Country: Svíþjóð
Tungumál: sænska
Heimild: Läkemedelsverket (Medical Products Agency)
adapalen; bensoylperoxid, hydratiserad
2care4 ApS
D10AD53
adapalene; benzoyl peroxide, hydrated
0,1 %/2,5 %
Gel
glycerol Hjälpämne; bensoylperoxid, hydratiserad 25 mg Aktiv substans; adapalen 1 mg Aktiv substans; propylenglykol Hjälpämne
Receptbelagt
Avregistrerad
2016-06-15
1 PACKAGE LEAFLET: INFORMATION FOR THE USER EPIDUO 0.1% / 2.5% GEL Adapalene/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 Epiduo is and what it is used for 2. What you need to know before you use Epiduo 3. How to use Epiduo 4. Possible side effects 5. How to store Epiduo 6. Contents of the pack and other information 1. WHAT EPIDUO 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 DO NOT USE EPIDUO: - If you are pregnant - If you are planning a pregnancy - If you are allergic to the adapalene or benzoyl peroxide or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS • You should not use Epiduo on areas where you have cuts, scrapes, sunburn or eczema. • Make sure Epiduo does not get into your eyes, mouth or nostrils, and other very sensitive areas of the body. Should this occur wash these areas immediately with plenty of warm water. • Avoid excessive exposure to sunlight and UV lamps. 2 • Avoid getting Epiduo on your hair or coloured fabrics as it may bleach them and wash your hands thoroughly af Lestu allt skjalið
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Epiduo 0.1% / 2.5% gel 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g of gel contains: Adapalene 1 mg (0.1% w/w) Benzoyl Peroxide, hydrous, equivalent to 25 mg (2.5% w/w) anhydrous benzoyl peroxide. Excipient with known effect: Propylene glycol (E1520) 40 mg/g (4.0%). 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 (see section 5.1). Epiduo is indicated in adults, adolescents and children aged 9 years and over. 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. 2 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 medicine contains 40 mg propylene glycol (E1520) in each gram which is equivalent to 4 Lestu allt skjalið