METEOSPASMYL Soft capsule Ref.[28249] Active ingredients: Alverine Simethicone

Source: Marketing Authorisation Holder  Revision Year: 2017  Publisher: Laboratoires MAYOLY SPINDLER, 6 Avenue de lEurope – B.P. 51, 78401 CHATOU CEDEX France, Standard: Tel.: +33(0) 134805555, Medical information: Tel.: +33(0) 134807260

Product name and form

METEOSPASMYL, soft capsule.

Pharmaceutical Form

Soft capsule.

Soft oblong capsule, size 6, shiny opaque white, containing a thick whitish suspension.

Qualitative and quantitative composition

Alverine citrate: 60.00 mg

Simeticone: 300.00 mg

For 1 soft capsule.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Alverine

Alverine is a drug used for functional gastrointestinal disorders. Alverine is a smooth muscle relaxant used to relieve cramps or spasms of the stomach and intestines. It acts directly on the muscle in the gut, causing it to relax. It is used in the treatment of irritable bowel syndrome. It has a role as an antispasmodic drug.

Simethicone

Simethicone is a chemically inert, non-systemic gastric defoaming agent that works by altering the elasticity of interfaces of mucus-embedded bubbles in the gastrointestinal tract. The gas bubbles are thus broken down or coalesced and in this form gas is more easily eliminated through eructation or passing flatus.

List of Excipients

Soft capsule shell: Gelatin, glycerol, titanium dioxide (E171).

Pack sizes and marketing

20, 30 or 40 soft capsules in blister packs (PVC/PE/PVDC-Aluminium).

20, 30 or 40 soft capsules in blister packs (PVC/Aluminium).

Not all pack sizes may be marketed.

Marketing authorization holder

Laboratoires MAYOLY SPINDLER, 6 Avenue de l’Europe – B.P. 51, 78401 CHATOU CEDEX – France, Standard: Tel.: +33(0) 134805555, Medical information: Tel.: +33(0) 134807260

Marketing authorization dates and numbers

34009 278 526 4 0: 20 soft capsules in blister packs (PVC/PE/PVDC-Aluminium)
34009 278 527 0 1: 30 soft capsules in blister packs (PVC/PE/PVDC-Aluminium)
34009 278 528 7 9: 40 soft capsules in blister packs (PVC/PE/PVDC-Aluminium)
34009 332 540 6 3: 20 soft capsules in blister packs PVC/Aluminium
34009 343 259 1 5: 30 soft capsules in blister packs PVC/Aluminium
34009 333 799 3 3: 40 soft capsules in blister packs PVC/Aluminium

Date of first authorisation: 05 June 1990
Date of latest renewal: 05 June 2010

Drugs

Drug Countries
METEOSPASMYL Ecuador, France, Hong Kong, Lithuania, Mexico, Poland, Romania, Singapore, Tunisia, Turkey

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