Valsts: Zviedrija
Valoda: zviedru
Klimata pārmaiņas: Läkemedelsverket (Medical Products Agency)
adapalen; bensoylperoxid, hydratiserad
Orifarm AB
D10AD53
adapalene; benzoyl peroxide, hydrated
0,1 %/2,5 %
Gel
propylenglykol Hjälpämne; bensoylperoxid, hydratiserad 25 mg Aktiv substans; glycerol Hjälpämne; adapalen 1 mg Aktiv substans
Receptbelagt
Avregistrerad
2017-06-21
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 Izlasiet visu dokumentu