Šalis: Airija
kalba: anglų
Šaltinis: 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
4 PACKAGE LEAFLET 5 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 page for the ingredients). TAKE SPECIAL CARE: • For oral use. Do not swallow. • Keep away from the eyes and ears. If the mouthwash accidentally comes into contact with your eyes, rinse out well with clean water immediately. • Brushing teeth with some toothpastes can stop some of the ingredients of Chlorhexidine Gluconate Antiseptic Mouthwash from working. Brushing with toothpaste should be done first and the mouth rinsed out well with water before using the mouthwash, or the mouthwash can be used at a different time of the day. PREGNANCY AND BREAST-FEEDING As with all medicines, if you are pregnant, thinking of becoming pregnant or breast-feeding, ask your doctor before using the mouthwash. IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS: Macrogol glycerol hydroxystearate may cause skin reactions. POSSIBLE SIDE EFFECTS • CHLORHEXIDINE CAN VERY RARELY CAUSE HYPSERSENSITIVITY, INCLUDING ANAPHYLACTIC SHOCK (THROAT OR LIP SWELLING, LOW BLOOD PRESSURE) AND ALLERGIC REACTIONS (E.G. DERMATITIS, ITCHING, REDNESS, ECZEMA, RASH, HIVES, SKIN IRRITATION, BLISTERS). IF ANY OF THESE REACTIONS OCCUR, STOP USING THE PRODUCT AND SEEK MEDICAL ATTENTION IMMEDIATELY. • Occasionally this mouthwash can cause a skin reaction and very rarely may cause swelling of the salivary glands. (The swelling will disappear Perskaitykite visą dokumentą
Health Products Regulatory Authority 31 October 2023 CRN00DXMW Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Chlorhexidine Gluconate Antiseptic Mouthwash Peppermint Flavour 0.2% w/v Oromucosal Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Chlorhexidine Gluconate 0.2% w/v Excipients with known effect: Macrogol glycerol hydroxystearate 0.7 % w/w For full list of excipients see Section 6.1 3 PHARMACEUTICAL FORM Oromucosal Solution. A clear colourless 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 Mouth Perskaitykite visą dokumentą