Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
CLARITHROMYCIN CITRATE
McDermott Laboratories Ltd t/a Gerard Laboratories
CLARITHROMYCIN CITRATE
500 Milligram
Modified-release Tablets
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
PACKAGE LEAFLET: INFORMATION FOR THE USER Klariger LA 500 mg Modified-release Tablets (clarithromycin) 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 of the 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 Klariger LA is and what it is used for 2. What you need to know before you take Klariger LA 3. How to take Klariger LA 4. Possible side effects 5. How to store Klariger LA 6. Contents of the pack and other information 1. WHAT KLARIGER LA IS AND WHAT IT IS USED FOR Klariger LA is an antibiotic belonging to a group of medicines called the macrolides. Antibiotics stop the growth of bacteria (bugs), which cause infections. Klariger LA tablets are modified-release tablets, which means that the active ingredient is released slowly from the tablet so that you only have to take it once a day. Klariger LA is indicated in adults and children 12 years and older. Klariger LA is used to treat infections such as: • Chest infections such as bronchitis and pneumonia • Throat and sinus infections • Mild to moderate skin and tissue infections, such as folliculitis, cellulitis or erysipelas. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE KLARIGER LA DO NOT TAKE KLARIGER LA IF YOU: - If you are allergic (hypersensitive) t Прочитать полный документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Klariger LA 500 mg Modified-release Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500 mg of clarithromycin as clarithromycin citrate. Excipient(s) with known effect: Each tablet contains 283.1 mg of lactose (as lactose monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Modified-release tablets. Yellow coloured, oblong shaped, biconvex film-coated tablets of length 19.15 ± 0.2mm, width 8.95 ± 0.2mm and thickness 7.55 ± 0.2mm with both sides plain. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Klariger LA is indicated for the treatment of the following infections caused by clarithromycin susceptible bacteria. (see sections 4.4 and 5.1) • Acute bacterial exacerbation of chronic bronchitis. • Mild to moderate community-acquired pneumonia. • Acute bacterial sinusitis • Bacterial pharyngitis. • Skin and soft tissue infections of mild to moderate severity, for example; folliculitis, cellulites and erysipelas. Consideration should be given to official guidance on the appropriate use of antibacterial agents. Klariger LA is indicated in adults and children 12 years and older. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: _Adults:_ The usual recommended dosage of Klariger LA in adults is one 500 mg modified-release tablet daily to be taken with food. In severe infections, the dosage can be increased to two 500 mg modified-release tablets taken as one dose daily. Dose must be taken at the same time every day. Tablets must be swallowed whole. The usual duration of treatment is 6 to 14 days. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 16/04/2014_ _CRN 2145738 Прочитать полный документ