País: Israel
Idioma: inglés
Fuente: Ministry of Health
ADAPALENE; BENZOYL PEROXIDE
A.M.I. MEDICAL TECHNOLOGIES LIMITED, ISRAEL
D10AE01
GEL
BENZOYL PEROXIDE 25 MG/G; ADAPALENE 1 MG/G
DERMAL
Required
LABORATOIRES GALDERMA, FRANCE
BENZOYL PEROXIDE
Cutaneous treatment of Acne vulgaris when comedones, papules and pustules are present.
2021-04-30
PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986 This medicine is sold with a doctor's prescription only EPIDUO GEL ACTIVE INGREDIENTS: 1 g of gel contains: 1 mg Adapalene (0.1%) 25 mg Benzoyl Peroxide (2.5%) For the list of the other ingredients, see section 6. See also 'Important information about some of the medicine's ingredients' in section 2. READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, please refer to your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if you think their medical condition is similar to yours. The gel is intended for use in children aged 9 years and older, adolescents and adults. 1. WHAT IS THE MEDICINE INTENDED FOR? The medicine is intended for treatment of acne. THERAPEUTIC GROUP: Topical treatment for acne: Adapalene - retinoid (vitamin A derivative). Benzoyl peroxide - peroxides. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: You are sensitive (allergic) to the active ingredients or to any of the other ingredients the medicine contains (for a list of the other ingredients, see section 6). You are pregnant or planning a pregnancy. SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE: Do not apply the gel to areas where the skin is damaged (e.g., scrapes, cuts), to sunburnt areas or if you have skin eczema. Avoid contact of the gel with the eyes, mouth, nostrils, and other sensitive areas. If the gel came into contact with these areas accidentally, wash immediately with plenty of warm water. Avoid excessive exposure to sun or UV radiation and ensure appropriate protection if you must be exposed to the sun (long sleeves and trousers/skirts, hat, sunscreen preparations etc.). Make sure the gel does not come into contact with the hair and with colored fabrics (e.g. clothing, towels, bed linens), since it may cause a color change (e.g. fading or b Leer el documento completo
1 Epiduo -DL-May 2016_march 2020_ 03_notif Doctor leaflet 1. NAME OF THE MEDICINAL PRODUCT Epiduo 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 gram of gel contains: Adapalene 1 mg (0.1%) Benzoyl Peroxide 25 mg (2.5%) Excipient with known effect: Propylene glycol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gel. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cutaneous treatment of _Acne vulgaris _when comedones, papules and pustules are present. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 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 and lips (see section 4.4). If irritation occurs, the patient should be directed to apply non-comedogenic moisturizers, to use the medication 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. The safety and effectiveness of Epiduo have not been studied in children below 9 years of age. 4.3 CONTRAINDICATIONS Pregnancy (see section 4.6) Women planning a pregnancy (see section 4.6) Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Epiduo Gel should not be applied to damaged skin, either broken (cuts or abrasions), eczematous or sunburned. Epiduo should not come into contact with the eyes, mouth, nostrils or mucous membranes. If product enters the eye, wash immediately with warm water. This product contains propylene glycol (E1520) that may cause skin irritation. If a reaction suggesting sensitivity to any component of the formula occurs, the use of Epiduo should be discontinued. Excessive exposure to sunlight or UV radiation should be avoided. Epiduo should not come into contact with any coloured m Leer el documento completo