Moxifloxacin tablets contains moxifloxacin as the active ingredient, which belongs to a group of
antibiotics called fluoroquinolones. Moxifloxacin tablets works by killing bacteria that cause infections.
Moxiwar is used in patients aged 18 years and older for treating the following bacterial infections when
caused by bacteria against which moxifloxacin is active. Moxiwar should only be used to treat these
infections when usual antibiotics cannot be used or have not worked:
Infection of the sinuses, sudden worsening of long term inflammation of the airways or infection of the
lungs (pneumonia) acquired outside the hospital (except severe cases).
Mild to moderate infections of the female upper genital tract (pelvic inflammatory disease), including
infections of the fallopian tubes and infections of the uterus mucous membrane.
Moxiwar tablets are not sufficient for sole therapy of this kind of infection. and Therefore, another
antibiotic in addition to Moxiwar tablets should be prescribed by your doctor for the treatment of
infections of the female upper genital tract (see section 2. What you need to know before you take
Moxiwar, Warnings and precautions, Talk to your doctor before taking Moxiwar).
If the following bacterial infections have shown improvement during initial treatment with Moxiwar solution
for infusion, Moxiwar tablets may also be prescribed by your doctor to complete the course of therapy:
Infection of the lungs (pneumonia) acquired outside the hospital, infections of the skin and soft tissue.
Moxiwar tablets should not be used to initiate therapy for any type of infections of the skin and soft
tissue or in severe infections of the lungs.

Contact your doctor if you are not sure if you belong to a patient group described below.
Do not take Moxiwar
• If you are allergic to the active substance moxifloxacin, any other quinolone antibiotics or any of the
other ingredients of this medicine (listed in section 6.).
• If you are pregnant or are breast-feeding.
• If you are under 18 years of age.
• If you have a history of tendons disease or disorder which was related to treatment with quinolone
antibiotics (see section Warnings and Precautions … and section 4. Possible side effects).
• If you were born with or have
• any condition with abnormal heart rhythm (seen on ECG, electrical recording of the heart)
• a salt imbalance in the blood (especially low levels of potassium or magnesium in the blood)
• a very slow heart rhythm (called ‘bradycardia’)
• a weak heart (heart failure)
• a history of abnormal heart rhythms
or
• if you are taking other medicines that result in abnormal ECG changes (see section Other
medicines and Moxiwar). This is because Moxiwar can cause changes on the ECG, that is a
prolongation of the QT-interval, i.e., delayed conduction of electrical signals.
• If you have a severe liver disease or increased liver enzymes (transaminases) higher than 5 times
the upper normal limit.
Warnings and precautions
Before taking this medicine
You should not take fluoroquinolone/quinolone antibacterial medicines, including Moxiwar, 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 Moxiwar
• Moxiwar can change your heart’s ECG, especially if you are female, or if you are elderly. If you are
currently taking any medicine that decreases your blood potassium levels, consult your doctor
before taking Moxiwar (see also sections Do not take and Other medicines and Moxiwar).
• If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores
after taking moxifloxacin.
• If you suffer from epilepsy or a condition which makes you likely to have convulsions talk to your
doctor before taking Moxiwar.
• If you have or have ever had any mental health problems, consult your doctor before taking Moxiwar.
• If you suffer from myasthenia gravis (abnormal muscle fatigue leading to weakness and in serious
cases paralysis), taking Moxiwar may worsen the symptoms of your disease. If you think you are
affected consult your doctor immediately.
• 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, Behçet´s disease, high blood pressure, or
known atherosclerosis, rheumatoid arthritis [a disease of the joints] or endocarditis [an infection of the heart]).
• If you are diabetic because you may experience a risk of change in blood sugar levels with moxifloxacin.
• If you or any member of your family have glucose-6-phosphate dehydrogenase deficiency
(a rare hereditary disease), tell your doctor, who will advise whether Moxiwar is suitable for you.
• If you have a complicated infection of the female upper genital tract (e.g. associated with an
abscess of the fallopian tubes and ovaries or of the pelvis), for which your doctor considers an
intravenous treatment necessary, treatment with Moxiwar tablets is not appropriate.
• For the treatment of mild to moderate infections of the female upper genital tract your doctor
should prescribe another antibiotic in addition to Moxiwar. If there is no improvement in symptoms
after 3 days of treatment, please consult your doctor.

