HEMINEVRIN Capsule Ref.[7168] Active ingredients: Chlormethiazole

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489 Greifswald, Germany

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.

Excipients with known effect: 7 mg Sorbitol (E420) per capsule.

For a full list of excipients, see 6.1.

Active Ingredient 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
hydrogenated hydrolysed starch
Titanium Dioxide (E171)
Brown Iron Oxide (E172)

Pack sizes and marketing

Amber glass bottle with white polyethylene child resistant clic-loc closure 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

CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489 Greifswald, Germany

Marketing authorization dates and numbers

PL 27041/0001

Date of first authorisation: 15th December 1967
Date of latest renewal: 18th March 2002

Drugs

Drug Countries
HEMINEVRIN Poland, United Kingdom

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