiratory tract

Acute exacerbation of chronic sinusitis

500 mg twice daily to 750 mg twice daily

7 to 14 days

Chronic suppurative otitis media

500 mg twice daily to 750 mg twice daily

7 to 14 days

Malignant external otitis

750 mg twice daily

28 days up to 3 months

Urinary tract infections

(see section 4.4)

Uncomplicated acute cystitis

250 mg twice daily to 500 mg twice daily

3 days

In pre-menopausal women, 500 mg single dose may be used

Complicated cystitis, Acute pyelonephritis

500 mg twice daily

7 days

Complicated pyelonephritis

500 mg twice daily to 750 mg twice daily

at least 10 days, it can be continued for longer than 21 days in some specific circumstances (such as abscesses)

Bacterial prostatitis

500 mg twice daily to 750 mg twice daily

2 to 4 weeks (acute) to 4 to 6 weeks (chronic)

Genital tract infections

Gonococcal uretritis and cervicitis due to susceptible Neisseria gonorrhoeae

500 mg as a single dose

1 day (single dose)

Epididymo-orchitis and pelvic inflammatory diseases including cases due to susceptible Neisseria gonorrhoeae

500 mg twice daily to 750 mg twice daily

at least 14 days

Infections of the gastro-intestinal tract and intra-abdominal infections

Diarrhoea caused by bacterial pathogens including Shigella spp. other than Shigella dysenteriae type 1 and empirical treatment of severe travellers’ diarrhoea

500 mg twice daily

1 day

Diarrhoea caused by Shigella dysenteriae type 1

500 mg twice daily

5 days

Diarrhoea caused by Vibrio cholerae

500 mg twice daily

3 days

Typhoid fever

500 mg twice daily

7 days

Intra-abdominal infections due to Gram-negative bacteria

500 mg twice daily to 750 mg twice daily

5 to 14 days

Infections of the skin and soft tissue caused by Gram-negative bacteria

500 mg twice daily to 750 mg twice daily

7 to 14 days

 

Bone and joint infections

500 mg twice daily to 750 mg twice daily

max. of 3 months

 

Neutropenic patients with fever that is suspected to be due to a bacterial infection.

Ciprofloxacin should be co-administered with appropriate antibacterial agent(s) in accordance to official guidance.

500 mg twice daily to 750 mg twice daily

Therapy should be continued over the entire period of neutropenia

 

Prophylaxis of invasive infections due to Neisseria meningitidis

500 mg as a single dose

1 day (single dose)

 

Inhalation anthrax post-exposure prophylaxis and curative treatment for persons able to receive treatment by oral route when clinically appropriate.

Drug administration should begin as soon as possible after suspected or confirmed exposure.

500 mg twice daily

60 days from the confirmation of Bacillus anthracis exposure

       

 

Paediatric population

 

Indications

Daily dose in mg

Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin)

Cystic fibrosis

20 mg/kg body weight twice daily with a maximum of 750 mg per dose.

10 to 14 days

Complicated urinary tract infections and acute pyelonephritis

10 mg/kg body weight twice daily to 20 mg/kg body weight twice daily with a maximum of 750 mg per dose.

10 to 21 days

Inhalation anthrax post-exposure prophylaxis and curative treatment for persons able to receive treatment by oral route when clinically appropriate. Drug administration should begin as soon as possible after suspected or confirmed exposure.

10 mg/kg body weight twice daily to 15 mg/kg body weight twice daily with a maximum of 500 mg per dose.

60 days from the confirmation of Bacillus anthracis exposure

Other severe infections

20 mg/kg body weight twice daily with a maximum of 750 mg per dose.

According to the type of infections

 

Elderly patients

Elderly patients should receive a dose selected according to the severity of the infection and the patient’s creatinine clearance.

 

Patients with renal and hepatic impairment

Recommended starting and maintenance doses for patients with impaired renal function:

 

Creatinine Clearance
[mL/min/1.73 m²]

Serum Creatinine
[µmol/L]

Oral Dose
[mg]

> 60

< 124

See Usual Dosage.

30‑60

124 to 168

250‑500 mg every 12 h

< 30

> 169

250‑500 mg every 24 h

Patients on haemodialysis

> 169

250‑500 mg every 24 h (after dialysis)

Patients on peritoneal dialysis

> 169

250‑500 mg every 24 h

 

In patients with impaired liver function no dose adjustment is required.

 

Dosing in children with impaired renal and/or hepatic function has not been studied.

 

Method of administration

Tablets are to be swallowed unchewed with fluid. They can be taken independent of mealtimes. If taken on an empty stomach, the active substance is absorbed more rapidly. Ciprofloxacin tablets should not be taken with dairy products (e.g. milk, yoghurt) or mineral-fortified fruit-juice (e.g. calcium-fortified orange juice) (see section 4.5).

 

In severe cases or if the patient is unable to take tablets (e.g. patients on enteral nutrition), it is recommended to commence therapy with intravenous ciprofloxacin until a switch to oral administration is possible.

 

If a dose is missed, it should be taken anytime but not later than 6 hours prior to the next scheduled dose. If less than 6 hours remain before the next dose, the missed dose should not be taken and treatment should be continued as prescribed with the next scheduled dose. Double doses should not be taken to compensate for a missed dose.


• Hypersensitivity to the active substance, to other quinolones or to any of the excipients listed in section 6.1. • Concomitant administration of ciprofloxacin and tizanidine (see section 4.5).

