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

actavis pharma, 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. 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 woman. if dutasteride and tamsulosin hydrochloride capsules are used during pregnancy, or if the patient becomes pregnant while taking dutasteride and tamsulosin hydrochloride capsules, the patient should be apprised of the potential hazard to the fetus [see warnings and precautions (5.6), use in specific populations (8.1)] . - women of childbearing potential [see warnings and precautions (5.6), use

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

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

aristo pharma gmbh wallenroder straße 8–10, 13435, berlin, germany - dutasteride, tamsulosin hydrochloride - hard capsule - dutasteride 0.5 mg tamsulosin hydrochloride 0.4 mg - urologicals

Malta - English - Medicines Authority

laboratorios q pharma, s.l c/ moratín, 15 entlo. oficinas 6-7, alicante 03008, spain - dutasteride, tamsulosin hydrochloride - hard capsule - dutasteride 0.5 mg tamsulosin hydrochloride 0.4 mg - urologicals

Malta - English - Medicines Authority

abanta pharma gmbh reichsstraße 78, 58840 plettenberg , germany - dutasteride, tamsulosin hydrochloride - hard capsule - dutasteride 0.5 mg tamsulosin hydrochloride 0.4 mg - urologicals

Malta - English - Medicines Authority

cande s.r.o. e. belluša 6752/4, piešany 92101, slovakia - dutasteride, tamsulosin hydrochloride - hard capsule - dutasteride 0.5 mg tamsulosin hydrochloride 0.4 mg - urologicals

Malta - English - Medicines Authority

pharmaceutical works polpharma sa 19 pelplinska steet, 83-200 starogard gdanski, poland - dutasteride, tamsulosin hydrochloride - hard capsule - tamsulosin hydrochloride 0.4 mg dutasteride 0.5 mg - urologicals

Malta - English - Medicines Authority

accord healthcare ireland ltd euro house, euro business park, little island cork, t45 k857, ireland - dutasteride, tamsulosin hydrochloride - hard capsule - dutasteride 0.5 mg tamsulosin hydrochloride 0.4 mg - urologicals