Country: Belanda
Bahasa: Belanda
Sumber: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
AMBRISENTAN 5 mg/stuk
AMBRISENTAN 5 mg/stuk
Filmomhulde tablet
ALLURAROOD AC (E 129) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; LACTOSE 1-WATER ; LECITHINE, SOYA (E 322) ; MAGNESIUMSTEARAAT (E 470b) ; POLYETHYLEENGLYCOL (E 1521) ; POLYVINYLALCOHOL (E 1203) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), ALLURAROOD AC (E129) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; LACTOSE 1-WATER ; LECITHINE, SOYA (E 322) ; MAGNESIUMSTEARAAT (E 470b) ; POLYETHYLEENGLYCOL (E 1521) ; POLYVINYLALCOHOL (E1203) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)
Oraal gebruik
1900-01-01
PIL – Ambrisentan 5 & 10 mg film-coated tablets NL/H/4644/001-002/IB/004 1 PACKAGE LEAFLET: INFORMATION FOR THE USER AMBRISENTAN GENEPHARM 5 MG, FILMOMHULDE TABLETTEN AMBRISENTAN GENEPHARM 10 MG, FILMOMHULDE TABLETTEN 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 [Product Name] is and what it is used for 2. What you need to know before you take [Product Name] 3. How to take [Product Name] 4. Possible side effects 5. How to store [Product Name] 6. Contents of the pack and other information 1. WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR [Product Name] 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. [Product Name] widens the pulmonary arteries, making it easier for the heart to pump blood through them. This lowers the blood pressure and relieves the symptoms. [Product Name] may also be used in combination with other medicines used to treat PAH. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [PRODUCT NAME] DO NOT TAKE [PRODUCT NAME]: • If you are ALLERGIC to ambrisentan, or soya Baca dokumen lengkap
SPC – Ambrisentan 5 & 10 mg film-coated tablets NL/H/4644/001-002/IB/004 1 1. NAME OF THE MEDICINAL PRODUCT Ambrisentan Genepharm 5 mg, filmomhulde tabletten Ambrisentan Genepharm 10 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION [Product Name] 5 mg film-coated tablets: Each tablet contains 5 mg of ambrisentan. _Excipient(s) with known effect: _ Εach tablet contains approximately 47.5 mg lactose (as monohydrate), 0.14 mg lecithin (soya) and 0.022 mg allura red AC (E129). _ _ [Product Name] 10 mg film-coated tablets: Each tablet contains 10 mg of ambrisentan. _Excipient(s) with known effect: _ Each tablet contains approximately 95 mg lactose (as monohydrate), 0.21 mg lecithin (soya) and 0.405 mg allura red AC (E129). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). [Product Name] 5 mg film-coated tablets Pale pink, square, convex film-coated tablet debossed with ‘5’ on one side, plain on the other side with a normal length/width of approximately 5.9 mm. [Product Name] 10 mg film-coated tablets Pink oblong biconvex film-coated tablet, debossed with “10” on one side, plain on the other side with a nominal length of approximately 11.1 mm and a nominal width of approximately 5.6 mm. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS SPC – Ambrisentan 5 & 10 mg film-coated tablets NL/H/4644/001-002/IB/004 2 [Product Name] 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. [Product Name] 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). 4.2. POSO Baca dokumen lengkap