Država: Malta
Jezik: engleski
Izvor: Medicines Authority
AZITHROMYCIN
Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
J01FA10
AZITHROMYCIN 500 mg
FILM-COATED TABLET
AZITHROMYCIN 500 mg
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Withdrawn
2013-03-05
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ACTAZITH 250 MG, FILM-COATED TABLETS ACTAZITH 500 MG, FILM-COATED TABLETS Azithromycin 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. See section 4. WHAT IS IN THIS LEAFLET: 1. What Actazith is and what it is used for 2. What you need to know before you take Actazith 3. How to take Actazith 4. Possible side effects 5. How to store Actazith 6. Contents of the pack and other information 1. WHAT ACTAZITH IS AND WHAT IT IS USED FOR Azithromycin belongs to a group of medicines called macrolide antibiotics. Antibiotics are used to treat infections caused by micro-organisms like bacteria. Azithromycin is used for the treatment of certain infections caused by bacteria that are sensitive to it, such as: - chest, throat or nasal infections (such as bronchitis, pneumonia, tonsillitis, sore throat (pharyngitis) and sinusitis) - ear infections - skin and soft tissue infections, with exception of infected burn wounds e.g. - infection of the tube that carries urine from the bladder (urethra) or the neck of the womb (cervix) caused by _Chlamidia trachomatis _(bacteria)_ _ _ _ _ _ 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ACTAZITH DO NOT TAKE Pročitajte cijeli dokument
Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Actazith 250 mg, film-coated tablets Actazith 500 mg, film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Actazith 250 mg film-coated tablets contain 250 mg azithromycin (as dihydrate). Actazith 500 mg film-coated tablets contain 500 mg azithromycin (as dihydrate). Excipients with known effect: 250 mg: Each tablet contains 60 mg lactose anhydrous 500 mg: Each tablet contains 120 mg lactose anhydrous For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Film-coated tablet 250 mg: White to off-white oval, 6.7 x 13.5 mm, biconvex film-coated tablets marked “250” on one side and plain on the other side. 500 mg: White to off-white oval, 9.7 x 17.9 mm, biconvex film-coated tablets marked “500” on one side and plain on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Azithromycin is indicated for the following bacterial infections induced by micro-organisms susceptible to azithromycin (see sections 4.4 and 5.1): - Acute bacterial sinusitis (adequately diagnosed) - Acute bacterial otitis media (adequately diagnosed) - Pharyngitis, tonsillitis - Acute exacerbation of chronic bronchitis (adequately diagnosed) - Mild to moderately severe community acquired pneumonia - Infections of the skin and soft tissues of mild to moderate severity e.g. folliculitis, cellulitis, erysipelas - Uncomplicated Chlamydia trachomatis urethritis and cervicitis _ _ Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Actazith should be given as a single dail Pročitajte cijeli dokument