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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)

Brufen Tablets belongs to a group of medicines called anti-inflammatory pain killers. They
can be used to relieve pain and inflammation in conditions such as osteoarthritis, rheumatoid
arthritis (including juvenile rheumatoid arthritis or Still's disease), arthritis of the spine,
ankylosing spondylitis, swollen joints, frozen shoulder, bursitis, tendinitis, tenosynovitis, lower
back pain, sprains and strains.
Brufen Tablets can also be used to treat other painful conditions such as toothache, pain after
operations, period pain and headache, including migraine. Its antipyretic activity is effective in
reducing fever.
The active ingredient in Brufen Tablets is ibuprofen and each tablet contains either 400 or 600
mg.


If the answer to any of the following questions is 'YES' please tell your doctor or
pharmacist BEFORE taking any Brufen Tablets:
• Are you pregnant or planning to become pregnant, or are you breast-feeding? Brufen
tablets may make it more difficult to become pregnant. You should inform your doctor if
you are planning to become pregnant or if you have problems becoming pregnant.
• Are you sensitive (allergic) to any of the ingredients in the tablets? These are listed in
Section 6.
• Do you have, or have you previously had, a stomach ulcer or other gastric complaint?
Do not take Brufen Tablets if you currently have a peptic ulcer (ulcer in your stomach or
duodenum) or bleeding in your stomach, or have had two or more episodes of peptic ulcers,
stomach bleeding or perforation in the past.
• Do you have a condition which increases your tendency to bleeding?
• Do you suffer from asthma or have you ever had an allergic reaction or suffered
from wheezing after taking ibuprofen, aspirin or other anti-inflammatory pain killers?
• Do you suffer from swelling and irritation inside the nose?
• Do you suffer from liver or kidney disease?
• Do you suffer from heart disease?
Medicines such as Brufen Tablets may be associated with a small increased risk of
heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses and
prolonged treatment. Do not exceed the recommended dose or duration of treatment. You
should discuss your treatment with your doctor or pharmacist before taking Brufen Tablets if
you:

- have heart problems including heart failure, angina (chest pain) or you have had a heart
attack, bypass surgery or peripheral artery disease (poor circulation in the legs or
feet due to narrow or blocked arteries).
- have any kind of stroke or think that you might be at risk of these conditions (e.g. if you
have a family history of heart disease or stroke, high blood pressure, diabetes, high
cholesterol or are a smoker).
• Do you have systemic lupus erythematosus (SLE, sometimes known as lupus) or a
connective tissue disease (autoimmune diseases affecting connective tissue)?
• Do you have chicken pox or shingles?
• Have you been told by your doctor that you have an intolerance to some sugars?

·         are you or your child dehydrated? There is a risk of kidney damage in dehydrated children  adolescents and the elderly.

Skin reactions

Serious skin reactions have been reported in association with Brufen Tablets treatment. You should stop taking Brufen Tablets and seek medical attention immediately, if you develop any skin rash, lesions of the mucous membranes, blisters or other signs of allergy since this can be the first signs of a very serious skin reaction. See section 4.

 

As with other NSAIDs, Brufen can mask symptoms of infection, which may lead to delayed initiation of appropriate treatment and thereby worsening the outcome of the infection. This has been observed in bacterial community acquired pneumonia and bacterial complications to varicella. When Brufen is administered for fever or pain relief in relation to infection, monitoring of infection is advised. In nonhospital settings, the patient should consult a doctor if symptoms persist or worsen.

Other medicines and Brufen tablet
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including medicines obtained without a prescription. In particular, tell your doctor
or pharmacist if you are taking any of the following medicines:
• Some medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/
acetylsalicyclic acid, warfarin, ticlodipine),
• some medicines that reduce high blood pressure (ACE-inhibitors such as captopril,
beta- blockers such as atenolol, or angiotensin-II receptor antagonists such as losartan)
and other medicines may affect or be affected by treatment with ibuprofen.
You should therefore always seek the advice of your doctor or pharmacist before you use
ibuprofen with other medicines.
In particular you should tell your doctor or pharmacist if you are taking any of the following
medicines in addition to those mentioned above:
• Diuretics (water tablets)
• Cardiac glycosides, such as digoxin, used to treat heart conditions
• Lithium
• Zidovudine (an anti-viral drug)
• Steroids (used in the treatment of inflammatory conditions)
• Methotrexate (used to treat certain cancers and rheumatoid arthritis)
• Medicines known as immunosuppressants such as ciclosporin and tacrolimus (used to
dampen down your immune response)
• Medicines known as selective serotonin reuptake inhibitors (SSRls), used for the

treatment of depression
• antibiotics called quinolones such as ciprofloxacin
• aminoglycosides (a type of antibiotic)
• Mifepristone
• any other ibuprofen, such as those you can buy without a prescription
• any other anti-inflammatory pain killer, including aspirin
• cholestyramine (a drug used to lower cholesterol)
• Medicines known as sulphonylureas such as glibenclamide (used to treat diabetes)
• voriconazole or fluconazole (type of anti-fungal drugs)
• Gingko biloba herbal medicine (there is a chance you may bleed more easily if you are
taking this with ibuprofen).

Alcohol: Brufen may cause some side effects including dizziness, drowsiness and stomach problems such as bleeding in the stomach. Drinking excessive alcohol with Brufen might make these side effects worse.

Pregnancy and breast-feeding
The use of Brufen whilst pregnant or breast feeding should be avoided. Brufen should not
be used in late (the last three months of) pregnancy and should only be taken in the first six
months of pregnancy on the advice of your doctor.
Driving and using machines
Brufen may make you feel dizzy or drowsy. If the tablets affect you in this way do not drive,
operate machinery or do anything that requires you to be alert.


ALWAYS take Brufen exactly as your doctor has told you. If you are not sure check with
your doctor or pharmacist.
Take your Brufen Tablets with or after food, with a glass of water. Brufen Tablets should be
swallowed whole and not chewed, broken, crushed or sucked to help prevent discomfort in
the mouth or irritation in the throat.
DOSAGE:
Adults and children over 12 years - The usual dosage is 600 to 1800 mg spread
throughout the day. Your doctor may choose to increase this depending on what you are
being treated for; but no more than 2400 mg should be taken in one day.
Children - The usual daily dose is 20 mg per kg of body weight each day, given in divided
doses. Brufen Tablets should NOT be taken by children weighing less than 7 kg. The 600
mg tablets should not be given to children under the age of 12 years.
In cases of severe juvenile arthritis your doctor my increase the dosage up to 40 mg/kg
in divided doses.
You should avoid excessive use of painkillers. If you usually take painkillers, especially
combinations of different painkillers , you may damage your kidneys, tell your doctor if you
are already taking another painkiller before taking this medicine and your doctor will
decide whether you should take this medicine. This risk may be increased if you are
dehydrated.

The use of painkillers for a long period of time has in some patients been linked to headaches, a condition called medication overuse headache (MOH). Patients who have frequent or daily headaches despite (or because of) the regular use of pain killers should not be treated with increased doses of Brufen. Tell your doctor if you have been having headaches while taking this medicine.

