Malta - English - Medicines Authority

galenicum health, s.l. calle sant gabriel, 50 08950 esplugues de llobregat (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 - tamsulosin hydrochloride 0.4 mg dutasteride 0.5 mg - urologicals

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

sandoz pty ltd - tamsulosin hydrochloride, quantity: 400 microgram - tablet, modified release - excipient ingredients: quinoline yellow; purified talc; polyethylene oxide; cochineal; microcrystalline cellulose; magnesium stearate; hyprolose; butylated hydroxytoluene; macrogol 400; titanium dioxide; iron oxide black; hypromellose; colloidal anhydrous silica - for the relief of lower urinary tract symptoms (luts) associated with benign prostatic hyperplasia (bph).

Malta - English - 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

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 - doubluts is indicated for the management of moderate to severe symptomatic benign prostatic hyperplasia (bph).

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

aurobindo sa-nv - dutasteride 0,5 mg; tamsulosin hydrochloride 0,4 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)

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 - 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

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