UNISOM SLEEPGELS Capsule Ref.[50437] Active ingredients: Diphenhydramine

Source: Medicines and Medical Devices Safety Authority (NZ)  Revision Year: 2018  Publisher: Pharmaco (NZ) Ltd, 4 Fisher Crescent, Mt Wellington, Auckland 1060, Telephone: 09 377 3336

4.1. Therapeutic indications

A night time sleep aid for the short-term management of insomnia.

4.2. Posology and method of administration

Adults and children over 12 years of age. The dose is one softgel (50 mg) at bedtime if needed.

Should sleeplessness persist for more than 7 to 10 nights further medical advice should be sought.

Do not give to children under 12 years of age. Do not exceed the recommended dosage.

4.9. Overdose

Antihistamine overdosage reactions may vary from central nervous system depression to stimulation. Stimulation is particularly likely in children. Atropine-like signs and symptoms such as dry mouth, fixed and dilated pupils, flushing and gastrointestinal symptoms may also occur.

Administration of activated charcoal should be considered. Empty stomach by aspiration and lavage. Emetics may be tried if the patient is alert.

For advice on the management of overdose please contact the National Poisons Centre on 0800 POISON (0800 764766).

6.3. Shelf life

Unisom SleepGels have a three year shelf-life.

6.4. Special precautions for storage

Store below 25°C.

6.5. Nature and contents of container

Blister pack of 10 capsules.

6.6. Special precautions for disposal and other handling

No special requirements for disposal.

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