Product Details

Product Information of Getzlox Intravenous 500mg Solution

What you need to know before you are given Getzlox solution for infusion

Do not have this medicine and tell your doctor 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 • you have ever had epilepsy PIL_Levofloxacin_5mg_ml_UK_Ver • you have ever had problems 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 • you are a child or a growing teenager • you are pregnant, might become pregnant, or think you may be pregnant • you are breast-feeding Do not have this medicine if any of the above applies to you. If you are not sure, talk to your doctor, nurse or pharmacist before you are given Levofloxacin. Warnings and precautions Before taking this medicine You should not take fluoroquinolone/quinolone antibacterial medicines, including Levofloxacin, 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 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, 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 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 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. 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. PIL_Levofloxacin_5mg_ml_UK_Ver 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, have been associated with very 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, depression, memory impairment, severe fatigue, and severe sleep disorders. If you experience any of these side effects after taking Levofloxacin, 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. Talk to your doctor, nurse or pharmacist before you are given Levofloxacin if: • you are 60 years of age or older • you are using corticosteroids, sometimes called steroids (see section “Other medicines and Levofloxacin”) • you have ever had a fit (seizure) • you have had damage to your brain due to a stroke or other brain injury • you have kidney problems • you have something known as ‘glucose- 6- phosphate dehydrogenase deficiency’. You are more likely to have serious problems with your blood when taking this medicine • you have ever had mental health problems • you have ever had heart problems. Caution should be taken when using this kind of medicine, if you were born with or have a family history of prolonged QT interval (seen on ECG, electrical recording of the heart), salt imbalance in the blood (especially low level of potassium or magnesium in the blood), a very slow heart rhythm (called ‘bradycardia’), a weak heart (heart failure), a history of heart attack (myocardial infarction), you are female or elderly or you are taking other medicines that result in abnormal ECG changes (see section ”Other medicines and Levofloxacin”) • you are diabetic • you have ever had liver problems • you have myasthenia gravis • you have been diagnosed with an enlargement or “bulge” of a large blood vessel (aortic aneurysm or large vessel peripheral aneurysm) • you have experienced a previous episode of aortic dissection (a tear in the aorta wall) • you have been diagnosed with leaking heart valves (heart valve regurgitation) • 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]) • you 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 applies to you, talk to your doctor, nurse or pharmacist before PIL_Levofloxacin_5mg_ml_UK_Ver being given Levofloxacin. Keep out of direct sunlight while having this medicine and for 2 days after you stop having it. This is because your skin will become much more sensitive to the sun and may burn, tingle or severely blister if you do not take the following precautions: • Make sure you use high factor sun cream • Always wear a hat and clothes which cover your arms and legs • Avoid sun beds Other medicines and Levofloxacin Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Levofloxacin can affect the way some other medicines work. Also, some medicines can affect the way Levofloxacin works. 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: • Corticosteroids, sometimes called steroids – used for inflammation. You may be more likely to have inflammation and/or rupture of your tendons • 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 • Non-steroidal anti-inflammatory drugs (NSAIDS) – used for pain and inflammation such as aspirin, ibuprofen, fenbufen, ketoprofen and indomethacin. You are more likely to have a fit (seizure) if taken with Levofloxacin • Cyclosporine – used after organ transplants. You may be more likely to get the side effects of cyclosporine • 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, and cimetidine – used for ulcers and heartburn. Special care should be taken when taking either of these medicines with Levofloxacin. If you have kidney problems, your doctor may want to give you a lower dose. Urine tests for opiates Urine tests may show ‘false-positive’ results for strong painkillers called ‘opiates’ in people having Levofloxacin. If your doctor has prescribed a urine test, tell your doctor you are having Levofloxacin. Tuberculosis tests This medicine may cause “false negative” results for some tests used in a laboratory to search for the bacteria causing tuberculosis. Pregnancy and breast-feeding Do not have this medicine if: • You are pregnant, might become pregnant or think you may be pregnant • You are breast-feeding or planning to breast-feed PIL_Levofloxacin_5mg_ml_UK_Ver Driving and using machines You may get side effects after being given 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 solution for infusion contains sodium This medicine contains 177 mg sodium (main component of cooking/table salt) in each 50 ml vial. This is equivalent to 8.85% of the recommended maximum daily dietary intake of sodium for an adult. This medicine contains 354 mg sodium (main component of cooking/table salt) in each 100 ml vial. This is equivalent to 17.7% of the recommended maximum daily dietary intake of sodium for an adult