TEMAZEPAM Uncoated tablet Ref.[7938] Active ingredients: Temazepam

Posology

The lowest effective dose should be employed, and treatment should, if possible, be intermittent. Dosage regimes should not extend beyond 4 weeks and treatment should gradually be withdrawn. Patients who have received benzodiazepines for a long time may require an extended withdrawal period. Long-term chronic use is not recommended.

Adults

Insomnia: 10-20mg on retiring. A dose of 20mg will be found satisfactory for most patients. This may be increased to 30-40mg in patients who do not respond to the lower dose.

Premedication: 20-40mg, half an hour to one hour prior to surgical or investigative procedures.

It is recommended that patients should be accompanied home after medication with Temazepam prior to surgical or investigative procedures.

Elderly and patients suffering from cerebrovascular disease

Dosage should be reduced to possibly half the normal adult dose. In general hypnotics should be avoided in the elderly as they are at risk of becoming ataxic and confused. This may lead to falls and injury.

Paediatric population

Not recommended for children. The safety and efficacy in children less than 18 years old has not be established.

Method of Administration

For oral administration.

As with other benzodiazepines, overdose should not present a threat to life unless combined with other CNS depressants (including alcohol).

In the management of overdose with any medicinal product, it should be borne in mind that multiple agents may have been taken.

Following overdose with oral benzodiazepines, vomiting should be induced (within one hour) if the patient is conscious or gastric lavage undertaken with the airway protected if the patient is unconscious. If there is no advantage in emptying the stomach, activated charcoal should be given to reduce absorption. Special attention should be paid to respiratory and cardiovascular functions in intensive care.

Overdose with oral benzodiazepines activated charcoal should be given to reduce absorption. 50g for adults and 10-15g for children if they have taken more than 1mg/kg within 1 hour, provided they are not too drowsy.

Overdose of benzodiazepines is usually manifested by degrees of central nervous system depression ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, mental confusion and lethargy, in more seious cases, symptoms may include ataxia, hypotonia, hypotension, respiratory depression, rarely coma and very rarely death.

Flumazenil may be useful as an antidote providing the overdose is not with mixed drugs.

Shelf-life: Two years from the date of manufacture.

Shelf-life after dilution/reconstitution: Not applicable.

Shelf-life after first opening: Not applicable.

250µm white PVC/60g/m² PVdC with 20µm aluminium foil blister packs: Store below 25°C. Store in the original package to protect from moisture. Keep the blister in the outer carton to protect from light.

All other containers: Store below 25°C in a dry place. Protect from light.

The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene containers with snap-on polyethylene lids; in case any supply difficulties should arise the alternative is amber glass containers with screw caps.

The product may also be supplied in blister packs and cartons:

• Carton: Printed carton manufactured from white folding box board.
• Blister pack: (i) 250µm white rigid PVC. (ii) Surface printed 20µm hard temper aluminium foil with 5-6g/M2 PVC and PVdC compatible heat seal lacquer on the reverse side or:
• Blister pack: 250µm white PVC/60g/m² PVdC with 20µm aluminium foil

Pack sizes: 7s, 21s, 28s, 30s, 50s, 56s, 60s, 84s, 100s, 112s, 250s, 500s, 1000s

Product may also be supplied in bulk packs, for reassembly purposes only, in polybags contained in tins, skillets or polybuckets filled with suitable cushioning material. Bulk packs are included for temporary storage of the finished product before final packaging into the proposed marketing containers.

Maximum size of bulk packs: 50,000.

Not all pack sizes may be marketed.

No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.