מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
LIDOCAINE HYDROCHLORIDE ; CHLOROCRESOL ; CETYLPYRIDINIUM CHLORIDE ; ETHANOL
Alliance Pharmaceuticals Ltd.
N01BB52
LIDOCAINE HYDROCHLORIDE ; CHLOROCRESOL ; CETYLPYRIDINIUM CHLORIDE ; ETHANOL
0.9/0.1/0.
Oromucosal Solution
Product not subject to medical prescription
lidocaine, combinations
Marketed
1983-04-01
Artwork Information Product Title: Anbesol liquid ROI PIL Date: 02-10-14 Product Size: 148.5mm x 105mm Label Number: 13-382 Version 2 Colours Used: Black Fonts Used: Hevletica light condensed & bold condensed, Arial Bold Font size: (min,max) 6.75pt, 11pt Guides, Dimensions and Cutter guide are NOT to be printed. P ATIENT INFORMATION LEAFLET Read all of this leaflet carefully before you start using this medicine because it contains important information for you. • Keep this leaflet. You may need 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. • You must talk to a doctor if you do not feel better or if you feel worse after 3 days. WHAT IS IN THIS LEAFLET: 1. What Anbesol Anaesthetic Antiseptic Oromucosal solution is and what it is used for 2. What you need to know before you use Anbesol Anaesthetic Antiseptic Oromucosal solution 3. How to use Anbesol Anaesthetic Antiseptic Oromucosal solution 4. Possible side effects 5. How to store Anbesol Anaesthetic Antiseptic Oromucosal solution 6. Contents of pack and other information 1. WHAT ANBESOL ANAESTHETIC ANTISEPTIC OROMUCOSAL SOLUTION IS AND WHAT IT IS USED FOR Anbesol Anaesthetic Antiseptic Oromucosal solution contains 0.90% w/w of lidocaine hydrochloride, 0.10% 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 Anaesthetic Antiseptic Oromucosal solution is used for the relief of pain caused by mouth ulcers and sore gums. Anbesol Anaesthetic Antiseptic Oromucosal solution can be used by adults, the elderly and adolescents and children aged 10-18 years old. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ANBESOL ANAESTHETIC ANTISEPTIC OROMUCOSAL SOLUTION Do not use Anbesol Anaesthetic Antiseptic Oromucosal solution: • If you are allerg קרא את המסמך השלם
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. Anbesol Anaesthetic Antiseptic Oromucosal Solution is indicated in adults, the elderly and adolescents and children aged 10 to 18 years. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: oromucosal FOR ADULTS, THE ELDERLY, ADOLESCENTS AND CHILDREN AGED 10 TO 18 YEARS Apply undiluted to the affected area with the fingertip. Two applications immediately will normally be sufficient to obtain pain relief. It should not be used more frequently than every 3 hours or as directed by the physician or dentist. 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 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. Lidocaine Hydrochloride 0.90 % w/w Chlorocresol 0.10 % w/w Cetylpyridinium Chloride 0.02 % w/w H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ קרא את המסמך השלם