Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Clarithromycin
Rowex Ltd
J01FA; J01FA09
Clarithromycin
250 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Macrolides; clarithromycin
Marketed
2004-10-08
Health Products Regulatory Authority 05 April 2022 CRN00CS3L Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clorom 250 mg Film-Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 250 mg of clarithromycin. Excipients with known effect: Each film-coated tablet contains 6.8 mg of lactose and 0.13 mmol (3.06 mg) of sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet White, oblong, convex, coated tablets, scored on both faces. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Clorom is indicated in adults and adolescents 12 years and older for the treatment of the following bacterial infections, when caused by clarithromycin-susceptible bacteria (see section 4.4 and 5.1): Acute bacterial exacerbation of chronic bronchitis Mild to moderate community acquired pneumonia Acute bacterial sinusitis Bacterial pharyngitis Skin infections and soft tissue infections of mild to moderate severity, such as folliculitis, cellulitis and erysipelas Clorom can also be used in appropriate combination with antibacterial therapeutic regimes and an appropriate ulcer healing agent for the eradication of Helicobacter pylori in patients with Helicobacter pylori associated ulcers (see section 4.2). Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The dosage of clarithromycin depends on the clinical condition of the patient and has to be defined in any case by the physician. Adults and adolescents (12 years and older) The usual dosage is 250 mg twice daily. In severe infections, dosage can be increased to 500 mg twice daily. Children younger than 12 years Use of clarithromycin film-coated tablets is not recommended for children younger than 12 years. Use clarithromycin paediatric suspensions. Clinical trials have been conducted using clarithromycin pediatric suspension in Les hele dokumentet