Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
riociguat
Bayer AG
C02KX05
riociguat
Antihypertensives for pulmonary arterial hypertension
Hypertension, Pulmonary
Chronic thromboembolic pulmonary hypertension (CTEPH) Adempas is indicated for the treatment of adult patients with WHO Functional Class (FC) II to III withinoperable CTEPH,persistent or recurrent CTEPH after surgical treatment,to improve exercise capacity. Pulmonary arterial hypertension (PAH) Adempas, as monotherapy or in combination with endothelin receptor antagonists, is indicated for the treatment of adult patients with pulmonary arterial hypertension (PAH) with WHO Functional Class (FC) II to III to improve exercise capacity. Efficacy has been shown in a PAH population including aetiologies of idiopathic or heritable PAH or PAH associated with connective tissue disease.
Revision: 9
Authorised
2014-03-26
30 B. PACKAGE LEAFLET 31 PACKAGE LEAFLET: INFORMATION FOR THE USER ADEMPAS 0.5 MG FILM-COATED TABLETS ADEMPAS 1 MG FILM-COATED TABLETS ADEMPAS 1.5 MG FILM-COATED TABLETS ADEMPAS 2 MG FILM-COATED TABLETS ADEMPAS 2.5 MG FILM-COATED TABLETS riociguat 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 Adempas is and what it is used for 2. What you need to know before you take Adempas 3. How to take Adempas 4. Possible side effects 5. How to store Adempas 6. Contents of the pack and other information 1. WHAT ADEMPAS IS AND WHAT IT IS USED FOR Adempas contains the active substance riociguat. Riociguat is a type of medicine called a guanylate cyclase (sGC)-stimulator. It works by widening the pulmonary arteries (the blood vessels that connect the heart to the lungs), making it easier for the heart to pump blood through the lungs. Adempas can be used to treat adults with certain forms of pulmonary hypertension, a condition in which these blood vessels become narrowed, making it harder for the heart to pump blood through them and leading to high blood pressure in the vessels. Because the heart must work harder than normal, people with pulmonary hypertension feel tired, dizzy and short of breath. By widening the narrowed arteries, Adempas leads to an improvement in your ability to carry out physical activity. Adempas is used in either of two types of pulmonary hypertension: CHRONIC THROMBOEMBOLIC PULMONARY HYPERTENSION (CTEPH) . In CTEPH, the blood vessels of the lung are blocked or narrowed with blood c Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Adempas 0.5 mg film-coated tablets Adempas 1 mg film-coated tablets Adempas 1.5 mg film-coated tablets Adempas 2 mg film - coated tablets Adempas 2.5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Adempas 0.5 mg film-coated tablets Each film-coated tablet contains 0.5 mg of riociguat. Adempas 1 mg film-coated tablets Each film-coated tablet contains 1 mg of riociguat. Adempas 1.5 mg film-coated tablets Each film-coated tablet contains 1.5 mg of riociguat. Adempas 2 mg film-coated tablets Each film-coated tablet contains 2 mg of riociguat. Adempas 2.5 mg film-coated tablets Each film-coated tablet contains 2.5 mg of riociguat. Excipient with known effect _Adempas 0.5 mg film-coated tablets _ Each 0.5 mg film-coated tablet contains 37.8 mg lactose (as monohydrate). _Adempas 1 mg film-coated tablets _ Each 1 mg film-coated tablet contains 37.2 mg lactose (as monohydrate). _Adempas 1.5 mg film-coated tablets _ Each 1.5 mg film-coated tablet contains 36.8 mg lactose (as monohydrate). _Adempas 2 mg film-coated tablets _ Each 2 mg film-coated tablet contains 36.3 mg lactose (as monohydrate). _Adempas 2.5 mg film-coated tablets _ Each 2.5 mg film-coated tablet contains 35.8 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). _0.5 mg tablet:_ white, round, biconvex tablets of 6 mm, marked with the Bayer cross on one side and 0.5 and an “R” on the other side. _1 mg tablet:_ pale yellow, round, biconvex tablets of 6 mm, marked with the Bayer cross on one side and 1 and an “R” on the other side. _1.5 mg tablet:_ yellow-orange, round, biconvex tablets of 6 mm, marked with the Bayer cross on one side and 1.5 and an “R” on the other side. 3 _2 mg tablet:_ pale orange, round, biconvex tablets of 6 mm, marked with the Bayer cross on one side and 2 and an “R” on the other side. _2.5 mg tablet:_ red-orange, round, biconv Aqra d-dokument sħiħ