País: Regne Unit
Idioma: anglès
Font: MHRA (Medicines & Healthcare Products Regulatory Agency)
Benzocaine
Reckitt Benckiser Healthcare (UK) Ltd
D04AB04
Benzocaine
30mg/1gram
Cutaneous cream
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13030000; GTIN: 5010934001481 5010934001511
Reckitt Benckiser 0002 PL 00063/0671 CCDS update 1.3.2 Mock-up-leaflet-proposed Lanacane Medicated Skin Cream EU National Page 1 Llegiu el document complet
OBJECT 1 LANACANE CREME Summary of Product Characteristics Updated 05-Mar-2015 | Reckitt Benckiser Healthcare (UK) Ltd 1. Name of the medicinal product Lanacane Creme 2. Qualitative and quantitative composition Active Ingredient % Specification Benzocaine 3.0 E.P. 3. Pharmaceutical form Emulsion creme in an aluminium tube. 4. Clinical particulars 4.1 Therapeutic indications For symptomatic relief of minor pain, itching, and irritation in the following localised skin conditions, such as insect bites, nettle stings, minor skin abrasions, and external genital and external anal itching. 4.2 Posology and method of administration For short term use only. If pain persists for more than 7 days, or worsens, seek medical advice. POSOLOGY For adults, the elderly and children aged12 years and over: Apply a small amount to the affected area up to 3 times a day. METHOD OF ADMINISTRATION For topical administration. 4.3 Contraindications Hypersensitivity to benzocaine or to any of the excipients listed in section 6.1 or paraaminobenzoic acid (PABA), parabens or paraphenylenediamine or to commercial hair dyes as there is cross-sensitivity between these products. A history of allergy to local anaesthetics such as procaine, butacaine or any other 'caine' anaesthetics. In patients who have a history of or are suspected to have methaemoglobinaemia (see section 4.8). Do not use with sulphonamides (see section 4.5). Do not use with cholinesterase inhibitors (see section 4.5). Do not apply to large areas of skin, eczematous, sunburnt, infected or broken skin. 4.4 Special warnings and precautions for use Local anaesthetics should not be used in patients with complete heart block. Not for use on extensive body area or on the mouth or eyes or under conditions in which significant inhalation is likely. 4.5 Interaction with other medicinal products and other forms of interaction SULPHONAMIDES: Benzocaine is metabolised to para-aminobenzoic acid and may antagonise the effects of sulphonamides. CHOLINESTERASE INHIBITORS: Cholinesterase inhibit Llegiu el document complet