Volibris 5mg tablets

Country: Միացյալ Թագավորություն

language: անգլերեն

source: MHRA (Medicines & Healthcare Products Regulatory Agency)

active_ingredient:

Ambrisentan

MAH:

GlaxoSmithKline UK Ltd

ATC_code:

C02KX02

INN:

Ambrisentan

dosage:

5mg

pharmaceutical_form:

Tablet

administration_route:

Oral

class:

No Controlled Drug Status

prescription_type:

Valid as a prescribable product

leaflet_short:

BNF: 02050100; GTIN: 5000123112593

PIL

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
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.
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 PLANNING TO BECOME PREGNANT, or if you
COULD BECOME
PREGNANT because you are not using reliable birth

SPC

OBJECT 1
VOLIBRIS 5 MG FILM COATED TABLETS
Summary of Product Characteristics Updated 05-May-2017 |
GlaxoSmithKline UK
1. Name of the medicinal product
_5 mg film-coated tablets_
Volibris
®
5 mg film-coated tablets
_10 mg film-coated tablets_
Volibris
®
10 mg film-coated tablets
2. Qualitative and quantitative composition
_5 mg film-coated tablets_
Each tablet contains 5 mg of ambrisentan.
_10 mg film-coated tablets_
Each tablet contains 10 mg of ambrisentan.
Excipient(s) with known effect:
_5 mg film-coated tablets_
Each tablet contains approximately 95 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).
_10 mg film-coated tablets_
Each tablet contains approximately 90 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).
_5 mg film-coated tablets_
Pale-pink, square, convex, film-coated tablet with “GS” debossed
on one side and “K2C” on the other
side.
_10 mg film-coated tablets_
Deep-pink, oval, convex, film-coated tablet with “GS” debossed on
one side and “KE3” on the other side.
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.
4.2 Posology and method of administration
Treatment must be initiated by a physician experienced in the
treatment of PAH.
Posology
_Ambrisentan monotherapy_
Volibris 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.
_Ambrisentan in combination with tadalafil_
When used in combination with tadalafil