País: Países Bajos
Idioma: neerlandés
Fuente: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
AMBRISENTAN 10 mg/stuk
Devatis GmbH Spitalstrasse 22 795 39 LORRACH (DUITSLAND)
C02KX02
AMBRISENTAN 10 mg/stuk
Filmomhulde tablet
ALLURAROOD AC ALUMINIUM LAK (E 129) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; LACTOSE 1-WATER ; LECITHINE, SOYA (E 322) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), ALLURAROOD AC ALUMINIUM LAK (E 129) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; LACTOSE 1-WATER ; LECITHINE, SOYA (E 322) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)
Oraal gebruik
Ambrisentan
2019-09-26
1 PACKAGE LEAFLET: INFORMATION FOR THE USER AMBRISENTAN DEVATIS 5 MG FILMOMHULDE TABLETTEN AMBRISENTAN DEVATIS 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 {invented name} is and what it is used for 2. What you need to know before you take {invented name} 3. How to take {invented name} 4. Possible side effects 5. How to store {invented name} 6. Contents of the pack and other information 1. WHAT {INVENTED NAME} IS AND WHAT IT IS USED FOR {invented 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. 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. {invented 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. {invented name} may also be used in combination with other medicines used to treat PAH. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE {INVENTED NAME} _ _ DO NOT TAKE {INVENTED NAME}: if you are ALLERGIC to ambrisentan, soya, peanut or any of the other ingredients of this medicine (listed in section 6) IF YOU ARE PREGNANT, if you are Leer el documento completo
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ambrisentan Devatis 5 mg filmomhulde tabletten Ambrisentan Devatis 10 mg filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _5 mg tablets _ Each tablet contains 5 mg of ambrisentan. _10 mg tablets _ Each tablet contains 10 mg of ambrisentan. Excipients with known effect _5 mg tablets _ Each tablet contains approximately 67.2 mg of lactose (as monohydrate), approximately 0.11 mg of lecithin (soya) and approximately 0.04 mg of Allura red AC Aluminium Lake (E129). _10 mg tablets _ Each tablet contains approximately 134.4 mg of lactose (as monohydrate), approximately 0.21 mg of lecithin (soya) and approximately 0.35 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). _5 mg tablets _ Pale-pink coloured, square shaped, bi-convex, film-coated tablets (approximately 6 mm x 6 mm x3.3 mm). _10 mg tablets _ Deep-pink coloured, oval shaped, bi-convex, film coated tablets (approximately 10.1 mm x 6.6 mm x 4.4 mm). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS {invented 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment must be initiated by a physician experienced in the treatment of PAH. Posology _Ambrisentan monotherapy _ {invented name} is to be taken orally to begin at a dose of 5 mg once daily and may be increased to 10 mg daily depending upon clinical response and tolerability. 2 _Ambrisentan in combination with tadalafil _ When used in combination with tadalafil, ambrisentan should be titrated to 10 mg once daily. In the AMBITION study, patients received 5 mg ambrisentan daily for the first 8 weeks before up titrating to 10 mg, dependent on tolerabili Leer el documento completo