Ambrisentan Devatis 10 mg filmomhulde tabletten

Country: Холандија

Језик: Холандски

Извор: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Активни састојак:

AMBRISENTAN 10 mg/stuk

Доступно од:

Devatis GmbH Spitalstrasse 22 795 39 LORRACH (DUITSLAND)

АТЦ код:

C02KX02

INN (Међународно име):

AMBRISENTAN 10 mg/stuk

Фармацеутски облик:

Filmomhulde tablet

Састав:

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)

Пут администрације:

Oraal gebruik

Терапеутска област:

Ambrisentan

Датум одобрења:

2019-09-26

Информативни летак

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

Карактеристике производа

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