국가: 이스라엘
언어: 영어
출처: Ministry of Health
SELENIUM SULFIDE
TARO PHARMACEUTICAL INDUSTRIES LTD
D01AE13
SUSPENSION
SELENIUM SULFIDE 25 MG/ML
TOPICAL- SCALP
Not required
TARO PHARMACEUTICAL INDUSTRIES LTD
SELENIUM SULFIDE
SELENIUM SULFIDE
For the treatment of dandruff, seborrheic dermatitis of the scalp and tinea versicolor.
2021-08-31
Sebosel PIL _–_ Notification - 11.2023 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986 This medicine is dispensed without a doctor's prescription SEBOSEL_ _ SUSPENSION NAME AND CONCENTRATION OF THE ACTIVE INGREDIENT: Each 1 ml contains: selenium sulfide 25 mg Inactive ingredients and allergens in this medicine: see section 2 under ‘Important information about some of this medicine’s ingredients’, and section 6 ‘Additional information’ . READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. Use this medicine according to the instructions in the section about dose in this leaflet. Consult a pharmacist if you need further information. Consult your doctor if your condition does not improve or gets worse following or during the recommended treatment. 1. WHAT IS THIS MEDICINE INTENDED FOR?_ _ To treat dandruff, seborrheic dermatitis on the scalp, and tinea versicolor. THERAPEUTIC GROUP: antifungal. This product works against dandruff in two ways: • by reducing greasiness of the scalp • by slowing down growth of the layer of skin cells on the scalp that cause dandruff. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to the active ingredient (selenium sulfide) or to any of the other ingredients in this medicine (see Section 6). • You have cracked, infected, or severely inflamed skin in the affected area, as this may cause absorption of selenium sulfide into your blood. SPECIAL WARNINGS ABOUT USING THIS MEDICINE • Avoid contact of the medicine with the eyes. If the medicine accidentally gets in your eyes, rinse immediately with a lot of cold water. • Sebosel is meant for external use only. Sebosel is not to be swallowed or eaten. • Do not leave the medicine in contact with your hair or skin for longer than the recommended time. This can cause irritation, a burning sen 전체 문서 읽기
~ 1 ~ Sebosel SmPC – Notification November 2023 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Sebosel 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml of suspension contains 25 mg of selenium sulfide. Excipients with known effect: methyl paraben and propyl paraben. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Orange suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of dandruff, seborrheic dermatitis of the scalp and tinea versicolor. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Apply topically; scalp. _Adults and the elderly: _ _ _ • FOR TINEA VERSICOLOR Apply to affected areas and lather with a small amount of water. Allow product to remain on skin for 10 minutes, then rinse thoroughly. Repeat procedure once a day for seven days. • FOR SEBORRHEIC DERMATITIS AND DANDRUFF Generally 2 applications each week for 2 weeks will control symptoms. Subsequently, Sebosel may be used less frequently – weekly, every 2 weeks, every 3 to 4 weeks. Should not be applied more frequently than necessary to maintain control. _Pediatric Use:_ _ _ Safety and effectiveness in children have not been established. 4.3 CONTRAINDICATIONS - Hypersensitivity to the active substance (selenium sulfide) or to any of the excipients listed in section 6.1. - Do not allow contact with broken or severely inflamed skin. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE For external use only. ~ 2 ~ Sebosel SmPC – Notification November 2023 This suspension is an irritant to the eyes. It should therefore be kept away from the eyes. If the suspension comes in contact with the eyes, they should rinse thoroughly with cold water. Exposure of Sebosel to eyes may result in ocular injuries such as corneal abrasion (see section 4.8). Do not leave the suspension in contact with the hair or skin for more than the recommended duration as irritation, burning sensation or blistering may occur and do not use more often than recommended (see Section 4.2). Sebosel is not to be inges 전체 문서 읽기