If you take more Brufen tablet than you should
If you have taken more Brufen than you should, or if children have taken this medicine by

accident always contact a doctor or nearest hospital to get an opinion of the risk and advice
on action to be taken.
The symptoms can include nausea, stomach pain, vomiting (may be blood streaked),
headache, ringing in the ears, confusion and shaky eye movement. At high doses,
drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children),
weakness and dizziness, blood in urine, cold body feeling, and breathing problems have
been reported.
If you forget to take Brufen tablet
take them as soon as you remember, unless it is almost time for your next dose. If it is, do
not take the missed dose at all. Never double up on a dose to make up for the one you have
missed.


Like all medicines, this medicine can cause side effects, although not everybody gets
them. If any side effects become serious or if you notice any side effects that are not
listed in this leaflet, please tell your doctor or pharmacist. You can minimise the risk of
side effects by taking the least amount of tablets for the shortest amount of time necessary
to control your symptoms.
STOP TAKING Brufen Tablets and seek immediate medical help if you experience:
• Signs of aseptic meningitis such as severe headache, high temperature, stiffness of
the neck or intolerance to bright light.
• Signs of intestinal bleeding such as:
- Passing blood in your faeces (stools/motions)
- Passing black tarry stools
- Vomiting any blood or dark particles that look like coffee grounds

TELL YOUR DOCTOR AND STOP TAKING BRUFEN TABLETS IF YOU EXPERIENCE:
• Unexplained stomach pain (abdominal pain) or other abnormal stomach symptoms,
indigestion, heartburn, feeling sick and/or vomiting.
• Unexplained wheezing, shortness of breath, skin rash, itching or bruising (these may be
symptoms of an allergic reaction).
• Loss of vision blurred or disturbed vision (visual impairment) or seeing/hearing strange
things (hallucinations).
• Severe spreading skin rash (‘Stevens-Johnson Syndrome’, ‘toxic epidermal necrolysis’
and ‘erythema multiforme’, symptoms include severe skin rash, blistering of skin, including
inside mouth, nose, and genitals, as well as skin peeling which may be accompanied with
symptoms such as aching, headaches, and feverishness).
• A severe skin reaction known as DRESS syndrome can occur. Symptoms of DRESS
include: skin rash, fever, swelling of lymph nodes and an increase of eosinophils (a type of
white blood cells).
Medicines such as Brufen Tablets have been associated with a small increased risk of
high blood pressure, heart attack (myocardial infarction), stroke or heart failure.
Medicines such as Brufen Tablets have in exceptional cases been associated with severe
skin problems for patients with chicken pox or shingles

Blood disorders such as reduction in blood cells and platelet counts – the first signs are: high
temperature, sore throat, mouth ulcers, flu-like symptoms, bleeding from the mouth, nose, ear
and the skin. Kidney problems such as reduced kidney function, fluid retention (oedema),
inflammation of the kidney and kidney failure. Liver problems such as inflammation of the
liver, reduced liver function and yellowing of the eyes and/or skin (jaundice) or severe skin
reactions may occur rarely with ibuprofen.
Brufen has also been shown to sometimes worsen the symptoms of Crohn's disease or
colitis.

Other side effects
Common (affects up to 1 in 10 people}:
• feeling dizzy or tired
• diarrhoea, wind, constipation
• headache - if this happens while you are taking this medicine it is important not to take
any other medicines for pain to help with this.
Uncommon (affects up to 1 in a 100 people):
• feeling drowsy
• feeling anxious
• feeling a tingling sensation or 'pins and needles'
• difficulty sleeping
• hives
• skin becomes sensitive to light
• hearing problems
• sneezing, blocked, itchy or runny nose (rhinitis)
• stomach or gut ulcer, hole in the wall of the digestive tract
• inflammation of your stomach lining
• ringing in ears (tinnitus)
• sensation of spinning (vertigo)
• mouth ulcers

Rare (affects up to 1 in a 1000 people):
• feeling depressed or confused
Very rare (affects up to 1 in 10,000 people):
• inflammation of the pancreas

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

•     A red, scaly widespread rash with bumps under the skin and blisters mainly localized on the skin folds, trunk, and upper extremities accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis). Stop using Brufen Tablets if you develop these symptoms and seek medical attention immediately. See also section 2.

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):

-National Pharmacovigilance Center (NPC)

o Fax: +966-11-205-7662

o SFDA Call Center: 19999

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

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


• Keep this medicine out of the sight and reach of children.
• Brufen 400mg: store your tablets at a temperature below 25°C.
• Brufen 600mg: store your tablets at a temperature below 25°C.
• Store your tablets in the original package in order to protect from moisture.
• Do not use this medicine after the expiry date which is stated on the package after
abbreviation “EXP” used for expiry date (month and year). The expiry date refers to the last
day of that month.
• 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 to
protect the environment.
Shelf Life
36 Months


• The active substance in Brufen Tablets is Ibuprofen Ph.Eur. available as 400 or 600 mg
tablets.
Brufen 400 mg Tablets inactive ingredients:
Tablet core: Stearic acid, Maize starch, Aerosil 200, Maize starch dried, Pregelled
maize starch, Varnish: Opaglos regular
Coating: Acacia spray dried, Calcium sulphate dihydrate, Refined sugar, Opalux pink
AS 1537, Sodium carboxymethylcellulose, Carnauba wax powder, Printing Ink Opacode S-
1-277001 Black
Brufen 600 mg Tablets inactive ingredients:
Tablet core: Stearic acid, Maize starch, Aerosil 200, Maize starch dried, Pregelled maize
starch
Coating: Opaspray white M-1-7111B, Hydroxypropylmethylcellulose, Talc, Printing Ink:
Opacode S- 1-277001 Black


Brufen 400 tablets are light magenta coloured sugar coated tablet, smooth in texture with a polished surface and with 400 BRUFEN printed in black on one face. Each pack contains 25 tablets Brufen 600 tablets are A white film coated oblong tablet printed with an identifying motif. Each pack contains 30 tablets

Abbott Laboratories Limited
Abbott House, vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, SL6 4XE, UK
Manufacturer:
Reckitt Benckiser Healthcare international, Nottingham, UK


March 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)

ينتمي بروفين أقراص إلى مجموعة من الأدوية تسمى مسكنات الألم المضادة للالتهابات . ويمكن استخدامها لتخفيف الألم والالتهاب في حالات مثل التهاب المفاصل (بما في ذلك التهاب المفاصل الروماتويدي أو داء ستيل) ، والتهاب المفاصل في العمود الفقري ، التهاب الفقار اللاصق ، تورم المفاصل ، تيبس الكتف ، التهاب الجراب (التهاب التجويف الكيسي) ، التهاب الأوتار ، التهاب غمد الوتر ، ألم أسفل الظهر ، التمزق العضلي  و الالتواء  .

ويمكن أيضا أن تستخدم أقراص بروفين لعلاج الحالات المؤلمة الأخرى مثل وجع الأسنان ، وآلام ما بعد العمليات ، وآلام الدورة الشهرية  والصداع ، بما في ذلك الصداع النصفي . و له نشاط ناجح المفعول في تخفيض الحمى.

