Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
dimethyl fumarate
Almirall S.A
L04AX07
dimethyl fumarate
Immunosuppressants
Psoriasis
Skilarence is indicated for the treatment of moderate to severe plaque psoriasis in adults in need of systemic medicinal therapy.
Revision: 11
Authorised
2017-06-23
27 B. PACKAGE LEAFLET 28 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SKILARENCE 30 MG GASTRO-RESISTANT TABLETS dimethyl fumarate 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 Skilarence is and what it is used for 2. What you need to know before you take Skilarence 3. How to take Skilarence 4. Possible side effects 5. How to store Skilarence 6. Contents of the pack and other information 1. WHAT SKILARENCE IS AND WHAT IT IS USED FOR WHAT SKILARENCE IS Skilarence is a medicine that contains the active substance dimethyl fumarate. Dimethyl fumarate works on cells of the immune system (the body's natural defences). It changes the activity of the immune system by reducing the production of certain substances involved in causing psoriasis. WHAT SKILARENCE IS USED FOR Skilarence tablets are used to treat moderate to severe plaque psoriasis in adults. Psoriasis is a disease causing thickened, inflamed, red areas on the skin, often covered by silvery scales. Response to Skilarence can be generally seen as early as week 3 and improves over time. Experience with related products containing dimethyl fumarate shows treatment benefit for at least up to 24 months. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SKILARENCE DO NOT TAKE SKILARENCE - if you are allergic to dimethyl fumarate or any of the other ingredients of this medicine (listed in section 6) - if you have severe problems with your stomach or intestines - if you have severe liver or kidney problems - if you are pregnant or breast-feeding WARNINGS AND Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Skilarence 30 mg gastro-resistant tablets Skilarence 120 mg gastro-resistant tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Skilarence 30 mg gastro-resistant tablets Each gastro-resistant tablet contains 30 mg dimethyl fumarate. _Excipient with known effect _ Each gastro-resistant tablet contains 34.2 mg lactose (as monohydrate). Skilarence 120 mg gastro-resistant tablets Each gastro-resistant tablet contains 120 mg dimethyl fumarate. _Excipient with known effect _ Each gastro-resistant tablet contains 136.8 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant tablet Skilarence 30 mg gastro-resistant tablets White, film-coated, round, biconvex tablet with a diameter of approximately 6.8 mm. Skilarence 120 mg gastro-resistant tablets Blue, film-coated, round, biconvex tablet with a diameter of approximately 11.6 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Skilarence is indicated for the treatment of moderate to severe plaque psoriasis in adults in need of systemic medicinal therapy. _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Skilarence is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of psoriasis. Posology To improve tolerability of Skilarence, it is recommended to begin treatment with a low initial dose with subsequent gradual increases. In the first week, a 30 mg dose is taken once daily (1 tablet in the evening). In the second week, a 30 mg dose is taken twice daily (1 tablet in the morning and 1 in the evening). In the third week, a 30 mg dose is taken three times daily (1 tablet in the morning, 1 at midday, and 1 in the evening). From the fourth week, treatment is switched to only 1 tablet of 3 a 120 mg dose in the evening. This dose is then increased by one 120 mg tablet per week at different times of day for the subsequent 5 weeks, as shown in the table below. The maximum daily dos Прочетете целия документ