Երկիր: Իռլանդիա
Լեզու: անգլերեն
Աղբյուրը: HPRA (Health Products Regulatory Authority)
CICLOPIROX OLAMINE
GlaxoSmithKline (Ireland) Limited
D01AE; D01AE14
CICLOPIROX OLAMINE
15 milligram(s)/gram
Shampoo
Product subject to prescription which may be renewed (B)
Other antifungals for topical use; ciclopirox
Marketed
2001-10-05
Reason for update: EU Excipient guideline update. - RFI Market: IE Agency Approval Date: Text Date: 18/08/2020 Text Issue and Draft No.: Issue 6 Draft 2 PACKAGE LEAFLET: INFORMATION FOR THE USER STIEPROX 15 MG/G SHAMPOO ciclopirox olamine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. - In this leaflet, Stieprox 15 mg/g Shampoo will be called Stieprox. WHAT IS IN THIS LEAFLET 1. What Stieprox is and what it is used for 2. What you need to know before you use Stieprox 3. How to use Stieprox 4. Possible side effects 5. How to store Stieprox 6. Contents of the pack and other information 1. WHAT STIEPROX IS AND WHAT IT IS USED FOR Stieprox contains the active substance ciclopirox olamine. This belongs to a group of medicines called ‘anti-fungals’. Stieprox is used to treat scalp disorders such as dandruff and seborrhoeic dermatitis (red, flaky, itchy scalps) in adults and adolescents aged over 12 years. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE STIEPROX DO NOT USE STIEPROX If you are allergic to ciclopirox olamine or any of the other ingredients in this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Stieprox If you have grey, white or damaged hair. This is because Stieprox may affect the colour of your hair. Stieprox is for external use only. Stieprox may cause stinging and irritation to the eyes. If you accidentally get Stieprox in your eyes, wash the affected area with water. Stieprox may cause skin irritation. If irritation occurs and persists, treatment should be d Կարդացեք ամբողջական փաստաթուղթը
Health Products Regulatory Authority 23 June 2021 CRN009ZK5 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Stieprox 15 mg/g Shampoo 2 QUALITATIVE AND QUANTITATIVE COMPOSITION EACH GRAM OF SHAMPOO CONTAINS 15 MG/G CICLOPIROX OLAMINE. EXCIPIENTS WITH KNOWN EFFECT: Fruitier timotei AF17050 contains allergens (see section 6.1) FOR THE FULL LIST OF EXCIPIENTS, SEE SECTION 6.1. 3 PHARMACEUTICAL FORM Shampoo. Clear, straw to light-orange coloured, viscous shampoo. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Stieprox is indicated in the treatment of scalp disorders such as dandruff and seborrhoeic dermatitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS AND ADOLESCENTS AGED OVER 12 YEARS: Stieprox is only for topical application to the scalp and adjacent areas. The hair should be wetted and sufficient Stieprox applied to produce an abundant lather. The scalp and adjacent areas should be vigorously massaged with the fingertips. The hair should then be thoroughly rinsed and the procedure repeated. The shampoo should remain in contact with the scalp for a total contact time of 3-5 minutes over the two applications. Stieproxshould be used two to three times weekly or as often as necessary for the treatment of scalp disorders. A mild shampoo can be used in between applications of Stieprox. The recommended treatment period is 4 weeks. ELDERLY PATIENTS: The dosage instructions given above are suitable for the elderly. PAEDIATRIC POPULATION: The safety and efficacy of Stieprox in children under 12 years of age have not been established. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance,ciclopirox olamine,or to any of the excipients listed in section 6.1. Health Products Regulatory Authority 23 June 2021 CRN009ZK5 Page 2 of 5 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Stieprox is for external use only. As with all shampoo products avoid contact with eyes. Ciclopirox olamine may cause eye irritation. In case of accidental contact with the eyes, rinse with water. Stieprox ma Կարդացեք ամբողջական փաստաթուղթը