When taking Moxiwar
• If you experience palpitations or irregular heart beat during the period of treatment, you should
inform your doctor immediately. He/she may wish to perform an ECG to measure your heart rhythm.
• The risk of heart problems may increase with increase of the dose. Therefore, the recommended
dosage should be followed.
• There is a rare chance that you may experience a severe, sudden allergic reaction (an
anaphylactic reaction/shock) even with the first dose. Symptoms include tightness in the chest,
feeling dizzy, feeling sick or faint, or dizziness when standing up. If so, stop taking Moxiwar and
seek medical advice immediately.
• Moxiwar may cause a rapid and severe inflammation of the liver which could lead to lifethreatening
liver failure (including fatal cases, see section 4. Possible side effects). Please contact
your doctor before you continue the treatment If you develop signs such as rapidly feeling unwell and/or
are being sick associated with yellowing of the whites of the eyes, dark urine, itching of the skin, a
tendency to bleed or liver induced disease of the brain (symptoms of a reduced liver function or a rapid
and severe inflammation of the liver) please contact your doctor before taking any more tablets.
• Serious skin reactions
• Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute
generalised exanthematous pustulosis (AGEP) have been reported with the use of moxifloxacin.
• SJS/TEN can appear initially as reddish target-like spots or circular patches often with central
blisters on the trunk. Also, ulcers of mouth, throat, nose, genitals and eyes (red and swollen eyes)
can occur. These serious skin rashes are often preceded by fever and/or flu-like symptoms.
• The rashes may progress to widespread peeling of the skin and life-threatening complications or be fatal.
• AGEP appears at the initiation of treatment as a red, scaly widespread rash with bumps under
the skin and blisters accompanied by fever. The most common location: mainly localized on the
skin folds, trunk, and upper extremities.
• If you develop a serious rash or another of these skin symptoms, stop taking moxifloxacin and
contact your doctor or seek medical attention immediately.
• Quinolone antibiotics, including Moxiwar, may cause convulsions. If this happens, stop taking
Moxiwar and contact your doctor immediately.
• Prolonged, disabling and potentially irreversible serious side effects.
Fluoroquinolone/quinolone antibacterial medicines, including Moxiwar, 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 Moxiwar, 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.
• 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 Moxiwar and inform your doctor immediately in order to prevent the
development of potentially irreversible condition.
• You may experience mental health problems even when taking quinolone antibiotics, including
Moxiwar, for the first time. In very rare cases depression or mental health problems have led to
suicidal thoughts and self-injurious behaviour such as suicide attempts (see section 4. Possible side
effects). If you develop such reactions, stop taking Moxiwar and inform your doctor immediately.
• You may develop diarrhoea whilst or after taking antibiotics including Moxiwar. If this becomes
severe or persistent or you notice that your stool contains blood or mucus you should stop taking
Moxiwar immediately and consult your doctor. You should not take medicines that stop or slow
down bowel movement.
• Pain and swelling in the joints and inflammation or rupture of tendons may occur rarely (see
sections Do not take Moxiwar and 4. Possible side effects). 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 also taking corticosteroids. Inflammation and ruptures of tendons may occur within the first 48
hours of treatment and even up to several months after stopping of Moxiwar therapy. At the first sign
of pain or inflammation of a tendon (for example in your ankle, wrist, elbow, shoulder or knee), stop
taking Moxiwar, 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 are elderly and have kidney problems make sure that you drink plenty whilst taking Moxiwar.
• If you get dehydrated this may increase the risk of kidney failure.
• If your eyesight becomes impaired or if your eyes seem to be otherwise affected, consult an eye
specialist immediately (see sections Driving and using machines and 4. Possible side effects).
• Fluoroquinolone antibiotics may cause an increase of your disturbances in blood sugar level, above
normal levels (hyperglycemia), or lowering of your blood sugar levels below normal levels
(hypoglycaemia), potentially leading to loss of consciousness (hypoglycaemic coma) in severe cases (see
section 4. Possible side effects). If you suffer from diabetes, your blood sugar should be carefully monitored.
• Quinolone antibiotics may make your skin become more sensitive to sunlight or UV light. You
should avoid prolonged exposure to sunlight or strong sunlight and should not use a sunbed or any
other UV lamp while taking Moxiwar.
