Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
Chlorhexidine gluconate
Ecolab Deutschland GmbH
A01AB; A01AB03
Chlorhexidine gluconate
0.2 percent weight/volume
Oromucosal solution
Antiinfectives and antiseptics for local oral treatment; chlorhexidine
Not marketed
2000-02-18
CHLORHEXIDINE GLUCONATE ANTISEPTIC MOUTHWASH Original Flavour 0.2% w/v OROMUSCAL SOLUTION A medicated mouthwash for treatment and prevention of gum problems. 300ml 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 KEEP OUT OF SIGHT AND REACH OF CHILDREN The active ingredient is Chlorhexidine Gluconate 0.2% w/v andthe other ingredients are ethanol, sorbitol, macrogol glycerolhydroxystearate, flavour E2309 10 N1, ponceau 4R E124 (redcolouring) and purified water. See attached leaflet for further information. MA HOLDER & MANUFACTURER Ecolab Deutschland GmbH Ecolab-Allee 1, D-40789 Germany PA1843/3/1 WHAT CHLORHEXIDINE GLUCONATE ANTISEPTIC MOUTHWASH IS AND WHAT IT IS USED FOR Chlorhexidine Gluconate Antiseptic Mouthwash (chlorhexidine gluconate 0.2% w/v) is an antimicrobial solution which means it kills harmful bacteria present on your teeth and gums. • It helps to stop dental plaque from forming and to maintain good oral hygiene. • It helps to treat and prevent gingivitis (gum disease). • It manages mouth ulcers, oral thrush and denture sore mouth. • It promotes gum healing following oral surgery. BEFORE YOU USE CHLORHEXIDINE GLUCONATE ANTISEPTIC MOUTHWASH DO NOT USE: • Do not use Chlorhexidine Gluconate Antiseptic Mouthwash if you are allergic to any of the ingredients (see front Baca dokumen lengkap
Health Products Regulatory Authority 21 March 2023 CRN00DF5H Page 1 of 5 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 Chlorhexidine Gluconate 0.2% w/v Excipients with known effect: 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 Antis Baca dokumen lengkap