Maa: Israel
Kieli: englanti
Lähde: Ministry of Health
CHLORHEXIDINE DIGLUCONATE
TARO INTERNATIONAL LTD, ISRAEL
A01AB03
SOLUTION (ORAL)
CHLORHEXIDINE DIGLUCONATE 0.12 %W/V
LOCAL ORAL
Not required
LACER S.A., SPAIN
CHLORHEXIDINE
1. As an aid to maintaining oral hygiene. 2. As an aid in the treatment and prevention of gingivitis. 3. Inhibition of formation of dental plaque. 4. For use in aphtous ulceration and oral candidal infections (e.g. denture stomatitis and thrush). 5. For use in a post- periodontal surgery or treatment regimen to promote gingival healing.
2019-01-01
Page 1 of 5 CHX Lacer MW – PIL Notif 12.2021 Clean PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed without a doctor's prescription CHLORHEXIDINE LACER MOUTHWASH NAME AND CONCENTRATION OF ACTIVE INGREDIENT: CHLORHEXIDINE DIGLUCONATE 0.12% W/V Inactive ingredients and allergens: see section 2 ‘Important information about some of this medicine's ingredients’ and section 6 'Additional information'. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. THIS MEDICINE IS INTENDED FOR USE IN PATIENTS OVER 12 YEARS OLD. CONSULT YOUR DOCTOR BEFORE USE IN YOUNGER PATIENTS. Use this medicine according to the instructions in the section about dose in this leaflet. Consult your pharmacist if you need further information. Consult your doctor if your symptoms of illness get worse or do not improve. 1. WHAT IS THIS MEDICINE INTENDED FOR? • As an aid in the treatment and prevention of gum inflammation (gingivitis). • For use following dental surgery or treatments, to promote healing of the gums. • For use in mouth ulcers, inflammations due to dentures, and oral thrush. • As an aid to maintaining oral hygiene. • Inhibition of formation of dental plaque. THERAPEUTIC GROUP: antiseptic 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: YOU HAVE HAD AN ALLERGIC REACTION to chlorhexidine digluconate or to any of this medicine’s ingredients. SPECIAL WARNINGS REGARDING USE OF THIS MEDICINE Page 2 of 5 CHX Lacer MW – PIL Notif 12.2021 Clean • DO NOT USE ANYWHERE OTHER THAN IN YOUR MOUTH. Do not swallow. In case of contact with the eyes or ears, rinse thoroughly with water. • IN CASE OF A SEVERE ALLERGIC REACTION, STOP USING THIS MEDICINE AND GET HELP IMMEDIATELY. See ‘Side effects’. • DO NOT USE IMMEDIATELY AFTER YOU BRUSH TEETH. See ‘How to use this medicine’ for more information. • Lue koko asiakirja
_This leaflet format has been determined by the Ministry of Health and the content has been checked and _ _approved in January 2019_ SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Chlorhexidine Lacer Mouthwash 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Chlorhexidine Digluconate 0.12% w/v (equivalent to Chlorhexidine Digluconate Solution 0.636% w/w) Also contains PEG-40 Hydrogenated Castor Oil. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oromucosal solution Colourless solution and with a characteristic odour. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Antibacterial solution for the disinfection of the mouth. 1. As an aid to maintaining oral hygiene. 2. As an aid in the treatment and prevention of gingivitis. 3. Inhibition of formation of dental plaque. 4. For use in aphtous ulceration and oral candidal infections (e.g. denture stomatitis and thrush). 5. For use in a post- periodontal surgery or treatment regimen to promote gingival healing. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults Thoroughly rinse the mouth for about one minute with 15 ml twice daily. Spit out after use. In the dental surgery, the patient should be instructed to rinse the mouth 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 dental stomatitis, the dentures should be cleansed and soaked in Chlorhexidine Lacer Mouthwash for fifteen minutes twice daily. Do not exceed the stated dose. Children and the Elderly Page 1 of 5 Cholrexidine Lacer Mouthwash – SmPC final The normal adult dose is appropriate for elderly patients and children of 12 years and over unless otherwise recommended by the dentist or the physician. Children under 12 years of age should not use the product unless recommended by a healthcare professional. Lue koko asiakirja