国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
HEXETIDINE
McNeil Healthcare (Ireland) Ltd
A01AB12
HEXETIDINE
0.1 %w/v
Oromucosal Solution
Product not subject to medical prescription
Antiinfectives and antiseptics for local oral treatment
Authorised
1995-03-26
Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse have told you. n Keep this leaflet. You may need to read it again. n This medicine is used to relieve throat and mouth infections. n This medicine is for use by adults and children aged 6 years and over. n Ask your pharmacist if you need more information or advice. n If you get any side-effects, talk to your doctor, pharmacist or nurse. This include any side- effects not listed in this leaflet. _See section 4_ n Do not use this medicine: n If you have had a bad reaction to Oraldene or any of the ingredients in it. _See section 6_ n Follow the dosage instructions carefully. 1 What the medicine is for The mouthwash contains hexetidine, which is an antibacterial and antifungal and is used to help treat throat and mouth infections, including mouth ulcers, thrush, sore or bleeding gums (called gingivitis), bad breath (halitosis) or sore throat. It can also be used before and after dental surgery to help prevent infections. 2 Before using this medicine This medicine is suitable for most people, but a few people should not use it. If you are in any doubt, talk to your doctor or pharmacist. Do not use this medicine… n If you have ever had a bad reaction (e.g: hypersensitivity or allergic reaction) to Oraldene or any of its ingredients n If there is evidence of increased inflammation, the treatment should be stopped. If the above applies to you, get advice from your doctor or pharmacist without using Oraldene. If you are pregnant or breast-feeding n Ask your doctor or pharmacist for advice before using Oraldene if you are pregnant or breast-feeding. Some of the ingredients can cause problems n Oraldene contains 0.611 g of ethanol (alcohol) per 15 ml dose, equivalent to 15.48 ml of beer at 5% vol and 6.45 ml of wine at 12% vol. Harmful for those suffering from alcoholism. To be taken into account in p 阅读完整的文件
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Oraldene 0.1% w/v Gargle/Mouthwash 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Contains Hexetidine 0.10% w/v Excipients with known effect: contain 4.3g Ethanol (96%) per 100ml ie: up to 0.611g ethanol per 15ml dose and trace amounts of Azorubine 85% (E122) For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Gargle/mouthwash A clear, red coloured liquid for use as a gargle or mouthwash. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oraldene is recommended as a topical antiseptic in the management of superficial infections of the oropharynx and in their prophylaxis in the preoperative period of dental surgery or pharyngeal surgery in geriatric nursing. Oraldene can also be used as an adjunct to systemic therapy of oropharyngeal infections. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY USUAL DOSAGE IN ADULTS AND CHILDREN 6 YEARS AND OVER Rinse the mouth or gargle with at least 15 ml of solution two or three times daily or as directed. Do not swallow. ELDERLY As for adults. UNDER 6 YEARS: Not recommended METHOD OF ADMINISTRATION For oromucosal use 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Oraldene should not be taken internally. Oraldene is for external use only; the solution must therefore not be swallowed. 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _2_ _1_ _/_ _0_ _3_ _/ 阅读完整的文件