PROSCAR Film-coated tablet Ref.[6839] Active ingredients: Finasteride

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, UK

Product name and form

PROSCAR 5mg film-coated Tablets (finasteride).

Pharmaceutical Form

Blue-coloured, apple-shaped, film-coated tablets marked ‘Proscar’ on one side and ‘MSD 72’ on the other.

Qualitative and quantitative composition

Each tablet contains 5 mg of finasteride.

Active Ingredient Description
Finasteride

Finasteride is a competitive inhibitor of human 5α-reductase, an intracellular enzyme which metabolises testosterone into the more potent androgen, dihydrotestosterone (DHT). In benign prostatic hyperplasia (BPH), enlargement of the prostate gland is dependent upon the conversion of testosterone to DHT within the prostate. Finasteride is highly effective in reducing circulating and intraprostatic DHT. Finasteride has no affinity for the androgen receptor.

List of Excipients

Cellulose, Microcrystalline (E460)
Docusate sodium
Lactose monohydrate
Magnesium stearate (E572)
Pregelatinised maize starch
Sodium starch glycollate Type A
Yellow iron oxide (E172)
Hydroxypropylcellulose (E463)
Indigo carmine aluminium lake (E132)
Hypromellose (E464)
Talc
Titanium dioxide (E171)

Pack sizes and marketing

Opaque PVC/PE/PVDC blisters lidded with aluminium foil; packs of 28 tablets.

Marketing authorization holder

Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, UK

Marketing authorization dates and numbers

PL 0025/0279

July 1997

Drugs

Drug Countries
PROSCAR Austria, Australia, Brazil, Canada, Germany, Ecuador, Spain, Finland, Hong Kong, Croatia, Ireland, Italy, Mexico, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

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