The use of Ciprofloxacin Bayer should be avoided in patients who have experienced serious adverse reactions in the past when using quinolone or fluoroquinolone containing products (see section 4.8). Treatment of these patients with Ciprofloxacin Bayer should only be initiated in the absence of alternative treatment options and after careful benefit/risk assessment (see also section 4.3).

 

Severe infections and mixed infections with Gram-positive and anaerobic pathogens

Ciprofloxacin monotherapy is not suited for treatment of severe infections and infections that might be due to Gram-positive or anaerobic pathogens. In such infections ciprofloxacin must be co-administered with other appropriate antibacterial agents.

 

Streptococcal Infections (including Streptococcus pneumoniae)

Ciprofloxacin is not recommended for the treatment of streptococcal infections due to inadequate efficacy.

 

Genital tract infections

Gonococcal uretritis, cervicitis, epididymo-orchitis and pelvic inflammatory diseases may be caused by fluoroquinolone-resistant Neisseria gonorrhoeae isolates.

Therefore, ciprofloxacin should be administered for the treatment of gonococcal uretritis or cervicitis only if ciprofloxacin-resistant Neisseria gonorrhoeae can be excluded.

For epididymo-orchitis and pelvic inflammatory diseases, empirical ciprofloxacin should only be considered in combination with another appropriate antibacterial agent (e.g. a cephalosporin) unless ciprofloxacin-resistant Neisseria gonorrhoeae can be excluded. If clinical improvement is not achieved after 3 days of treatment, the therapy should be reconsidered.

 

Urinary tract infections

Resistance to fluoroquinolones of Escherichia coli – the most common pathogen involved in urinary tract infections – varies across the European Union. Prescribers are advised to take into account the local prevalence of resistance in Escherichia coli to fluoroquinolones.

The single dose of ciprofloxacin, that may be used in uncomplicated cystitis in pre-menopausal women, is expected to be associated with lower efficacy than the longer treatment duration. This is all the more to be taken into account as regards the increasing resistance level of Escherichia coli to quinolones.

 

Intra-abdominal infections

There are limited data on the efficacy of ciprofloxacin in the treatment of post-surgical intra-abdominal infections.

 

Travellers’ diarrhoea

The choice of ciprofloxacin should take into account information on resistance to ciprofloxacin in relevant pathogens in the countries visited.

 

Infections of the bones and joints

Ciprofloxacin should be used in combination with other antimicrobial agents depending on the results of the microbiological documentation.

 

Inhalational anthrax

Use in humans is based on in-vitro susceptibility data and on animal experimental data together with limited human data. Treating physicians should refer to national and/or international consensus documents regarding the treatment of anthrax.

 

Paediatric population

The use of ciprofloxacin in children and adolescents should follow available official guidance. Ciprofloxacin treatment should be initiated only by physicians who are experienced in the treatment of cystic fibrosis and/or severe infections in children and adolescents.

 

Ciprofloxacin has been shown to cause arthropathy in weight-bearing joints of immature animals. Safety data from a randomised double-blind study on ciprofloxacin use in children (ciprofloxacin: n=335, mean age = 6.3 years; comparators: n=349, mean age = 6.2 years; age range = 1 to 17 years) revealed an incidence of suspected drug-related arthropathy (discerned from joint-related clinical signs and symptoms) by Day +42 of 7.2% and 4.6%. Respectively, an incidence of drug-related arthropathy by 1-year follow-up was 9.0% and 5.7%. The increase of suspected drug-related arthropathy cases over time was not statistically significant between groups. Treatment should be initiated only after a careful benefit/risk evaluation, due to possible adverse events related to joints and/or surrounding tissue (see section 4.8).

 

Broncho-pulmonary infections in cystic fibrosis

Clinical trials have included children and adolescents aged 5‑17 years. More limited experience is available in treating children between 1 and 5 years of age.

 

Complicated urinary tract infections and pyelonephritis

Ciprofloxacin treatment of urinary tract infections should be considered when other treatments cannot be used, and should be based on the results of the microbiological documentation.

Clinical trials have included children and adolescents aged 1‑17 years.

 

Other specific severe infections

Other severe infections in accordance with official guidance, or after careful benefit-risk evaluation when other treatments cannot be used, or after failure to conventional therapy and when the microbiological documentation can justify a ciprofloxacin use.

The use of ciprofloxacin for specific severe infections other than those mentioned above has not been evaluated in clinical trials and the clinical experience is limited. Consequently, caution is advised when treating patients with these infections.

 

Hypersensitivity

Hypersensitivity and allergic reactions, including anaphylaxis and anaphylactoid reactions, may occur following a single dose (see section 4.8) and may be life-threatening. If such reaction occurs, ciprofloxacin should be discontinued and an adequate medical treatment is required.

 

Prolonged, disabling and potentially irreversible serious adverse drug reactions

Very rare cases of prolonged (continuing months or years), disabling and potentially irreversible serious adverse drug reactions affecting different, sometimes multiple, body systems (musculoskeletal, nervous, psychiatric and senses) have been reported in patients receiving quinolones and fluoroquinolones irrespective of their age and pre-existing risk factors. Ciprofloxacin Bayer should be discontinued immediately at the first signs or symptoms of any serious adverse reaction and patients should be advised to contact their prescriber for advice.

 

Tendinitis and tendon rupture

Ciprofloxacin should generally not be used in patients with a history of tendon disease/disorder related to quinolone treatment. Nevertheless, in very rare instances, after microbiological documentation of the causative organism and evaluation of the risk/benefit balance, ciprofloxacin may be prescribed to these patients for the treatment of certain severe infections, particularly in the event of failure of the standard therapy or bacterial resistance, where the microbiological data may justify the use of ciprofloxacin.