المادة الفعالة في أقراص بروفين هو ايبوبروفين ويحتوي كل قرص إما 400 أو 600 ملغم .

إن كانت إجابتك على أي من الأسئلة التالیة ھي "نعم"، یرُجى إبلاغ طبیبك أو الصیدلي قبل تناول أي أقراص بروفین:

• ھل أنت حامل أو تخططین لتصبحي حاملا، أو في مرحلة الرضاعة الطبیعیة؟ أقراص بروفین قد تجعل الأمر أكثر صعوبة لتصبحي حاملا. یجب علیك إبلاغ طبیبك إذا كنت تخططین لتصبحي حاملا أو إذا كان لدیك مشاكل من أن تصبحي حاملا.

·         إذا كنت تعاني من حساسة (فرط الحساسية) إلى أي من المكونات في بروفين أقراص و المدرجة في القسم 6.

ھل تعاني حالیا أو كان لدیك سابقا قرحة في المعدة أو غیرھا من شكوى بالمعدة؟
لا تتناول بروفین أقراص إذا كنت تعاني من القرحة الھضمیة (قرحة في المعدة أو الإثني عشر) أو نزیف في المعدة، أو كان لدیك مسبقا نوبات القرحة
الھضمیة، ونزیف في المعدة أو انثقاب في الماضي.
• ھل تعاني من النزیف أو المیل إلى النزیف؟
• ھل تعاني من الربو أو كان لدیك في أي وقت مضى حساسیة أو مشاكل في التنفس بعد تناول الإیبوبروفین، والأسبرین أو غیرھا من مسكنات
الألم المضادة للالتھابات؟
• ھل تعاني من التورم والاحمرار بالأنف؟
• ھل تعاني من أمراض الكبد أو الكلى؟
• ھل كنت تعاني من أمراض القلب؟
قد یرتبط تناول أدویة مثل أقراص بروفین بزیادة طفیفة في مخاطر الإصابة بنوبة قلبیة (احتشاء عضلة القلب) أو السكتة الدماغیة. تزداد ھذه المخاطر
مع تناول الجرعات العالیة والعلاج لفترات طویلة. لا تتجاوز الجرعة الموصى بھا أو مدة العلاج. یجب علیك مناقشة العلاج مع طبیبك أو الصیدلاني
قبل تناول بروفین أقراص إذا كان:
- لدیك مشاكل في القلب بما في ذلك فشل القلب، والذبحة الصدریة (ألم في الصدر) أو كان لدیك نوبة قلبیة، تخضع لعملیة جراحیة وشیكة
أو تعاني من اعتلال الشرایین المُحیطیة (ضعف الدورة الدمویة في الساقین أو القدمین لتضییق أو انسداد الشرایین).

- لدیك أي نوع من السكتة الدماغیة أو تعتقد أنك قد تكون عرضة للإصابة بھذه الحالة (على سبیل المثال، إذا كان لدیك تاریخ عائلي من
الإصابة بأمراض القلب أو السكتة الدماغیة، وارتفاع ضغط الدم، ومرض السكري، وارتفاع الكولسترول أو أنك مدخنا).

إذا كان لديك الذئبة الحمامية الجهازية (SLE، التي تعرف أحيانا باسم الذئبة) أو أمراض النسيج الضام (أمراض المناعة الذاتية التي تؤثر على النسيج الضام) .

• ھل لدیك جدري الماء أو القوباء المنطقیة (الحزام الناري)؟

• ھل أخبرك طبیبك من قبل بوجود مشاكل مع تناول السكریات؟

·            هل تعاني أنت أو يعاني طفلك من الجفاف؟ هناك مخاطر من حدوث تلف الكلى في الأطفال والمراهقين وكبار السن المصابين بالجفاف.

التفاعلات الجلدية

تم الإبلاغ عن حدوث تفاعلات جلدية خطيرة ذات علاقة بالعلاج بأقراص بروفين. يجب التوقف عن تناول أقراص بروفين والتماس الرعاية الطبية على الفور إذا أصبت بأي طفح جلدي أو إصابات في الأغشية المخاطية، أو بثور أو غيرها من علامات الحساسية حيث قد تمثل هذه الإصابات العلامات الأولى لحدوث تفاعل جلدي خطير للغاية. انظر قسم 4.

وكما هو الحال مع مضادات الالتهاب اللاستيرويدية الأخرى، يمكن أن يؤدي بروفين إلى إخفاء أعراض العدوى، ما قد يؤدي إلى التأخر في بدء العلاج المناسب وبالتالي تفاقم نتيجة العدوى. وقد لوحظ هذا في الالتهاب  الرئوي البكتيري المكتسب من المجتمع والمضاعفات البكتيرية للجدري المائي. عندما يتم تناول بروفين لخفض الحمى أو لتسكين الألم المرتبط بالعدوى، يُنصح بمراقبة العدوى. ويتعين على المريض الذي يتلقى العلاج خارج المستشفى استشارة الطبيب في حالة استمرار الأعراض أو تفاقمها.


تناول أدویة أخرى مع بروفین أقراص:
أخبر طبیبك أو الصیدلي أو الممرضة إذا كنت تناولت، أو قد تتناول مؤخرا أي أدویة أخرى، بما في ذلك الأدویة التي تم تناولھا دون وصفة طبیة،
وعلى وجھ الخصوص أخبر طبیبك إذا كنت تتناول أي من الأدویة التالیة :

• بعض الأدویة التي تنتمي إلى مضادات التخثر التي تعمل على منع التجلط مثل (الأسبرین / حمض السالیسیلیك، الوارفارین، تیكلودیبین)

·         بعض الأدوية التي تقلل من ارتفاع ضغط الدم  كمثبطات إنزيم ACE مثل كابتوبريل أو حاصرات بيتا مثل أتينولول أو مضادات مستقبلات أنجيوتنسين -II مثل اللوسارتان) ، والأدوية الأخرى التي قد تؤثر أو تتأثر بالعلاج باستخدام ايبوبروفين .

لذلك یجب علیك دائما الحصول على المشورة من الطبیب أو الصیدلي قبل استخدام ایبوبروفین مع أدویة أخرى.

