Țară: Malaezia
Limbă: engleză
Sursă: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CLARITHROMYCIN
ABBOTT LABORATORIES (M) SDN. BHD.
CLARITHROMYCIN
14 Tablets; 28 Tablets
AbbVie S.r.l
_Consumer Medication Information Leaflet (RiMUP) _ KLACID TABLET 500MG _Clarithromycin _ (500mg) 1 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. The full name of your medicine is KLACID ® TABLET 500MG. In this leaflet the shorter name Klacid ® is used. WHAT IS IN THIS LEAFLET 1. What Klacid ® is used for 2. How Klacid ® works 3. Before you use Klacid ® 4. How to use Klacid ® 5. While you are using Klacid ® 6. Side effect 7. Storage and Disposal of Klacid® 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 1. WHAT KLACID ® IS USED FOR Each Klacid ® tablet contains 500 mg of the active ingredient _clarithromycin_ . Klacid ® tablets are used to treat infections such as: 1. Chest infections such as bronchitis and pneumonia 2. Throat and sinus infections 3. Mild to moderate tisu infections, such as cellulitis, folliculitis and erysipelas 4. _Helicobacter pylori _ infection associated with duodenal ulcer Klacid 500mg Tablets is indicated in adults and children 12 years and older. 2. HOW KLACID ® WORKS Klacid belongs to a group of medicines called macrolide antibiotics. Antibiotics stop the growth of bacteria (bugs) which cause infections. 3. BEFORE YOU USE KLACID ® - Do not take Klacid if you are taking any of the following medicines: domperidone (used for nausea & vomiting). DO NOT TAKE KLACID ® TABLETS IF YOU; • know that you are ALLERGIC to _clarithromycin_ , side antibiotics such as erythromycin or azithromycin, or any of the other ingredients in the tablets. • are taking medicines ca Citiți documentul complet
1. NAME OF THE MEDICINAL PRODUCT Klacid ® Tablet 500 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 500 mg Clarithromycin. Tablet sodium content: 6.1mg per tablet For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL DESCRIPTION A pale yellow, ovaloid, film-coated immediate release tablet containing 500 mg of clarithromycin as active substance 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Clarithromycin is indicated for treatment of infections due to susceptible organisms in adults and children 12 years and older. Such infections include: • Treatment of infections caused by pathogens sensitive to Clarithromycin. • Infection of nose-pharynx tract (tonsillitis, pharyngitis) and of paranasal sinuses. • Infections of lower respiratory tract: bronchitis, bacterial pneumonia and atypical pneumonia. • Skin infections: impetigo, erysipelas, folliculitis, furunculosis and septic wounds. • Eradication of H.pylori in patients with duodenal ulcers in the presence of acid suppression effected by omeprazole. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral use. _Adults _ The usual recommended dosage of clarithromycin in adults and children 12 years of age or older, is one 250mg tablet twice daily. In more severe infections, the dosage can be increased to 500mg twice daily. The usual duration of therapy is 5 to 14 days, excluding treatment of community acquired pneumonia and sinusitis which require 6 to 14 days of therapy. _Eradication of H.pylori in patients with duodenal ulcers _ Adults: The usual dose of Clarithromycin is 500 mg three times daily for 14 days. Dual therapy: Klacid should be administered with oral omeprazole 40 mg once daily. The pivotal study was conducted with omeprazole 40 mg once daily for 28 days. Supportive studies have been conducted with omeprazole 40 mg once daily for 14 days. Triple Therapy: Klacid 500 mg twice daily should be given with amoxycillin 1000mg twice daily and omeprazole 20 mg daily for 10 days. _Elderly: _ As for adults. _Renal impairm Citiți documentul complet