Tendinitis and tendon rupture (especially but not limited to Achilles tendon), sometimes bilateral, may occur as early as within 48 hours of starting treatment with quinolones and fluoroquinolones and have been reported to occur even up to several months after discontinuation of treatment (see section 4.8). The risk of tendinitis and tendon rupture is increased in older patients, patients with renal impairment, patients with solid organ transplants, and those treated concurrently with corticosteroids. Therefore, concomitant use of corticosteroids should be avoided.

At the first sign of tendinitis (e.g. painful swelling, inflammation) the treatment with Ciprofloxacin Bayer should be discontinued and alternative treatment should be considered. The affected limb(s) should be appropriately treated (e.g. immobilisation). Corticosteroids should not be used if signs of tendinopathy occur.

 

Patients with myasthenia gravis

Ciprofloxacin should be used with caution in patients with myasthenia gravis, because symptoms can be exacerbated (see section 4.8).

 

Aortic aneurysm and dissection, and heart valve regurgitation/incompetence

Epidemiologic studies report an increased risk of aortic aneurysm and dissection, particularly in elderly patients, and of aortic and mitral valve regurgitation after intake of fluoroquinolones. Cases of aortic aneurysm and dissection, sometimes complicated by rupture (including fatal ones), and of regurgitation/incompetence of any of the heart valves have been reported in patients receiving fluoroquinolones (see section 4.8).

Therefore, fluoroquinolones should only be used after careful benefit-risk assessment and after consideration of other therapeutic options in patients with positive family history of aneurysm disease or congenital heart valve disease, or in patients diagnosed with pre-existing aortic aneurysm and/or dissection or heart valve disease, or in presence of other risk factors or conditions predisposing:

- for both aortic aneurysm and dissection and heart valve regurgitation/incompetence (e.g. connective tissue disorders such as Marfan syndrome or Ehlers-Danlos syndrome, Turner syndrome, Behcet´s disease, hypertension, rheumatoid arthritis) or additionally

- for aortic aneurysm and dissection (e.g. vascular disorders such as Takayasu arteritis or giant cell arteritis, or known atherosclerosis, or Sjögren’s syndrome) or additionally

- for heart valve regurgitation/incompetence (e.g. infective endocarditis).

The risk of aortic aneurysm and dissection, and their rupture may also be increased in patients treated concurrently with systemic corticosteroids.

In case of sudden abdominal, chest or back pain, patients should be advised to immediately consult a physician in an emergency department.

Patients should be advised to seek immediate medical attention in case of acute dyspnoea, new onset of heart palpitations, or development of oedema of the abdomen or lower extremities.

 

Vision disorders

If vision becomes impaired or any effects on the eyes are experienced, an eye specialist should be consulted immediately.

 

Photosensitivity

Ciprofloxacin has been shown to cause photosensitivity reactions. Patients taking ciprofloxacin should be advised to avoid direct exposure to either extensive sunlight or UV irradiation during treatment (see section 4.8).

 

 

 

Seizures

Ciprofloxacin like other quinolones are known to trigger seizures or lower the seizure threshold. Cases of status epilepticus have been reported. Ciprofloxacin should be used with caution in patients with CNS disorders which may be predisposed to seizure. If seizures occur ciprofloxacin should be discontinued (see section 4.8).

 

Peripheral neuropathy

Cases of sensory or sensorimotor polyneuropathy resulting in paraesthesia, hypaesthesia, dysesthesia, or weakness have been reported in patients receiving quinolones and fluoroquinolones. Patients under treatment with Ciprofloxacin Bayer should be advised to inform their doctor prior to continuing treatment if symptoms of neuropathy such as pain, burning, tingling, numbness, or weakness develop in order to prevent the development of potentially irreversible condition (see section 4.8).

 

Psychiatric reactions

Psychiatric reactions may occur even after first administration of ciprofloxacin. In rare cases, depression or psychosis can progress to suicidal ideations/thoughts culminating in attempted suicide or completed suicide. If depression, psychotic reactions, suicide-related thoughts or behavior occur, ciprofloxacin should be discontinued.

 

Cardiac disorders

Caution should be taken when using fluoroquinolones, including ciprofloxacin, in patients with known risk factors for prolongation of the QT interval such as, for example:

·                congenital long QT syndrome

·                concomitant use of drugs that are known to prolong the QT interval (e.g. Class IA and III anti-arrhythmics, tricyclic antidepressants, macrolides, antipsychotics)

·                uncorrected electrolyte imbalance (e.g. hypokalaemia, hypomagnesaemia)

·                cardiac disease (e.g. heart failure, myocardial infarction, bradycardia)

 

Elderly patients and women may be more sensitive to QTc-prolonging medications. Therefore, caution should be taken when using fluoroquinolones, including ciprofloxacin, in these populations.

 

(See section 4.2 Elderly patients, section 4.5, section 4.8, section 4.9).

 

Dysglycaemia

As with all quinolones, disturbances in blood glucose, including both hypoglycaemia and hyperglycaemia have been reported (see section 4.8), usually in elderly diabetic patients receiving concomitant treatment with an oral hypoglycaemic agent (e.g. glibenclamide) or with insulin. Cases of hypoglycaemic coma have been reported. In diabetic patients, careful monitoring of blood glucose is recommended.

 

Gastrointestinal System

The occurrence of severe and persistent diarrhoea during or after treatment (including several weeks after treatment) may indicate an antibiotic-associated colitis (life-threatening with possible fatal outcome), requiring immediate treatment (see section 4.8). In such cases, ciprofloxacin should immediately be discontinued, and an appropriate therapy initiated. Anti-peristaltic drugs are contraindicated in this situation.