على وجھ الخصوص یجب علیك إخبار الطبیب أو الصیدلي إذا كنت تأخذ أي من الأدویة التالیة بالإضافة إلى تلك المذكورة أعلاه:
• مدرات البول (أقراص المیاه)
• جلیكوسیدات القلب، مثل الدیجوكسین، وتستخدم لعلاج أمراض القلب
• اللیثیوم
• زیدوفودین (عقار مضاد للفیروسات)
• المنشطات (المستخدمة في علاج الحالات الالتھابیة)
• میثوتریكسیت (یستخدم لعلاج بعض أنواع السرطان والتھاب المفاصل الروماتویدي)
• الأدویة المعروفة باسم مثبطات المناعة مثل السیكلوسبورین وتاكرولیموس (التي تستخدم لتخفیف الاستجابة المناعیة)

·         الأدوية المعروفة باسم مثبطات امتصاص السيروتونين الانتقائية (SSRIs) ، تستخدم لعلاج الاكتئاب

• المضادات الحیویة التي تسمى الكینولونات مثل السیبروفلوكساسین
• أمینوجلیكوزیدات (نوع من المضادات الحیویة)
• المیفیبریستون
• دواء آخر یحتوي على إیبوبروفین آخر، مثل تلك التي یمكنك شراءھا دون وصفة طبیة.
• مسكن للألم آخر مضاد للالتھابات، بما في ذلك الأسبرین
• الكولسترامین (دواء یستخدم لخفض الكولسترول)
• الأدویة المعروفة باسم السلفونیل یوریا مثل جلیبینكلامید (المستخدمة لعلاج مرض السكري)
• فوریكونازول أو فلوكونازول (نوع من الأدویة المضادة للفطریات)
• الأدویة العشبیة الجینكو بیلوبا (حیث أن تناولھا مع ایبوبروفین یؤدي إلى زیادة فرصة حدوث نزیف).

·            الكحول: يمكن أن يسبب البروفين بعض الآثار الجانبية بما فيها الدوخة، والنعاس ومشكلات المعدة مثل نزيف المعدة. تناول الكحول بشكل مفرط بالتزامن مع البروفين يمكن أن يؤدي إلى تفاقم هذه الآثار الجانبية.


الحمل والرضاعة الطبیعیة:
یجب تجنب استخدام بروفن أثناء الحمل أو الرضاعة الطبیعیة. وبالأخص لا ینبغي استخدام بروفین في أواخر الحمل (الأشھر الثلاثة الأخیرة من
الحمل) وینبغي أن لا تؤخذ إلا في الأشھر الستة الأولى من الحمل وبناء على نصیحة الطبیب.
القیادة واستخدام الآلات:
تناول بروفن قد یجعلك تشعر بالدوار أو النعاس. إذا شعرت بذلك، فلا تقم بتشغیل الآلات أو القیام بأي شيء یتطلب منك أن تكون في یقظة.

 

 

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تناول دائمًا ھذا الدواء كما وصف لك الطبیب، إن لم تكن متأكدا استشر طبیبك أو الصیدلي.
یجب تناول أقراص بروفین مع أو بعد الطعام، مع تناول كوب من الماء. یجب ابتلاع أقراص بروفین كاملة ولا ینبغي مضغھا، كسرھا، سحقھا لمنع
حدوث مشاكل في الفم أو تھیج في الحلق.

الجرعة:

البالغین والأطفال فوق 12 سنة - الجرعة المعتادة ھي 600 إلى 1800 ملغم ویتم توزیعھا على مدار الیوم. قد یقرر طبیبك زیادة الجرعة اعتمادا
على حالتك ومدى احتیاجك؛ ولكن لا ینبغي أن تتناول أكثر من 2400 ملغم في یوم واحد.
الأطفال - الجرعة الیومیة المعتادة ھي 20 ملغم لكل كیلوجرام من وزن الجسم كل یوم، على جرعات مقسمة. یجب عدم إعطاء أقراص بروفین
للأطفال الذي یقل وزنھم عن 7 كجم. لا ینبغي إعطاء أقراص 600 ملغم للأطفال دون سن 12 عاما.
في الحالات الحادة من التھاب المفاصل العصبي قد یقرر الطبیب زیادة الجرعة إلى 40 ملغم / كجم مقسمة على جرعات.

يجب تجنب الإفراط في استخدام المسكنات. إذا كنت تتناول عادة مسكنات الألم ، خاصة مزيج من مسكنات الألم المختلفة ، فقد تتسبب في تلف الكلى. أخبر طبيبك إذا كنت تتناول بالفعل مسكنًا آخر للألم قبل تناول هذا الدواء وسيقرر طبيبك ما إذا كان يجب عليك تناول هذا الدواء. قد يزداد هذا الخطر إذا كنت تعاني من الجفاف.

ارتبط استخدام مسكنات الألم لفترة طويلة في بعض المرضى بالصداع، وهي حالة يُطلق عليها اسم الصداع الناتج عن الاستخدام الزائد للأدوية (MOH). يحظر علاج المرضى الذين يصابون بصداع يومي أو متكرر على الرغم من الاستخدام المنتظم لمسكنات الألم (أو بسببه) بجرعات زائدة من البروفين. أخبر طبيبك إذا كنت تصاب بأي من أنواع الصداع أثناء تناول هذا الدواء.

إذا تناولت جرعة زائدة من بروفین أقراص:

إن تناولت كمیة أكبر مما ینبغي من بروفین، أو إن تناول الأطفال ھذا الدواء عن طریق الخطأ, فاتصل دوماً بالطبيب أو بأقرب مستشفى للإستشارة بخصوص الخطر والنصیحة بخصوص ما ینبغي القیام بھ.

یمكن للأعراض أن تتضمن الغثيان وألم المعدة والقيء (قد تكون بھ خیوط دمویة) والصداع والرنين في الأذنين والإرتباك ورعشة حركة العین. في الجرعات العالیة، وردت تقاریر بخصوص الدوخة وألم الصدر والخفقان وفقدان الوعي والتشنجات (خاصة لدى الأطفال) والضعف والدوخة ووجود
دم في البول والشعور ببرودة الجسم ومشكلات تنفسیة .

إذا نسیت تناول بروفین أقراص:

إذا نسيت أن تتناول جرعة تناولها حالما تتذكر ، ومع ذلك ، إذا أوشك وقت الجرعة التالية ، قم بإلغاء الجرعة المنسية ، وقم بالعودة إلى الجدول الزمني للجرعات العادية ، لا تتناول جرعة مضاعفة لتعويض الجرعة المنسية .

مثل جمیع الأدویة، یمكن أن یتسبب ھذا الدواء في آثار جانبیة، على الرغم من أنھا لا تؤثر في الجمیع.
إذا زادت حدة أي من الآثار الجانبیة وأصبحت خطیرة أو إذا لاحظت أي آثار جانبیة غیر مدرجة في ھذه النشرة، یرجى إخبار الطبیب أو الصیدلي.
یمكنك تقلیل مخاطر الآثار الجانبیة عن طریق تناول أقل كمیة من الأقراص لأقصر قدر من الوقت اللازم للسیطرة على الأعراض الخاصة بك.
یجب التوقف عن تناول أقراص بروفین وطلب المساعدة الطبیة الفوریة إذا واجھت:

• علامات التھاب السحایا العقیم مثل الصداع الشدید، وارتفاع درجة الحرارة، تصلب في الرقبة أو عدم تحمل الضوء الساطع.
• علامات نزیف الأمعاء مثل
- إخراج الدم في البراز
- إخراج براز أسود
- تقیؤ دموي وجسیمات داكنة تبدو كالقھوة

أخبر طبیبك وتوقف عن تناول أقراص بروفین إذا كنت تواجھ:
• ألم غیر مبرر في المعدة (ألم في البطن) أو أعراض أخرى غیر طبیعیة في المعدة، وعسر الھضم، وحرقة، والشعور بالمرض و / أو التقیؤ.
• صوت صفیر بالتنفس غیر مفسر أو ضیق التنفس أو طفح جلدي أو حكة أو كدمات (قد تكون ھذه أعراض رد فعل تحسسي).
• فقدان البصر وعدم وضوح الرؤیة أو اضطراب (ضعف البصر) أو رؤیة / سماع أشیاء غریبة (الھلوسة).

