• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Moxifloxacin is and what it is used for
2. What you need to know before you take Moxifloxacin
3. How to take Moxifloxacin
4. Possible side effects
5. How to store Moxifloxacin
6. Contents of the pack and other information

• 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 previously had problems with your tendons 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 Moxifloxacin). This is because Moxifloxacin 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.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist.

Before taking this medicine

You should not take fluoroquinolone/quinolone antibacterial medicines, including Moxifloxacin, 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 Moxifloxacin

• Moxifloxacin 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 Moxifloxacin (see also sections Do not take Moxifloxacin and Other medicines and Moxifloxacin).
• 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 Moxifloxacin.
• If you have or have ever had any mental health problems, consult your doctor before taking Moxifloxacin.
• If you suffer from myasthenia gravis (abnormal muscle fatigue leading to weakness and in serious cases paralysis), taking Moxifloxacin 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, Ehlers-Danlos syndrome, Turner syndrome, Sjogrens 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 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 you whether Moxifloxacin 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 Moxifloxacin 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 Moxifloxacin. If there is no improvement in symptoms after 3 days of treatment, please consult your doctor.

When taking Moxifloxacin

• 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 Moxifloxacin and seek medical advice immediately.
• Prolonged, disabling and potentially irreversible serious side effects
  Fluoroquinolone/quinolone antibacterial medicines, including moxifloxacin, have been associated with rare but serious side effects, some of them being long lasting (continuing for 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, mental health effects which may include, but are not necessarily limited to, anxiety, panic attacks, confusion, or depression, memory impairment, severe fatigue, and severe sleep disorders. There are no medicines that have been established as being effective treatments for the symptoms of long lasting or disabling side effects associated with fluoroquinolones.
  If you experience any of these side effects after taking moxifloxacin, then do not take any further doses and contact your doctor immediately. You and your doctor will decide on whether to continue treatment, considering alternative options.
• You may experience psychiatric reactions when taking Moxifloxacin, including when taking it for the first time. If you suffer from depression or psychosis, your symptoms may become worse under treatment with Moxifloxacin. In rare cases, depression or psychosis can progress to thoughts of suicide or suicide attempts. If this happens, stop taking Moxifloxacin and contact your doctor immediately. You may not notice some changes in your mood and behaviour so it is very important to tell your friends and family that you are taking Moxifloxacin, and that there may be rare psychiatric side effects. Others may notice changes and help you quickly identify any symptoms that you need to talk to your doctor about.
• 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.
• Moxifloxacin may cause a rapid and severe inflammation of the liver which could lead to life threatening liver failure (including fatal cases, (see section 4. Possible side effects). If you suddenly feel unwell and/or are being sick and also have 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, Acute Generalised Exanthematous Pustulosis (AGEP) and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) 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.
  • DRESS appears initially as flu-like symptoms and a rash on the face then an extended rash with a high body temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes.
  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 Moxifloxacin, may cause convulsions. If this happens, stop taking Moxifloxacin 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 moxifloxacin and inform your doctor immediately in order to prevent the development of potentially irreversible condition.
• You may develop diarrhoea whilst or after taking antibiotics including Moxifloxacin. If this becomes severe or persistent or you notice that your stool contains blood or mucus you should stop taking Moxifloxacin 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 Moxifloxacin 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 moxifloxacin therapy. At the first sign of pain or inflammation of a tendon (for example in your ankle, wrist, elbow, shoulder or knee), stop taking moxifloxacin, 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 Moxifloxacin. 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 blood sugar levels 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 Moxifloxacin (see section 4. Possible side effects).
• The efficacy of Moxifloxacin 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.

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 Moxifloxacin).

Tell your doctor or pharmacist about any other medicines that you are taking, took recently or might take.

For Moxifloxacin, be aware of the following:

• If you are taking Moxifloxacin and other medicines that affect your heart there is an increased risk for altering your heart rhythm. Therefore, do not take Moxifloxacin together with the following medicines:
  • medicines that belong to the group of antiarrhythmics (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide) used to suppress abnormal rhythms of the heart
  • antipsychotics (e.g. phenothiazines, pimozide, sertindole, haloperidol, sultopride) used in the treatment of psychotic conditions such as schizophrenia or bipolar disorder
  • tricyclic antidepressants
  • some antimicrobials (e.g. saquinavir, sparfloxacin, intravenous erythromycin, pentamidine, antimalarials particularly halofantrine) used in the treatment of infections
  • some antihistamines (e.g. terfenadine, astemizole, mizolastine) used to treat allergic conditions
  • 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 Moxifloxacin.
• 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 Moxifloxacin tablets. Take your Moxifloxacin tablet 6 hours before or after taking the other medicine.
• Taking any medicine containing charcoal at the same time as Moxifloxacin tablets reduces the action of Moxifloxacin. 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.

Moxifloxacin can be taken with or without food (including dairy products).

Do not take Moxifloxacin if you are pregnant or breastfeeding.

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.

Moxifloxacin 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.

If you have been told by your doctor that you have an intolerance to some sugars, speak to your doctor before taking Moxifloxacin.

Moxifloxacin contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’.

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 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 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store. By reporting side effects, you can help provide more information on the safety of this medicine.

The active substance is moxifloxacin. Each film-coated tablet contains 400 mg of moxifloxacin hydrochloride.

The other ingredients are:

Tablet Core: Lactose Monohydrate, Povidone K29/32, Lactose (Anhydrous), Croscarmellose Sodium, Silica Colloidal (Anhydrous) and Magnesium Stearate.

Film coat: Hypromellose, Titanium dioxide (E171) Macrogol 400 and Iron Oxide Red (E172)

Each dull red film coated tablet is caplet shaped with a “M” debossed on one side and “400” on the other side.

Moxifloxacin tablets are available in blister packs of 5, 7, 14, and 10 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer¹