 

Renal and urinary system

Crystalluria related to the use of ciprofloxacin has been reported (see section 4.8). Patients receiving ciprofloxacin should be well hydrated and excessive alkalinity of the urine should be avoided.

 

Impaired renal function

Since ciprofloxacin is largely excreted unchanged via renal pathway dose adjustment is needed in patients with impaired renal function as described in section 4.2 to avoid an increase in adverse drug reactions due to accumulation of ciprofloxacin.

 

Hepatobiliary system

Cases of hepatic necrosis and life-threatening hepatic failure have been reported with ciprofloxacin (see section 4.8). In the event of any signs and symptoms of hepatic disease (such as anorexia, jaundice, dark urine, pruritus, or tender abdomen), treatment should be discontinued.

 

Glucose-6-phosphate dehydrogenase deficiency

Haemolytic reactions have been reported with ciprofloxacin in patients with glucose-6-phosphate dehydrogenase deficiency. Ciprofloxacin should be avoided in these patients unless the potential benefit is considered to outweigh the possible risk. In this case, potential occurrence of haemolysis should be monitored.

 

Resistance

During or following a course of treatment with ciprofloxacin bacteria that demonstrate resistance to ciprofloxacin may be isolated, with or without a clinically apparent superinfection. There may be a particular risk of selecting for ciprofloxacin-resistant bacteria during extended durations of treatment and when treating nosocomial infections and/or infections caused by Staphylococcus and Pseudomonas species.

 

Cytochrome P450

Ciprofloxacin inhibits CYP1A2 and thus may cause increased serum concentration of concomitantly administered substances metabolised by this enzyme (e.g. theophylline, clozapine, olanzapine, ropinirole, tizanidine, duloxetine, agomelatine). Therefore, patients taking these substances concomitantly with ciprofloxacin should be monitored closely for clinical signs of overdose, and determination of serum concentrations (e.g. of theophylline) may be necessary (see section 4.5). Co-administration of ciprofloxacin and tizanidine is contra-indicated.

 

Methotrexate

The concomitant use of ciprofloxacin with methotrexate is not recommended (see section 4.5).

 

Interaction with tests

The in-vitro activity of ciprofloxacin against Mycobacterium tuberculosis might give false negative bacteriological test results in specimens from patients currently taking ciprofloxacin.


Effects of other products on ciprofloxacin:

 

Drugs known to prolong QT interval

Ciprofloxacin, like other fluoroquinolones, should be used with caution in patients receiving drugs known to prolong QT interval (e.g. Class IA and III anti-arrhythmics, tricyclic antidepressants, macrolides, antipsychotics) (see section 4.4).

 

Chelation Complex Formation

The simultaneous administration of ciprofloxacin (oral) and multivalent cation-containing drugs and mineral supplements (e.g. calcium, magnesium, aluminium, iron), polymeric phosphate binders (e.g. sevelamer or lanthanum carbonate), sucralfate or antacids, and highly buffered drugs (e.g. didanosine tablets) containing magnesium, aluminium, or calcium reduces the absorption of ciprofloxacin. Consequently, ciprofloxacin should be administered either 1‑2 hours before or at least 4 hours after these preparations. The restriction does not apply to antacids belonging to the class of H2 receptor blockers.

 

Food and Dairy Products

Dietary calcium as part of a meal does not significantly affect absorption. However, the concurrent administration of dairy products or mineral-fortified drinks alone (e.g. milk, yoghurt, calcium-fortified orange juice) with ciprofloxacin should be avoided because absorption of ciprofloxacin may be reduced.

 

Probenecid

Probenecid interferes with renal secretion of ciprofloxacin. Co-administration of probenecid and ciprofloxacin increases ciprofloxacin serum concentrations.

 

Metoclopramide

Metoclopramide accelerates the absorption of ciprofloxacin (oral) resulting in a shorter time to reach maximum plasma concentrations. No effect was seen on the bioavailability of ciprofloxacin.

 

Omeprazole

Concomitant administration of ciprofloxacin and omeprazole containing medicinal products results in a slight reduction of Cmax and AUC of ciprofloxacin.

 

Effects of ciprofloxacin on other medicinal products:

 

Tizanidine

Tizanidine must not be administered together with ciprofloxacin (see section 4.3). In a clinical study with healthy subjects, there was an increase in serum tizanidine concentration (Cmax increase: 7-fold, range: 4 to 21-fold; AUC increase: 10-fold, range: 6 to 24-fold) when given concomitantly with ciprofloxacin. Increased serum tizanidine concentration is associated with a potentiated hypotensive and sedative effect.

 

Methotrexate

Renal tubular transport of methotrexate may be inhibited by concomitant administration of ciprofloxacin, potentially leading to increased plasma levels of methotrexate and increased risk of methotrexate-associated toxic reactions. The concomitant use is not recommended (see section 4.4).

 

Theophylline

Concurrent administration of ciprofloxacin and theophylline can cause an undesirable increase in serum theophylline concentration. This can lead to theophylline-induced side effects that may rarely be life threatening or fatal. During the combination, serum theophylline concentrations should be checked and the theophylline dose reduced as necessary (see section 4.4).

 

Other xanthine derivatives

On concurrent administration of ciprofloxacin and caffeine or pentoxifylline (oxpentifylline), raised serum concentrations of these xanthine derivatives were reported.

 

Phenytoin

Simultaneous administration of ciprofloxacin and phenytoin may result in increased or reduced serum levels of phenytoin such that monitoring of drug levels is recommended.

