Boots Bite & Sting Relief 2 Years Plus Antihistamine
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bite and Sting Relief Antihistamine Cream
Boots Bite & Sting Relief 2 Years Plus Antihistamine Cream (GSL only)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
% quantity
Mepyramine maleate, Ph Eur 2.0% w/w
3. PHARMACEUTICAL FORM
Cream.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
P: For the symptomatic relief of insect bites and stings and nettle rash.
GSL: For the symptomatic relief of insect bites and stings and nettle stings.
4.2 Posology and method of administration
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.
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.
For topical application to the skin.
4.3 Contraindications
Hypersensitivity to any of the ingredients or other antihistamines.
Should not be applied to acute vesicular and exudative dermatoses or eczema.
4.4 Special warnings and precautions for use P & GSL:
Do not apply to broken skin or eczema.
Not to be applied to large areas of skin.
If rash develops or gets worse stop using the product.
For external use only.
Keep all medicines out of the reach of children.
If symptoms do not go away, talk to your doctor.
In addition GSL:
Do not apply to sunburnt skin.
4.5 Interaction with other medicinal products and other forms of interaction
No clinically significant drug interactions expected.
4.6 Pregnancy and lactation
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.
4.7 Effects on ability to drive and use machines
No adverse effects known.
4.8 Undesirable effects
Occasional local hypersensitivity reactions.
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.
4.9 Overdose
In cases of excessive application to the skin, sufficient absorption may occur to give rise to systemic adverse effects. Treatment should be symptomatic.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic Properties
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.
5.2 Pharmacokinetic Properties
Mepyramine maleate is readily absorbed through the skin, metabolised in the liver and excreted, mainly as metabolites in the urine.
5.3 Preclinical Safety Data
There are no preclinical data of relevance to the prescriber which are additional to that already included.
6. PHARMACEUTICAL PARTICULARS
6.1 List of Excipients
White soft paraffin BP Liquid paraffin Ph Eur Anhydrous lanolin EP Arlacel 83 HSE Cetomacrogol 1000 BP Cetostearyl alcohol Ph Eur Citric acid monohydrate Ph Eur Sodium citrate Ph Eur
Purified water Ph Eur
6.2 Incompatibilities
None known.
6.3 Shelf Life
24 months.
6.4 Special Precautions for Storage
Do not store above 25°C.
6.5 Nature and Contents of Container
A collapsible internally lacquered aluminium tube with membrane seal fitted with a high density polyethylene cap.
Pack size:
P: 25gm, 30gm.
GSL: 20 gm
6.6 Instruction for Use, Handling and Disposal
Not applicable.
7. MARKETING AUTHORISATION HOLDER
The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA
PL 00014/0440
THE
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
Date of first authorisation: 28th September 1993
Date of last renewal: 13 th November 1998
10 DATE OF REVISION OF THE TEXT
04/06/2015