For topical application to the skin.

P: For adults, children and the elderly: Rub gently on to the affected area sparingly two or three times each day for up to three days. Early application is essential to obtain the optimum response.

GSL: For adults, elderly and children 2 years of age and over: Rub gently on to the affected area sparingly two or three times each day for up to three days. Early application is essential to obtain the optimum response.

Hypersensitivity to any of the ingredients or other antihistamines.

Should not be applied to acute vesicular and exudative dermatoses or eczema.

P & GSL:

Do not apply to broken skin or eczema.

Not to be applied to large areas of skin.

If a rash develops, gets worse or if skin sensitisation occurs, stop using the product.

Do not use for longer than a few days. If skin sensitisation occurs, stop using the product immediately. If symptoms do not go away, talk to your doctor.

This medicine contains lanolin and cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis)

For external use only.

Keep all medicines out of the reach of children.

In addition GSL:

Do not apply to sunburnt skin.

No clinically significant drug interactions expected.

The safety of this product during pregnancy and lactation has not been established. In view of the potential for systemic absorption through the skin, the product should not be used during these periods unless under medical supervision.

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.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store.

If accidentally ingested, the amount of mepyramine in a whole tube 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 H₁ receptor antagonist (antihistamine) of the ethylene diamine type. It diminishes or abolishes the effects of histamine in the body by competitive reversible blockade of histamine receptor sites on tissues.

Mepyramine maleate is readily absorbed through the skin, metabolised in the liver and excreted, mainly as metabolites in the urine.

There are no preclinical data of relevance to the prescriber which are additional to that already included.

White soft paraffin BP

Liquid paraffin Ph Eur

Anhydrous lanolin EP

Arlacel 83 HSE

Cetomacrogol 1000 BP

Cetostearyl alcohol Ph Eur

CitricacidmonohydratePhEur

Sodium citrate Ph Eur

Purified water Ph Eur

None known.

24 months.

Do not store above 25° C.

A collapsible internally lacquered aluminium tube with membrane seal fitted with a high density polyethylene cap.

Pack size

P: 25gm, 30gm.

GSL: 20g

Not applicable.