Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
Clindamycin; Anhydrous Benzoyl Peroxide
PCO Manufacturing Ltd.
D10AF; D10AF51
Clindamycin; Anhydrous Benzoyl Peroxide
10+50 milligram(s)/gram
Gel
Antiinfectives for treatment of acne; clindamycin, combinations
2020-11-13
_ _ _ _ _ _ _ _ _ _ _ _ PACKAGE LEAFLET: INFORMATION FOR THE USER DUAC ® ONCE DAILY 10 MG/G + 50 MG/G GEL clindamycin + anhydrous benzoyl peroxide READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. – Keep this leaflet. You may need to read it again. – If you have any further questions, ask your doctor or pharmacist. – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. – If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What DUAC ONCE DAILY GEL is and what it is used for 2. What you need to know before you use DUAC ONCE DAILY GEL 3. How to use DUAC ONCE DAILY GEL 4. Possible side effects 5. How to store DUAC ONCE DAILY GEL 6. Contents of the pack and other information 1. WHAT DUAC ONCE DAILY GEL IS AND WHAT IT IS USED FOR DUAC ONCE DAILY GEL contains two medicines: clindamycin and benzoyl peroxide. DUAC ONCE DAILY GEL belongs to a group of medicines known as ‘anti-acne preparations’. DUAC ONCE DAILY GEL is used for treating mild to moderate acne on your skin. Clindamycin is an antibiotic which stops the bacteria involved in acne from reproducing Benzoyl peroxide reduces blackheads and whiteheads. It also kills the bacteria involved in acne. Used together in DUAC ONCE DAILY GEL, these work by: fighting the bacteria that can cause acne treating existing blackheads, whiteheads, and spots lowering the number of red, inflamed acne spots DUAC ONCE DAILY GEL is for use by adults and adolescents aged twelve years or over. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE DUAC ONCE DAILY GEL DO NOT USE DUAC ONCE DAILY GEL: if you are allergic to clindamycin, lincomycin, benzoyl peroxide or any of the other ingredients of DUAC ONCE DAILY GEL (listed in Section 6) Do not use DUAC ONCE DAILY GEL if any of the Przeczytaj cały dokument
Health Products Regulatory Authority 13 November 2020 CRN00C00Y Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Duac Once Daily 10 mg/g + 50 mg/g Gel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g of gel contains: 10 mg clindamycin as clindamycin phosphate 50 mg anhydrous benzoyl peroxide as hydrous benzoyl peroxide For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Gel. _Product imported from Greece:_ White to slightly yellow homogeneous gel 4 CLINICAL PARTICULARS As per PA1077/120/001 5 PHARMACOLOGICAL PROPERTIES As per PA1077/120/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Carbomer Dimeticone Disodium lauryl sulfosuccinate Disodium edetate Glycerol Silica, colloidal hydrated Poloxamer 182 Purified water Sodium hydroxide 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date of this product shall be the date shown on the tube and outer package of the product on the market in the country of origin. Shelf life of medicinal product after dispensing 2 months. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Store in a refrigerator (2° C - 8° C). Do not freeze. Health Products Regulatory Authority 13 November 2020 CRN00C00Y Page 2 of 2 Storage conditions after dispensing Do not store above 25° C. 6.5 NATURE AND CONTENTS OF CONTAINER Tube in an outer carton. Pack size: 30 g 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Ltd. Unit 10, Ashbourne Business Park Rath Ashbourne Co. Meath Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA0465/457/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 13 th November 2020 10 DATE OF REVISION OF THE TEXT Przeczytaj cały dokument