This information is intended for use by health professionals

1. Name of the medicinal product

Bite and Sting Relief Antihistamine Cream or Boots Bite & Sting Relief 2 Years Plus Antihistamine Cream

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:

GSL:

For the symptomatic relief of insect bites and stings and nettle rash.

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

CitricacidmonohydratePhEur

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: 20g

6.6 Special precautions for disposal and other handling

Not applicable.

7. Marketing authorisation holder

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

8. Marketing authorisation number(s)

PL 00014/0440

9. Date of first authorisation/renewal of the authorisation

Date of first authorisation: 28 September 1993

Date of last renewal: 12 November 2003

10. Date of revision of the text

4 June 2015