CYTOTEC Tablet Ref.[7772] Active ingredients: Misoprostol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom

Product name and form

Cytotec 200 microgram tablets.

Pharmaceutical Form


White to off-white hexagonal tablets scored both sides, engraved SEARLE 1461 on one side for oral administration.

Qualitative and quantitative composition

Each tablet contains 200 micrograms misoprostol.

For the full list of excipients, see section 6.1.

Active Ingredient Description

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
Sodium starch glycolate (Type A)
Hydrogenated castor oil

Pack sizes and marketing

Cold-formed aluminium blister packs of 56, 60, 112, 120 or 140 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom

Marketing authorization dates and numbers

PL 00057/0956

Date of first authorisation: 10 May 2002
Date of latest renewal: 24 June 2013


Drug Countries
CYTOTEC Ecuador, Estonia, Spain, Finland, Hong Kong, Ireland, Israel, Japan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Singapore, Turkey, United Kingdom, United States, South Africa

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