TAVEGIL Tablet Ref.[27502] Active ingredients: Clemastine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

4.1. Therapeutic indications

Allergic rhinitis, including hay fever and perennial rhinitis, vasomotor rhinitis.

Allergic dermatoses, including pruritus, atopic eczema and contact dermatitis.

Urticaria. Angioneurotic oedema, drug allergy.

4.2. Posology and method of administration

Adults

1mg clemastine base (one tablet) night and morning.

In individual cases the dose may be increased to 6mg clemastine base daily if necessary (six tablets).

Children

1 to 3 years: 250 microgrammes to 500 microgrammes clemastine base (¼ - ½ tablet night and morning.

3 to 6 years: 500 microgrammes clemastine base (½ tablet) night and morning.

6 to 12 years: 500 microgrammes to 1000 microgrammes clemastine base (½ - 1 tablet) night and morning.

Use in the elderly

No evidence exists that elderly patients require different dosages or show different side effects from younger patients.

Oral administration only.

Maximum duration of use: Clemastine fumarate should not be used for more than 14 days without consulting a doctor. Do not exceed the recommended dose.

4.9. Overdose

Symptoms

The effects of antihistamine overdose may vary from CNS depression to stimulation such as depressed level of consciousness, excitability, hallucinations, or convulsions. Anticholinergic symptoms such as dry mouth, mydriasis or flushing, gastrointestinal reactions and tachycardia may also develop.

Treatment

Treatment consists of symptomatic therapy or as recommended by the national poisons centres, where applicable.

6.3. Shelf life

36 months.

6.4. Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5. Nature and contents of container

PVC/PVDC blister pack (50 or 60 tablets).

6.6. Special precautions for disposal and other handling

None.

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