SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Wasp-Eze Spray

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Benzocaine    1.0% wlw

Mepyramine maleate 0.5% w/w

For the full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Aerosol spray.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For the treatment of all insect bites and stings, nettle stings and jellyfish stings.

4.2    Posology and method of administration

Route of administration: For cutaneous application

Adults, the elderly and children:

Hold nozzle approximately five inches from the skin and spray once for 2-3 seconds. Stop spraying immediately if a white deposit or ‘frost’ appears. Repeat once after 15 minutes if necessary. If pain persists, seek medical advice.

4.3 Contraindications

Do not use if you are sensitive to benzocaine, any chemically related anaesthetics (butylcaine and tetracaline) or mepyramine maleate.

Do not use if you are sensitive to any of the excipients or to para-amino benzoic acid (PABA), parabens or paraphynylenediamine or to commercial hair dyes as there is cross-sensitivity between these products.

Do not apply to large areas of skin, eczematous, sunburnt, infected or broken skin.

Do not use the spray on the face.

4.4 Special warnings and precautions for use

Patients with any known allergy should seek medical advice. If pain persists, seek medical advice.

Do not use near the mouth or eyes or under conditions in which significant inhalation is likely.

Not for repeated or prolonged use.

For external use only. Keep out of the sight and reach of children.

Flammable. Do not use near fire or flame. Pressurised container. Protect from sunlight and do not expose to temperatures exceeding 50°C. Do not pierce or burn, even after use. Do not spray on a naked flame or any incandescent material. Do not use near or place container on polished or painted surfaces.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Fertility, Pregnancy and lactation

Pregnancy:

There are no or limited amount of data from the use of benzocaine in pregnant woman. As a precautionary measure, it is preferable to avoid the use of benzocaine during pregnancy.

Lactation:

There is insufficient information on the excretion of benzocaine or its metabolites in human milk. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from benzocaine therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

Fertility:

There is no known effect on fertility.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

Blood and lymphatic system disorders Methaemoglobinaemia (frequency not known)

Immune System Disorders Hypersensitivity (frequency not known)

Skin and Subcutaneous Tissue Disorders Dermatitis allergic (frequency not known) Rash ((frequency not known)

4.9 Overdose

Overdose is unlikely with this dosage form. There are no known effects and no specific treatment.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

ATC Code: Benzocaine (D04 AB04)

Mepyramine maleate (D04 AA02)

Pharmacotherapeutic group: Antipruritics, incl. Antihistamines, Anesthetics, etc., ATC code: D04A.

The active ingredients, benzocaine and mepyramine maleate, reduce pain and histamine responses to stings. The physical effects of the cooling propellants help reduce pain.

Benzocaine causes a reversible blockade of nerve conduction by decreasing nerve membrane permeability to sodium, which notably increases the recovery period following repolarisation.

5.2 Pharmacokinetic properties

Not applicable.

5.3 Preclinical safety data

Not applicable.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Propylene glycol Denatured Ethanol Iso-butane N-pentane Dimethyl ether

6.2 Incompatibilities

None known.

Shelf life

36 months unopened.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

Aluminium cans (30ml and 60ml) internally coated with epoxyphenolic lacquer fitted with valve assembly and actuator button, protected by a plastic cap.

6.6 Special precautions for disposal

Not applicable.

7 MARKETING AUTHORISATION HOLDER

G R Lane Health Products Ltd.

Sisson Road Gloucester GL2 0GR United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

PL 01074/0251

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

15/09/2005

DATE OF REVISION OF THE TEXT

04/03/2015