HEMINEVRIN Capsule (2018)
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Περιεχόμενα
Name of the medicinal product
Heminevrin 192 mg Capsules. Clomethiazole 192 mg 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.
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
Posology <u>Management of restlessness and agitation in the elderly:</u> one capsule three times daily. <u>Severe insomnia in the elderly:</u> 1-2 capsules before going to bed. The lower dose should be ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 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
Clomethiazole is an inhibitor of CYP2A6 and CYP2E1. The plasma clearance of CYP2E1 substrates may be decreased by clomethiazole. For CYP2El substrate chlorzoxazone, a threefold decrease of plasma clearance ...
Fertility, pregnancy and lactation
Pregnancy 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 ...
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 hydrogenated hydrolysed starch Titanium Dioxide (E171) Brown Iron Oxide (E172)
Incompatibilities
Not applicable.
Shelf life
Amber glass bottles: 2 years. Aluminium foil blister packs: 2 years.
Special precautions for storage
Do not store above 25°C. Store in the original container to protect from light and moisture.
Nature and contents of container
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 ...
Special precautions for disposal and other handling
The capsules should remain in the container in which they are supplied.
Marketing authorization holder
CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489 Greifswald, Germany
Marketing authorization number(s)
PL 27041/0001
Date of first authorization / renewal of the authorization
Date of first authorisation: 15th December 1967 Date of latest renewal: 18th March 2002
Date of revision of the text
30/04/2018
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