Kraj: Wielka Brytania
Język: angielski
Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)
Lidocaine hydrochloride; Chlorocresol; Cetylpyridinium chloride
Alliance Pharmaceuticals Ltd
D04AB
Lidocaine hydrochloride; Chlorocresol; Cetylpyridinium chloride
20mg/1gram ; 1mg/1gram ; 200microgram/1gram
Oromucosal gel
Oromucosal; Gingival
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 12030100; GTIN: 5038483197301
L150 - 140 x 150mm Artwork Information Keylines, Guides, Dimensions and Cutter guide are NOT to be printed. Product Title: Anbesol Adult Gel Date: 09-07-21 Product Size: 140mm x 150mm Label Number: 20-0514 Colours Used: BLACK Fonts Used: Arial, Arial Bold Font size (min): 7pt Version: 3 ANBESOL ® ADULT STRENGTH GEL Lidocaine Hydrochloride, Chlorocresol and Cetylpyridinium Chloride PATIENT INFORMATION LEAFLET Read all of this leaflet carefully before using this medicine as it contains important information for you. • Keep this leaflet. You may wish to read it again. • Ask your pharmacist if you need more information or advice. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. What is in this leaflet: 1. WHAT ANBESOL ADULT STRENGTH GEL IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ANBESOL ADULT STRENGTH GEL 3. HOW TO USE ANBESOL ADULT STRENGTH GEL 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE ANBESOL ADULT STRENGTH GEL 6. CONTENTS OF PACK AND OTHER INFORMATION 1. WHAT ANBESOL ADULT STRENGTH GEL IS AND WHAT IT IS USED FOR Anbesol Adult Strength Gel contains 2.0%w/w of lidocaine hydrochloride, 0.1%w/w of chlorocresol and 0.02%w/w of cetylpyridinium chloride. Lidocaine hydrochloride is a local anaesthetic which works by stopping the sensation of pain. Chlorocresol and cetylpyridinium chloride kill bacteria. Anbesol Adult Strength Gel is used for temporary relief of pain caused by recurrent MOUTH ULCERS and DENTURE IRRITATION for adults and children over 12 years. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ANBESOL ADULT STRENGTH GEL DO NOT USE ANBESOL ADULT STRENGTH GEL: • If you are allergic to lidocaine hydrochloride, chlorocresol, cetylpyridinium chloride, other anaesthetics similar to lidocaine or any of the other ingredients in this medicine (listed in Section 6). • You have porphyria (a disease which causes stomach pain, constipation, changes in the colour of urine, skin rashes and disturbed behaviour). WAR Przeczytaj cały dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Anbesol Adult Strength Gel. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Lidocaine Hydrochloride 2.0% w/w Chlorocresol 0.1% w/w Cetylpyridinium Chloride 0.02% w/w Excipients with known effect: Each 1ml of the product contains 100 micrograms of Ponceau 4R (E124) and 66.605%w/w of ethanol 96% (equivalent to 63.9% w/w ethanol 100%) For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Oromucosal gel A soft pink clear gel 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the temporary relief of pain caused by recurrent mouth ulcers, denture irritation. Not for use in children under 12 years. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: oromucosal Adults, the elderly and children over 12 years: apply a small amount to the affected area with a clean fingertip. One application should be sufficient. It should not be used more frequently than every 3 hours. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substances, anaesthetics of the amide-type or to any of the excipients listed in section 6.1. Lidocaine is considered to be unsafe in patients with porphyria because it has been shown to be porphyrinogenic in animals. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Not suitable for treatment of teething in children. Excessive dosage, or short intervals between doses, may result in high plasma levels and serious adverse effects (see Section 4.9). Anbesol should be used with caution in patients with wounds or traumatised mucosa in the region of the proposed application. A damaged mucosa will permit increased systemic absorption resulting in systemic effects, such as convulsions, particularly if excessive quantities are used. This medicinal product contains chlorocresol and the azo dye Ponceau 4R (E124) which may cause allergic reactions in sensitive individuals. This medicinal product contains 66.605% w/w of ethanol 96% (alcohol) (equivalent to 63.9% w/w ethanol 100%). The small amount of alcohol in this medicine w Przeczytaj cały dokument