Country: Холандија
Језик: Холандски
Извор: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ALITRETINOÏNE
Regiomedica GmbH
D11AH04
ALITRETINOÏNE
Capsule, zacht
GELATINE (E 441) ; GLYCEROL (E 422) ; GLYCEROLMONOSTEARAAT (E 471) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; PLANTAARDIGE OLIE, GEHYDREERD ; SOJABOONOLIE, GEDEELTELIJK GEHYDREERD ; SOJAOLIE, GEZUIVERD ; SORBITOL, VLOEIBAAR, NIET-KRISTALLISEERBAAR (E 420) ; TITAANDIOXIDE (E 171) ; TOCOFEROL, DL-ALFA (E 307) ; TRIGLYCERIDEN MIDDELLANGE KETEN ; WATER, GEZUIVERD
Oraal gebruik
Alitretinoin
2019-01-18
PACKAGE LEAFLET: INFORMATION FOR THE USER ARTESONIN 10 MG ZACHTE CAPSULES ARTESONIN 30 MG ZACHTE CAPSULES Alitretinoïne WARNING CAN SERIOUSLY HARM AN UNBORN BABY Women must use effective contraception Do not use if you are pregnant or you think you may be pregnant This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any 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. WHAT IS IN THIS LEAFLET 1. What Artesonin is and what it is used for 2. What you need to know before you take Artesonin 3. How to take Artesonin 4. Possible side effects 5. How to store Artesonin 6. Contents of the pack and other information 1. WHAT ARTESONIN IS AND WHAT IT IS USED FOR The active substance in Artesonin is alitretinoin. It belongs to a group of medicines known as _retinoids, _which are related to Vitamin A. Artesonin capsules come in two strengths, containing 10 mg or 30 mg of alitretinoin. Artesonin is used to treat adults with severe chronic hand eczema that has not got better after any other topical treatments, including steroids. Treatment with Artesonin must be supervised by a specialist skin doctor (a dermatologist). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ARTESONIN DO NOT TAKE ARTESONIN: If you are PREGNANT or BREAST-FEEDING. If there is any chance you could become pregnant, you must follow the precautions under “Pregnancy and prevention programme, see section on Прочитајте комплетан документ
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAAM VAN HET GENEESMIDDEL Artesonin 10 mg zachte capsules Artesonin 30 mg zachte capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule, soft contains 10 mg of alitretinoin Each capsule, soft contains 30 mg of alitretinoin Excipients with known effect Soya-bean oil. Each 10 mg capsule contains 92.94 mg soya-bean oil. Each 30 mg capsule contains 278.83 mg soya-bean oil. Sorbitol. Each 10 mg capsule contains 13.28 mg sorbitol. Each 30 mg capsule contains 25.55 mg sorbitol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FROM Capsule, soft Artesonin 10 mg capsules are light brown, oval, soft-gelatin capsules, 10 mm x 6 mm, containing a yellow to orange, opaque, viscous suspension. Artesonin 30 mg capsules are yellow, oval, soft-gelatin capsules, 13 mm x 8 mm, containing a yellow to orange, opaque, viscous suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Artesonin is indicated for use in adults who have severe chronic hand eczema that is unresponsive to treatment with potent topical corticosteroids. Patients in whom the eczema has predominantly hyperkeratotic features are more likely to respond to treatment than in those in whom the eczema predominantly presents as pompholyx (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Artesonin should only be prescribed by dermatologists, or physicians with experience in the use of systemic retinoids who have full understanding of the risks of systemic retinoid therapy and monitoring requirements. Prescriptions of Artesonin for women of childbearing potential should be limited to 30 days of treatment and continuation of treatment requires a new prescription. Ideally, pregnancy testing, issuing a prescription and dispensing of Artesonin should occur on the same day. Dispensing of Artesonin should occur within a maximum of 7 days of the prescription. Posology The recommended dose for alitretinoin is 10 mg or 30 mg once daily. The recommended starting dose for alitretinoin is 30 mg once Прочитајте комплетан документ