SPASMONAL Hard capsule Ref.[49655] Active ingredients: Alverine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Product name and form

SPASMONAL 60 mg.

Pharmaceutical Form

Hard capsules.

An opaque size 3 capsule with a grey cap and blue body, marked “SP 60”.

Qualitative and quantitative composition

Each capsule contains 60mg alverine citrate.

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.

List of Excipients

Maize starch
Magnesium stearate

Capsule Shell:

Gelatin, E132, E171, E172
Printing ink: Shellac, Black Iron Oxide (E172), Propylene Glycol

Pack sizes and marketing

Plastic containers of 20 or 100 capsules; foil/UPVC blister packs containing 3, 10, 12, 20, 90 or 100 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Marketing authorization dates and numbers

PL 46302/0141

June 1998

Drugs

Drug Countries
SPASMONAL Hong Kong, Ireland, United Kingdom

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