Страна: Велика Британія
мова: англійська
Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)
Adapalene
DE Pharmaceuticals
D10AD03
Adapalene
1mg/1gram
Cutaneous cream
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13060100
Galderma-Differin-UK-Cream Galderma-Differin-UK-Cream Прочитайте повний документ
1. NAME OF THE MEDICINAL PRODUCT Differin 0.1% w/w Cream 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Adapalene 0.1% w/w 1g cream contains 1mg adapalene. Excipients with known effect: Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Cream White shiny cream 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _ _ Differin Cream is proposed for the cutaneous treatment of mild to moderate acne vulgaris where comedones, papules and pustules predominate. Differin Cream is best suited for use on dry and fair skin. Acne of the face, chest or back is appropriate for treatment. _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION_ _ Differin Cream should be applied to the acne affected areas once a day before retiring and after washing. A thin film of cream should be applied, with the fingertips, avoiding the eyes and lips (see 4.4 _Special _ _warnings and special precautions for use_, below). Ensure that the affected areas are dry before application. Since it is customary to alternate therapies in the treatment of acne, it is recommended that the physician assess the continued improvement of the patient after three months of treatment with Differin Cream. With patients for whom it is necessary to reduce the frequency of application or to temporarily discontinue treatment, frequency of application may be restored or therapy resumed once it is judged that the patient can again tolerate the treatment. If patients use cosmetics, these should be non-comedogenic and non-astringent. _Paediatric population:_ The safety and effectiveness of Differin Cream have not been studied in children below 12 years of age. 1.1 4.3 CONTRAINDICATIONS Pregnancy (see section 4.6). Women planning a pregnancy. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE If a reaction suggesting sensitivity or severe irritation occurs, use of the medication should be discontinued. If the degre Прочитайте повний документ