HAYLEVE Tablet Ref.[49960] Active ingredients: Chlorphenamine

Revision Year: 2020  Publisher: Chelonia Healthcare Limited, 11 Boumpoulinas Street, 3rd Floor, 1060 Nicosia, Cyprus

4.1. Therapeutic indications

The tablets are indicated for symptomatic control of all allergic conditions responsive to antihistamines, including urticaria, hayfever, food allergy, drug and serum reactions, insect bites, vasomotor rhinitis and angioneurotic oedema.

Also indicated for the symptomatic relief of itch associated with chickenpox.

4.2. Posology and method of administration

Oral Administration only.

Do not exceed the stated dose or frequency of dosing.

Adults and children over 12 years

1 tablet four to six hourly.

Maximum daily dose: 6 tablets (24 mg) in any 24 hours.

Elderly

The elderly are more likely to experience neurological anticholinergic effects. Consideration should be given to using a lower daily dose (e.g. a maximum of 12 mg in any 24 hours).

Children aged 6-12 years

½ tablet 4 to 6 hourly.

Maximum daily dose: 3 tablets (12 mg) in any 24 hours.

Not recommended for children under the age of 6 years.

4.9. Overdose

Symptoms and signs

The estimated lethal dose of chlorphenamine is 25 to 50 mg/kg bodyweight. Symptoms and signs include sedation, paradoxic stimulation of the CNS, toxic psychosis, apnoea, convulsions, anticholinergic effects, dystonic reactions and cardiovascular collapse including arrhythmias.

Treatment

Symptomatic and supportive measures should be provided with special attention to cardiac, respiratory, renal and hepatic functions and fluid and electrolyte balance. If overdosage is by the oral route, treatment with activated charcoal should be considered provided there are no contraindications for use and the overdose has been taken recently(treatment is most effective if given within an hour of ingestion).Treat hypotension and arrhythmias vigorously. CNS convulsions may be treated with IV diazepam. Haemoperfusion may be used in severe cases.

6.3. Shelf life

Plastic containers: 36 months.

Blister-packs: 36 months.

6.4. Special precautions for storage

Keep containers well closed. Protect from light. Store below 25°C.

6.5. Nature and contents of container

High density polystyrene with polythene lids and/or polypropylene containers with polypropylene or polythene lids and polyurethane or polythene inserts.

Pack sizes: 100, 500 and 1,000.

PVC/Aluminium foil blister packs.

Pack sizes: 10, 28, 30 and 60.

6.6. Special precautions for disposal and other handling

No special instructions.

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