البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
CHLORHEXIDINE DIGLUCONATE
TARO INTERNATIONAL LTD, ISRAEL
A01AB03
OROMUCOSAL GEL
CHLORHEXIDINE DIGLUCONATE 0.2 %W/W
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 (eg denture stomatitis and thrush). 5. For use in a post- periodontal surgery or treatment regimen to promote gingival healing.
2018-12-25
Page 1 of 5 CHX Lacer Gel – PIL Notif 12.21 Clean PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed without a doctor's prescription CHLORHEXIDINE LACER GEL NAME AND CONCENTRATION OF ACTIVE INGREDIENT: CHLORHEXIDINE DIGLUCONATE 0.20% W/W 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 are sensitive (allergic) to the active ingredient or to any of the other Page 2 of 5 CHX Lacer Gel – PIL Notif 12.21 Clean ingredients that this medicine contains. See section 6 ‘Additional information’ for a list of inactive ingredients. SPECIAL WARNINGS REGARDING USE OF THIS MEDICINE • 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 IMMEDIATEL اقرأ الوثيقة كاملة
Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Chlorhexidine Lacer Gel 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Chlorhexidine Digluconate 0.2% w/w (equivalent to Chlorhexidine Digluconate Solution Ph. Eur. 1.06 % w/w) Also contains PEG-40 Hydrogenated Castor Oil. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oromucosal gel. It is a transparent gel with characteristic odour. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. Inhibition of formation of dental plaque. 2. As an aid in the treatment and prevention of gingivitis. 3. As an aid to maintaining oral hygiene. 4. For use in a post- periodontal surgery or treatment regimen to promote gingival healing. 5. For use in aphtous ulceration and oral candidal infections (e.g. denture stomatitis and thrush). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults: Brush the teeth thoroughly with one inch of gel on a moistened toothbrush, once or twice daily for about one minute. Spit out any excess. Do not rinse after applying gel. For the treatment of gingivitis, a course of about one month is advisable. When used for the management of aphthous ulceration and oral candidal infections an alternative method of delivery may be required which facilitates application of the gel to affected areas. This should be used once or twice daily for about one minute. The length of treatment time should be decided on the basis of clinical response. During the treatment of denture stomatitis, thoroughly brush all over the dentures with 2.5 cm of gel on a moistened toothbrush, once or twice daily for about one minute. Do not exceed the stated dose. Children and Elderly patients: Page 2 of 5 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. ROUTE OF ADMINISTRATION: For oral (external) use only. 4.3 CONTRAINDICATIONS Chlor اقرأ الوثيقة كاملة