DUODART Capsule, hard Ref.[51037] Active ingredients: Dutasteride Tamsulosin

Source: Web Search Revision Year: 2022 Publisher: Manufacturer: Catalent Germany Schorndorf GmbH, Schorndorf, Germany License holder and importer: GlaxoSmithKline (Israel) Ltd., 25 Basel St., Petach Tikva

Product name and form

Duodart.

Pharmaceutical Form
Capsule, hard. Oblong, hard capsules with a brown body and an orange cap imprinted with GS 7CZ in black ink. Each hard capsule contains tamsulosin hydrochloride modified release pellets and one dutasteride soft gelatin capsule.

Qualitative and quantitative composition

Each hard capsule contains 0.5 mg dutasteride and 0.4 mg tamsulosin hydrochloride, (equivalent to 0.367 mg tamsulosin).

Excipients with known effect: Each capsule contains lecithin (which may contain soya oil) and Sunset Yellow (E 110). Each capsule contains ≤0.1 mg sunset yellow.

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Dutasteride	Dutasteride reduces circulating levels of dihydrotestosterone (DHT) by inhibiting both type 1 and type 2, 5α-reductase isoenzymes which are responsible for the conversion of testosterone to DHT.
Tamsulosin	Tamsulosin binds selectively and competitively to post-synaptic α₁-adrenoreceptors, prevailingly their subtypes designated α_1A and α_1D. Thus relaxation of smooth muscles of the prostate and urethra is achieved, which leads to a reduction of tonus and an improvement of the urinary flow.

List of Excipients
Hard Capsule Shell: Hypromellose Iron Oxide Red (E172) Titanium Dioxide (E171) Water, Purified Carrageenan (E407) Potassium Chloride FD&C Yellow 6 (E110) Carnauba Wax Maize Starch Contents in Dutasteride Soft Capsule: Mono-di-glycerides of caprylic/capric acid (MDC) Butylhydroxytoluene (BHT) Soft Capsule Shell: Gelatin Glycerol Titanium dioxide (E171) ferric oxide (E172) Triglycerides, medium chain Lecithin (may contain soya oil) Tamsulosin Pellets: Cellulose, Microcrystalline Methacrylic acid – ethyl acrylate copolymer 1:1 dispersion 30 per cent (also contains polysorbate 80 and sodium laurilsulfate) Talc Triethyl citrate Black Inks (SW-9010 or SW-9008): Shellac Iron Oxide Black (E172) Propylene Glycol Potassium Hydroxide (in Black Ink SW-9008 only)

Pack sizes and marketing

Opaque, white high density polyethylene (HDPE) bottles with polypropylene child-resistant closures with polyethylene-faced, foil induction heat-seal liners. The bottles contain either 7, 30, 90 capsules.

Marketing authorization holder

Manufacturer: Catalent Germany Schorndorf GmbH, Schorndorf, Germany

License holder and importer: GlaxoSmithKline (Israel) Ltd., 25 Basel St., Petach Tikva

Marketing authorization dates and numbers

146-34-33278

Drugs

Drug	Countries
DUODART	Austria, Australia, Cyprus, Ecuador, Spain, Finland, Hong Kong, Croatia, Israel, Nigeria, Poland, Romania, Singapore, South Africa

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