• The efficacy of Moxiwar in the treatment of severe burns, infections of deep tissue and diabetic foot
infections with osteomyelitis (infections of the bone marrow) has not been established.

Children and adolescents
Do not give this medicine to children and adolescents under the age of 18 because efficacy and safety
have not been established for this age group (see section Do not take Moxiwar).
Other medicines and Moxiwar
Tell your doctor or pharmacist about any other medicines that you are taking, took recently or might take.
For Moxiwar, be aware of the following:
• If you are taking Moxiwar and other medicines that affect your heart there is an increased risk for
altering your heart rhythm. Therefore, do not take Moxiwar together with the following medicines:
• medicines that belong to the group of anti-arrhythmics (e.g. quinidine, hydroquinidine,
disopyramide, amiodarone, sotalol, dofetilide, ibutilide)
• antipsychotics (e.g. phenothiazines, pimozide, sertindole, haloperidol, sultopride)
• tricyclic antidepressants
• some antimicrobials (e.g. saquinavir, sparfloxacin, intravenous erythromycin, pentamidine,
antimalarials particularly halofantrine)
• some antihistamines (e.g. terfenadine, astemizole, mizolastine)
• other medicines (e.g. cisapride, intravenous vincamine, bepridil and diphemanil).
• You must tell your doctor if you are taking other medicines that can lower your blood potassium levels
(e.g. some diuretics, some laxatives and enemas [high doses] or corticosteroids [anti-inflammatory
drugs], amphotericin B) or cause a slow heart rate because these can also increase the risk of
serious heart rhythm disturbances while taking Moxiwar.
• Any medicine containing magnesium or aluminium (such as antacids for indigestion), iron, zinc
or didanosine or any medicine containing sucralfate (to treat stomach disorders) can reduce the
action of Moxiwar tablets. Take your Moxiwar tablet 6 hours before or after taking the other medicine.
• Taking any medicine containing charcoal at the same time as Moxiwar tablets reduces the action of
Moxiwar. It is recommended that these medicines are not used together.
• If you are currently taking drugs to thin your blood (oral anti-coagulants such as warfarin), it may
be necessary for your doctor to monitor your blood clotting time.
Moxiwar with food and drink
Moxiwar can be taken with or without food (including dairy products).
Pregnancy, breast-feeding and fertility
Do not take Moxiwar if you are pregnant or 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.
Animal studies do not indicate that your fertility will be impaired by taking this medicine.
Driving and using machines
Moxiwar may make you feel dizzy or light-headed, you may experience a sudden, transient loss of
vision, or you may faint for a short period. If you are affected do not drive or operate machinery.
Moxiwar contains lactose and sodium
If you have been told by your doctor that you have an intolerance to some sugars, speak to your doctor
before taking Moxiwar.
This medicine contains less than 1 millimol sodium (23 milligramm) per film-coated tablet, that is to say
essentially “sodium-free”.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure how to take Moxifloxacin tablets.
The recommended dose for adults is one 400mg film-coated tablet once daily.
Moxiwar tablets are for oral use. Swallow the tablet whole (to mask the bitter taste) and with plenty of
liquid. You can take Moxiwar with or without food. It is recommended that you take the tablet at
approximately the same time each day.
The same dose can be taken by elderly patients, patients with a low bodyweight or in patients with
kidney problems.
The time you will take Moxiwar for depends on your infection. Unless your doctor tells you otherwise,
your treatment will be as follows:
• for sudden worsening of chronic bronchitis (acute exacerbation) exacerbation of chronic obstructive
pulmonary disease including bronchitis).
• for infection of the lungs (pneumonia) except for pneumonia which starts during a stay in hospital 10 days
• for acute infection of the sinuses (acute bacterial sinusitis) 7 days
• Mild to moderate infections of the female upper genital tract (pelvic inflammatory disease), including
infection of the fallopian tubes and infection of the uterus mucous membrane 14 days When
Moxiwar film-coated tablets are used to complete a course of therapy started with Moxiwar solution
for infusion, the recommended durations of use are:

of the fallopian tubes and infection of the uterus mucous membrane 14 days When
Moxiwar film-coated tablets are used to complete a course of therapy started with Moxiwar solution
for infusion, the recommended durations of use are:
• Infection of the lungs (pneumonia) acquired outside the hospital 7 -14 days
Most patients with pneumonia were switched to oral treatment with Moxiwar film-coated tablets
within 4 days.
