Krajina: Holandsko
Jazyk: holandčina
Zdroj: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ALITRETINOÏNE 30 mg/stuk
Regiomedica GmbH Spitalstrasse 22 79539 LÖRRACH (DUITSLAND)
D11AH04
ALITRETINOÏNE 30 mg/stuk
Capsule, zacht
GELATINE (E 441) ; GLYCEROL (E 422) ; GLYCEROLMONOSTEARAAT (E 471) ; IJZEROXIDE GEEL (E 172) ; PLANTAARDIGE OLIE, GEHYDREERD ; SOJABOONOLIE, GEDEELTELIJK GEHYDREERD (E 479b) ; SOJAOLIE, GEZUIVERD ; SORBITOL, VLOEIBAAR, NIET-KRISTALLISEERBAAR (E 420) ; TITAANDIOXIDE (E 171) ; TOCOFEROL, DL-ALFA (E 307) ; TRIGLYCERIDEN MIDDELLANGE KETEN ; WATER, GEZUIVERD, GELATINE (E 441) ; GLYCEROL (E 422) ; GLYCEROLMONOSTEARAAT (E 471) ; IJZEROXIDE GEEL (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, GELATINE (E 441) ; GLYCEROL (E 422) ; GLYCEROLMONOSTEARAAT (E 471) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (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
1900-01-01
PACKAGE LEAFLET: INFORMATION FOR THE USER ALIPALMTIN 10 MG ZACHTE CAPSULES ALIPALMTIN 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 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 Alipalmtin is and what it is used for 2. What you need to know before you take Alipalmtin 3. How to take Alipalmtin 4. Possible side effects 5. How to store Alipalmtin 6. Contents of the pack and other information 1. WHAT ALIPALMTIN IS AND WHAT IT IS USED FOR The active substance in Alipalmtin is alitretinoin. It belongs to a group of medicines known as _retinoids, _which are related to Vitamin A. Alipalmtin capsules come in two strengths, containing 10 mg or 30 mg of alitretinoin. Alipalmtin is used to treat adults with severe chronic hand eczema that has not got better after any other topical treatments, including steroids. Treatment with Alipalmtin must be supervised by a specialist skin doctor (a dermatologist). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALIPALMTIN DO NOT TAKE ALIPALMTIN: • 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 “Warnings and precautions”. • If you have LIVER DISEASE. • If you have SEVERE KIDNEY DISEASE. • If you have HIGH BLOOD FATS (such as high cholesterol or raised triglycerides). • If you have THYROID DISE Prečítajte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAAM VAN HET GENEESMIDDEL Alipalmtin 10 mg zachte capsules Alipalmtin 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 Alipalmtin 10 mg capsules are light brown, oval, soft-gelatin capsules, 10 mm x 6 mm, containing a yellow to orange, opaque, viscous suspension. Alipalmtin 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 Alipalmtin 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 Alipalmtin 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 Alipalmtin 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 Alipalmtin should occur on the same day. Dispensing of Alipalmtin 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 Prečítajte si celý dokument