Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
AZITHROMYCIN DIHYDRATE
Actavis Group PTC ehf
AZITHROMYCIN DIHYDRATE
500 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
PACKAGE LEAFLET: INFORMATION FOR THE USER AZITHROMYCIN ACTAVIS 250 MG, FILM-COATED TABLETS AZITHROMYCIN ACTAVIS 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 Azithromycin Actavis is and what it is used for 2. What you need to know before you take Azithromycin Actavis 3. How to take Azithromycin Actavis 4. Possible side effects 5. How to store Azithromycin Actavis 6. Contents of the pack and other information 1. WHAT AZITHROMYCIN ACTAVIS 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 _Chlamydia trachomatis _(bacteria)_ _ _ _ 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AZITHROMYCIN ACTAVIS DO NOT TAKE AZITHROMYCIN ACTAVIS IF: - you are ALLERGIC to azithromycin dihydrate, erythromycin or any macrolide or ketolide an read_full_document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Azithromycin Actavis 500 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Azithromycin Actavis 500 mg film-coated tablets contain 500 mg azithromycin (as dihydrate). Excipients with known effect: Each tablet contains 120 mg lactose anhydrous For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated Tablet 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 Azithromycin Actavis should be given as a single daily dose. Duration of the treatment for the different infection diseases is given below. The tablets can be taken with or without food. The tablets should be taken with ½ glass of water. _Children and adolescents with a body weight above 45 kg, adults and the elderly:_ The total dose is 1500 mg, administered as 500 mg once daily for 3 days. Alternatively, the same total dose (1500 mg) can be administered in a period of 5 days, 500 mg read_full_document