• Infections of the skin and soft tissue 7 -21 days
Most patients with infections of the skin and soft tissue were switched to oral treatment with
Moxiwar film-coated tablets within 6 days.
It is important that you complete the course of treatment even if you begin to feel better after a few days.
If you stop taking Moxiwar too soon your infection may not be completely cured and the infection may return
or your condition may get worse. The bacteria causing your infection may become resistant to Moxiwar.
The recommended dose and duration of treatment should not be exceeded (see section 2. What you
need to know before you take Moxiwar, Warnings and precautions).
If you take more Moxiwar than you should
If you take more than the prescribed one tablet a day, get medical help immediately. Try to take any remaining
tablets, the packaging or this leaflet with you to show the doctor or pharmacist what you have taken.
If you forget to take Moxiwar
If you forget to take your tablet you should take it as soon as you remember on the same day. If
you do not remember on the same day, take your normal dose (one tablet) on the next day. Do not
take a double dose to make up for a forgotten dose.
If you are unsure about what to do ask your doctor or pharmacist.
If you stop taking Moxiwar
If you stop taking this medicine too soon your infection may not be completely cured. Talk to your
doctor if you wish to stop taking your tablets before the end of the course of treatment.
If you have any further questions about this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them. The most
serious side effects observed during treatment with Moxiwar are listed below:
If you notice
• an abnormal fast heart rhythm (rare side effect)
• that you suddenly start feeling unwell or notice yellowing of the whites of the eyes, dark urine, itching
of the skin, a tendency to bleed or disturbances of thought or wakefulness (these can be signs and
symptoms of fulminant inflammation of the liver potentially leading to life-threating liver failure (very rare
side effect, fatal cases have been observed) serious skin rashes including Stevens-Johnson syndrome
and toxic epidermal necrolysis. These can appear as reddish target-like macules or circular patches often
with central blisters on the trunk, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes and
can be preceded by fever and flu-like symptoms (very rare side effects, potentially life threatening)
• a red, scaly widespread rash with bumps under the skin and blisters accompanied by fever at
the initiation of treatment (acute generalised exanthematous pustulosis) (frequency of this side
effect is ‘not known’).
• syndrome associated with impaired water excretion and low levels of sodium (SIADH) (very rare
side effect).
• loss of consciousness due to severe decrease in blood sugar levels (hypoglycaemic coma) (very
rare side effect).
• inflammation of blood vessels (signs could be red spots on your skin, usually on your lower legs
or effects like joint pain) (very rare side effect).
• a severe, sudden generalised allergic reaction incl. very rarely a life-threatening shock (e.g. difficulty
in breathing, drop of blood pressure, fast pulse) (rare side effect)
• swelling incl. swelling of the airway (rare side effect, potentially life-threatening)
• convulsions (rare side effect)
• troubles associated with the nervous system such as pain, burning, tingling, numbness and/or
weakness in extremities (rare side effect)
• depression (in very rare cases leading to self-harm, such as suicidal ideations/thoughts, or suicide
attempts) (rare side effect)
• insanity (potentially leading to self-harm, such as suicidal ideations/thoughts, or suicide attempts)
(very rare side effect)
• severe diarrhoea containing blood and/or mucus (antibiotic associated colitis incl.
pseudomembranous colitis), which in very rare circumstances, may develop into complications that
are life-threatening (rare side effects)
• pain and swelling of the tendons (tendonitis) (rare side effect) or a tendon rupture (very rare side effect),
• muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell, have a
high temperature or have dark urine. They may be caused by an abnormal muscle breakdown
which can be life threatening and lead to kidney problems (a condition called rhabdomylosis)
(frequency of this side effect is ‘not known’).
Stop taking Moxiwar and tell your doctor immediately as you may need urgent medical advice.
In addition, if you notice
• transient loss of vision (very rare side effect),
• discomfort or pain to the eyes, especially due to light exposure (very rare to rare side effect)
contact an eye specialist immediately.
If you have experienced life-threatening irregular heart beat (Torsade de Pointes) or stopping of heart
beat while taking Moxiwar (very rare side effects), tell your treating doctor immediately that you
have taken Moxiwar and do not restart the treatment.
