Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
FINASTERIDE
Pfizer Healthcare Ireland
5 Milligram
Film Coated Tablet
2011-08-05
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Finasteride Pfizer 5 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 5 mg finasteride. Excipient: lactose monohydrate (97.5 mg). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Blue coloured, circular, biconvex, beveled edged film-coated tablets debossed with ‘E’ on one side and ‘61’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Finasteride Pfizer 5 mg 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 reduce need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. Finasteride Pfizer should be administered in patients with an enlarged prostate (prostate volume above ca. 40ml). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Finasteride Pfizer is for oral use only. DOSAGE IN ADULTS 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 THE ELDERLY Dosage adjustments are not necessary although pharmacokinetic studies have shown that the elimination rate of finasteride is slightly decreased in patients over the age of 70. DOSAGE IN HEPATIC INSUFFICIENCY There is no data available in patients with hepatic insufficiency (see section 4.4). DOSAGE IN RENAL Lesen Sie das vollständige Dokument