البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
ADAPALENE
A.M.I. MEDICAL TECHNOLOGIES LIMITED, ISRAEL
D10AD03
CREAM
ADAPALENE 0.1 %W/W
TOPICAL
Required
LABORATORIES GALDERMA, FRANCE
ADAPALENE
ADAPALENE
For the cutaneous treatment of acne vulgaris, where comedones, papules and postules predominate. Acne of the face, chest or back is appropriate for treatment. The treatment is limited up to six months in adolescents over 12 years.
2022-02-28
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS( – 1986 This medicine is sold with a doctor’s prescription only Adaferin Cream Active ingredient and its concentration: Adapalene 0.1% w/w Each 1 gram contains 1 mg Adapalene For the list of the additional ingredients – see section 6. See also ‘Important information about some of the medicine’s ingredients’ in section 2. Read the leaflet carefully in its entirety before using the medicine. This leaflet contains concise information about the medicine. If you have further questions, 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. 1. WHAT IS THE MEDICINE INTENDED FOR? Adaferin Cream is intended for treatment of acne. The preparation works only on inflamed areas where lumps are apparent on the skin as a result of the development of acne vulgaris. Therapeutic group Derivative of vitamin A )retinoid( for external use. 2. BEFORE USING THE MEDICINE Do not use the medicine if: • You are sensitive )allergic( to the active ingredient or to any of the additional ingredients the medicine contains )for the list of the additional ingredients – see section 6(. • Do not use on infants and children under the age of 12 years old. • You are pregnant. • You are planning a pregnancy. Special warnings regarding the use of this medicine: • Adaferin Cream may cause extra sensitivity upon exposure to sun or UV light. Therefore, avoid exposure to the sun )or artificial UV light( and make sure to use appropriate protective measures )long clothing, hat, sunscreens, etc.(. • If you suffer from sunburnt skin due to exposure to the sun, avoid using Adaferin Cream until full recovery. • Do not apply Adaferin Cream on open wounds, cuts, burns, grazed skin and inflamed skin )including eczema(. • Do not use Adaferin Cream in severe cases of acne. • Avoid contact with the eyes, mucous membranes )such as اقرأ الوثيقة كاملة
Adaferin cream -DL-August 2020-03 Summary of Product Characteristics 1. NAME OF THE MEDICINAL PRODUCT Adaferin Cream 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Adapalene 0.1% w/w. 1g cream contains 1mg adapalene. Excipients with known effect: Methyl parahydroxybenzoate Propyl parahydroxybenzoate For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Cream White shiny cream 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the cutaneous treatment of acne vulgaris, where comedones, papules and postules predominate. Acne of the face, chest or back is appropriate for treatment. The treatment is limited up to six months in adolescents over 12 years. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adaferin 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 Adaferin 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 Adaferin Cream have not been studied in children below 12 years of age. 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 degree of اقرأ الوثيقة كاملة