País: Malta
Idioma: anglès
Font: Medicines Authority
clarithromycin 500 mg
Abbott Laboratories Limited
J01FA09
clarithromycin
film-coated tablet
Authorised
2005-10-26
Page 1 of 8 KLACID 500 MG COATED TABLETS Clarithromycin PHARMACOTHERAPEUTIC CATEGORY Antibacterials for systemic use – Macrolides. THERAPEUTIC INDICATIONS Treatment of infections caused by pathogens susceptible to clarithromycin. Infections of the rhinopharyngeal tract (tonsillitis, pharyngitis), paranasal sinuses. Infections of the lower respiratory tract: bronchitis, bacterial pneumonia and atypical pneumonia. Infections of the skin: impetigo, erysipelas, folliculitis, furunculosis and infected wounds. Localised or diffuse mycobacterial infections caused by Mycobacterium avium or Mycobacterium intracellulare. Localised infections due to Mycobacterium chelonae, fortuitum or kansasii. In the presence of reduced gastric acidity, clarithromycin is indicated in the eradication of Helicobacter pylori, producing a consequent decrease in the recurrence of peptic ulcer. KLACID 500 mg coated tablets is indicated in adults and in children over the age of 12 years. KLACID 125 mg/5 ml granules for oral suspension is indicated in children from 6 months to 12 years of age CONTRAINDICATIONS Hypersensitivity to macrolide antibiotics or any of the excipients (see “Composition” section). The concomitant administration of clarithromycin is contraindicated with any of the following drugs: astemizole, cisapride, pimozide and terfenadine since they can induce prolongation of the QT interval and cardiac arrhythmias, including ventricular tachycardia, ventricular fibrillation and torsades de pointes. The concomitant administration of clarithromycin and ticagrelor or ranolazine is contraindicated. The concomitant administration of clarithromycin and ergot alkaloids Llegiu el document complet
Page 1 of 19 _ _ SUMMARY OF PRODUCT CHARACTERISTICS KLACID 1. NAME OF THE MEDICINAL PRODUCT KLACID 250 mg Coated Tablets KLACID 500 mg Coated Tablets KLACID 125 mg/5 ml Granules for Oral Suspension KLACID XL 500 mg Modified-Release Coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION - KLACID 250 mg Coated tablets: Each coated tablet contains: Active substance: clarithromycin 250 mg Sodium content: 3.4 mg per tablet - KLACID 500 mg Coated tablets: Each coated tablet contains: Active substance: clarithromycin 500 mg Sodium content: 6.1 mg per tablet - KLACID 125 mg/5 ml Granules for oral suspension: 100 ml of reconstituted suspension contains: Active substance: clarithromycin 2.50 g Excipients: sucrose 550 mg/ml castor oil: 3.2 mg/ml - KLACID XL 500 mg Modified-release tablets Each modified release tablet contains: Active substance: clarithromycin 500 mg Excipients: lactose 115 mg per tablet sodium content: 15.3 mg per tablet For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM - Coated tablets. - Granules for oral suspension. - Modified-release tablets. Page 2 of 19 _ _ 4. CLINICAL PARTICULARS 4.1. Therapeutic indications KLACID is indicated in adults and in children over the age of 12 years. KLACID 125 mg/5 ml granules for oral suspension is indicated in children from 6 months to 12 years of age For all pharmaceutical forms: Treatment of infections caused by pathogens susceptible to clarithromycin. Infections of the rhinopharyngeal tract (tonsillitis, pharyngitis), paranasal sinuses. Infections of the Llegiu el document complet