 

Cyclosporin

A transient rise in the concentration of serum creatinine was observed when ciprofloxacin and cyclosporin containing medicinal products were administered simultaneously. Therefore, it is frequently (twice a week) necessary to control the serum creatinine concentrations in these patients.

 

Vitamin K antagonists

Simultaneous administration of ciprofloxacin with a vitamin K antagonist may augment its anti-coagulant effects. The risk may vary with the underlying infection, age and general status of the patient so that the contribution of ciprofloxacin to the increase in INR (international normalised ratio) is difficult to assess. The INR should be monitored frequently during and shortly after co-administration of ciprofloxacin with a vitamin K antagonist (e.g., warfarin, acenocoumarol, phenprocoumon, or fluindione).

 

Duloxetine

In clinical studies, it was demonstrated that concomitant use of duloxetine with strong inhibitors of the CYP450 1A2 isozyme such as fluvoxamine, may result in an increase of AUC and Cmax of duloxetine. Although no clinical data are available on a possible interaction with ciprofloxacin, similar effects can be expected upon concomitant administration (see section 4.4).

 

Ropinirole

It was shown in a clinical study that concomitant use of ropinirole with ciprofloxacin, a moderate inhibitor of the CYP450 1A2 isozyme, results in an increase of Cmax and AUC of ropinirole by 60% and 84%, respectively. Monitoring of ropinirole-related side effects and dose adjustment as appropriate is recommended during and shortly after co-administration with ciprofloxacin (see section 4.4).

 

Lidocaine

It was demonstrated in healthy subjects that concomitant use of lidocaine containing medicinal products with ciprofloxacin, a moderate inhibitor of CYP450 1A2 isozyme, reduces clearance of intravenous lidocaine by 22%. Although lidocaine treatment was well tolerated, a possible interaction with ciprofloxacin associated with side effects may occur upon concomitant administration.

 

Clozapine

Following concomitant administration of 250 mg ciprofloxacin with clozapine for 7 days, serum concentrations of clozapine and N-desmethylclozapine were increased by 29% and 31%, respectively. Clinical surveillance and appropriate adjustment of clozapine dosage during and shortly after co-administration with ciprofloxacin are advised (see section 4.4).

 

Sildenafil

Cmax and AUC of sildenafil were increased approximately twofold in healthy subjects after an oral dose of 50 mg given concomitantly with 500 mg ciprofloxacin. Therefore, caution should be used prescribing ciprofloxacin concomitantly with sildenafil taking into consideration the risks and the benefits.

 

Agomelatine

In clinical studies, it was demonstrated that fluvoxamine, as a strong inhibitor of the CYP450 1A2 isoenzyme, markedly inhibits the metabolism of agomelatine resulting in a 60-fold increase of agomelatine exposure. Although no clinical data are available for a possible interaction with ciprofloxacin, a moderate inhibitor of CYP450 1A2, similar effects can be expected upon concomitant administration (see ‘Cytochrome P450’ in section 4.4).

 

Zolpidem

Co-administration of ciprofloxacin may increase blood levels of zolpidem, concurrent use is not recommended.


Pregnancy

The data that are available on administration of ciprofloxacin to pregnant women indicates no malformative or feto/neonatal toxicity of ciprofloxacin. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. In juvenile and prenatal animals exposed to quinolones, effects on immature cartilage have been observed, thus, it cannot be excluded that the drug could cause damage to articular cartilage in the human immature organism / foetus (see section 5.3).

As a precautionary measure, it is preferable to avoid the use of ciprofloxacin during pregnancy.

 

Breast-feeding

Ciprofloxacin is excreted in breast milk. Due to the potential risk of articular damage, ciprofloxacin should not be used during breast-feeding.


Due to its neurological effects, ciprofloxacin may affect reaction time. Thus, the ability to drive or to operate machinery may be impaired.


The most commonly reported adverse drug reactions (ADRs) are nausea and diarrhoea.

 

ADRs derived from clinical studies and post-marketing surveillance with Ciprofloxacin Bayer (oral, intravenous, and sequential therapy) sorted by categories of frequency are listed below. The frequency analysis takes into account data from both oral and intravenous administration of ciprofloxacin.

 

System Organ Class

Common

≥ 1/100 to < 1/10

Uncommon

≥ 1/1,000 to < 1/100

Rare

≥ 1/10,000 to < 1/1,000

Very Rare

< 1/10,000

Frequency not known

(cannot be estimated from the available data)

Infections and Infestations

 

Mycotic superinfections

 

 

 

Blood and Lymphatic System Disorders

 

Eosinophilia

Leukopenia

Anaemia

Neutropenia

Leukocytosis

Thrombocytopenia

Thrombocytaemia

Haemolytic anaemia

Agranulocytosis

Pancytopenia (life-threatening)

Bone marrow depression (life-threatening)

 

Immune System Disorders

 

 

Allergic reaction

Allergic oedema / angiooedema

Anaphylactic reaction

Anaphylactic shock (life-threatening) (see section 4.4)

Serum sickness-like reaction

 

Endocrine disorders

 

 

 

 

Syndrome of inappropriate secretion of antidiuretic hormone (SIADH)

Metabolism and Nutrition Disorders

 

Decreased appetite

Hyperglycaemia

Hypoglycaemia (see section 4.4)

 

Hypoglycaemic coma (see section 4.4)

Psychiatric Disorders*

 

Psychomotor hyperactivity / agitation

Confusion and disorientation

Anxiety reaction

Abnormal dreams

Depression (potentially culminating in suicidal ideations/thoughts or suicide attempts and completed suicide) (see section 4.4)

