COMBODART Capsule, hard Ref.[10460] Active ingredients: Dutasteride Tamsulosin

Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: GlaxoSmithKline UK Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS Trading as: GlaxoSmithKline UK Limited

Product name and form

Combodart 0.5 mg / 0.4 mg hard capsules.

Pharmaceutical Form
Capsule, hard. Oblong, hard-shell 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 (E110). 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 Carrageenan (E407) Potassium Chloride Titanium Dioxide (E171) Iron Oxide Red (E172) Sunset Yellow (E110) Carnauba Wax Maize Starch Contents in Dutasteride Soft Capsule: Mono-di-glycerides of caprylic/capric acid Butylhydroxytoluene (E321) Soft Capsule Shell: Gelatin Glycerol Titanium dioxide (E171) Iron Oxide Yellow (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 Propylene Glycol Iron Oxide Black (E172) 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:

7 hard capsules in 40 ml bottle

30 hard capsules in 100 ml bottle

90 hard capsules in 200 ml bottle

Not all pack sizes may be marketed.

Marketing authorization holder

GlaxoSmithKline UK Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS

Trading as: GlaxoSmithKline UK Limited

Marketing authorization dates and numbers

PL 19494/0046

Date of first authorisation: 28 April 2010

Date of latest renewal: 11 June 2015

Drugs

Drug	Countries
COMBODART	Brazil, Estonia, France, Ireland, Lithuania, Malta, Mexico, Netherlands, United Kingdom

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