Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Macitentan
Janssen-Cilag International N.V.
C02KX04
macitentan
Antihypertensives,
Hypertension, Pulmonary
Opsumit, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III.Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease.
Revision: 23
Authorised
2013-12-20
24 B. PACKAGE LEAFLET 25 PACKAGE LEAFLET: INFORMATION FOR THE USER OPSUMIT 10 MG FILM-COATED TABLETS macitentan 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 Opsumit is and what it is used for 2. What you need to know before you take Opsumit 3. How to take Opsumit 4. Possible side effects 5. How to store Opsumit 6. Contents of the pack and other information 1. WHAT OPSUMIT IS AND WHAT IT IS USED FOR Opsumit contains the active substance macitentan, which belongs to the class of medicines called “endothelin receptor antagonists”. Opsumit is used for the long-term treatment of pulmonary arterial hypertension (PAH) in adults; it can be used on its own or with other medicines for PAH. PAH is high blood pressure in the blood vessels that carry blood from the heart to the lungs (the pulmonary arteries). In people with PAH, these arteries get narrower, so the heart has to work harder to pump blood through them. This causes people to feel tired, dizzy, and short of breath. Opsumit widens the pulmonary arteries, making it easier for the heart to pump blood through them. This lowers the blood pressure, relieves the symptoms and improves the course of the disease. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE OPSUMIT DO NOT TAKE OPSUMIT if you are allergic to macitentan, soya or any of the other ingredients of this medicine (listed in section 6). if you are pregnant, if you are planning to become pregnant, or if you could become pregnant because you are not using reliable birth control (contracept Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Opsumit 10 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg macitentan. Excipients with known effect Each film-coated tablet contains approximately 37 mg of lactose (as monohydrate) and approximately 0.06 mg of soya bean lecithin (E322). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). 5.5 mm, round, biconvex, white to off-white film-coated tablets, debossed with “10” on both sides. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Opsumit, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III. Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH. Posology The recommended dose is 10 mg once daily. Special populations _Elderly_ No dose adjustment is required in patients over the age of 65 years (see section 5.2). _Hepatic impairment_ Based on pharmacokinetic (PK) data, no dose adjustment is required in patients with mild, moderate or severe hepatic impairment (see sections 4.4 and 5.2). However, there is no clinical experience with the use of macitentan in PAH patients with moderate or severe hepatic impairment. Opsumit must not be initiated in patients with severe hepatic impairment, or clinically significant elevated hepatic aminotransferases (greater than 3 times the Upper Limit of Normal (> 3 × ULN); see sections 4.3 and 4.4). 3 _Renal impairment_ Based on PK data, no dose adjustment is required in patients with renal impairment. There is no clinical experience with the use of macitentan in PAH pati Przeczytaj cały dokument