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Clomethiazole 192 mg Capsules (2011)

Active ingredients: Chlormethiazole

Product Name and Form

Heminevrin 192 mg Capsules.

Clomethiazole 192 mg Capsules.

Pharmaceutical form

Soft Capsules.

Greyish-brown, soft gelatin capsules.

Qualitative and Quantitative Composition

Clomethiazole 192 mg (base) per capsule.

10 mg Sorbitol (E420) per capsule.

For a full list of excipients, see 6.1.

Chemical substance
Description
Chlormethiazole

Clomethiazole has sedative, muscle relaxant and anticonvulsant properties. It is used for hypnosis in elderly and institutionalised patients, for preanaesthetic sedation and especially in the management of withdrawal from ethanol.

List of excipients

Medium-chain triglycerides
Gelatin
Glycerol (85%)
Sorbitol (E420)
Mannitol
Oligosaccharides
Titanium Dioxide (E171)
Brown Iron Oxide (E172)

Pack sizes and Marketing

Amber glass bottle with either a screw cap or clic-loc cap containing 60 or 100 capsules.

Transparent plastic bag in a cardboard outer for bulk packaging of 20,000 capsules.

Aluminium foil blister packs each containing 10 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

CHEPLAPHARM Arzneimettel GmbH
Bahnhofstrasse 1A
D-17498
Mesekenhagen
Germany

18th March 2002 / 7th March 2003

Marketing authorization number:

PL 27041/0001