Ülke: Avrupa Birliği
Dil: İngilizce
Kaynak: EMA (European Medicines Agency)
ambrisentan
GlaxoSmithKline (Ireland) Limited
C02KX02
ambrisentan
Antihypertensives,
Hypertension, Pulmonary
Volibris is indicated for treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment (see section 5.1). Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease.Volibris is indicated for treatment of PAH in adolescents and children (aged 8 to less than 18 years) of WHO Functional Class (FC) II to III including use in combination treatment. Efficacy has been shown in IPAH, familial, corrected congenital and in PAH associated with connective tissue disease (see section 5.1).
Revision: 23
Authorised
2008-04-20
37 B. PACKAGE LEAFLET 38 PACKAGE LEAFLET: INFORMATION FOR THE USER VOLIBRIS 2.5 MG FILM-COATED TABLETS VOLIBRIS 5 MG FILM-COATED TABLETS VOLIBRIS 10 MG FILM-COATED TABLETS ambrisentan 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Volibris is and what it is used for 2. What you need to know before you take Volibris 3. How to take Volibris 4. Possible side effects 5. How to store Volibris 6. Contents of the pack and other information 1. WHAT VOLIBRIS IS AND WHAT IT IS USED FOR Volibris contains the active substance ambrisentan. It belongs to a group of medicines called other antihypertensives (used to treat high blood pressure). It is used to treat pulmonary arterial hypertension (PAH) in adults, adolescents and children aged 8 years and over. PAH is high blood pressure in the blood vessels (the pulmonary arteries) that carry blood from the heart to the lungs. 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. Volibris widens the pulmonary arteries, making it easier for the heart to pump blood through them. This lowers the blood pressure and relieves the symptoms. Volibris may also be used in combination with other medicines used to treat PAH. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VOLIBRIS DON'T TAKE VOLIBRIS: • if you are ALLERGIC to ambrisentan, soya, or any of the other ingredients of this medicine (listed in section 6) • IF YOU ARE PREGNANT, if you are P Belgenin tamamını okuyun
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Volibris 2.5 mg film-coated tablets Volibris 5 mg film-coated tablets Volibris 10 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Volibris 2.5 mg film-coated tablets Each tablet contains 2.5 mg of ambrisentan. _Excipient(s) with known effect _ Each tablet contains approximately 92.6 mg of lactose (as monohydrate) and approximately 0.25 mg of lecithin (soya) (E322). Volibris 5 mg film-coated tablets Each tablet contains 5 mg of ambrisentan. _Excipient(s) with known effect _ Each tablet contains approximately 90.3 mg of lactose (as monohydrate), approximately 0.25 mg of lecithin (soya) (E322) and approximately 0.11 mg of allura red AC aluminium lake (E129). Volibris 10 mg film-coated tablets Each tablet contains 10 mg of ambrisentan. _Excipient(s) with known effect _ Each tablet contains approximately 85.5 mg of lactose (as monohydrate), approximately 0.25 mg of lecithin (soya) (E322) and approximately 0.45 mg of allura red AC aluminium lake (E129). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) Volibris 2.5 mg film-coated tablets White, 7 mm round, convex, film-coated tablet with “GS” debossed on one side and “K11” on the other side. Volibris 5 mg film-coated tablets Pale-pink, 6.6 mm square, convex, film-coated tablet with “GS” debossed on one side and “K2C” on the other side. Volibris 10 mg film-coated tablets Deep-pink, 9.8 mm × 4.9 mm oval, convex, film-coated tablet with “GS” debossed on one side and “KE3” on the other side. 3 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Volibris is indicated for treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment (see section 5.1). Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease. Volibris is indicated for treatment of PAH in adolescents and child Belgenin tamamını okuyun