انتشار الطفح الجلدي الشديد (متلازمة ستيفنز جونسون وحمامي متعدد الأشكال ، وتشمل الأعراض طفح جلدي حاد ، وتورم الجلد ، بما في ذلك داخل الفم والأنف والأعضاء التناسلية ، فضلا عن تقشير الجلد الذي قد يصاحبه أعراض مثل الألم ، والصداع ، والحمى) .

• یمكن حدوث تفاعل جلدي شدید یسمى متلازمة الطفح الجلد الدوائي المصحوب بكثرة الیوزینیات والأعراض الجھازیة (DRESS) تتضمن أعراض متلازمة الطفح الجلد الدوائي المصحوب بكثرة الیوزینیات والأعراض الجھازیة (DRESS) ما یلي: الطفح الجلدي، والحمى، وتورم العقد اللمفاویة، وزیادة الیوزینیات (نوع من خلایا الدم البیضاء).

وقد ارتبط تناول بعض الأدویة مثل أقراص بروفین مع زیادة خطر ارتفاع ضغط الدم، والأزمة القلبیة (احتشاء عضلة القلب)، والسكتة الدماغیة أو
الفشل القلبي.

وقد ارتبط تناول أقراص بروفین أیضا بمشاكل شدیدة في الجلد للمرضى الذین یعانون من جدري الماء أو القوباء المنطقیة.

اضطرابات الدم مثل نقص أعداد خلایا الدم الحمراء والصفائح وتتضمن علاماتھا الأولى ما یلي: ارتفاع درجة الحرارة، وألم الحلق، وتقرحات الفم،
والأعراض الشبیھة بالأنفلونزا، والنزیف من الفم والأنف والأذن والجلد. مشكلات الكلى مثل نقص الوظیفة الكلویة، واحتباس السوائل (الوذمة)،
والتھاب الكلیة والفشل الكلوي. قد تحدث في حالات نادرة مشكلات الكبد مثل التھاب الكبد، ونقص الوظیفة الكبدیة واصفرار العینین و/أو الجلد
(الیرقان) أو التفاعلات الجلدیة الشدیدة مع إیبروبروفین.
كما تبین أن بروفین أحیانا یؤدي إلى تفاقم أعراض مرض كرون أو التھاب القولون.

أعراض جانبیة أخرى
شائعة (قد تصیب ما یصل إلى شخص من أصل 10 أشخاص):
• الشعور بالدوار أو التعب

• الإسھال، والانتفاخ، والإمساك
• الصداع - إذا حدث ھذا أثناء تناولك لھذا الدواء من المھم عدم تناول أي أدویة أخرى للألم للمساعدة في ذلك.
• غیر شائع (قد تصیب ما یصل إلى شخص من أصل 100 شخص):
• الشعور بالنعاس
• الشعور بالقلق
• الشعور والإحساس بالوخز
• صعوبة النوم
• قشعریرة
• زیادة حساسیة الجلد للضوء
• مشاكل في السمع
• العطس، الزكام، حكة أو سیلان الأنف (الأنف)
• قرحة المعدة أو الأمعاء، حفرة في جدار الجھاز الھضمي
• التھاب بطانة المعدة
• رنین في الأذنین (طنین)
• الإحساس بالدوران (الدوار)
• قرحة الفم

نادر (قد تصیب ما یصل إلى شخص من أصل 1000 شخص):
• الشعور بالاكتئاب أو الاضطراب
نادرة جدا (قد تصیب ما یصل إلى شخص من أصل 10000 شخص):
• التھاب البنكریاس

غير معروفة (يتعذر تقديرها من البيانات المتاحة):

·         طفح جلدي قشري أحمر واسع الانتشار مصحوب بنتوءات تحت الجلد وبثور موضعية توجد بشكل رئيسي على طيات الجلد، والجذع، والأطراف العلوية مصحوبة بالحمى في بدء العلاج (داء البثور العام الحاد ذو الطفح الجلدي الظاهر). أوقف استخدام أقراص بروفين إذا أصبت بهذه الأعراض والتمس الرعاية الطبية على الفور. انظر أيضًا قسم  2.

إذا زادت حدة  أي من هذه الأعراض الجانبية ، أو لاحظت ظهور أعراض جانبية غير ما تم ذكره في هذه النشرة ، يرجى إبلاغ الطبيب المعالج أو الصيدلي . وهذا يشمل أي آثار جانبية محتملة غير مدرجة في هذه النشرة . بالإبلاغ عن الآثار الجانبية يمكنك المساعدة في توفير مزيد من المعلومات حول أمان هذا الدواء .

للإبلاغ عن الأعراض الجانبية

-          المركز الوطني للتيقظ والسلامة الدوائية (NPC)

o      فاكس 7662-205-11-966+

o      مركز الاتصال: 19999

o      البريد الإلكتروني: npc.drug@sfda.gov.sa

o      الموقع الإلكتروني: https://ade.sfda.gov.sa

 

 

• یحفظ بعیدا عن متناول أیدي الأطفال أو على مرأى منھم.
• بروفین 400 : یحفظ في درجة حرارة أقل من 25 درجة مئویة.
• بروفین 600 : یحفظ في درجة حرارة أقل من 25 درجة مئویة.
• یجب حفظ الأقراص داخل عبوتھا الأصلیة وذلك لحمایتھا من الرطوبة.

·      لا تستخدم بروفين أقراص بعد انتهاء تاريخ الصلاحية المذكور على العبوة الخارجية . تاريخ انتهاء الصلاحية يشير إلى اليوم الأخير من ذلك الشهر .

• لا ینبغي أن یتم التخلص من الأدویة في میاه الصرف الصحي أو عن طریق النفایات المنزلیة. اسأل الصیدلي عن كیفیة التخلص من الأدویة التي
لم تعد مطلوبة. ھذه التدابیر تساعد في الحفاظ على البیئة.

فترة الصلاحیة: 36 شھر

 

ما تحویھ علبة بروفین أقراص:
• المادة الفعالة ھي ایبوبروفین المتوافق مع دستور الأدویة الأوروبي. حیث یحتوي كل قرص على 400 ملغم أو 600 ملغم من ایبوبروفین.

·      الصواغات الأخرى:

السليلوز الجريزوفولفين ، كروسكارميلوس الصوديوم ، مونوهيدرات اللاكتوز، السيليكا الغروية اللامائية ، لوريل سلفات الصوديوم ، ستيرات المغنيسيوم ، أوباسبراي الأبيض كود (M-1- 7111 B) (التي تحتوي على هيبروميلوز 2910  وثاني أكسيد التيتانيوم) ، اللون الجاف ، أبيض كود (06A28611) (أو مزيج من أوباسبراي الأبيض M-1- 7111 B ، هيدروكسي بروبيلين والتلك) .

