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Sandoz Ltd

By Adeyanju Patrick at 4:19 pm, Sep 05, 2011

Levofloxacin 500 mg film-coated tablet

PACKAGE LEAFLET: INFORMATION FOR THE USER Levofloxacin 500 mg Film-coated Tablets
Levofloxacin

Read all of this leaflet carefully before you start taking this medicine. - 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Levofloxacin Tablets are and what they are used for 2. Before you take Levofloxacin Tablets 3. How to take Levofloxacin Tablets 4. Possible side effects 5. How to store Levofloxacin Tablets 6. Further information 1. WHAT LEVOFLOXACIN TABLETS ARE AND WHAT THEY ARE USED FOR Levofloxacin belong to a group of medicinal products called antibacterial agents of the quinolone class. It inhibits bacterial growth by affecting the bacterial enzyme system. Levofloxacin is used to treat mild to moderate infections in adults caused by bacteria sensitive to levofloxacin. Levofloxacin may be used to treat the following: Acute infection of the sinuses Acute aggravation of chronic bronchitis (inflammation of the bronchial mucous) Pneumonia (community-acquired) Complicated urinary tract infections including pyelonephritis (bacterial infection of the renal pelvis and tissue) Chronic infection of the prostate caused by bacteria Skin and tissue infection

Your doctor may have prescribed a different use. You should always follow your doctors instructions. 2. BEFORE YOU TAKE Do not take Levofloxacin Tablets if you:

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Sandoz Ltd Levofloxacin 500 mg film-coated tablet

are allergic (hypersensitive) to levofloxacin, other antibacterial agents of the quinolone class or any of the other ingredients of Levofloxacin Tablets. suffer from epilepsy. have had a history of tendon problems from using this type of medicine before. are pregnant. are breast-feeding

Levofloxacin must not be given to children and adolescents of growing age. Take special care with Levofloxacin Tablets You should contact your doctor if you: - experience symptoms of inflammation of tendons and tendon ruptures during the treatment in such case you might experience pain or swelling in the region of the affected tendon. It may be necessary to stop treatment if pain or swelling occurs. - experience diarrhoea, especially if you have severe, persistent and/or bloody diarrhoea. - have a tendency towards having fits. - suffer from a lack of glucose-6-phosphate dehydrogenase. - have impaired kidney function. Your doctor may have to adjust the dose. - are or have been psychotic or if you have a mental illness. You should speak to your doctor before you start taking levofloxacin. - have Myasthenia (condition that causes some muscles around your body to become weak and easily tired). To avoid hypersensitivity to light, do not stay out in strong sunlight and do not use artificial UV radiation. Monitoring and blood tests If you are elderly or if you are taking corticosteroids you will be monitored during treatment with levofloxacin. Special blood values will be measured if you are treated with levofloxacin and vitamin K antagonists (blood thinning medicine). Taking other medicines You should speak to your doctor before taking levofloxacin if you take: Iron preparations, magnesium- or aluminium-containing antacids (acid-reducing drugs). These should not be taken 2 hours before or after intake of levofloxacin. Sucralfate (for gastric ulcer). You should take these 2 hours after taking levofloxacin. Theophyline (for asthma), fenbufen or similar NSAID drugs (or other agents which lower the convulsion threshold). Probenecid (for metabolic disorders) or cimetidine (for gastric ulcer). Ciclosporin (immune suppression drug used e.g. in connection with transplants). Vitamin K antagonist (blood thinning drugs, e.g. warfarin). Special bloods values will be measured if you are treated with levofloxacin and vitamin K antagonists. Drugs known to prolong QT interval - caution is needed when taking some antiarrhytmics (drugs for irregular heart beat), antidepressants (a medicine for depression) or macrolides (used to treat certain infection).

