HISTERGAN Coated tablet Ref.[27731] Active ingredients: Diphenhydramine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: Norma Chemicals Ltd., 51-53 Stert Street, Abingdon, Oxfordshire OX14 3JF United Kingdom

4.1. Therapeutic indications

As an antihistamine

Treatment of allergic conditions e.g. hay fever, vasomotor rhinitis, stings, urticaria, angioneurotic oedema, drug sensitivity, contact dermatitis and photosensitivity.

As a sleep aid

As a short term hypnotic.

4.2. Posology and method of administration

As an antihistamine

Adults and Children over 12 years: 1 or 2 tablets three or four times per day. In severe or chronic conditions this may be increased at the discretion of a doctor, but not to exceed 300mg in any 24 hour period.

Paediatric Population

Not recommended for children under the age of 12.

Elderly

As for adults, use cautiously, reduce dose if required.

As a sleep aid

Adults

1 or 2 tablets at bedtime, or after retiring when sleep is not readily achieved.

Paediatric Population

Not recommended for children under the age of 16.

Elderly

As for adults, use cautiously, reduce dose if required.

4.9. Overdose

Overdose is likely to result in effects similar to those listed under adverse reactions. Additional symptoms may include mydriasis, fever, flushing, agitation, tremor, dystonic reactions, hallucinations and ECG changes. Large overdose may cause rhabdomyolysis, convulsions, delirium, toxic psychosis, arrhythmias, coma and cardiovascular collapse.

Treatment should be supportive and directed towards specific symptoms. Convulsions and marked CNS stimulation should be treated with parenteral diazepam.

6.3. Shelf life

36 months.

6.4. Special precautions for storage

Store below 25°C.

6.5. Nature and contents of container

Blister packs of 8, 16 and 20 tablets.

6.6. Special precautions for disposal and other handling

None stated.

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