Země: Malta
Jazyk: angličtina
Zdroj: Medicines Authority
LEVOFLOXACIN
Beximco Pharma UK Ltd 102, College Road, Harrow HA1 1ES, United Kingdom
J01MA12
LEVOFLOXACIN 500 mg
FILM-COATED TABLET
LEVOFLOXACIN 500 mg
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Withdrawn
2015-12-04
1 PACKAGE LEAFLET: INFORMATION FOR THE USER LEVOFLOXACIN BEXIMCO 250 MG FILM-COATED TABLETS LEVOFLOXACIN BEXIMCO 500 MG FILM-COATED TABLETS Levofloxacin READ THIS ALL 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. See section 4. WHAT IS IN THIS LEAFLET: 1. What Levofloxacin BeximcoTablet is and what it is used for 2. What you need to know before you take Levofloxacin Beximco Tablet 3. How to take Levofloxacin BeximcoTablet 4. Possible side effects 5. How to store Levofloxacin Beximco Tablet 6. Contents of the pack and other information 1. WHAT LEVOFLOXACIN BEXIMCOTABLET IS AND WHAT IT IS USED FOR The name of your medicine is Levofloxacin Beximco tablets. Levofloxacin Beximco 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 BEXIMCO 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, Levofloxacin Beximco tablets may be used to lessen the chances of getting a pulmonary disease named anthrax or worsening of the disease after you are exposed to the bacteria causing anthrax. 2 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEVOFLOXACIN BEXIMCO TABLET DO NOT TAKE LEVOFLOXACI Přečtěte si celý dokument
Page 1 of 19 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Levofloxacin Beximco 250 mg film-coated tablets Levofloxacin Beximco 500 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 250/500 mg film-coated tablet contains 250/500 mg of levofloxacin as levofloxacin hemihydrate. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Film-coated tablet. Levofloxacin Beximco 250 mg film-coated tablets: Pink coloured, capsule shaped, biconvex, film coated tablet of about 13 mm in length and about 6 mm in width, with break line on both sides. Debossed ‘L’ and ‘F’ either side of the break line on one face. Levofloxacin Beximco 500 mg film-coated tablets: Pink coloured, capsule shaped, biconvex, film coated tablet of about 16 mm in length and about 8 mm in width, with break line on both sides. Debossed ‘L’ and ‘V’ either side of the break line on one face. The tablet can be divided into equal doses. 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 Beximco 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) Page 2 of 19 • Chronic bacterial prostatitis • Uncomplicated cystitis (see section 4.4) • Inhalation Anthrax: post exposure prophylaxis and curative treatment (see section 4.4) Levofloxacin Beximco 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 PO Přečtěte si celý dokument