Anthisan Bite And Sting 2% W/W Cream
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Anthisan Bite and Sting 2% w/w Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Mepyramine Maleate 2% w/w Also contains:
Castor oil 23,60% w/w
Ceto-stearyl alcohol 13,80% w/w
Propylene glycol 600 monostearate 4,90% w/w Methyl hydroxybenzoate 0,20% w/w
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
A smooth off-white cream
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Symptomatic relief of skin irritation caused by insect stings, insect bites and nettle stings.
Route of Administration: Topical.
4.2 Posology and method of administration
Adults, elderly and children 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.
Contraindications
4.3
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.
4.4 Special warnings and precautions for use
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.
4.5 Interaction 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 Bite and Sting Cream should not be used during pregnancy or lactation, unless considered essential.
4.7 Effects on ability to drive and use machines
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.
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 Y ellow Card Scheme at: www.mhra.gov.uk/yellowcard
4.9 Overdose
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 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
Pharmacotherapeutic group: Mepyramine maleate is an antihistamine with antipruritic and local analgesic actions.
ATC code: Antihistamines for Topical Use R06AC01
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 in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Ceto-stearyl alcohol
Polyethylene glycol 600 monostearate
Castor oil
Methyl hydroxybenzoate
Foin coupe (fragrance) Silicone antifoam Purified water
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years
6.4 Special precautions for storage
Store below 30°C
6.5 Nature and contents of container
Collapsible aluminium tube with extended nozzle and polyethylene screw cap containing 20g cream.
6.6 Special precautions for disposal
No special requirements.
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(S)
PL 04425/0275
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
07/06/2000 / 09/09/2005
10 DATE OF REVISION OF THE TEXT
17/07/2013