SOMINEX Tablet Ref.[7734] Active ingredients: Promethazine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Actavis Group PTC ehf, Reykjavíkurvegi 76-78, 220 Hafnarfjordur, Iceland

Therapeutic indications

As a night-time sleep aid, for the correction of temporary disturbances of sleep pattern where there is difficulty in going to sleep or staying asleep, caused for example by specific dislocation of normal routine.

Posology and method of administration

Posology

For bedtime use only.

Adults

One tablet at bedtime. May be taken up to one hour after going to bed when sleep is difficult to achieve.

Paediatric population

Not to be given to children under the age of 16 years except on medical advice.

Elderly

The normal adult dose may be taken.

Method of administration

For oral administration.

Overdose

Common features include: nausea, vomiting, flushing, dilated pupils, dry mouth and tongue, hot dry skin, fever, sinus tachycardia, hypertension, ataxia, nystagmus, drowsiness, delirium, agitation and visual hallucinations.

Uncommon systemic features include: myoclonic jerking, coma, convulsions, cardiac conduction abnormalities and dysrhythmias, cardiovascular collapse, paralytic ileus, urinary retention and cardiorespiratory depression.

Patients who have been unconscious may be hypothermic.

In cases of unintentional exposure: Children may also experience combinations of excitation, ataxia, incoordination, athetosis and hallucinations.

Treatment

Gastric lavage or activated charcoal is only recommended if the patient presents within 1 hour of ingestion of a potentially toxic amount.

Treatment is otherwise supportive with attention to maintenance of adequate respiratory and circulatory status. Convulsions should be treated with diazepam or other suitable anticonvulsants.

Forced diuresis, haemodialysis and haemoperfusion are of no value.

Shelf life

60 months unopened.

Special precautions for storage

None.

Nature and contents of container

Opaque blister strip of polyvinylchloride/polyvinylidine chloride. Backed with aluminium foil. Each strip contains 8 tablets. One or two strips are packed into each cardboard carton.

Special precautions for disposal and other handling

None.

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