מדינה: מלטה
שפה: אנגלית
מקור: Medicines Authority
JNTL Consumer Health I (Ireland) Limited Block 5, High Street, Tallaght, Dublin 24, , Ireland
A01AB12
HEXETIDINE 0.1 % (W/V)
GARGLE MOUTH WASH
HEXETIDINE 0.1 % (W/V)
OTC
STOMATOLOGICAL PREPARATIONS
Authorised
2006-08-10
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 If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Some of the ingredients can cause problems n This medicine contains 607.8 mg of alcohol (ethanol) in each 15 ml dose. The amount in 15 ml of dose of this medicine is equivalent to 15 קרא את המסמך השלם
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF 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 4.052g Ethanol (96%) per 100ml i.e.: up to 0.6078g ethanol per 15ml dose Azorubine (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 ADULTS AND CHILDREN 6 YEARS AND OVER Rinse the mouth or gargle with at least 15 ml of solution two to three times daily or as directed. Do not swallow the solution but spit out after use. An adult should supervise use in children to ensure that product is administered correctly. ELDERLY As for adults. Children u NDER 6 YEARS: Not recommended METHOD OF ADMINISTRATION For oromucosal use only. Do not swallow. 2 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. This medicine contains 607.8 mg of alcohol (ethanol) in each 15 ml dose. The amount in 15 ml of dose of this medicine is equivalent to 15 ml beer, 6 ml wine. If swallowed, the amount of alcohol in this medicine is not likely to have an effect in adults and adolescents, and its effects in children are not likely to be noticeable. It may have some effects in younger children, for example feeling sleepy. If swallowed, the alcohol in this medicine may alter the effects of other med קרא את המסמך השלם