Hallucinations

Psychotic reactions (potentially culminating in suicidal ideations/thoughts or suicide attempts and completed suicide) (see section 4.4)

Mania, incl. hypomania

Nervous System Disorders*

 

Headache

Dizziness

Sleep disorders

Taste disorders

Par- and Dysaesthesia

Hypoaesthesia

Tremor

Seizures (incl. status epilepticus see section 4.4)

Vertigo

Migraine

Disturbed coordination

Gait disturbance Olfactory nerve disorders

Intracranial hypertension and pseudotumor cerebri

Peripheral neuropathy and polyneuropathy (see section 4.4)

Eye Disorders*

 

 

Visual disturbances (e.g. diplopia)

Visual colour distortions

 

Ear and Labyrinth Disorders*

 

 

Tinnitus

Hearing loss / Hearing impaired

 

 

Cardiac Disorders**

 

 

Tachycardia

 

Ventricular arrhythmia and torsades de pointes (reported predominantly in patients with risk factors for QT prolongation), ECG QT prolonged (see sections 4.4 and 4.9)

Vascular Disorders**

 

 

Vasodilatation

Hypotension

Syncope

Vasculitis

 

Respiratory, Thoracic and Mediastinal Disorders

 

 

Dyspnoea (including asthmatic condition)

 

 

Gastrointestinal Disorders

Nausea

Diarrhoea

Vomiting

Gastrointestinal and abdominal pains

Dyspepsia

Flatulence

Antibiotic associated colitis (very rarely with possible fatal outcome) (see section 4.4)

Pancreatitis

 

Hepatobiliary Disorders

 

Increase in transaminases

Increased bilirubin

Hepatic impairment

Cholestatic icterus

Hepatitis

Liver necrosis (very rarely progressing to life-threatening hepatic failure) (see section 4.4)

 

Skin and Subcutaneous Tissue Disorders

 

Rash

Pruritus

Urticaria

Photosensitivity reactions (see section 4.4)

Petechiae

Erythema multiforme

Erythema nodosum

Stevens-Johnson syndrome (potentially life-threatening)

Toxic epidermal necrolysis (potentially life-threatening)

Acute Generalised Exanthematous Pustulosis (AGEP)

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)

Musculoskeletal and Connective Tissue Disorders*

 

Musculoskeletal pain (e.g. extremity pain, back pain, chest pain)

Arthralgia

Myalgia

Arthritis

Increased muscle tone and cramping

Muscular weakness

Tendinitis

Tendon rupture (predominantly Achilles tendon) (see section 4.4)

Exacerbation of symptoms of myasthenia gravis (see section 4.4)

 

Renal and Urinary Disorders

 

Renal impairment

Renal failure

Haematuria

Crystalluria (see section 4.4)

Tubulointerstitial nephritis

 

 

General Disorders and Administration Site Conditions*

 

Asthenia

Fever

Oedema

Sweating (hyperhidrosis)

 

 

Investigations

 

Increase in blood alkaline phosphatase

Increased amylase

 

International normalised ratio increased (in patients treated with Vitamin K antagonists)

 

* Very rare cases of prolonged (up to months or years), disabling and potentially irreversible serious drug reactions affecting several, sometimes multiple, system organ classes and senses (including reactions such as tendonitis, tendon rupture, arthralgia, pain in extremities, gait disturbance, neuropathies associated with paraesthesia, depression, fatigue, memory impairment, sleep disorders,  and impairment of hearing, vision, taste and smell) have been reported in association with the use of quinolones and fluoroquinolones in some cases irrespective of pre-existing risk factors (see Section 4.4).

 

** Cases of aortic aneurysm and dissection, sometimes complicated by rupture (including fatal ones), and of regurgitation/incompetence of any of the heart valves have been reported in patients receiving fluoroquinolones (see section 4.4).

 

Paediatric population

The incidence of arthropathy (arthralgia, arthritis), mentioned above, is referring to data collected in studies with adults. In children, arthropathy is reported to occur commonly (see section 4.4).

 

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via:

 

Saudi Arabia

The National Pharmacovigilance Centre (NPC).

SFDA Call Center: 19999

E-mail: npc.drug@sfda.gov.sa

Website: https://ade.sfda.gov.sa

 

Other GCC States:

Please contact the relevant competent authority.


An overdose of 12 g has been reported to lead to mild symptoms of toxicity. An acute overdose of 16 g has been reported to cause acute renal failure.

Symptoms in overdose consist of dizziness, tremor, headache, tiredness, seizures, hallucinations, confusion, abdominal discomfort, renal and hepatic impairment as well as crystalluria and haematuria. Reversible renal toxicity has been reported.

 

Apart from routine emergency measures, e.g. ventricular emptying followed by medical carbon, it is recommended to monitor renal function, including urinary pH and acidify, if required, to prevent crystalluria. Patients should be kept well hydrated. Calcium or magnesium containing antacids may theoretically reduce the absorption of ciprofloxacin in overdoses.

Only a small quantity of ciprofloxacin (<10%) is eliminated by haemodialysis or peritoneal dialysis.

 

In the event of overdose, symptomatic treatment should be implemented. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation.


Pharmacotherapeutic group: Fluoroquinolones, ATC code: J01MA02

 

Mechanism of action

As a fluoroquinolone antibacterial agent, the bactericidal action of ciprofloxacin results from the inhibition of both type II topoisomerase (DNA-gyrase) and topoisomerase IV, required for bacterial DNA replication, transcription, repair and recombination.