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Sandoz Ltd Levofloxacin 500 mg film-coated tablet

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Taking Levofloxacin Tablets with food and drink Levofloxacin Tablets may be taken during or between meals. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine. Do not take levofloxacin if you are pregnant or if you are breast-feeding. Driving and using machines Levofloxacin may cause side effects which could impair your ability to operate machines or drive. These side effects may be dizziness, drowsiness or visual disturbances. Important information about some of the ingredients of Levofloxacin Tablets This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. 3. HOW TO TAKE LEVOFLOXACIN TABLETS Levofloxacin Tablets should be taken once or twice daily. The dosage depends on the type and severity of the infection and the sensitivity of the bacteria. Your doctor will tell you how much to take. Levofloxacin Tablets should be swallowed whole with a sufficient amount of liquid. They may be divided at the score line to adapt the dosage. Levofloxacin Tablets should be taken at least two hours before or after the intake of iron salts, antacids (acid-reducing drugs) and sucralfate (against gastric ulcer). Dosage in patients with normal renal function Area of use Acute infection of the sinuses Acute aggravation of chronic bronchitis Community-acquired pneumonia Complicated urinary tract infections including pyelonephritis Chronic infection of the prostate caused by bacteria Skin and soft tissue infections Dose and duration of treatment 500 mg once daily for 10-14 days 250-500 mg once daily for 7-10 days 500 mg once or twice daily for 7-14 days 250 mg* once daily for 7-10 days 500 mg once daily for 28 days 250 mg* once daily or 500 mg once or twice daily for 7-14 days

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Sandoz Ltd Levofloxacin 500 mg film-coated tablet

* may be increased in cases of severe infection Impaired kidney function: It is necessary to adjust the dose. You must follow your doctors instructions. Elderly: It is not necessary to adjust the dose. You must follow your doctors instructions. Impaired liver function: It is not necessary to adjust the dose. You must follow your doctors instructions. Children: Levofloxacin Tablets must not be given to children and adolescents of growing age. Always take Levofloxacin Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. If you take more Levofloxacin Tablets than you should Contact your doctor, the hospital or your pharmacist if you have taken more Levofloxacin Tablets than written in this leaflet or more than your doctor has prescribed. Symptoms of overdose: Confusion, dizziness, impaired consciousness, convulsions, nausea and damaged mucous membrane in the gastrointestinal tract. If you forget to take Levofloxacin Tablets If you forget to take a dose you should take it as soon as you remember unless it is time to take your next dose. If this happens, do not take the forgotten dose but take your usual dose at the correct time. Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this product, ask your doctor of pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, levofloxacin can cause side effects, although not everybody gets them. Very common: Common: Uncommon: Rare: Very rare: not konown: more than 1 user in 10 1 to 10 users in 100 1 to 10 users in 1,000 1 to 10 users in 10,000 less than 1 user in 10,000 frequency cannot be estimated from the available data

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Sandoz Ltd Levofloxacin 500 mg film-coated tablet

Common side effects: increase in blood levels of liver enzymes nausea, diarrhoea. Uncommon side: increase or decrease in number of white blood cells itching, rash loss of appetite, stomach upset (dyspepsia), vomiting or pain in the abdominal region, constipation, flatulence headache, dizziness, drowsiness, sleeping problems, nervousness blood test abnormalities due to liver or kidney problems general weakness fungal growth, growth of other resistant micro-organisms vertigo. Rare side effects: bloody diarrhoea which in very rare cases may be a sign of enterocolitis (inflammation of the bowel), including pseudomembranous colitis) general allergic reactions (anaphylactic / anaphylactoid reactions) (which may sometimes occur even after the first dose and which may develop fast within minutes or hours of intake) with symptoms such as wheals (urticaria) cramping of the bronchi and possibly severe breathing problems, as well as in very rare cases swelling of the skin and mucous membranes (e.g.in the face and throat) feeling like tingling, e.g. in the hands (paraesthesia), fits or convulsions and confusion may be experienced anxiety, depression, psychotic reactions, restlessness (agitation) abnormally rapid beating of the heart, abnormally low blood pressure tendon pain and inflammation (tendinitis), joint pain or muscule pain decrease in the number of blood platelets leading to a tendency to bruise and bleed easily Very rare side effects: sudden drop in blood pressure or collapse (shock). Such general allergic reactions may sometimes be preceded by e.g. mild skin reactions. circulatory collapse (anaphylactic like shock) tendon rupture (e.g.: Achiles tendon) as with other fluoroquinolones, this side effect may occur within 48 hours after starting the treatment and may be bilateral.Muscular weakness, which may be of special importance in patients with myasthenia gravis (a rare disease of the nervous system) inflammation of the liver disturbances of kidney function and occasional kidney failure which may be due to allergic kidney reactions (interstitial nephritis) severe decrease in the number of white blood cells (agranulocytosis) leading to symptoms such as recurrence or persistence of fever, sore throat and feeling more ill again fever, allergic inflammation of small blood vessels or allergic lung reactions hallucinations, psychotic reactions with risk of suicidal thoughts or actions

