País: Malta
Idioma: inglés
Fuente: Medicines Authority
BENZOCAINE, MEPYRAMINE MALEATE
Seton Products Limited Tubiton House, Medlock Street, Oldham, United Kingdom
D04AB04
BENZOCAINE 1 % (W/W) MEPYRAMINE MALEATE 0.5 % (W/W)
CUTANEOUS SPRAY
BENZOCAINE 1 % (W/W) MEPYRAMINE MALEATE 0.5 % (W/W)
OTC
ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
Withdrawn
2007-12-10
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Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF MEDICINAL PRODUCT Wasp-Eze Spray 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Benzocaine 1.0% w/w Mepyramine maleate 0.5% w/w For excipients, see 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 _ _ Topical. 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 apply to broken skin. Do not use near the eyes. Do not use if you are sensitive to benzocaine. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Patients with any known allergy should seek medical advice. If pain persists, seek medical advice. For external use only. Keep out of the 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. Page 2 of 3 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known. 4.6 PREGNANCY AND LACTATION No known effects in pregnancy and lactation. However, as with all medicines, use with caution. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None known. 4.8 UNDESIRABLE EFFECTS Skin rash. Methaemoglobinaemia especially in infants and children. 4.9 OVER Leer el documento completo