Common Technical Document    Wasp-Eze Bites and Stings Spray

Module 1 - Administrative and Prescribing Information Module 1.3 - Product Information

Text to appear on the patient information leaflet WASP-EZE

BITES AND STINGS SPRAY

Benzocaine 1% w/w and Mepyramine maleate 0.5% w/w PATIENT INFORMATION LEAFLET

Please read this leaflet carefully before using Wasp-Eze Bites and Stings Spray.

•    Keep this leaflet, you may wish to read it again.

•    Ask your pharmacist if you need more information or advice.

What is this spray used for?

The cutaneous spray solution is used to treat insect bites and stings, and nettle and jellyfish stings.

Before using this spray Do not use...

•    If you are sensitivie or allergic to any of the ingredients in this product or any chemically related anaesthetics (butylcaine and tetracaine) or mepyramine maleate or para-aminobenzoic acid, parabens or paraphenylenediamine or to commercial hair dyes. See 'what this spray contains' for the full list of ingredients.

•    If you are pregnant or breast feeding, except on medical advice.

•    Do not apply to large area of skin, eczematous (A skin inflammation characterized chiefly by redness, itching, and the outbreak of lesions that may discharge serous matter and become encrusted and scaly), sunburnt, infected or broken skin.

•    Do not use the spray on the face.

•    Near to the eyes or mouth

Take special care..

•    Patients with any known allergy should seek medical advice.

•    The spray is not for repeated or prolonged use.

•    If you are allergic or sensitive to insect bites or stings, please immediately.

How to use this spray Adults and children 2 years and over:

•    Hold the nozzle 12.5 cm (5 inches) from the bite or sting.

•    Press the nozzle down firmly and spray once for 2 to 3 seconds. Stop spraying straight away if a white deposit or (frost) appears.

•    If the bite or sting still hurts, you can use the spray once more after 15 minutes.

If the bite or sting is still painful, please tell your doctor or pharmacist.

If you accidentally swallow the spray or get it into your eyes...

The spray is for external use only - do not spray in your mouth or eyes. If accidentally swallowed or sprayed into your eyes or mouth, wash out with plenty of lukewarm water and contact your doctor or pharmacist immediately.

Common Technical Document    Wasp-Eze Bites and Stings Spray

Module 1 - Administrative and Prescribing Information Module 1.3 - Product Information

Possible side effects

As with all medicines, this spray can have side effects in some people.

•    A blood condition called methaemoglobinaemia which can cause headache, breathlessness and blue-tinged skin, may occur rarely, especially in infants and children. If you suffer this serious side effect, stop using the spray and call your doctor or local hospital immediately.

•    You may experience a skin rash, allergic skin reactions, or other allergic reactions.

If you feel you are reacting badly to this medicine in any way, or notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store this spray

•    Keep out of the sight and reach of children.

•    Do not store above 25°C and keep away from heat and sunlight.

•    Caution 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 use near or place container on polished or painted surfaces.

•    There is an expiry date on the label. For example. EXP 03/06 means that you should not use the spray after the end of March 2006.

•    If you find that you still have this medicine after its expiry date, return it to your local pharmacist who will dispose of it properly.

What this spray contains

Wasp-Eze Bites and Stings contains the active ingredients 1% by weight of the active ingredient benzocaine and 0.5% by weight of mepyramine maleate.

Benzocaine belongs to a group of medicines called local anaesthetics (pain-killers that work on the area where they are applied) and mepyramine to a group called antihistamines. Both help to reduce pain and swelling.

It also contains ethanol, propylene glycol, n-pentane, isobutane and dimethyl ether.

Wasp-Eze Bites and Stings Spray comes in an aluminium can containing 30ml.

Marketing Authorisation Holder: G R Lane Health Products Ltd. Sisson Road, Gloucester, GL2 0GR UK.

Manufactured by: INyx Pharma Ltd., Runcorn, Chesire, UK.

Date of revision: February 2013 Sea-legs is a trade mark of the SSL group

January 2015 - LB