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Sandoz Ltd Levofloxacin 500 mg film-coated tablet

increased sensitivity of the skin to sun and ultraviolet light may also occur decrease in blood sugar to a low level (hypoglycaemia) which may be of special importance in patients treated for diabetes this medicine may trigger attacks of porphyria in patients with porphyria (a very rare metabolic disedase) vision and hearing disorders, disturbances to the taste and smell, numbness, disorders of movement, including walking difficulties. Isolated cases: allergic reactions, potentially serious (ranging from mild oedema to shock) severe blistering reactions of the skin and mucous membranes (Steven's Johnson syndrome), toxic epidermal necrolysis (Lyells' syndrome) and erythema exsudativum multiforme heart disorders, possibly leading to abnormal heart rhythm jaundice and severe liver disease, including liver failure (in patients with underlying diseases) muscle reactions with muscle cell damage (rhabdomyolisis) decrease in red blood cells (anaemia) due to blood cell damage, decrease in the number of all types of blood cells ringing or buzzing in the ears pain (chest or back pain, pain in hands and legs). Any antibacterial treatment that kills certain germs may lead to a disturbance of the microorganisms (bacteria / fungi) that are normally found in humans. Consequently, the number of other bacteria or fungi may increase, which in rare cases requires treatment. In rare or very rare cases other serious side effects may occur. If you would like to have some information about these side effects, please ask your doctor or pharmacist. Tell your doctor or pharmacist if you experience side effects which are persistent and uncomfortable. Some side effects may require treatment. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE LEVOFLOXACIN TABLETS Keep out of the reach and sight of children. This medicinal product does not require any special storage conditions. Do not use Levofloxacin Tablets after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

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Sandoz Ltd Levofloxacin 500 mg film-coated tablet

6. FURTHER INFORMATION What Levofloxacin Tablets contains The active substance is levofloxacin. Each tablet contains 500 mg of levofloxacin (as hemihydrate). The other ingredients are: Tablet core: Lactose monohydrate Povidone K30 Sodium starch glycolate (type A) Talc Silica, colloidal anhydrous Croscarmellose sodium Glycerol dibehenate Tablet coating: Hypromellose Hydroxypropylcellulose Macrogol 6000 Titanium dioxide (E 171) Iron oxide, yellow (E 172) Iron oxide, red (E 172) Talc What Levofloxacin Tablets looks like and contents of the pack Tablets are orange-pink, octagonal, biconvex and have a score-line on one side. PVC/TE/PVDC//Al blisters containing 1, 3, 4, 5, 7, 10, 14, 28, 200, 500 film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Sandoz Limited Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR. United Kingdom Manufacturers:

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Sandoz Ltd Levofloxacin 500 mg film-coated tablet

Lek Pharmaceuticals d.d. Verovkova 57 1526 Ljubljana Slovenia Or Salutas Pharma GmbH Otto-von-Guericke-Allee 1 39179 Barleben Germany Or Salutas Pharma GmbH Dieselstrasse 5 70839 Gerlingen Germany Or LEK S.A. ul. Podlipie 16 95-010 Strykw Poland Or LEK S.A. ul. Domaniewska 50 C, 02-672 Warszawa Poland This leaflet was last approved in 08/2011 (To be amended after approval)

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