País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
LIDOCAINE HYDROCHLORIDE CHLOROCRESOL CETYLPYRIDINIUM CHLORIDE ETHANOL
SSL International plc
0.9/0.1/0. Unknown
Oromucosal Solution
2006-04-13
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Anbesol Anaesthetic Antiseptic Oromucosal Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Excipients: Each 1ml of the product contains 2.76 micrograms of amaranth (E123) and 2.58 micrograms of sunset yellow (E110) and 68.239%w/w of ethanol 96%w/v. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oromucosal Solution A clear yellow liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Properties: A local anaesthetic/antiseptic combination. Indications for use: In the symptomatic relief of mouth ulcers and sore gums. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For patients of 10 years and over: Apply to the affected area 3-4 times daily or as directed by the physician or dentist. 4.3 CONTRAINDICATIONS Patients with a known history of hypersensitivity or allergic type reactions to any of the constituents of the product. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The label will contain the following statements: Lidocaine Hydrochloride 0.90 % w/w Chlorocresol 0.10 % w/w Cetylpyridinium Chloride 0.02 % w/w 1. If there is no improvement in 3 days, consult your doctor or dentist. 2. Do not persist with any medication if results seem unsatisfactory, except on doctor’s advice. 3. Do not exceed the stated dose. 4. 5. Keep all medicines out of the reach of children. This product contains the azo dyes; amaranth (E123) and sunset yellow (E110) which may cause allergic reactions in sensitive individuals. This medicinal product contains 68vol% ethanol (alcohol) i.e. up to 546mg per ml equivalent to 10.9ml beer or 4.6ml wine per ml. To be taken into account in pregnant or breast-feeding women, children, and high risk groups such as patients with liver disease or epilepsy. IRISH MEDICINES BOARD ___________ Leer el documento completo