ما هو شكل بروفين أقراص ومحتويات العلبة؟

بروفين أقراص 400  ملغم عبارة عن أقراص ذات لون أرجواني فاتح مغلفة بطبقة من السكر ، ملمسها ناعم مع سطح لامع و مطبوع عليها 400 BRUFEN . وتحتوي كل علبة على 25 قرص .

بروفين أقراص 600  ملغم عبارة عن أقراص مستطيلة ، مغطاه بطبقة رقيقة ذات اللون الأبيض . وتحتوي كل علبة على 30 قرص .

صاحب حق التسویق:
أبوب لابوراتوریز لیمیتد،
أبوت ھاوس، فانوال بزنس بارك،
فانوال رود، میدینھید بیركشر، إس إل 4 6 إكس إي، المملكة المتحدة
المصنع:
ریكیت بنكایزر ھیلث كیر انترناشونال، نوتنغھام، المملكة المتحدة

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

Brufen® Tablets 400mg

Each Brufen tablet contains 400 mg Ibuprofen. For the full list of excipients, see section 6.1.

A light magenta coloured sugar coated tablet, smooth in texture with a polished surface and with 400 BRUFEN printed in black on one face

Brufen is indicated for its analgesic and anti-inflammatory effects in the treatment of rheumatoid arthritis
(including juvenile rheumatoid arthritis or Still's disease), ankylosing spondylitis, osteoarthritis and other
non-rheumatoid (seronegative) arthropathies.
In the treatment of non-articular rheumatic conditions, Brufen is indicated in periarticular conditions such
as frozen shoulder (capsulitis), bursitis, tendonitis, tenosynovitis and low back pain; Brufen can also be
used in soft tissue injuries such as sprains and strains.
Brufen is also indicated for its analgesic effect in the relief of mild to moderate pain such as
dysmenorrhoea, dental and post-operative pain and for symptomatic relief of headache, including
migraine headache.
Brufen antipyretic activity is effective in reducing fever.


Undesirable effects may be minimised by using the lowest effective dose for the shortest duration
necessary to control symptoms (see section 4.4).
Adults and children over 12 years of age: The recommended dosage of Brufen is 1200-1800 mg daily in
divided doses. Some patients can be maintained on 600-1200 mg daily. In severe or acute conditions, it
can be advantageous to increase the dosage until the acute phase is brought under control, provided
that the total daily dose does not exceed 2400 mg in divided doses.
Children: The daily dosage of Brufen is 20 mg/kg of body weight in
divided doses. For young children, more suitable formulations are
available.

In Juvenile Rheumatoid Arthritis, up to 40 mg/kg of body weight daily in divided doses may
be taken. Not recommended for children weighing less than 7 kg.
Elderly: The elderly are at increased risk of serious consequences of adverse reactions. If an NSAID is
considered necessary, the lowest effective dose should be used and for the shortest possible duration.
The patient should be monitored regularly for GI bleeding during NSAID therapy. If renal or hepatic
function is impaired, dosage should be assessed individually.
For oral administration. It is recommended that patients with sensitive stomachs take Brufen with food. If
taken shortly after eating, the onset of action of Brufen may be delayed. To be taken preferably with or
after food, with plenty of fluid. Brufen tablets should be swallowed whole and not chewed, broken,
crushed or sucked on to avoid oral discomfort and throat irritation.


Brufen is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. Brufen should not be used in patients who have previously shown hypersensitivity reactions (e.g. asthma, urticaria, angioedema or rhinitis) after taking ibuprofen, aspirin or other NSAIDs. Brufen is also contraindicated in patients with a history of gastrointestinal bleeding or perforation, related to previous NSAID therapy. Brufen should not be used in patients with active, or history of, recurrent peptic ulcer or gastrointestinal haemorrhage (two or more distinct episodes of proven ulceration or bleeding). Brufen should not be given to patients with conditions involving an increased tendency to bleeding. Brufen is contraindicated in patients with severe heart failure (NYHA Class IV), hepatic failure and renal failure (see section 4.4). Brufen is contraindicated during the last trimester of pregnancy (see section 4.6).

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration
necessary to control symptoms (see section 4.2, and GI and cardiovascular risks below).
Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucosegalactose
malabsorption should not take this medication.
As with other NSAIDs, ibuprofen may mask the signs of infection. which may lead to delayed initiation of appropriate treatment and thereby worsening the outcome of the infection. This has been observed in bacterial community acquired pneumonia and bacterial complications to varicella. When Brufen is administered for fever or pain relief in relation to infection, monitoring of infection is advised. In nonhospital settings, the patient should consult a doctor if symptoms persist or worsen.
The use of Brufen with concomitant NSAIDs, including cyclooxygenase-2 selective inhibitors, should be
avoided due to the increased risk of ulceration or bleeding (see section 4.5).
Elderly
The elderly have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal
bleeding and perforation, which may be fatal (see section 4.2).
Paediatric population
There is a risk of renal impairment in dehydrated children and adolescents.

Gastrointestinal bleeding, ulceration and perforation
GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at anytime
during treatment, with or without warning symptoms or a previous history of serious GI events.
The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a
history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), and in the
elderly. These patients should commence treatment on the lowest dose available. Combination therapy
with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these
patients, and also for patients requiring concomitant low dose aspirin, or other drugs likely to increase
gastrointestinal risk (see below and section 4.5).
Patients with a history of gastrointestinal disease, particularly when elderly, should report any unusual
abdominal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment.
Caution should be advised in patients receiving concomitant medications which could increase the risk of
ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotoninreuptake
inhibitors or anti- platelet agents such as aspirin (see section 4.5).

When GI bleeding or ulceration occurs in patients receiving Brufen, the treatment should be withdrawn.
NSAIDs should be given with care to patients with a history of ulcerative colitis or Crohn's disease as these
conditions may be exacerbated (see section 4.8).
Respiratory disorders and hypersensitivity reactions
Caution is required if Brufen is administered to patients suffering from, or with a previous history of,
bronchial asthma, chronic rhinitis or allergic diseases since NSAIDs have been reported to precipitate
bronchospasm, urticaria or angioedema in such patients.
Cardiac, renal and hepatic impairment
The administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and
precipitate renal failure. The habitual concomitant intake of various similar painkillers further increases
this risk. Patients at greatest risk of this reaction are those with impaired renal function, cardiac
impairment, liver dysfunction, those taking diuretics and the elderly. For these patients, use the lowest
effective dose, for the shortest possible duration and monitor renal function especially in long-term
treated patients (see also section 4.3).

Brufen should be given with care to patients with a history of heart failure or hypertension since oedema
has been reported in association with ibuprofen administration.
Cardiovascular and cerebrovascular effects
Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to
moderate congestive heart failure as fluid retention and oedema have been reported in association with
NSAID therapy.
Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400 mg/ day) may be
associated with a small increased risk of arterial thrombotic events such as myocardial infarction or
stroke. Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g. ≤ 1200mg/day) is
associated with an increased risk of arterial thrombotic events.
Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischaemic
heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with
ibuprofen after careful consideration and high doses (2400mg/day) should be avoided. Careful
consideration should also be exercised before initiating long-term treatment of patients with risk factors
for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if
high doses of ibuprofen (2400mg/day) are required.

