TOPOGYNE Tablet Ref.[7773] Active ingredients: Misoprostol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2014  Publisher: EXELGYN, 216, Boulevard Saint-Germain, 75007 Paris, France

Product name and form

Topogyne 400 microgram tablets

Pharmaceutical Form

Tablet.

White, round, flat tablets, with a diameter of 11 mm and thickness of 4.4 mm, with “M400” engraved on one side.

Qualitative and quantitative composition

One tablet contains 400 microgram 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

Microcrystalline cellulose
Hypromellose
Sodium starch glycolate (type A)
Hydrogenated castor oil

Pack sizes and marketing

1, 4, 16 or 40 tablet per carton box.

Tablets are packed in perforated unit-dose PVC-PCTFE/Alu or OPA-Alu-PVC/Alu blister.

Not all pack sizes may be marketed.

Marketing authorization holder

EXELGYN, 216, Boulevard Saint-Germain, 75007 Paris, France

Marketing authorization dates and numbers

PL 16152/0003

18/01/2013

Drugs

Drug Countries
TOPOGYNE Austria, Estonia, Romania, United Kingdom

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