ANGUSTA Tablet Ref.[27660] Active ingredients: Misoprostol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Norgine Pharmaceuticals Limited, Norgine House, Widewater Place, Moorhall Road, Harefield, Uxbridge, UB9 6NS, UK

Product name and form

Angusta 25 microgram tablets.

Pharmaceutical Form

Tablet.

White, uncoated oval shaped tablets with the dimensions 7.5 × 4.5 mm with a score line on one side and plain on the other.The score line is not intended for breaking the tablet.

Qualitative and quantitative composition

Each tablet contains 25 micrograms misoprostol.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Misoprostol

Misoprostol is an analogue of naturally occurring prostaglandin E1 which promotes peptic ulcer healing and symptomatic relief. Misoprostol protects the gastroduodenal mucosa by inhibiting basal, stimulated and nocturnal acid secretion and by reducing the volume of gastric secretions, the proteolytic activity of the gastric fluid, and increasing bicarbonate and mucus secretion.

List of Excipients

Hypromellose
Cellulose, microcrystalline
Maize starch
Crospovidone
Croscarmellose sodium
Silica, colloidal anhydrous

Pack sizes and marketing

Angusta is available in a pack of double layer aluminium foil blister containing 8 tablets.

Marketing authorization holder

Norgine Pharmaceuticals Limited, Norgine House, Widewater Place, Moorhall Road, Harefield, Uxbridge, UB9 6NS, UK

Marketing authorization dates and numbers

PL 20011/0072

Date of first authorisation: 02 September 2020

Drugs

Drug Countries
ANGUSTA Austria, Estonia, Finland, France, Croatia, Ireland, Malta, Netherlands, Poland, Romania, United Kingdom

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