sanofi-aventis

Anthisan Cream 2%w/w

Mepyramine maleate 2%w/w.

Also contains Methyl parahydroxybenzoate (E218) and Cetostearyl Alcohol.

For a full list of excipients, see section 6.1.

Cream.

Smooth homogenous cream of fairly firm consistency, off-white to pale in colour.

Anthisan has analgesic, anti-histaminic and anti-pruritic properties.

Symptomatic relief in insect bites, stings and nettle rash.

The route of administration is topical.

Recommended Dosage

Apply to affected area 2 to 3 times daily for up to 3 days or as directed by the physician.

Acute vesicular and exudative dermatoses.

Use on broken skin.

Use with occlusive dressings.

Use in patients hypersensitive to mepyramine maleate or any of the excipients of Anthisan Cream.

Use in premature infants and neonates.

Pregnancy and lactation.

If symptoms persist, consult a doctor.

None

There is no evidence of the safety of Mepyramine Maleate in human pregnancy. 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.

Anthisan cream may be absorbed when applied over large areas of skin. This could cause somnolence and mild disorientation. If this happens, do not drive or use any tools or machines.

Topical therapy may produce hypersensitivity reactions, particularly of the skin, and cross sensitivity to related drugs may occur.

Skin sensitisation, eczematous reactions and photosensitivity may develop after topical application.

Systemic side-effects have been reported after topical application of antihistamines to large areas of the skin.

A 25 gram tube of Anthisan Cream contains 500mg Mepyramine Maleate. If accidentally ingested this dose would constitute a dangerous overdose in young children.

Overdose may be fatal especially in infants and children. Overdosage is associated with antimuscarinic, extrapyramidal, gastrointestinal and central nervous system effects. In infants and children, central nervous system stimulation predominates over central nervous system depression. This can cause ataxia, excitement, tremors, psychoses, hallucinations, convulsions and hyperpyrexia. Deepening coma and cardiorespiratory collapse may follow. In adults, central nervous system depression is more common with drowsiness, coma and convulsions, progressing to respiratory failure or possibly cardiovascular collapse.

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 agains pneumonia.

ATC: D04 AA02

A topical preparation with analgesic, antihistamine and anti-pruritic properties.

No pharmacokinetic data available by any route of administration.

None.

Cetostearyl Alcohol

Macrogol 600 monostearate

Castor Oil

Methyl Parahydroxybenzoate (E218)

Foin Coupe (36% benzyl benzoate, 21% oil of cedarwood, other aromatics and essential oils)

Silicone MS antifoam A (a mixture of liquid dimethicones containing finely divided silicone dioxide)

Purified water

Not applicable.

3 years.

Store below 30°C.

Collapsible internally lacquered aluminium tube with extended nozzle and polyethylene cap, packed in outer carton.

Pack size: 25g.

No special requirements.

sanofi-aventis Ireland Ltd.,

Citywest Business Campus,

Dublin 24.

PA 540/92/1

1^st April 1979/ 1^st April 2009.

July 2009.