Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CLARITHROMYCIN
Teva Pharma B.V.
500 Milligram
Tablet Prolonged Release
2010-10-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clarie LA 500mg Prolonged-release Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Clarithromycin citrate equivalent to Clarithromycin 500mg Excipients: Each tablet contains lactose For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release tablet Yellow, oblong prolonged-release tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Clarie LA is indicated in the following infections caused by susceptible organisms: - Community acquired pneumonia - Acute exacerbation of chronic bronchitis - Acute bacterial sinusitis (adequately diagnosed) - Bacterial pharyngitis and tonsillitis - Skin and soft tissue infections (mild to moderate severity) Consideration should be given to official guidance on the appropriate use of antibacterial agents. Clarie LA is indicated in adults and children 12 years and older. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS: The usual recommended dosage of Clarie LA in adults is one 500 mg prolonged-release tablet daily to be taken with food. In more severe infections, the dosage can be increased to two 500 mg prolonged-release tablets taken as one dose daily. Dose must be taken at the same time every day. Tablets must be swallowed whole. The usual duration of treatment is 6 to 14 days. CHILDREN OLDER THAN 12 YEARS: As for adults. CHILDREN YOUNGER THAN 12 YEARS: Use of Clarie LA is not recommended for children younger than 12 years. Clarithromycin suspension should be used in this age group. PATIENTS WITH RENAL IMPAIRMENT: Clarie LA should not be used in patients with renal impairment (creatinine clearance less than 30 ml/min). Clarithromycin immediate-release tablets should be used in this patient population (see section 4.3). IRISH ME Read the complete document