देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
CLARITHROMYCIN
Ranbaxy Ireland Limited
J01FA09
CLARITHROMYCIN
500 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
Macrolides
Transfer Pending
2006-10-20
Package leaflet: Information for the user: CLARITHROMYCIN 250MG FILM-COATED TABLETS CLARITHROMCYIN 500MG FILM-COATED TABLETS 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 CLARITHROMYCIN FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLARITHROMYCIN FILM-COATED TABLETS 3. HOW TO TAKE CLARITHROMYCIN FILM-COATED TABLETS 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE CLARITHROMYCIN FILM-COATED TABLETS 6. CONTENTS OF THE PACK AND OTHER INFORMATION _ _ 1. WHAT CLARITHROMYCIN FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR Clarithromycin is a macrolide antibiotic which is highly effective in the treatment of a variety of infections including: Throat and sinus infections, Chest infections such as bronchitis and pneumonia, Skin and soft tissue infections _Helicobacter pylori_ infections associated with duodenal ulcers Clarithromycin film-coated tablets are indicated in adults and children 12 years and older. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLARITHROMYCIN FILM-COATED TABLETS Do not take Clarithromycin Film-Coated Tablets if: - You are allergic to clarithromycin, other macrolides (similar antibiotics) or any of the other ingredients of this medicine ( listed पूरा दस्तावेज़ पढ़ें
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clarithromycin 500mg, Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains clarithromycin 500 mg. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated Tablet Light yellow coloured, oval shaped biconvex film-coated tablet, with “C” and “2” embossed on either side of a breakline on one side and notched on both sides. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Consideration should be given to official guidance on the appropriate use of antibacterial agents. Clarithromycin is indicated in adults and children 12 years and older: Clarithromycin Tablets are indicated for treatment of the following infections when caused by susceptible organisms. Indications include: Lower respiratory tract infections for example acute and chronic bronchitis, and pneumonia. Upper respiratory tract infections for example sinusitis and pharyngitis. Clarithromycin is appropriate for initial therapy in community acquired respiratory infections and has been shown to be active in vitro against common and atypical respiratory pathogens as listed in the microbiology section Clarithromycin is also indicated in skin and soft tissue infections of mild to moderate severity. Clarithromycin in the presence of acid suppression effected by omeprazole or lansoprazole is also indicated for the eradication of _H. pylori _in patients with duodenal ulcers. (See section 4.2, POSOLOGY AND METHOD OF ADMINISTRATION). Clarithromycin is usually active against the following organisms in vitro: Gram-positive Bacteria: _Staphylococcus aureus _(methicillin susceptible); _Streptococcus pyogenes _(Group A beta- hemolytic streptococci); alpha-hemolytic streptococci पूरा दस्तावेज़ पढ़ें