Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Zentiva Pharma UK Limited, 12 New Fetter Lane, London, EC4A 1JP, United Kingdom
Loprazolam is indicated for the short-term treatment of insomnia including difficulty in falling asleep and/or frequent nocturnal awakenings. Benzodiazepines should be used to treat insomnia only when it is severe, disabling or subjecting the individual to extreme distress. An underlying cause of insomnia should be sought before deciding upon the use of benzodiazepines for symptomatic relief.
The recommended dose is 1mg at bedtime. This may be increased to 1.5mg or 2mg if necessary.
Dosage in the elderly should be limited to 1mg at bedtime.
A starting dose of a half tablet may be appropriate. Dosage should not exceed 1mg.
Treatment should if possible be intermittent.
The lowest dose to control symptoms should be used. Treatment should not normally be continued beyond 4 weeks.
Long term chronic use is not recommended.
Treatment should always be tapered off gradually.
Patients who have taken benzodiazepines for a long time may require a longer period during which doses are reduced.
There is insufficient evidence to recommend the use of Loprazolam in children.
As with other benzodiazepines, overdosage does not usually present a threat to life. Treatment is symptomatic and gastric lavage may be of use if performed shortly after ingestion. Use of a specific antidote such as flumazenil in association with symptomatic treatment in hospital should be considered.
Shelf life: 24 months.
Store below 25°C in a dry place. Protect from light.
UPVC/aluminium foil blisters, packaged in cartons of 10, 28 or 30 tablets.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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