 

Pharmacokinetic/pharmacodynamic relationship

Efficacy mainly depends on the relation between the maximum concentration in serum (Cmax) and the minimum inhibitory concentration (MIC) of ciprofloxacin for a bacterial pathogen and the relation between the area under the curve (AUC) and the MIC.

 

Mechanism of resistance

In-vitro resistance to ciprofloxacin can be acquired through a stepwise process by target site mutations in both DNA gyrase and topoisomerase IV. The degree of cross-resistance between ciprofloxacin and other fluoroquinolones that results is variable. Single mutations may not result in clinical resistance, but multiple mutations generally result in clinical resistance to many or all active substances within the class.

Impermeability and/or active substance efflux pump mechanisms of resistance may have a variable effect on susceptibility to fluoroquinolones, which depends on the physiochemical properties of the various active substances within the class and the affinity of transport systems for each active substance. All in-vitro mechanisms of resistance are commonly observed in clinical isolates. Resistance mechanisms that inactivate other antibiotics such as permeation barriers (common in Pseudomonas aeruginosa) and efflux mechanisms may affect susceptibility to ciprofloxacin.

Plasmid-mediated resistance encoded by qnr-genes has been reported.

 

Spectrum of antibacterial activity

Breakpoints separate susceptible strains from strains with intermediate susceptibility and the latter from resistant strains:

 

EUCAST Recommendations

 

Microorganisms

 

Susceptible

 

Resistant

 

Enterobacteriaceae

S £ 0.25 mg/L

R > 0.5 mg/L

Salmonella spp.

S £ 0.06 mg/L

R > 0.06 mg/L

Pseudomonas spp.

S £ 0.5 mg/L

R > 0.5 mg/L

Acinetobacter spp.

S £ 1 mg/L

R > 1 mg/L

Staphylococcus spp.1

S £ 1 mg/L

R > 1 mg/L

Haemophilus influenzae

S £ 0.06 mg/L

R > 0.06 mg/L

Moraxella catarrhalis

S £ 0.125 mg/L

R > 0.125 mg/L

Neisseria gonorrhoeae

S £ 0.03 mg/L

R > 0.06 mg/L

Neisseria meningitidis

S £ 0.03 mg/L

R > 0.03 mg/L

Non-species-related breakpoints*

S £ 0.25 mg/L

R > 0.5 mg/L

1    Staphylococcus spp. - breakpoints for ciprofloxacin relate to high dose therapy.

*    Non-species-related breakpoints have been determined mainly on the basis of PK/PD data and are independent of MIC distributions of specific species. They are for use only for species that have not been given a species-specific breakpoint and not for those species where susceptibility testing is not recommended.

 

    

 

The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.

 

Groupings of relevant species according to ciprofloxacin susceptibility (for Streptococcus species see section 4.4).

 

COMMONLY SUSCEPTIBLE SPECIES

Aerobic Gram-positive micro-organisms

Bacillus anthracis (1)

Aerobic Gram-negative micro-organisms

Aeromonas spp.

Brucella spp.

Citrobacter koseri

Francisella tularensis

Haemophilus ducreyi

Haemophilus influenzae*

Legionella spp.

Moraxella catarrhalis*

Neisseria meningitidis

Pasteurella spp.

Salmonella spp.*

Shigella spp.*

Vibrio spp.

Yersinia pestis

Anaerobic micro-organisms

Mobiluncus

Other micro-organisms

Chlamydia trachomatis ($)

Chlamydia pneumoniae ($)

Mycoplasma hominis ($)

Mycoplasma pneumoniae ($)

SPECIES FOR WHICH ACQUIRED RESISTANCE MAY BE A PROBLEM

Aerobic Gram-positive micro-organisms

Enterococcus faecalis ($)

Staphylococcus spp. *(2)

Aerobic Gram-negative micro-organisms

Acinetobacter baumannii+

Burkholderia cepacia+*

Campylobacter spp.+*

Citrobacter freundii*

Enterobacter aerogenes

Enterobacter cloacae*

Escherichia coli*

Klebsiella oxytoca

Klebsiella pneumoniae*

Morganella morganii*

Neisseria gonorrhoeae*

Proteus mirabilis*

Proteus vulgaris*

Providencia spp.

Pseudomonas aeruginosa*

Pseudomonas fluorescens

Serratia marcescens*

Anaerobic micro-organisms

Peptostreptococcus spp.

Propionibacterium acnes

INHERENTLY RESISTANT ORGANISMS

Aerobic Gram-positive micro-organisms

Actinomyces

Enteroccus faecium

Listeria monocytogenes

Aerobic Gram-negative micro-organisms

Stenotrophomonas maltophilia

Anaerobic micro-organisms

Excepted as listed above

Other micro-organisms

Mycoplasma genitalium

Ureaplasma urealitycum

*     Clinical efficacy has been demonstrated for susceptible isolates in approved clinical indications

+           Resistance rate ≥ 50% in one or more EU countries

($): Natural intermediate susceptibility in the absence of acquired mechanism of resistance

(1): Studies have been conducted in experimental animal infections due to inhalations of Bacillus anthracis spores; these studies reveal that antibiotics starting early after exposition avoid the occurrence of the disease if the treatment is made up to the decrease of the number of spores in the organism under the infective dose. The recommended use in human subjects is based primarily on in-vitro susceptibility and on animal experimental data together with limited human data. Two-month treatment duration in adults with oral ciprofloxacin given at the following dose, 500 mg bid, is considered as effective to prevent anthrax infection in humans. The treating physician should refer to national and/or international consensus documents regarding treatment of anthrax.

