Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - dutasteride, quantity: 500 microgram - capsule, soft - excipient ingredients: butylated hydroxytoluene; iron oxide yellow; gelatin; titanium dioxide; glyceryl caprylate/caprate; glycerol; propylene glycol; butan-1-ol; isopropyl alcohol; iron oxide red; strong ammonia solution; simethicone; ethanol; shellac; sulfuric acid - this medicine is indicated for use as monotherapy for the management of symptomatic benign prostatic,hyperplasia (bph) or as combination therapy with an alpha blocker which is approved for use in bph and,which has been dose titrated in accordance with the relevant recommendations in the product information,for that alpha blocker.

United States - English - NLM (National Library of Medicine)

epic pharma, llc - dutasteride (unii: o0j6xjn02i) (dutasteride - unii:o0j6xjn02i) - dutasteride 0.5 mg - dutasteride capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (bph) in men with an enlarged prostate to: dutasteride capsules in combination with the alpha-adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic bph in men with an enlarged prostate. dutasteride capsules are not approved for the prevention of prostate cancer. dutasteride capsules are contraindicated for use in: risk summary dutasteride is contraindicated for use in pregnancy because it may cause harm to the male fetus [see contraindications (4)]. dutasteride is not indicated for use in women. dutasteridem is a 5 alpha-reductase inhibitor that prevents conversion of testosterone to dihydrotestosterone (dht), a hormone necessary for normal development of male genitalia. abnormalities in the genitalia of male fetuses is an expected physiological consequence of inhibition of this conversion. these results are similar to observations in male infants with genetic 5 alpha-reductase deficienc

Malta - English - Medicines Authority

teva pharma b.v. (utrecht) swensweg 5, 2031 ga haarlem, netherlands - dutasteride - soft capsule - dutasteride 0.5 mg - urologicals

Malta - English - Medicines Authority

galenicum health, s.l.u calle sant gabriel, 50 esplugues de llobregat 08950 barcelona, spain - dutasteride - soft capsule - dutasteride 0.5 mg - urologicals

Malta - English - Medicines Authority

galenicum health, s.l.u calle sant gabriel, 50 esplugues de llobregat 08950 barcelona, spain - dutasteride, tamsulosin hydrochloride - hard capsule - dutasteride 0.5 mg tamsulosin hydrochloride 0.4 mg - urologicals

Malta - English - Medicines Authority

galenicum health, s.l.u calle sant gabriel, 50 esplugues de llobregat 08950 barcelona, spain - dutasteride, tamsulosin hydrochloride - hard capsule - dutasteride 0.5 mg tamsulosin hydrochloride 0.4 mg - urologicals

Malta - English - Medicines Authority

sandoz pharmaceuticals d.d. verovškova ulica 57, si-1000 ljubljana, slovenia - dutasteride, tamsulosin hydrochloride - hard capsule - dutasteride 0.5 mg tamsulosin hydrochloride 0.4 mg - urologicals

Malta - English - Medicines Authority

biogaran 15, boulevard charles de gaulle, colombes 92700, france - dutasteride, tamsulosin hydrochloride - hard capsule - dutasteride 0.5 mg tamsulosin hydrochloride 0.4 mg - urologicals

Malta - English - Medicines Authority

accord healthcare ireland ltd euro house, euro business park, little island cork, t45 k857, ireland - dutasteride - soft capsule - dutasteride 0.5 mg - urologicals

United States - English - NLM (National Library of Medicine)

par pharmaceutical, inc. - dutasteride (unii: o0j6xjn02i) (dutasteride - unii:o0j6xjn02i), tamsulosin hydrochloride (unii: 11sv1951mr) (tamsulosin - unii:g3p28oml5i) - dutasteride 0.5 mg - dutasteride and tamsulosin hydrochloride capsules are indicated for the treatment of symptomatic bph in men with an enlarged prostate. dutasteride-containing products, including dutasteride and tamsulosin hydrochloride capsules, are not approved for the prevention of prostate cancer. dutasteride and tamsulosin hydrochloride capsules are contraindicated for use in: - pregnancy. dutasteride use is contraindicated in females who are pregnant. in animal reproduction and developmental toxicity studies, dutasteride inhibited development of male fetus external genitalia. therefore, dutasteride and tamsulosin hydrochloride capsules may cause fetal harm when administered to a pregnant female. [see warnings and precautions (5.6), use in specific populations (8.1) ] . - patients with previously demonstrated, clinically significant hypersensitivity (e.g., serious skin reactions, angioedema, urticaria, pruritus, respiratory symptoms) to dutasteride, other 5-alpha-reductase inhibitors, tamsulosin, or any other component o