A worsening of the symptoms of myasthenia gravis has been observed in very rare cases. If this
happens, consult your doctor immediately.
If you suffer from diabetes and you notice that your blood sugar is increased or decreased (rare or very
rare side effect), inform your doctor immediately.
If you are elderly with existing kidney problems and you notice decrease in urine output, swelling in
your legs, ankles or feet, fatigue, nausea, drowsiness, shortness of breath or confusion (these can be
signs and symptoms of kidney failure, a rare side effect), consult your doctor immediately.
Other side effects which have been observed during treatment with Moxiwar are listed below by how
likely they are:

Common (may affect up to 1 in 10 people)
• nausea
• diarrhoea
• dizziness
• stomach and abdominal ache
• vomiting
• headache
• increase of a special liver enzyme in the blood (transaminases)
• infections caused by resistant bacteria or fungi e.g. oral and vaginal infections caused by Candida
• change of the heart rhythm (ECG) in patients with low blood potassium level
Uncommon (may affect up to 1 in 100 people)
• rash
• stomach upset (indigestion/heartburn)
• changes in taste (in very rare cases loss of taste)
• sleep problems (predominantly sleeplessness)
• increase of a special liver enzyme in the blood (gamma-glutamyl-transferase and/or alkaline phosphatase)
• low number of special white blood cells (leukocytes, neutrophils)
• constipation
• itching
• sensation of dizziness (spinning or falling over)
• sleepiness
• wind
• change of the heart rhythm (ECG)
• impaired liver function (incl. increase of a special liver enzyme in the blood (LDH))
• decreased appetite and food intake
• low white blood cells count
• aches and pains such as back, chest, pelvic and extremities pains
• increase of special blood cells necessary for blood clotting
• sweating
• increased specialised white blood cells (eosinophils)
• anxiety
• feeling unwell (predominantly weakness or tiredness)
• shaking
• joint pain
• palpitations
• irregular and fast heart beat
• difficulty in breathing incl. asthmatic conditions
• increase of a special digestive enzyme in the blood (amylase)
• restlessness / agitation
• tingling sensation (pins and needles) and/or numbness
• skin hives
• widening of blood vessels
• confusion and disorientation
• decrease of special blood cells necessary for blood clotting
• visual disturbances incl. double and blurred vision
• decreased blood clotting
• increased blood lipids (fats)
• low red blood cell count
• muscle pain
• allergic reaction
• increase of bilirubin in the blood
• inflammation of the stomach
• dehydration
• severe heart rhythm abnormalities
• dry skin
• angina pectoris
Rare (may affect up to 1 in 1,000 people)
• muscle twitching
• muscle cramp
• hallucination
• high blood pressure
• swelling (of the hands, feet, ankles, lips, mouth, throat)
• low blood pressure
• kidney impairment (incl. increase in special kidney laboratory test results like urea and creatinine)
• inflammation of the liver
• inflammation of the mouth
• ringing/noise in the ears
• jaundice (yellowing of the whites of the eyes or skin)
• impairment of skin sensation
• abnormal dreams
• disturbed concentration
• difficulty in swallowing
• changes in smell (incl. loss of smell)
• balance disorder and poor co-ordination (due to dizziness)
• partial or total loss of memory
• hearing impairment including deafness (usually reversible)
• increased blood uric acid
• emotional instability
• impaired speech
• fainting
• muscle weakness

Very rare (may affect up to 1 in 10,000 people)
• a drop in the number of red and white blood cells and platelets (pancytopenia)
• inflammation of joints
• abnormal heart rhythms
• increase of skin sensitivity
• a feeling of self-detachment (not being yourself)
• increased blood clotting
• muscle rigidity
• significant decrease of special white blood cells (agranulocytosis)
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 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, Warnings and precautions).
Furthermore, there have been very rare cases of the following side effects reported following treatment
with other quinolone antibiotics, which might possibly also occur during treatment with Moxiwar:
• Raised pressure in the skull (symptoms include headache, visual problems including blurred vision,
“blind” spots, double vision, loss of vision).
• Increased blood sodium levels
• Increased blood calcium levels
• A special type of reduced red blood cell count (haemolytic anaemia)
• Increased sensitivity of the skin to sunlight or UV light.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and on the carton after EXP. The
expiry date refers to the last day of that month.
Store below 30°C.
This medicinal product does not require any special storage conditions.
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.