Anthisan Bite and Sting 2% w/w Cream

Mepyramine Maleate 2% w/w

For a full list of excipients, see section 6.1

A smooth off-white cream

Symptomatic relief of skin irritation caused by insect stings, insect bites and nettle stings.

Route of Administration: Topical

Adults, elderly and children over 2 years of age and older. Anthisan Bite and Sting 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 Bite and Sting Cream should not be used in eczematous conditions or on extensively broken skin surfaces, or if the skin is cut or grazed. Do not use on large areas of skin or on areas of sunburnt skin.

Hypersensitivity to the active substance or to any of the excipients.

Repeated application of Anthisan Bite and Sting Cream to the same area for longer than three 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 Bite and Sting Cream should not be used during pregnancy or lactation, unless considered essential.

Anthisan Bite and Sting Cream has minor or moderate influence on the ability to drive and use machines.

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 20g tube of Anthisan Bite and Sting Cream contains 400mg mepyramine maleate. If accidentally ingested this dose would constitute a dangerous overdose in young children.

The chief symptoms 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 anti-pruritic 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 in other sections of the SPC.

Ceto-stearyl alcohol

Polyethylene glycol 600 monostearate

Castor oil

Methyl hydroxybenzoate

Foin coupe (fragrance)

Silicone antifoam

Purified water

Not applicable

3 years

Store below 30°C

Collapsible aluminium tube with extended nozzle and polyethylene screw cap containing 20g cream.

No special requirements

Sanofi-aventis

One Onslow Street

Guildford

Surrey, GU1 4YS, UK

PL 04425/0275

September 2005

18 November 2010

GSL