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
10mg/1gram ; 1mg/1gram ; 200microgram/1gram
Oromucosal gel
Oromucosal; Gingival
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 12030100; GTIN: 0000096032909
ANBESOL ® TEETHING 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 TEETHING GEL IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ANBESOL TEETHING GEL 3. HOW TO USE ANBESOL TEETHING GEL 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE ANBESOL TEETHING GEL 6. CONTENTS OF PACK AND OTHER INFORMATION 1. WHAT ANBESOL TEETHING GEL IS AND WHAT IT IS USED FOR Anbesol Teething Gel contains 1.0%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 Teething Gel is used to help relieve pain and discomfort associated with TEETHING, in children from 5 months of age, when other non-medicinal methods such as massaging of the gums or use of teething rings do not provide necessary relief. The product may also be used for the temporary relief of pain caused by recurrent MOUTH ULCERS and DENTURE IRRITATION. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ANBESOL TEETHING GEL DO NOT USE ANBESOL TEETHING 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). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Anbesol Teething Gel: • If you have open wounds or damaged areas in Przeczytaj cały dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Anbesol Teething Gel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Lidocaine hydrochloride 1.0%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% 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 and denture irritation. For relief of pain and discomfort associated with teething in children from 5 months of age, where non-pharmacological treatments have failed to provide sufficient relief. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: oromucosal ADULTS AND THE ELDERLY: Apply a small amount to the affected area with a clean fingertip. Two applications immediately will normally be sufficient to obtain pain relief. It should not be used more frequently than every 3 hours. BABIES TEETHING AND CHILDREN: Apply a pea-sized amount (0.2 grams) of Anbesol teething gel with a clean finger to the affected area. The dose may be repeated if necessary after 3 hours, up to a maximum of 6 doses in 24 hours. Treatment should be stopped once symptoms have resolved. Not to be used for more than 7 days. Parents or carers should seek medical attention if the child’s condition deteriorates during treatment. In case of vomiting, spitting or accidental ingestion, the dose should not be repeated immediately. The dose may be repeated if necessary after 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 Do not use more than one product containing lidocaine at the same time. Excessi Przeczytaj cały dokument