País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
DUTASTERIDE
GlaxoSmithKline (Ireland) Limited
0.5 Milligram
Capsules, Soft
2004-12-17
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Duagen 0.5 mg soft capsules. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 0.5 mg dutasteride. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, soft. The capsules are opaque, yellow, oblong soft gelatin capsules imprinted with GX CE2 on one side in red ink. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH). Reduction in the risk of acute urinary retention (AUR) and surgery in patients with moderate to severe symptoms of BPH. For information on effects of treatment and patient populations studied in clinical trials please see section 5.1. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults (including elderly):_ The recommended dose of Duagen is one capsule (0.5 mg) taken orally once a day. The capsules should be swallowed whole and may be taken with or without food. Although an improvement may be observed at an early stage, it can take up to 6 months before a response to the treatment can be achieved. No dose adjustment is necessary in the elderly. _Renal impairment_ The effect of renal impairment on dutasteride pharmacokinetics has not been studied. No adjustment in dosage is anticipated for patients with renal impairment _(see section 5.2)._ _Hepatic impairment_ The effect of hepatic impairment on dutasteride pharmacokinetics has not been studied so caution should be used in patients with mild to moderate hepatic impairment _(see section 4.4 and section 5.2). _In patients with severe hepatic impairment, the use of dutasteride is contraindicated _(See section 4.3 Contraindications)._ 4.3 CONTRAINDICATIONS Duagen is contraindicated in: o women and children and adolescents _(s Llegiu el document complet