Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
BENZOCAINE
SSL International PLC
BENZOCAINE
1 %w/w
Cutaneous Spray Solution
Product not subject to medical prescription
Authorised
0000-00-00
BURNEZE SPRAY Benzocaine 1.0% w/w PATIENT INFORMATION LEAFLET Please read this leaflet carefully before using Burneze 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? Burneze Spray contains local anaesthetic called Benzocaine which relieves pain. This spray solution is applied to the skin to relieve pain from minor superficial burns and scalds, where the skin is unbroken. Before using this spray Do not use… • If you are allergic to any of the ingredients in this product or any chemically related anaesthetics (butylcaine and tetracaine) or para- aminobenzoic acid, parabens or paraphenylenediamine or to commercial hair dyes. See 'what this spray contains' for the full list of ingredients. • On large areas or on broken skin or on infected skin. • In or near to the eyes or mouth, or under conditions in which significant inhalation is likely. Take special care… • If you are pregnant or breast feeding speak to your doctor or pharmacist before using. Burneze spray is for external use only. Avoid freezing the skin by repeated or prolonged use. Seek medical attention if the burns are extensive (especially in young children or if they affect fingers, toes or sensitive areas). How to use this spray To reduce pain and blistering use Burneze spray as quickly as possible. • Hold the nozzle 12.5 cm (5 inches) from the skin. • Press down firmly and spray once for 2 to 3 seconds. Stop spraying straight away if a white deposit or ‘frost’ appears. • If necessary the application may be repeated once only after 15 minutes. If pain persists, speak to your doctor or pharmacist. Possible side effects As with all medicines, this spray can have side effects in some people. Läs hela dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Burneze Spray 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Benzocaine 1 % w/w. _For full list of excipients, see section 6.1._ 3 PHARMACEUTICAL FORM Cutaneous spray, solution. Clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the symptomatic relief of pain from minor superficial burns and scalds where the skin is unbroken. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Method of administration: for topical administration. Adults, the elderly and children: To reduce pain and blistering use Burneze Spray as quickly as possible. Hold nozzle five inches (10 cm) from the skin and spray once for 2-3 seconds. Stop spraying immediately if a white frost deposit (frost) appears. If necessary, the application may be repeated once only after 15 minutes. If pain persists seek medical advice. 4.3 CONTRAINDICATIONS Do not use if you are sensitive to benzocaine or any chemically related anaesthetics (butylcaine and tetracaine). Do not use if you are sensitive to any of the excipients or to PABA, parabens or paraphenylenediamine or to commercial hair dyes as there is cross-sensitivity between these products. Do not use on broken or infected skin. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Patients with any known allergy should seek medical advice. Do not apply to large areas or to broken skin. Do not use in or near the mouth or eyes or under conditions in which significant inhalation is likely. Avoid freezing the skin by repeated or prolonged use. Seek medical advice immediately if burns are extensive (particularly in young children or if they affect fingers, toes or sensitive areas). For external use only. Keep out of the reach of children. IRISH MEDICINES BOARD ________________________________ Läs hela dokumentet