Ambrisentan Genepharm 5 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

AMBRISENTAN 5 mg/stuk

INN (Algemene Internationale Benaming):

AMBRISENTAN 5 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

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)

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

1900-01-01

Bijsluiter

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

Productkenmerken

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