Product Details

Product Information of Levofloxacin 500mg Tablets

What you need to know before you take Levofloxacin tablets

Do not take Levofloxacin tablets if you:

• are allergic to levofloxacin, any other quinolone antibiotic such as moxifloxacin, ciprofloxacin or ofloxacin or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue • have ever had epilepsy • have ever had a problem with your tendons such as tendonitis that was related to treatment with a ‘quinolone antibiotic’. A tendon is the cord that joins your muscle to your skeleton • are a child or a growing teenager • are pregnant, might become pregnant or think you may be pregnant • are breast-feeding Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Levofloxacin tablets. Warnings and precautions Talk to your doctor or pharmacist before taking Levofloxacin tablets if you: • are 60 years of age or older • are using corticosteroids, sometimes called steroids (see section “Other medicines and Levofloxacin tablets”) • have ever had a fit (seizure) • have had damage to your brain due to a stroke or other brain injury • have kidney problems • have something known as ‘glucose – 6 – phosphate dehydrogenase deficiency’. You are more likely to have serious problems with your blood when taking this medicine • have ever had mental health problems • have ever had heart problems: caution should be taken when using this kind of medicine, if you were born with or have family history of prolonged QT interval (seen on ECG, electrical recording of the heart), have salt imbalance in the blood (especially low level of potassium or magnesium in the blood), have a very slow heart rhythm (called ‘bradycardia’), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), you are female or elderly or you are taking other medicines that result in abnormal ECG changes or are taking vitamin K antagonists (e.g. warfarin), due to a possible increase in coagulation tests and/or bleeding (see section “Other medicines and Levofloxacin tablets”) • are diabetic • have ever had liver problems • have myasthenia gravis • have been diagnosed with an enlargement or “bulge” of a large blood vessel (aortic aneurysm or large vessel peripheral aneurysm) • have experienced a previous episode of aortic dissection (a tear in the aorta wall) • have been diagnosed with leaking heart valves (heart valve regurgitation) • 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 vascular 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]) • have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking levofloxacin. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Levofloxacin tablets. Before taking this medicine You should not take fluoroquinolone/quinolone antibacterial medicines, including Levofloxacin tablets, 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. When taking this medicine • 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 Levofloxacin tablets therapy. At the first sign of pain or inflammation of a tendon (for example in your ankle, wrist, elbow, shoulder or knee), stop taking Levofloxacin tablets, contact your doctor and rest the painful area. Avoid any unnecessary exercise as this might increase the risk of a tendon rupture. • 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 Levofloxacin tablets and inform your doctor immediately in order to prevent the development of a potentially irreversible condition. If you feel sudden, severe pain in your abdomen, chest or back, which can be symptoms of aortic aneurysm and dissection, go immediately to a hospital accident and emergency department. 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. Serious skin reactions Serious skin reactions including Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with the use of levofloxacin. • 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. • 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 levofloxacin and contact your doctor or seek medical attention immediately. Prolonged, disabling and potentially irreversible serious side effects Fluoroquinolone/quinolone antibacterial medicines, including Levofloxacin tablets, 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 Levofloxacin tablets, 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. Children and adolescents This medicine must not be given to children or teenagers. Other medicines and Levofloxacin tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Levofloxacin tablets can affect the way some other medicines work. Also some medicinces can affect the way Levofloxacin tablets work. In particular, tell your doctor if you are taking any of the following medicines. This is because it can increase the chance of you getting side effects, when taken with Levofloxacin tablets: • Corticosteroids, sometimes called steroids – used for inflammation. You may be more likely to have inflammation and/or rupture of your tendons • Vitamin K antagonists such as Warfarin – used to thin the blood. You may be more likely to have a bleed. Your doctor may need to take regular blood tests to check how well your blood can clot • Theophylline – used for breathing problems. You are more likely to have a fit (seizure) if taken with Levofloxacin tablets • Non-steroidal anti-inflammatory drugs (NSAIDs) – used for pain and inflammation such as aspirin, ibuprofen, fenbufen, ketoprofen and indometacin. You are more likely to have a fit (seizure) if taken with Levofloxacin tablets • Ciclosporin – used after organ transplants. You may be more likely to get the side effects of ciclosporin • Medicines known to affect the way your heart beats. This includes medicines used for abnormal heart rhythm (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide and amiodarone), for depression (tricyclic antidepressants such as amitriptyline and imipramine), for psychiatric disorders (antipsychotics), and for bacterial infections (‘macrolide’ antibiotics such as erythromycin, azithromycin and clarithromycin) • Probenecid (used for gout) or cimetidine (used for ulcers and heartburn). Special care should be taken when taking either of these medicines with Levofloxacin tablets. If you have kidney problems, your doctor may want to give you a lower dose. Do not take Levofloxacin tablets at the same time as the following medicines. This is because it can affect the way Levofloxacin tablets work: • Iron tablets (for anaemia), zinc supplements, magnesium or aluminium-containing antacids (for acid or heartburn), didanosine, or sucralfate (for stomach ulcers). See section 3 “If you are already taking iron tablets, zinc supplements, antacids, didanosine or sucralfate” below. Urine tests for opiates Urine tests may show ‘false-positive’ results for strong painkillers called ‘opiates’ in people taking Levofloxacin tablets. If your doctor has prescribed a urine test, tell your doctor you are taking Levofloxacin tablets. Tuberculosis tests This medicine may cause “false negative” results for some tests used in laboratory to search for the bacteria causing tuberculosis. Pregnancy and breast-feeding Do not take this medicine if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby. Driving and using machines You may get side effects after taking this medicine, including feeling dizzy, sleepy, a spinning feeling (vertigo) or changes to your eyesight. Some of these side effects can affect you being able to concentrate and your reaction speed. If this happens, do not drive or carry out any work that requires a high level of attention. Levofloxacin tablets contain lactose If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product. Levofloxacin tablets contain sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.