Volibris

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

ambrisentan

Available from:

GlaxoSmithKline (Ireland) Limited

ATC code:

C02KX02

INN (International Name):

ambrisentan

Therapeutic group:

Antihypertensives,

Therapeutic area:

Hypertension, Pulmonary

Therapeutic indications:

Volibris 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.Volibris 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).

Product summary:

Revision: 23

Authorization status:

Authorised

Authorization date:

2008-04-20

Patient Information leaflet

37
B. PACKAGE LEAFLET
38
PACKAGE LEAFLET: INFORMATION FOR THE USER
VOLIBRIS 2.5
MG FILM-COATED TABLETS
VOLIBRIS 5
MG FILM-COATED TABLETS
VOLIBRIS 10
MG FILM-COATED TABLETS
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 Volibris is and what it is used for
2.
What you need to know before you take Volibris
3.
How to take Volibris
4.
Possible side effects
5.
How to store Volibris
6.
Contents of the pack and other information
1.
WHAT VOLIBRIS IS AND WHAT IT IS USED FOR
Volibris 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.
Volibris widens the pulmonary arteries, making it easier for the heart
to pump blood through them.
This lowers the blood pressure and relieves the symptoms.
Volibris may also be used in combination with other medicines used to
treat PAH.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VOLIBRIS
DON'T TAKE VOLIBRIS:
•
if you are
ALLERGIC
to ambrisentan, soya, or any of the other ingredients of this medicine
(listed
in section 6)
•
IF YOU ARE PREGNANT,
if you are
P

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Volibris 2.5 mg film-coated tablets
Volibris 5 mg film-coated tablets
Volibris 10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Volibris 2.5 mg film-coated tablets
Each tablet contains 2.5 mg of ambrisentan.
_Excipient(s) with known effect _
Each tablet contains approximately 92.6 mg of lactose (as monohydrate)
and approximately 0.25 mg
of lecithin (soya) (E322).
Volibris 5 mg film-coated tablets
Each tablet contains 5 mg of ambrisentan.
_Excipient(s) with known effect _
Each tablet contains approximately 90.3 mg of lactose (as
monohydrate), approximately 0.25 mg of
lecithin (soya) (E322) and approximately 0.11 mg of allura red AC
aluminium lake (E129).
Volibris 10 mg film-coated tablets
Each tablet contains 10 mg of ambrisentan.
_Excipient(s) with known effect _
Each tablet contains approximately 85.5 mg of lactose (as
monohydrate), approximately 0.25 mg of
lecithin (soya) (E322) and approximately 0.45 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)
Volibris 2.5 mg film-coated tablets
White, 7 mm round, convex, film-coated tablet with “GS” debossed
on one side and “K11” on the
other side.
Volibris 5 mg film-coated tablets
Pale-pink, 6.6 mm square, convex, film-coated tablet with “GS”
debossed on one side and “K2C” on
the other side.
Volibris 10 mg film-coated tablets
Deep-pink, 9.8 mm × 4.9 mm oval, convex, film-coated tablet with
“GS” debossed on one side and
“KE3” on the other side.
3
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Volibris 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.
Volibris is indicated for treatment of PAH in adolescents and child