Negara: Inggris
Bahasa: Inggris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Cetylpyridinium chloride; Chlorocresol; Lidocaine hydrochloride
Alliance Pharmaceuticals Ltd
N01BB52
Cetylpyridinium chloride; Chlorocresol; Lidocaine hydrochloride
200microgram/1gram ; 1mg/1gram ; 9mg/1gram
Oromucosal solution
Oromucosal; Gingival
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 12030400; GTIN: 0000096032916 0000096032930 5036631001340 0000096183458
Guides, Dimensions and Cutter guide are NOT to be printed. 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 Liquid is and what it is used for 2. What you need to know before you use Anbesol Liquid 3. How to use Anbesol Liquid 4. Possible side effects 5. How to store Anbesol Liquid 6. Contents of pack and other information 1. WHAT ANBESOL LIQUID IS AND WHAT IT IS USED FOR? Anbesol Liquid contains 0.9%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 Liquid 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 by adults, children and the elderly for the temporary relief of pain caused by recurrent mouth ulcers and denture irritation. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ANBESOL LIQUID Do not use Anbesol Liquid: • 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) • If your child is under 5 months old • At the same time as other products containing lidocaine. Do not use more Anbesol Liquid than recommended (as listed in Section 3) as this may result Baca dokumen lengkapnya
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Anbesol Liquid 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Lidocaine hydrochloride 0.9%w/w Chlorocresol 0.1%w/w Cetylpyridinium chloride 0.02%w/w Excipients with known effect: Each 1ml of the product contains 2.76 micrograms of amaranth (E123), 2.58 micrograms of sunset yellow (E110) and 68.24%w/w of ethanol 96% For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Oromucosal solution (oromucosal liquid) A clear yellow liquid 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ADULTS, THE ELDERLY AND CHILDREN: For the temporary relief of pain caused by recurrent mouth ulcers and denture irritation. IN CHILDREN FROM 5 MONTHS OF AGE: For relief of pain and discomfort associated with teething 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 to the affected area, a small undiluted amount of Anbesol Liquid, by covering the bottle mouth with a clean fingertip, inverting once and returning the bottle to the upright position. Two applications immediately will normally be sufficient to obtain pain relief. The application may be repeated if necessary after 3 hours. BABIES TEETHING AND CHILDREN: Apply once to the affected area, 0.25 ml of undiluted Anbesol Liquid, by covering the bottle mouth with a clean fingertip, inverting once and returning the bottle to the upright position. The application may be repeated if necessary after 3 hours, up to a maximum of 6 applications 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. One application may be repeated if necessary after 3 hours. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substances, anaest Baca dokumen lengkapnya