Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
FINASTERIDE
Teva Pharma B.V.
5 Milligram
Film Coated Tablet
2008-02-29
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Finasteride TEVA 5 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 5 mg finasteride. Excipient: One film-coated tablet contains 75 mg lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet White, round, biconvex, film-coated tablet, diameter 7 mm, embossed “F” and “5” on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Finasteride is indicated for the treatment and control of benign prostatic hyperplasia (BPH) to: - cause regression of the enlarged prostate, improve urinary flow and improve the symptoms associated with BPH - reduce the incidence of acute urinary retention and the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. Finasteride 5 mg tablets should be administered in patients with an enlarged prostate (prostate volume above ca. 40 ml). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral use only. The recommended dosage is one 5 mg tablet daily with or without food. The tablet should be swallowed whole and must not be divided or crushed (see section 6.6). Even though improvement can be seen within a short time, treatment for at least 6 months may be necessary in order to determine objectively whether a satisfactory response to treatment has been achieved. _Dosage in hepatic insufficiency_ There are no data available in patients with hepatic insufficiency (see section 4.4). _Dosage in renal insufficiency_ Dosage adjustments are not necessary in patients with varying degrees of renal insufficiency (with creatinine clearance down to as low as 9 ml/min) as in pharmacokinetic studies renal insufficiency was not found to affect the elimin Přečtěte si celý dokument