DUTASTERIDE Capsules Ref.[7224] Active ingredients: Dutasteride

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

Product name and form

Dutasteride 0.5 mg soft capsules.

Pharmaceutical Form

Capsule, soft.

The capsules are opaque, yellow, oblong soft gelatin capsules filled with an oily and yellowish liquid, without printing.

Soft capsules dimensions are: 19 ± 0.8 mm x 6.9 ± 0.4 mm

Qualitative and quantitative composition

Each soft capsule contains 0.5 mg dutasteride.

Excipient with known effect: Each soft capsule contains lecithin (which may contain soya oil).

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.

List of Excipients

Capsule contents:

Butylhydroxytoluene (E321)
Glycerol monocaprylocaprate type I

Capsule shell:

Gelatin
Glycerol
Titanium dioxide (E171)
Yellow iron oxide (E172)

Other ingredients:

Triglycerides, medium chain
Lecithin (may contain soya oil) (E-322)
Water, purified

Pack sizes and marketing

White opaque PVC/PVDC – Aluminium blisters containing 10, 30, 50, 60, 90 capsules and perforated blister packs of 10x1, 30x1, 50x1, 60x1 and 90x1 capsule.

Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

Marketing authorization dates and numbers

PL 20075/0423

23/09/2015

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