מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
Selenium disulfide
Sanofi-Aventis Ireland Limited T/A SANOFI
D11AC; D11AC03
Selenium disulfide
2.5 percent weight/volume
Shampoo
Product not subject to medical prescription
Medicated shampoos; selenium compounds
Marketed
1983-04-01
PACKAGE LEAFLET: INFORMATION FOR THE USER SELSUN ® 2.5% W/V SHAMPOO (SELENIUM SULPHIDE) MEDICAL TREATMENT FOR DANDRUFF Read all of this leaflet carefully because it contains important information for you. This medicine is available without prescription. However, you still need to use Selsun carefully to get the best results from it. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist._ _ IN THIS LEAFLET: 1. What Selsun Shampoo is and what it is used for 2. Before you use Selsun Shampoo 3. How to use Selsun Shampoo 4. Possible side effects 5. How to store Selsun Shampoo 6. Further information 1. WHAT SELSUN SHAMPOO IS AND WHAT IT IS USED FOR SELSUN SHAMPOO IS A MEDICATED SHAMPOO USED TO TREAT DANDRUFF AND SEBORRHOEIC DERMATITIS (A GREASY, CRUSTING, ITCHING SCALP CAUSED BY EXCESS OIL). It works against dandruff in two ways: • By reducing greasiness of the scalp and • By slowing down growth of the layer of skin cells on the scalp that cause dandruff 2. BEFORE YOU USE SELSUN SHAMPOO DO NOT USE SELSUN SHAMPOO IF: • You are allergic (hypersensitive) to the active ingredient selenium sulphide, or any of the other ingredients of Selsun Shampoo • You have broken or severely inflamed skin on your scalp TAKE SPECIAL CARE WITH SELSUN SHAMPOO USER PRECAUTIONS • Avoid contact with the eyes. If the shampoo does get in your eyes, you can experience severe eye irritation that may lead to injury. If this occurs, rinse immediately with lots of cold water. • In case of eye contact, if severe eye pain, eye swelling, change in vision develop and persist after rinsing with water talk to your doctor or pharmacist (see section 4). • Selsun is not to be ingested or eaten. • Do not leave the shampoo in contact with the hair or skin for more than the recommended duration as irritation, burning sensation or blistering קרא את המסמך השלם
Health Products Regulatory Authority 09 June 2021 CRN009ZRL Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Selsun Shampoo 2.5% w/v 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 100ml of suspension contains 2.5 g (2.5% w/v) of Selenium disulphide Ph. Eur. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Shampoo. Beige to pale yellow to pale orange uniform suspension; free from large particles. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Simple Dandruff and seborrhoeic dematitis of the scalp. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Apply topically to the scalp. _Adults and the elderly:_ After thoroughly wetting the hair massage Selsun in to form a lather. Rinse after 2 to 3 minutes. Usage should be twice a week for the first tow weeks and then once a week for the next two weeks to control the condition. After this initial course of treatment Selsun should not be used more often than necessary. _Children aged 5-14 years:_ As for adults. _Children under 5 years of age:_ Not recommended. 4.3 CONTRAINDICATIONS Hypersensitivity to any of the ingredients. Do not allow contact with broken or severely inflamed skin. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE For external use only. This shampoo is an irritant to the eyes. It should therefore be kept away from the eyes. If the shampoo comes in contact with the eyes, they should rinse thoroughly with cold water. Exposure of Selsun to eyes may result in ocular injuries such as corneal abrasion (see section 4.8). Selsun must not be left in contact with the hair or skin for more than the recommended duration as irritation, burning sensation or blistering may occur. Selsun is not to be ingested. In the event of accidental ingestion, take all appropriate measures immediately. Selsun is not to be used more often than recommended. Health Products Regulatory Authority 09 June 2021 CRN009ZRL Page 2 of 4 Selsun must not be applied to or on infected or broken skin as this may cause systemic absorption of the selenium sulfi קרא את המסמך השלם