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

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

glaxosmithkline australia pty ltd - dutasteride, quantity: 500 microgram; tamsulosin hydrochloride, quantity: 400 microgram - capsule, modified release - excipient ingredients: maize starch; carrageenan; gelatin; purified talc; butylated hydroxytoluene; iron oxide yellow; titanium dioxide; iron oxide red; glycerol; medium chain triglycerides; potassium chloride; microcrystalline cellulose; methacrylic acid - ethyl acrylate copolymer (1:1); purified water; triethyl citrate; lecithin; glyceryl caprylate/caprate; sunset yellow fcf; carnauba wax; hypromellose; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; shellac; iron oxide black; simethicone; strong ammonia solution; potassium hydroxide - duodart is indicated for the management of moderate to severe symptomatic benign prostatic hyperplasia (bph).

Malta - English - Malta Medicines Authority

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

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

prasco laboratories - 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 category x. there are no adequate and well-controlled studies in pregnant women with the fixed-dose formulation of dutasteride and tamsulosin hydrochloride capsules or its individual components. dutasteride dutasteride is contraindicated for use in women of childbearing potential and during pregnancy. dutasteride is a 5-alpha-reductase inhibitor that prevents conversion of testosterone to dihydrotestosterone (dht), a hormone necessary for normal development of male genitalia. in animal reproduction and developmental toxicity studies, dutasteride inhibited normal development of external genitalia in male fetuses. therefore, dutasteride may

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

accord healthcare b.v. - dutasteride 0,5 mg; tamsulosin hydrochloride 0,4 mg - eq. tamsulosin 0,367 mg - capsule, hard - 0,5 mg - 0,4 mg - dutasteride 0.5 mg; tamsulosin hydrochloride 0.4 mg - tamsulosin and dutasteride

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

krka d.d. novo mesto d.d. - tamsulosin hydrochloride 0,4 mg - eq. tamsulosin 0,367 mg; dutasteride 0,5 mg - capsule, hard - 0,5 mg - 0,4 mg - dutasteride 0.5 mg; tamsulosin hydrochloride 0.4 mg - tamsulosin and dutasteride

Malta - English - Malta Medicines Authority

doc generici srl via turati, 40-20121, milano, italy - dutasteride, tamsulosin hydrochloride - hard capsule - tamsulosin hydrochloride 0.4 mg dutasteride 0.5 mg - urologicals

Malta - English - Malta Medicines Authority

farmoz-sociedade tecnico medicinal s.a. rue da tapada grande no 2, abrunheira 2710-089 sintra, portugal - dutasteride, tamsulosin hydrochloride - hard capsule - dutasteride 0.5 mg tamsulosin hydrochloride 0.4 mg - urologicals

Malta - English - Malta Medicines Authority

azure pharmaceuticals ltd 12 hamilton drive, the rock road, blackrock, co. louth a91 t997, ireland - dutasteride, tamsulosin hydrochloride - hard capsule - dutasteride 0.5 mg tamsulosin hydrochloride 0.4 mg - urologicals

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

zydus pharmaceuticals usa inc. - dutasteride (unii: o0j6xjn02i) (dutasteride - unii:o0j6xjn02i), tamsulosin hydrochloride (unii: 11sv1951mr) (tamsulosin - unii:g3p28oml5i) - 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 of