(2): Methicillin-resistant S. aureus very commonly express co-resistance to fluoroquinolones. The rate of resistance to methicillin is around 20 to 50% among all staphylococcal species and is usually higher in nosocomial isolates.

 


Absorption

Following oral administration of single doses of 250 mg, 500 mg, and 750 mg of ciprofloxacin tablets, ciprofloxacin is absorbed rapidly and extensively, mainly from the small intestine, reaching maximum serum concentrations 1‑2 hours later.

Single doses of 100‑750 mg produced dose-dependent maximum serum concentrations (Cmax) between 0.56 and 3.7 mg/L. Serum concentrations increase proportionately with doses up to 1000 mg.

The absolute bioavailability is approximately 70‑80%.

A 500 mg oral dose given every 12 hours has been shown to produce an area under the serum concentration-time curve (AUC) equivalent to that produced by an intravenous infusion of 400 mg ciprofloxacin given over 60 minutes every 12 hours.

 

Distribution

Protein binding of ciprofloxacin is low (20‑30%). Ciprofloxacin is present in plasma largely in a non-ionised form and has a large steady state distribution volume of 2‑3 L/kg body weight. Ciprofloxacin reaches high concentrations in a variety of tissues such as lung (epithelial fluid, alveolar macrophages, biopsy tissue), sinuses, inflamed lesions (cantharides blister fluid), and the urogenital tract (urine, prostate, endometrium) where total concentrations exceeding those of plasma concentrations are reached.

 

Biotransformation

Low concentrations of four metabolites have been reported, which were identified as: desethyleneciprofloxacin (M 1), sulphociprofloxacin (M 2), oxociprofloxacin (M 3) and formylciprofloxacin (M 4). The metabolites display in-vitro antimicrobial activity but to a lower degree than the parent compound.

Ciprofloxacin is known to be a moderate inhibitor of the CYP 450 1A2 iso-enzymes.

 

Elimination

Ciprofloxacin is largely excreted unchanged both renally and, to a smaller extent, faecally. The serum elimination half-life in subjects with normal renal function is approximately 4‑7 hours.

 

Excretion of ciprofloxacin (% of dose)

 

Oral Administration

Urine

Faeces

Ciprofloxacin

44.7

25.0

Metabolites (M1-M4)

11.3

7.5

 

Renal clearance is between 180‑300 mL/kg/h and the total body clearance is between 480‑600 mL/kg/h. Ciprofloxacin undergoes both glomerular filtration and tubular secretion. Severely impaired renal function leads to increased half lives of ciprofloxacin of up to 12 h.

 

Non-renal clearance of ciprofloxacin is mainly due to active trans-intestinal secretion and metabolism. 1% of the dose is excreted via the biliary route. Ciprofloxacin is present in the bile in high concentrations.

 

Paediatric patients

The pharmacokinetic data in paediatric patients are limited.

 

In a study in children Cmax and AUC were not age-dependent (above one year of age). No notable increase in Cmax and AUC upon multiple dosing (10 mg/kg three times daily) was observed.

 

In 10 children with severe sepsis Cmax was 6.1 mg/L (range 4.6‑8.3 mg/L) after a 1-hour intravenous infusion of 10 mg/kg in children aged less than 1 year compared to 7.2 mg/L (range 4.7‑11.8 mg/L) for children between 1 and 5 years of age. The AUC values were 17.4 mg*h/L (range 11.8‑32.0 mg*h/L) and 16.5 mg*h/L (range 11.0‑23.8 mg*h/L) in the respective age groups.

 

These values are within the range reported for adults at therapeutic doses. Based on population pharmacokinetic analysis of paediatric patients with various infections, the predicted mean half-life in children is approx. 4‑5 hours and the bioavailability of the oral suspension ranges from 50 to 80%.


Non-clinical data reveal no special hazards for humans based on conventional studies of single dose toxicity, repeated dose toxicity, carcinogenic potential, or toxicity to reproduction.

Like a number of other quinolones, ciprofloxacin is phototoxic in animals at clinically relevant exposure levels. Data on photomutagenicity/photocarcinogenicity show a weak photomutagenic or phototumorigenic effect of ciprofloxacin in-vitro and in animal experiments. This effect was comparable to that of other gyrase inhibitors.

 

Articular tolerability

As reported for other gyrase inhibitors, ciprofloxacin causes damage to the large weight-bearing joints in immature animals. The extent of the cartilage damage varies according to age, species and dose; the damage can be reduced by taking the weight off the joints. Studies with mature animals (rat, dog) revealed no evidence of cartilage lesions. In a study in young beagle dogs, ciprofloxacin caused severe articular changes at therapeutic doses after two weeks of treatment, which were still observed after 5 months.


Tablet core:

Cellulose microcrystalline,

Crospovidone,

Maize starch,

Magnesium stearate,

Silica colloidal anhydrous.

 

Film-coat:

Hypromellose,

Macrogol 4000,

Titanium dioxide (E171).


Not applicable.


4 years

Not to be stored above 30°C.


One of the following primary packaging materials is used:

Transparent colourless or white opaque PVC/PVDC/Aluminum blister

Transparent colourless or white opaque PP/Aluminum blister

Aluminum/Aluminum blister

Pack sizes of 6, 8, 10, 12, 14, 16, 20, 28, 50, 100, 160 or 500 film-coated tablets

Not all pack sizes may be marketed.


No special requirements.


Bayer AG Kaiser-Wilhelm-Allee 1 51368 Leverkusen, Germany.

08/2021
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