Renal effects
Caution should be used when initiating treatment with ibuprofen in patients with considerable dehydration.
As with other NSAIDs, long-term administration of ibuprofen has resulted in renal papillary necrosis and
other renal pathologic changes. Renal toxicity has also been seen in patients in whom renal
prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients,
administration of an NSAID may cause a dose- dependant reduction in prostaglandin formation and,
secondarily, in renal blood flow, which may cause renal failure. Patients at greatest risk of this reaction are
those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE
inhibitors and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment
state.
SLE and mixed connective tissue disease
In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders there may be
an increased risk of aseptic meningitis (see below and section 4.8).
Dermatological effects

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome,
and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see
section 4.8). Patients appear to be at highest risk of these reactions early in the course of therapy, the
onset of the reaction occurring within the first month of treatment in the majority of cases. Brufen should
be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Haematological effects
Ibuprofen, like other NSAIDs, can interfere with platelet aggregationand prolong bleeding time in normal
subjects.
Aseptic meningitis
Aseptic meningitis has been observed on rare occasions in patients on ibuprofen therapy. Although it is
probably more likely to occur in patients with systemic lupus erythematosus and related connective tissue
diseases, it has been reported in patients who do not have an underlying chronic disease.
Impaired female fertility
The use of Brufen may impair female fertility and is not recommended in women attempting to conceive.
In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of
Brufen should be considered.


Care should be taken in patients treated with any of the following drugs as interactions have been
reported in some patients.
Antihypertensives, beta-blockers and diuretics: NSAIDs may reduce the effect of anti-hypertensives, such
as ACE inhibitors, angiotensin-II receptor antagonists, beta-blockers and diuretics. Diuretics can also
increase the risk of nephrotoxicity of NSAIDs.
Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma cardiac
glycoside levels.
Cholestyramine; The concomitant administration of ibuprofen and cholestyramine may reduce the
absorption of ibuprofen in the gastrointestinal tract. However, the clinical significance is unknown.
Lithium: Decreased elimination of lithium.
Methotrexate: NSAIDs may inhibit the tubular secretion of methotrexate and reduce clearance of
methotrexate. Ciclosporin: Increased risk of nephrotoxicity.
Mifepristone: A decrease in the efficacy of the medicinal product can theoretically occur due to the
antiprostaglandin properties of NSAIDs. Limited evidence suggests that coadministration of NSAIDs on
the day of prostaglandin administration does not adversely influence the effects of mifepristone or the
prostaglandin on cervical ripening or uterine contractility and does not reduce the clinical efficacy of
medicinal termination of pregnancy.

Other analgesics and cyclooxygenase-2 selective inhibitors: Avoid concomitant use of two or more
NSAIDs, including Cox-2 inhibitors, as this may increase the risk of adverse effects (see section 4.4).
Aspirin (Acetylsalicylic acid): As with other products containing NSAIDs, concomitant administration of
ibuprofen and aspirin is not generally recommended because of the potential of increased adverse
effects.
Experimental data suggest that ibuprofen may competitively inhibit the effect of low dose aspirin on
platelet aggregation when they are dosed concomitantly. Although there are uncertainties regarding
extrapolation of these data to the clinical situation, the possibility that regular, long-term use of ibuprofen
may reduce the cardioprotective effect of low-dose acetylsalicylic acid cannot be excluded. No clinically
relevant effect is considered to be likely for occasional use (see section 5.1).

Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding with NSAIDs (see section 4.4).
Anticoagulants: NSAIDs may enhance the effects of anticoagulants, such as warfarin (see section 4.4).
Quinolone antibiotics: Animal data indicate that NSAIDs can increase the risk of convulsions associated
with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of
developing convulsions.
Sulfonylureas: NSAIDs may potentiate the effects of sulfonylurea medications. There have been rare
reports of hypoglycaemia in patients on sulfonylurea medications receiving ibuprofen.
Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal
bleeding with NSAIDs (see section 4.4).
Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.
Zidovudine: Increased risk of haematological toxicity when NSAIDs are given with zidovudine. There is
evidence of an increased risk of haemarthroses and haematoma in HIV(+) haemophiliacs receiving
concurrent treatment with zidovudine and ibuprofen.
Aminoglycosides: NSAIDs may decrease the excretion of
aminoglycosides. Herbal extracts: Ginkgo biloba may potentiate the
risk of bleeding with NSAIDs.

CYP2C9 Inhibitors: Concomitant administration of ibuprofen with CYP2C9 inhibitors may increase the
exposure to ibuprofen (CYP2C9 substrate). In a study with voriconazole and fluconazole (CYP2C9
inhibitors), an increased S(+)- ibuprofen exposure by approximately 80 to 100% has been shown.
Reduction of the ibuprofen dose should be considered when potent CYP2C9 inhibitors are administered
concomitantly, particularly when high-dose ibuprofen is administered with either voriconazole or
fluconazole.


Pregnancy
Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or embryo/foetal
development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac
malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor in early pregnancy.
The risk is believed to increase with dose and duration of therapy. In animals, the administration of a
prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation losses
and embryo/foetal lethality. In addition, increased incidences of various.

malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis
inhibitor during the organogenetic period.
During the first and second trimester of pregnancy, Brufen should not be given unless clearly necessary.
If Brufen is used by a woman attempting to conceive, or during the first or second trimester of
pregnancy, the dose should be kept as low and duration of treatment as short as possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to the
following:
• Cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension)
• Renal dysfunction, which may progress to renal failure with oligohydramnios.
At the end of pregnancy, prostaglandin synthesis inhibitors may expose the mother and the neonate to the
following:
• Possible prolongation of bleeding time
• Inhibition of uterine contractions, which may result in delayed or prolonged labour. Consequently, Brufen is contraindicated during the
third trimester of pregnancy.
Lactation
In the limited studies so far available, NSAIDs can appear in the breast milk in very low concentrations.
NSAIDs should, if possible, be avoided when breastfeeding.
See section 4.4 Special warnings and precautions for use, regarding female fertility.


Undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances are possible after
taking NSAIDs. If affected, patients should not drive or operate machinery.


Gastrointestinal disorders: The most commonly observed adverse events are gastrointestinal in nature.
Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur (see
section 4.4). Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena,
haematemesis, ulcerative stomatitis, gastrointestinal haemorrhage and exacerbation of colitis and
Crohn's disease (see section 4.4) have been reported following ibuprofen administration. Less frequently,
gastritis, duodenal ulcer, gastric ulcer and gastrointestinal perforation have been observed.
Immune system disorders: Hypersensitivity reactions have been reported following treatment with
NSAIDs. These may consist of (a) non-specific allergic reaction and anaphylaxis, (b) respiratory tract
reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin
disorders, including rashes of various types, pruritus, urticaria, purpura, angioedema and, very rarely,
erythema multiforme, bullous dermatoses (including Stevens- Johnson syndrome and toxic epidermal
necrolysis).
Cardiac disorders and vascular disorders: Oedema, hypertension and cardiac failure have been reported
in association with NSAID treatment. Clinical studies suggest that use of ibuprofen, particularly at high
dose (2400 mg/day) may be associated with a small increased risk of arterial thrombotic events such as
myocardial infarction or stroke (see section 4.4).

