Clomethiazole 192 mg Capsules (2011)

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης	Intrapharm Laboratories Ltd
Διεύθυνση	The Granary, The Courtyard Barns, Choke Lane, Cookham Dean, Maidenhead, Berkshire, SL6 6PT

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Name of the medicinal product

Heminevrin 192 mg Capsules. Clomethiazole 192 mg 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.

Pharmaceutical form

Soft Capsules. Greyish-brown, soft gelatin capsules.

Therapeutic indications

Clomethiazole is a short acting hypnotic and sedative with anticonvulsant effect. It is used for the: management of restlessness and agitation in the elderly, short term treatment of severe insomnia in ...

Posology and method of administration

For oral use. The capsules should be swallowed whole. Management of restlessness and agitation in the elderly: one capsule three times daily. Severe insomnia in the elderly: 1 2 capsules before going ...

Contraindications

Known sensitivity to clomethiazole. Acute pulmonary insufficiency.

Special warnings and precautions for use

Clomethiazole should be used cautiously in patients with sleep apnoea syndrome and chronic pulmonary insufficiency. Clomethiazole may potentiate or be potentiated by centrally acting depressant drugs including ...

Interaction with other medicinal products and other forms of interaction

A combination of clomethiazole and diazoxide should be avoided as an adverse neonatal reaction suspected to be due to the maternal administration of this combination has been reported. The combination ...

Pregnancy and lactation

Do not use in pregnancy especially during the first and last trimesters, unless there are compelling reasons. There is no evidence of safety in human pregnancy, nor is there evidence from animal studies ...

Effects on ability to drive and use machines

As with all centrally acting depressant drugs, the driving of vehicles and the operating of machinery are to be avoided when under treatment.

Undesirable effects

The most common side-effect is nasal congestion and irritation, which may occur 15 to 20 minutes after drug ingestion. Conjunctival irritation has also been noted in some cases. Occasionally, these symptoms ...

Overdose

The main effects to be expected with overdose of clomethiazole are: coma, respiratory depression, hypotension and hypothermia. Hypothermia is thought to be due to a direct central effect as well as a result ...

Pharmacodynamic properties

Clomethiazole is pharmacologically distinct from both the benzodiazepines and the barbiturates. Clomethiazole has sedative, muscle relaxant and anticonvulsant properties. It is used for hypnosis in elderly ...

Pharmacokinetic properties

Clomethiazole has a short half-life, low oral bioavailability, high plasma clearance and shows no evidence of accumulation or altered pharmacokinetics after repeated dosage. It is excreted in urine after ...

Preclinical safety data

Extensive clinical use and experience with clomethiazole has provided a well established safety profile for this drug.

List of excipients

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

Incompatibilities

Not applicable.

Shelf life

Amber glass bottles: 24 months. Aluminium foil blister packs: 24 months.

Special precautions for storage

Do not store above 25°C. Store in the original container.

Nature and contents of container

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 ...

Special precautions for disposal and other handling

The capsules should remain in the container in which they are supplied. The capsules should be swallowed whole.

Marketing authorization holder

CHEPLAPHARM Arzneimettel GmbH Bahnhofstrasse 1A D-17498 Mesekenhagen Germany

Marketing authorization number(s)

PL 27041/0001

Date of first authorization / renewal of the authorization

18th March 2002 / 7th March 2003

Date of revision of the text

28 March 2011