Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Chlorhexidine gluconate
Dowelhurst Ltd
A01AB03
Chlorhexidine gluconate
2mg/1ml
Mouthwash
Oromucosal
No Controlled Drug Status
Valid as a prescribable product
BNF: 12030400
PEEL HERE ANTISEPTIC CHLORHEXIDINE GLUCONATE 0.2% W/V OROMUCOSAL SOLUTION 300ML A MEDICATED MOUTHWASH FOR TREATMENT AND PREVENTION OF GUM PROBLEMS O R I G I N A L F L A V O U R KEEP OUT OF SIGHT AND REACH OF CHILDREN MARKETING AUTHORISATION HOLDER AND MANUFACTURER Ecolab Ltd, Lotherton Way, Garforth, Leeds LS25 2JY, England Tel: +44 (0)113 232 0066 3037080 3037080F/08APR15/GB 4 028163 037080 Before using this mouthwash please peel back the label and read all the information carefully If you have any questions please discuss them with your pharmacist, doctor or dentist before use. How to use this mouthwash • Use as required, up to twice daily. • Fill the cap to the 10ml line. Rinse the mouth thoroughly for 1 minute. • Do not swallow the mouthwash. GINGIVITIS (GUM DISEASE): A one month course is usually recommended (2 bottles). MOUTH ULCERS AND ORAL THRUSH: Continue to use for 2 days after healing has occurred. DENTURE SORE MOUTH: Dentures should be cleaned and soaked in mouthwash for 15 minutes, morning and evening. BEFORE DENTAL SURGERY: Rinse the mouth thoroughly with 10ml for 1 minute. If symptoms persist please speak to your pharmacist, doctor or dentist. The active ingredient is Chlorhexidine Gluconate 0.2% w/v and the other ingredients are ethanol, sorbitol, macrogol glycerol hydroxystearate, flavour E2309 10 N1, ponceau 4R E124 (red colouring) and purified water. See attached leaflet for further information. Chlorhexidine gluconate antiseptic mouthwash original flavour Chlorhexidine gluconate antiseptic mouthwash original flavour PL 04509/0009 ANTISEPTIC CHLORHEXIDINE GLUCONATE 0.2% W/V OROMUCOSAL SOLUTION 300ML A MEDICATED MOUTHWASH FOR TREATMENT AND PREVENTION OF GUM PROBLEMS O R I G I N A L F L A V O U R KEEP OUT OF SIGHT AND REACH OF CHILDREN MARKETING AUTHORISATION HOLDER AND MANUFACTURER Ecolab Ltd, Lotherton Way, Garforth, Leeds LS25 2JY, England Tel: +44 (0)113 232 0066 3037080 3037080F/08APR15/GB Before using this mouthwash please peel back the label and read all the information carefully If Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Chlorhexidine Gluconate Antiseptic Mouthwash Original Flavour 0.2% W/V Oromucosal Solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Excipients: Ponceau 4R 0.001%w/w Macrogol glycerol hydroxystearate 0.7 % w/w For full list of excipients see Section 6.1 3. PHARMACEUTICAL FORM Oromucosal Solution A clear pink solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Chlorhexidine Gluconate Antiseptic Mouthwash is an antimicrobial solution which inhibits the formation of dental plaque. It is indicated as an aid to the treatment and prevention of gingivitis and in the maintenance of oral hygiene, particularly in situations where toothbrushing cannot be adequately employed (eg following oral surgery or in physically handicapped patients). It is used to promote gingival healing following periodontal surgery, to manage recurrent oral ulceration. Additionally it is useful in the treatment of denture stomatitis and thrush. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Children, adults and the elderly. Chlorhexidine Gluconate Antiseptic Mouthwash should be used as required up to twice daily. Rinse the mouth thoroughly for about 1 minute with 10 ml. Prior to dental surgery, the patient should be instructed to rinse the mouth with 10 ml for 1 minute. In the treatment of gingivitis a course of about one month is recommended (ie two bottles). For denture stomatitis cleanse and soak the denture in solution for 15 minutes twice daily. In the case of aphthous ulceration and oral candidal infections, treatment should be continued for 48 hours after clinical resolution. 4.3 CONTRAINDICATIONS Known hypersensitivity to the product or any of its components, especially in those with a history of possible chlorhexidine-related allergic reactions (see sections 4.4 and 4.8). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Chlorhexidine Gluconate Antiseptic Mouthwash contains chlorhexidine. Chlorhexidine is known to induce hypersensitivity, including generalised allergic re Read the complete document