国: マルタ
言語: 英語
ソース: Medicines Authority
HEXETIDINE
McNeil Products Limited
A01AB12
HEXETIDINE
OROMUCOSAL SOLUTION
HEXETIDINE 0.1 percent weight/volume
OTC
STOMATOLOGICAL PREPARATIONS
Authorised
2006-08-10
F309417 13/0005 _GINGIVITIS_ _MOUTH ULCERS_ _SORE GUMS_ _SORE THROAT_ ANTIBACTERIAL MOUTHWASH TO RELIEVE Hexetidine He xe tid in e 100 10 0 M M L Medicated Relief for Me dic ate d R eli ef fo r Mouth & Throat Infections Mo uth & Th ro at In fe cti on s LOT EXP Medicated Relief for Medicated Relief for Mouth & Throat Infections Mouth & Throat Infections Hexetidine Hexetidine Hexetidine Hexetidine 100 ML HOW TO USE THIS MEDICINE CHECK THE TABLE BELOW TO SEE HOW MUCH MEDICINE CHECK THE TABLE BELOW TO SEE HOW MUCH MEDICINE TO USE. TO USE. ORALDENE IS FOR TOPICAL USE ONLY, WHICH MEANS THAT ORALDENE IS FOR TOPICAL USE ONLY, WHICH MEANS THAT IT SHOULD NOT BE SWALLOWED OR TAKEN INTERNALLY. IT SHOULD NOT BE SWALLOWED OR TAKEN INTERNALLY. CHILDREN UNDER 6 YEARS OLD ORALDENE IS NOT RECOMMENDED FOR CHILDREN UNDER ORALDENE IS NOT RECOMMENDED FOR CHILDREN UNDER 6 YEARS OF AGE. 6 YEARS OF AGE. ADULTS AND CHILDREN AGED 6 YEARS AND OVER IF ANYONE ACCIDENTALLY SWALLOWS THIS PRODUCT IF ANYONE ACCIDENTALLY SWALLOWS THIS PRODUCT, IF ANYONE ACCIDENTALLY SWALLOWS THIS PRODUCT, CONTACT A DOCTOR OR YOUR NEAREST ACCIDENT CONTACT A DOCTOR OR YOUR NEAREST ACCIDENT AND EMERGENCY DEPARTMENT (CASUALTY) TAKING AND EMERGENCY DEPARTMENT (CASUALTY) TAKING THIS PACK WITH YOU. THIS PACK WITH YOU. IF YOU FORGET TO USE THE MEDICINE USE THE NEXT DOSE AS SOON AS YOU REMEMBER USE THE NEXT DOSE AS SOON AS YOU REMEMBER UNLESS IT IS TIME TO USE IT AGAIN. DO NOT USE UNLESS IT IS TIME TO USE IT AGAIN. DO NOT USE TWO QUANTITIES IN ONE GO. TWO QUANTITIES IN ONE GO. THIS CARTON WAS REVISED AUGUST 2013. © THIS CARTON WAS REVISED AUGUST 2013. © ORALDENE IS A REGISTERED TRADE MARK. ORALDENE IS A REGISTERED TRADE MARK. PRODUCT LICENCE HOLDER: MCNEIL PRODUCTS LTD, PRODUCT LICENCE HOLDER: MCNEIL PRODUCTS LTD, MAIDENHEAD, BERKSHIRE, SL6 3UG, UK. MAIDENHEAD, BERKSHIRE, SL6 3UG, UK. 完全なドキュメントを読む
Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS PRODUCT SUMMARY 1. NAME OF THE MEDICINAL PRODUCT ORALDENE 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ORALDENE contains 0.1% w/v hexetidine. 3. PHARMACEUTICAL FORM Mouthwash. A clear red solution. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS ORALDENE is indicated for use in minor mouth infections including thrush, as an aid in the prevention and treatment of gingivitis, and in the management of sore throat and recurrent aphthous ulcers. ORALDENE is also of value in the alleviation of halitosis and pre- and post-dental surgery. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology ADULTS AND CHILDREN 12 YEARS AND OVER Shake well before use. Rinse the mouth, or gargle with at least 15 ml of undiluted solution, two to three times a day. Do not swallow the solution but spit out after use. CHILDREN UNDER 12 YEARS Not recommended. METHOD OF ADMINISTRATION For oromucosal use. 4.3. CONTRAINDICATIONS Hypersensitivity to hexetidine or to any of the excipients in Oraldene. Page 2 of 6 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE ORALDENE mouthwash is for external use only; the solution must therefore not be swallowed. Not suitable for persistent symptoms. 4.5. INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION No interactions are known. 4.6. FERTILITY, PREGNANCY AND LACTATION No formal studies have been conducted in man. However, on the basis of animal studies and, in theory, the negligible systemic absorption it is considered highly unlikely that the use of ORALDENE during pregnancy will present a risk to the foetus. It is not known whether hexetidine is excreted in human breast milk, however, in view of the negligible amount of hexetidine which could be predicted to be systemically absorbed, it is unlikely that concentrations of hexetidine in the milk will present any risk to the neonate/infant. 4.7. EFFECTS ON ABILITY TO DRIVE AND USE MACHINES ORALDENE is unlikely affect ability to drive or operate machinery. 4.8. UNDESIRABLE EFFECTS ORALDENE is 完全なドキュメントを読む