Anthisan Cream
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Anthisan™ Cream
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Mepyramine maleate BP 2.0% w/w.
3. PHARMACEUTICAL FORM
Cream
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Symptomatic relief in insect stings and bites and nettle rash.
Route of Administration: Topical.
4.2 Posology and method of administration
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.
4.3 Contraindications
Anthisan Cream should not be used in eczematous conditions or on extensively broken skin surfaces.
4.4 Special warnings and special precautions for use
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.
4.5 Interactions with other medicinal products and other forms of interaction
No significant interactions described.
4.6 Pregnancy and lactation
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.
4.7 Effects on 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.
4.8 Undesirable effects
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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
4.9 Overdose
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.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Mepyramine maleate is an antihistamine with antipruritic and local analgesic actions.
5.2 Pharmacokinetic properties
No pharmacokinetic data available by any route of administration.
5.3 Preclinical safety data
There are no findings of relevance to the prescriber, additional to those already included elsewhere in the SPC.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Ceto-stearyl alcohol BP, Polyethylene glycol 600 monostearate, Castor oil BP, Methyl hydroxybenzoate BP, Foin coupe, Silicone antifoam, Purified water BP.
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
Do not store above 30°C.
6.5 Nature and contents of container
Collapsible aluminium tube with extended nozzle and polypropylene cap containing 25g cream.
6.6 Special precautions for disposal
None stated.
7 MARKETING AUTHORISATION HOLDER
Aventis Pharma Limited
One Onslow Street
Guildford
Surrey
GU1 4YS
UK
or trading as:-
Sanofi-aventis or Sanofi
One Onslow Street
Guildford
Surrey
GU1 4YS
UK
8. MARKETING AUTHORISATION NUMBER
PL 04425/0274
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
4th April 2002
10
DATE OF REVISION OF THE TEXT
10/09/2013