Product Details

What you need to know before you take Moxifloxacin

Contact your doctor if you are not sure if you belong to a patient group described below. Do not take Moxifloxacin · 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 Warnings and Precautions/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 (arrhythmias) or – if you are taking other medicines that result in certain 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 Warnings and precautions 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 and Other medicines and 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 or any member of your family have glucose-6-phosphate dehydrogenase deficiency (a rare hereditary disease), tell your doctor, who will advise 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 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. – If you have been diagnosed with an enlargement or “bulge” of a large blood vessel (aortic aneurysm or large vessel peripheral aneurysm). – If you have experienced a previous episode of aortic dissection (a tear in the aorta wall). – if you have been diagnosed with leaking heart valves (heart valve regurgitation). – If you have a family history of aortic aneurysm or aortic dissection or congenital heart valve disease, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome or Ehlers-Danlos syndrome, Turner syndrome, Sjögren’s syndrome [an inflammatory autoimmune disease], or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet’s disease, high blood pressure, or known atherosclerosis, rheumatoid arthritis [a disease of the joints] or endocarditis [an infection of the heart]). – If you are diabetic because you may experience a risk of change in blood sugar levels with moxifloxacin. – If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking moxifloxacin. When taking Moxifloxacin 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. 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. · 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. · Moxifloxacin 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). 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. · 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, Your risk is increased if you are elderly (above 60 years of age), have received an organ transplant, have kidney problems, or if you are being treated with corticosteroids. Inflammation and ruptures of tendons may occur within the first 48 hours of treatment and even up to several months after stopping of 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 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 (hyperglycaemia), 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. · 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. · 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. 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 Moxifloxacin). Other medicines and Moxifloxacin Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 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 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 [antiinflammatory 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. Take your Moxifloxacin 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 with food and drink. Moxifloxacin can be taken with or without food (including dairy products). Pregnancy, breast-feeding and fertility Do not take Moxifloxacin 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 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 machines. Moxifloxacin contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Moxifloxacin. Moxifloxacin contains Sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree’.