BUSCOPAN COMPOSITUM Solution for injection Ref.[50745] Active ingredients: Butylscopolamine Metamizole sodium

Source: Web Search  Revision Year: 2021  Publisher: sanofi-aventis south africa (pty) ltd, 2 Bond Street, 1685, Midrand, SA

Product name and form

BUSCOPAN COMPOSITUM 20 mg/2,5 g injection.

Pharmaceutical Form

A clear, slightly yellowish solution free from physical impurities.

Qualitative and quantitative composition

Each 5 ml ampoule contains:

Metamizole sodium monohydrate: 2500 mg
Hyoscine butylbromide: 20 mg

For the full list of excipients, see section 6.1.

Active Ingredient Description
Butylscopolamine

Butylscopolamine is an antispasmodic agent which relaxes smooth muscle of the organs of the abdominal and pelvic cavities. It is believed to act predominantly on the intramural parasympathetic ganglia of these organs.

Metamizole sodium

Metamizole sodium is a pyrazolone derivative with analgesic, antipyretic and slight antiinflammatory and spasmolytic properties. It has the most potent analgesic effect of all the pyrazolone derivatives. As with other analgesics, its mechanism of action has not been elucidated in detail. It includes inhibition of prostaglandin synthesis (PGE1 and PGE2) and reversible inhibition of platelet aggregation. It inhibits cyclo-oxygenase and influences the effect of arachidonic acid.

List of Excipients

Water for injection
Tartaric acid

Pack sizes and marketing

Ampoules of 5 ml in boxes of three ampoules.

Marketing authorization holder

sanofi-aventis south africa (pty) ltd, 2 Bond Street, 1685, Midrand, SA

Marketing authorization dates and numbers

E/11.2/504

30 March 1994

Drugs

Drug Countries
BUSCAPINA COMPOSITUM Spain, Mexico

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