Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Chlorhexidine gluconate
Haleon Ireland Limited
A01AB; A01AB03
Chlorhexidine gluconate
0.2 percent weight/volume
Mouthwash
Product not subject to medical prescription
Antiinfectives and antiseptics for local oral treatment; chlorhexidine
Marketed
1995-01-10
PACKAGE LEAFLET: INFORMATION FOR THE USER CORSODYL ANISEED 0.2% w/v MOUTHWASH chlorhexidine digluconate WHAT YOU SHOULD KNOW ABOUT CORSODYL ANISEED MOUTHWASH Please read this leaflet carefully before you start to use Corsodyl Aniseed Mouthwash, especially the section headed “Before you start using Corsodyl Aniseed Mouthwash”. This leaflet provides some of the information available on your medicine. If you have any questions or are not sure about anything, ask your dentist, doctor or pharmacist. In this leaflet: 1. What is Corsodyl Aniseed Mouthwash and what is it used for 2. Before you start using Corsodyl Aniseed Mouthwash 3. How to use Corsodyl Aniseed Mouthwash 4. Possible side effects 5. How to store Corsodyl Aniseed Mouthwash 6. Further information 1. WHAT IS CORSODYL ANISEED MOUTHWASH AND WHAT IS IT USED FOR? The active ingredients chlorhexidine digluconate is known as an antimicrobial. This means that it kills off a wide range of bacteria, yeasts, some fungi and some viruses that cause infection and inflammation in your mouth. Corsodyl Aniseed Mouthwash is a clear to slightly opalescent transparent solution with an odour of aniseed and is used to stop plaque forming on your teeth and gums. It helps in the treatment and prevention of gingivitis, which causes reddening, swelling and sometimes bleeding of gums. Other uses include: keeping your mouth clean in situations where you are unable to brush your teeth effectively (e.g. following dental surgery or treatment or if you have disabilities), helping healing in the mouth, and helping treat mouth ulcers, denture stomatitis (infection/inflammation in your mouth caused by your dentures) and oral thrush. These diseases are caused by a fungus called Candida albicans which leads to white furry patches in your mouth or redness under denture(s). 2. BEFORE YOU START USING CORSODYL ANISEED MOUTHWASH For external use in the mouth only. This means that you should only use the mouthwash in the mouth and you should try not to swallow any. Keep out of the eyes and ears Read the complete document
Health Products Regulatory Authority 12 July 2023 CRN00DM3P Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Corsodyl 0.2 % w/v Aniseed Mouthwash 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Chlorhexidine Digluconate 0.2% w/v (as Chlorhexidine Digluconate Solution). Excipients: Contains Macrogolglycerol Hydroxystearate 0.8% w/v For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Mouthwash. A clear to slightly opalescent, transparent solution with an odour of aniseed. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the inhibition of the formation of dental plaque. As an aid in the treatment and prevention of gingivitis, and in the maintenance of oral hygiene, particularly in situations where tooth brushing cannot be adequately employed (e.g. following oral surgery or in physically or mentally handicapped patients). Also for use in a post-periodontal surgery or treatment regimen to promote gingival healing. It is useful in the management of aphthous ulceration and oral candidal infections (e.g. denture stomatitis and thrush). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults: Thoroughly rinse the mouth for about one minute with 10 ml twice daily. Spit out after use. In the dental surgery the patient should be instructed to rinse the mouth with 10 ml for one minute prior to treatment. For the treatment of gingivitis, a course of about one month is advisable although some variation in response is to be expected. In the case of aphthous ulceration and oral candidal infections, treatment should be continued for 48 hours after clinical resolution. For the treatment of denture stomatitis the dentures should be cleansed and soaked in Corsodyl Mouthwash for fifteen minutes twice daily. Do not exceed the stated dose. Children and the Elderly: There are no special dosage recommendations for either elderly patients or children of 12 years and over. The normal adult dose is appropriate unless otherwise recommended by the dentist or the physician. CHILDREN UNDER 12 YEARS OF AG Read the complete document