Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
LEVOFLOXACIN HEMIHYDRATE
Teva Pharma B.V.
LEVOFLOXACIN HEMIHYDRATE
250 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
Withdrawn
2014-04-24
Copy of 1.3.1-Levofloxacin Teva-pil-clean 1 PACKAGE LEAFLET: INFORMATION FOR THE USER LEVOFLOXACIN TEVA 250 MG AND 500 MG FILM-COATED TABLETS Levofloxacin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - 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. WHATI IS INN THIS LEAFLET: 1. What Levofloxacin Teva is and what it is used for 2. What you need to know before you take Levofloxacin Teva 3. How to take Levofloxacin Teva 4. Possible side effects 5. How to store Levofloxacin Teva 6. Contents of the pack and other information 1. WHAT LEVOFLOXACIN TEVA IS AND WHAT IT IS USED FOR The name of your medicine is Levofloxacin Teva 250 mg or 500 mg Film-coated tablets contain a medicine called levofloxacin. This belongs to a group of medicines called antibiotics. Levofloxacin is a ‘quinolone’ antibiotic. It works by killing the bacteria that cause infections in your body. Levofloxacin Teva 250 mg or 500 mg Film-coated tablets can be used to treat infections of the: - Sinuses - Lungs, in people with long-term breathing problems or pneumonia - Urinary tract, including your kidneys or bladder - Prostate gland, where you have a long lasting infection - Skin and underneath the skin, including muscles. This is sometimes called ‘soft tissue’. In some special situations, Levoflo Прочетете целия документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Levofloxacin Teva 250 mg Film-Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 250 mg of levofloxacin corresponding to 256.23 mg of levofloxacin hemihydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Terra Cotta Pink, film-coated capsule shaped tablet, debossed with “LX” on the left hand side and “250” on the right side of the score on one side, scored and smooth on the opposite side. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Levofloxacin is indicated in adults for the treatment of the following infections (see sections 4.4 and 5.1): Acute bacterial sinusitis Acute exacerbations of chronic bronchitis Community-acquired pneumonia Complicated skin and soft tissue infections For the above-mentioned infections Levofloxacin should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections. Pyelonephritis and complicated urinary tract infections (see section 4.4) Chronic bacterial prostatitis Uncomplicated cystitis (see section 4.4) Inhalation Anthrax: postexposure prophylaxis and curative treatment (see section 4.4) Levofloxacin may also be used to complete a course of therapy in patients who have shown improvement during initial treatment with intravenous levofloxacin.Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Levofloxacin tablets are administered once or twice daily. The dosage depends on the type and severity of the infection and the sensitivity of the presumed causative pathogen. Levoflo Прочетете целия документ