Ambrisentan Norameda 5 mg, filmomhulde tabletten

Երկիր: Նիդերլանդեր

Լեզու: հոլանդերեն

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

Ակտիվ բաղադրիչ:

AMBRISENTAN

Հասանելի է:

UAB Norameda Meistru 8a 02189 VILNIUS (LITOUWEN)

INN (Միջազգային անվանումը):

AMBRISENTAN

Դեղագործական ձեւ:

Filmomhulde tablet

Կազմը:

ALLURAROOD AC ALUMINIUM LAK (E 129) ; 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)

Կառավարման երթուղին:

Oraal gebruik

Հաստատման ամսաթիվը:

2020-03-24

Տեղեկատվական թերթիկ

PIL – Ambrisentan Norameda 5 & 10 mg film-coated tablets
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PACKAGE LEAFLET
PIL – Ambrisentan Norameda 5 & 10 mg film-coated tablets
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PACKAGE LEAFLET: INFORMATION FOR THE USER
AMBRISENTAN NORAMEDA 5 MG, FILMOMHULDE TABLETTEN
AMBRISENTAN NORAMEDA 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 THIS LEAFLET
1.
What Ambrisentan Norameda is and what it is used for
2.
What you need to know before you take Ambrisentan Norameda
3.
How to take Ambrisentan Norameda
4.
Possible side effects
5.
How to store Ambrisentan Norameda
6.
Contents of the pack and other information
1.
WHAT AMBRISENTAN NORAMEDA IS AND WHAT IT IS USED FOR
Ambrisentan Norameda 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.
Ambrisentan Norameda widens the pulmonary arteries, making it easier
for the heart to pump blood
through them. This lowers the blood pressure and relieves the
symptoms.
Ambrisentan Norameda may also be used in combination with other
medicines used to treat PAH.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMBRISENTAN NORAMEDA
DO NOT TAKE AM

Ապրանքի հատկությունները

SPC – Ambrisentan 5 & 10 mg film-coated tablets
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SUMMARY OF PRODUCT CHARACTERISTICS
SPC – Ambrisentan 5 & 10 mg film-coated tablets
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1.
NAME OF THE MEDICINAL PRODUCT
Ambrisentan Norameda 5 mg film-coated tablets
Ambrisentan Norameda 10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 mg film-coated tablet contains 5 mg of ambrisentan
Each 10 mg film-coated tablet contains 10 mg of ambrisentan
Excipient(s) with known effect:
Ambrisentan Norameda 5 mg film-coated tablets: each tablet contains
approximately 47.5 mg
lactose (as monohydrate), 0.14 mg lecithin (soya), 0.022 mg allura red
AC (E129) and 0.38 mg
sodium.
Ambrisentan Norameda 10 mg film-coated tablets: each tablet contains
approximately 95 mg
lactose (as monohydrate), 0.21 mg lecithin (soya), 0.405 mg allura red
AC (E129) and 0.67 mg
sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
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.
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
Ambrisentan Norameda 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
SPC – Ambrisentan 5 & 10 mg film-coated tablets
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Treatment must be initiated by a physician experienced in the
treatment of PAH.
Posology
_Ambrisentan monotherapy _
Ambrisentan Norameda 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 res