Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CLARITHROMYCIN
Pfizer Healthcare Ireland
250 Milligram
Film Coated Tablet
2011-06-29
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clarithromycin Pfizer 250mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 250 mg clarithromycin. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Light yellow coloured, oval shaped, biconvex film-coated tablets, with ‘D’ debossed on one side and ‘62’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Clarithromycin is indicated for the treatment of thefollowing infections caused by clarithromycin susceptible organisms (see sections 4.4 and 5.1). • Bacterial pharyngitis • Mild to moderate community-acquired pneumonia • Acute bacterial sinusitis (adequately diagnosed) • Acute exacerbation of chronic bronchitis • Skin and soft tissue infections of mild to moderate severity. • In appropriate combination with antibacterial therapeutic regimens and an appropriate ulcer healing medicinal product for the eradication of _Helicobacter pylori _in adult 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 Posology: The dosage of Clarithromycin film-coated tablets depends on the type and severity of the infection and has to be defined in any case by the physician. _ADULTS AND ADOLESCENTS:_ o Standard dosage: The usual dose is 250mg twice daily (in the morning and in the evening) o High dosage treatment (severe infections): The usual dose may be increased to 500 mg twice daily in severe infections. _ERADICATION OF HELICOBACTER PYLORI IN ADULTS:_ In patients with gastro-duodenal ulcers due to _Helicobacter pylori _infection clarithromycin is given in a dosa Read the complete document