Anthisan^TM Cream.

Mepyramine maleate BP 2.0% w/w.

Cream.

Symptomatic relief in insect stings and bites and nettle rash.

Route of Administration: Topical.

Adults, elderly and children. Anthisan Cream should be applied directly to the affected parts two or three times a day for up to three days. Early application is essential to obtain the optimum response.

Anthisan Cream should not be used in eczematous conditions or on extensively broken skin surfaces.

Repeated application of Anthisan Cream for periods longer than a few days is not recommended and treatment should be discontinued immediately if skin sensitisation occurs.

No significant interactions described.

There is no evidence of the safety of mepyramine maleate in human pregnancy, but it has been widely used for many years without apparent ill consequence. Absorption of a significant amount after topical application is unlikely in the prescribed method of use, nevertheless, Anthisan Cream should not be used during pregnancy or lactation, unless considered essential.

May theoretically be extensively absorbed through the skin when applied over large areas and cause somnolence and mild disorientation.

Skin sensitisation has been reported on rare occasions.

A 25g tube of Anthisan Cream contains 500mg mepyramine maleate. If accidentally ingested this dose would constitute a dangerous overdose in young children.

The chief symptom of overdosage is unconsciousness and there may be convulsions in the intervening periods. The stomach should be washed out. Stimuli liable to provoke convulsions should be avoided, but if this complication should occur, parenteral Diazepam should be given; sedatives which are liable to increase respiratory depression should be avoided. Other measures such as artificial respiration and oxygen may also be required and an antibiotic can be given as a prophylactic against pneumonia.

Mepyramine maleate is an antihistamine with antipruritic and local analgesic actions.

No pharmacokinetic data available by any route of administration.

There are no findings of relevance to the prescriber, additional to those already included elsewhere in the SPC.

Ceto-stearyl alcohol BP, Polyethylene glycol 600 monostearate, Castor oil BP, Methyl hydroxybenzoate BP, Foin coupe, Silicone antifoam, Purified water BP.

Not applicable.

36 months.

Do not store above 30^oC.

Collapsible aluminium tube with extended nozzle and polythene cap containing 25g cream.

None stated.

Sanofi-aventis

One Onslow Street

Guildford

Surrey, GU1 4YS, UK

PL 04425/0274

4^th April 2002

November 2006

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