Држава: Израел
Језик: Енглески
Извор: Ministry of Health
BENZOYL PEROXIDE
RAFA LABORATORIES LTD
D10AE01
GEL
BENZOYL PEROXIDE 2.5 %W/W
TOPICAL
Not required
LABORATOIRES GALDERMA, FRANCE
BENZOYL PEROXIDE
BENZOYL PEROXIDE
For the topical treatment of acne vulgaris.
2011-11-30
BENZ GEL PL SH 280623 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS )PREPARATIONS( – 1986 The medicine is dispensed without a doctor’s prescription BENZAC 5% )W/W( Gel The active ingredient and its concentration: Benzoyl peroxide 5% For information regarding inactive ingredients and allergens, see section 6. See also ‘ Important information about some of the ingredients of the medicine ’ in section 2. Read the entire leaflet carefully before using the medicine. This leaflet contains concise information about the medicine. If you have additional questions, refer to the doctor or pharmacist. The gel is not generally indicated for children under 12 years of age. Use the medicine in accordance with the instructions in the Dosage section of this leaflet. Consult a pharmacist if you need further information. Refer to the doctor if the symptoms worsen or are not improving. 1. WHAT IS THE MEDICINE INTENDED FOR? For the topical treatment of acne vulgaris. Therapeutic group: Topical preparations for acne treatment – peroxides. 2. BEFORE USING THE MEDICINE Do not use this medicine if: You are sensitive )allergic) to the active ingredient or to any of the additional ingredients contained in the medicine )for the list of additional ingredients, see section 6). An allergic reaction may be manifested by, for example, rash or itching. Special warnings regarding use of the medicine: • Avoid contact of the gel and the eyes )including the eyelids), mouth, nostrils or other mucous membranes. If contact is accidentally made between the gel and these areas, immediately rinse the area thoroughly with warm water. • Do not use the gel on damaged or inflamed skin or on open wounds. • The use of the medicine may cause swelling and blistering of the skin. If these symptoms occur, the use of the medicine should be discontinued. • The gel has a bleaching quality, therefore, avoid contact of the gel with the hair, or with colored fabrics )e.g., clothing, towels, bed linens). Make sure to wash your h Прочитајте комплетан документ
_ _ 1 Benzac-DL-Jan 2016-01 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT BENZAC 2.5% BENZAC 5% BENZAC 10% 2. QUALITATIVE AND QUANTITATIVE COMPOSITION BENZAC 2.5% GEL: benzoyl peroxide 2.5 %w/w BENZAC 5% GEL: benzoyl peroxide 5 %w/w BENZAC 10% GEL: benzoyl peroxide 10 % w/w Excipient with known effect: propylene glycol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gel for topical use. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS For the topical treatment of acne vulgaris. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION To be adapted according to treatment response and individual tolerance (see section 4.4). In general, 1 to 2 daily applications. Benzac 2.5 % and Benzac 5 % should preferably be used in the following cases: for emerging acne in teenagers, In subjects with sensitive skin, notably children and blond-haired or red-haired subjects, at the start of treatment, during a trial period, to ensure that the product is well tolerated, for maintenance treatment of acne scars. 1 application every 2-3 days as maintenance treatment for Benzac 2.5 % and Benzac 5 %. Apply Benzac by massaging gently with the fingertips until fully absorbed. Wash hands after use. Keep away from heat and flame. 4.3. CONTRAINDICATIONS Patients with known hypersensitivity to benzoyl peroxide or to any of the excipients listed in section 6.1. 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE For external use only. Specific information for patients may prevent early and unjustified interruption of treatment. _ _ 2 This product may cause mild irritation (slight burning sensation, redness and desquamation of the skin), especially at the beginning of treatment. It does not indicate intolerance or allergy to the topical treatment as long as it remains moderate. However, individual sensitivity should be determined by a patch test (repeated applications to a small area of the skin for 10 to 15 consecutive days). To reduce irritation as much as possible: Do not apply to skin irri Прочитајте комплетан документ