Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
FINASTERIDE
Helsinn Birex Therapeutics Ltd
5 Milligram
Film Coated Tablet
2008-09-26
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fintex 5 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg of the active ingredient Finasteride. Also contains 90.962mg of Lactose Monohydrate. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated Tablet. Blue, 7 mm, round biconvex, film-coated tablets marked “F5” on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 'Fintex' is indicated for the treatment and control of benign prostatic hyperplasia (BPH) and for the prevention of urologic events to: − reduce the risk of acute urinary retention − reduce the risk of surgery including transurethral resection of the prostate (TURP) and prostatectomy. 'Fintex' causes regression of the enlarged prostate, improves urinary flow and improves the symptoms associated with BPH. Patients with an enlarged prostate are the appropriate candidates for therapy with 'Fintex'. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The recommended dosage is one 5 mg tablet daily, with or without food. Although early improvement in symptoms may be seen, treatment for at least six months may be necessary to assess whether a beneficial response has been achieved. The risk of acute urinary retention is reduced within four months of treatment. Use in renal insufficiency No adjustment in dosage is required in patients with varying degrees of renal insufficiency (creatinine clearances as low as 9 ml/min), as pharmacokinetic studies did not indicate any change in the disposition of finasteride. Use in the elderly No dosage adjustment is required in elderly patients. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 24/08/2011_ _C Read the complete document