Infections and infestations: Rhinitis and aseptic meningitis (especially in patients with existing autoimmune
disorders, such as systemic lupus erythematosus and mixed connective tissue disease) with symptoms of
stiff neck, headache, nausea, vomiting, fever or disorientation (see section 4.4).
Exacerbation of infection-related inflammations coinciding with the use of NSAIDs has been described. If
signs of an infection occur or get worse during use of Ibuprofen the patient is therefore recommended to
go to a doctor without delay.
Skin and subcutaneous tissue disorders: In exceptional cases, severe skin infections and soft-tissue
complications may occur during a varicella infection (see also "Infections and infestations")
The following adverse reactions possibly related to ibuprofen and displayed by MedDRA frequency
convention and system organ classification. Frequency groupings are classified according to the
subsequent conventions: very common (≥1/10), 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) and Not known (cannot be estimated from
the available data).

 

System organ classFrequencyAdverse reaction
Infections and infestationsUncommonRhinitis
RareMeningitis aseptic (see section 4.4)
Blood and lymphatic system
disorders
RareLeukopenia, thrombocytopenia, neutropenia,
agranulocytosis, aplastic anaemia , haemolytic
anaemia
Immune system disordersRareAnaphylactic reaction
Psychiatric disordersUncommonInsomnia, anxiety
RareDepression, confusional state
Nervous system disordersCommonHeadache, dizziness
UncommonParaesthesia, somnolence
RareOptic neuritis
Eye disordersUncommonVisual impairment
RareToxic optic neuropathy
Ear and labyrinth disordersUncommonHearing impaired , tinnitus, vertigo
Respiratory, thoracic and
mediastinal disorders
UncommonAsthma, bronchospasm, dyspnoea
Gastrointestinal disordersCommonDyspepsia, diarrhoea, nausea, vomiting,
abdominal pain, flatulence, constipation,
melaena, haematemesis, gastrointestinal
haemorrhage
UncommonGastritis, duodenal ulcer, gastric ulcer, mouth
ulceration, gastrointestinal perforation
Very rarePancreatitis
Not knownExacerbation of Colitis and Crohn´s disease
Hepatobiliary disordersUncommonHepatitis, jaundice, hepatic function abnormal
Very RareHepatic failure
Skin and subcutaneous tissue
disorders
CommonRash
UncommonUrticaria, pruritus, purpura, angioedema,
photosensitivity reaction
Very rareSevere forms of skin reactions ( e.g. Erythema
multiforme, bullous reactions, including Stevens-
Johnson syndrome,and toxic epidermal
necrolysis)
Renal and urinary disordersUncommonNephrotoxity in various forms
e.g.Tubulointerstitial nephritis, nephrotic
syndrome and renal failure
General disorders and
administration site conditions
CommonFatigue
RareOedema
Cardiac disordersVery rareCardiac failure, myocardial infarction (also see
section 4.4)
 Very rareHypertension

 

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

 

To report any side effect(s):

National Pharmacovigilance Center (NPC)

o Fax: +966-11-205-7662

o SFDA Call Center: 19999

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

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


Toxicity
Signs and symptoms of toxicity have generally not been observed at doses below 100 mg/kg in children
or adults. However, supportive care may be needed in some cases. Children have been observed to
manifest signs and symptoms of toxicity after ingestion of 400 mg/kg or greater.
Symptoms
Most patients who have ingested significant amounts of ibuprofen will manifest symptoms within 4 to 6
hours. The most frequently reported symptoms of overdose include nausea, vomiting, abdominal pain,
lethargy and drowsiness. Central nervous system (CNS) effects include headache, tinnitus, dizziness,
convulsion, and loss of consciousness. Nystagmus, metabolic acidosis, hypothermia, renal effects,
gastrointestinal bleeding, coma, apnoea, diarrhoea and depression of the CNS and respiratory system
have also been rarely reported. Disorientation, excitation, fainting and cardiovascular toxicity, including
hypotension, bradycardia and tachycardia have been reported. In cases of significant overdose, renal
failure and liver damage are possible. Large overdoses are generally well tolerated when no other drugs
are being taken.

Therapeutic measures
Patients should be treated symptomatically as required. Within one hour of ingestion of a potentially toxic
amount, activated charcoal should be considered. Alternatively, in adults, gastric lavage should be
considered within one hour of ingestion of a potentially life-threatening overdose.
Good urine output should be ensured.
Renal and liver function should be closely monitored.
Patients should be observed for at least four hours after ingestion of potentially toxic amounts.
Frequent or prolonged convulsions should be treated with intravenous diazepam. Other measures may
be indicated by the patient's clinical condition.


Pharmacotherapeutic classification: Anti-inflammatory and antirheumatic products, nonsteroidal;
propionic acid derivatives.
ATC code: M01AE01

Ibuprofen is a propionic acid derivative with analgesic, anti-inflammatory and anti-pyretic activity. The
drug's therapeutic effects as an NSAID is thought to result from its inhibitory effect on the enzyme cyclooxygenase,
which results in a marked reduction in prostaglandin synthesis.
Experimental data suggest that ibuprofen may competitively inhibit the effect of low dose aspirin on
platelet aggregation when they are dosed concomitantly. Some pharmacodynamic studies show that
when single doses of ibuprofen 400mg were taken within 8 hours before or within 30 minutes after
immediate release aspirin dosing (81mg), a decreased effect of aspirin on the formation of thromboxane
or platelet aggregation occurred. Although there are uncertainties regarding extrapolation of these data
to the clinical situation, the possibility that regular, long- term use of ibuprofen may reduce the
cardioprotective effect of low-dose acetylsalicylic acid cannot be excluded. No clinically relevant effect is
considered to be likely for occasional ibuprofen use. (see section 4.5)


Ibuprofen is rapidly absorbed from the gastrointestinal tract, peak serum concentrations occurring 1-2
hours after administration. The elimination half-life is approximately 2 hours.
Ibuprofen is metabolised in the liver to two inactive metabolites and these, together with unchanged
ibuprofen, are excreted by the kidney either as such or as conjugates. Excretion by the kidney is both
rapid and complete.
Ibuprofen is extensively bound to plasma proteins.


Not applicable.


Tablet core: Ibuprofen, Stearic acid, Maize starch, Aerosil 200, Maize starch dried, Pregelled maize starch,
Varnish: Opaglos regular
Coating: Acacia spray dried, Calcium sulphate dihydrate, Refined sugar, Opalux pink AS 1537, Sodium
carboxymethylcellulose, Carnauba wax powder, Printing Ink Opacode S-1-277001 Black


Not applicable.


36 months

Store below 25°C, store in the original package.


HDPE bottle– pack size 25 tablets.


None.


Abbott Laboratories Limited Abbott House Vanwall Business Park Vanwall Road Maidenhead Berkshire SL6 4XE United Kingdom

September 2016
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