Страна: Южна Африка
Език: английски
Източник: South African Health Products Regulatory Authority (SAHPRA)
Galderma Laboratories S.A. (Pty) Ltd
See ingredients
GEL
EACH 1,0 g GEL CONTAINS ADAPALENE 1,0 mg BENZOYL PEROXIDE 25,0 mg
Registered
2014-02-10
_Applicant/PHRC: _ GALDERMA LABORATORIES SOUTH AFRICA (PTY) LTD _Product proprietary name: _ EPIDUO 0.1 %/ 2.5 % _Dosage form and strength: _ Gel 1 mg (0,1 %) of adapalene and 25 mg (2,5 %) of benzoyl peroxide per 1 gram Page 1 of 11 PATIENT INFORMATION LEAFLET SCHEDULING STATUS EPIDUO® 0,1 % / 2,5 % (GEL) adapalene and benzoyl peroxide READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING EPIDUO 0,1 % / 2,5 %. • Keep this leaflet. You may need to read it again. • If you have further questions, please ask your doctor, pharmacist, nurse or other health care provider. • Epiduo has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours. WHAT IS IN THIS LEAFLET 1. What Epiduo 0,1 % / 2,5 % is and what it is used for 2. What you need to know before you take Epiduo 0,1 % / 2,5 % 3. How to use Epiduo 0,1 % / 2,5 % 4. Possible side effects 5. How to store Epiduo 0,1 % / 2,5 % 6. Contents of the pack and other information S3 _Applicant/PHRC: _ GALDERMA LABORATORIES SOUTH AFRICA (PTY) LTD _Product proprietary name: _ EPIDUO 0.1 %/ 2.5 % _Dosage form and strength: _ Gel 1 mg (0,1 %) of adapalene and 25 mg (2,5 %) of benzoyl peroxide per 1 gram Page 2 of 11 1. WHAT EPIDUO 0,1 % / 2,5 % GEL IS AND WHAT IT IS USED FOR Epiduo is used for the treatment of acne. This gel combines two active ingredients, adapalene and benzoyl peroxide which work together but in different ways: Adapalene belongs to a group of products known as retinoids and acts specifically on the skin processes that cause acne. The other active ingredient, benzoyl peroxide, works as an antimicrobial agent and by softening and peeling the outer layer of the skin. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE EPIDUO 0,1 % / 2,5 % Always tell your health care provider if you are taking any other medicine. If you are pregnant or breast feeding your baby. please consult your health care provider for advice before using this medicine. DO NOT USE EPIDUO • If you a Прочетете целия документ
_Applicant/PHRC: _ GALDERMA LABORATORIES SOUTH AFRICA (PTY) LTD _Product proprietary name: _ EPIDUO 0.1 %/ 2.5 % _Dosage form and strength: _ Gel 1 mg (0,1 %) of adapalene and 25 mg (2,5 %) of benzoyl peroxide per 1 gram Page 1 of 10 PROFESSIONAL INFORMATION SCHEDULING STATUS: S3 1. NAME OF THE MEDICINE EPIDUO ® 0,1 % / 2,5 % ® Gel 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of Epiduo 0,1 % / 2,5 % contains: Adapalene 1 mg (0,1 %) Benzoyl peroxide 25 mg (2,5 %) _Excipients with known with known effect_: Propylene glycol (E1520; 4 %.) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gel A white to very pale yellow opaque gel. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cutaneous treatment of _Acne vulgaris_ when comedones, papules and pustules are present in adults, adolescents and children aged 9 years and over (See section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY _Applicant/PHRC: _ GALDERMA LABORATORIES SOUTH AFRICA (PTY) LTD _Product proprietary name: _ EPIDUO 0.1 %/ 2.5 % _Dosage form and strength: _ Gel 1 mg (0,1 %) of adapalene and 25 mg (2,5 %) of benzoyl peroxide per 1 gram Page 2 of 10 Epiduo should be applied to the entire acne affected areas once a day in the evening on a clean and dry skin. A thin film of gel should be applied, with the fingertips, avoiding the eyes, lips and nostrils (See section 4.4). If irritation occurs, the patient should be directed to apply non-comedogenic moisturisers, to use Epiduo less frequently (e.g. every other day), to suspend use temporarily, or to discontinue use altogether. The duration of treatment should be determined by the doctor on the basis of the clinical condition. Early signs of clinical improvement usually appear after 1 to 4 weeks of treatment. S PECIAL POPULATIONS _Paediatric population _ The safety and effectiveness of Epiduo have not been studied in children below 9 years of age. METHOD OF ADMINISTRATION For external cutaneous use only. 4.3 CONTRAINDICATIONS • Hypersensitivity to the active ing Прочетете целия документ