Stayveer

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

bosentan (as monohydrate)

Available from:

Janssen-Cilag International NV

ATC code:

C02KX01

INN (International Name):

bosentan monohydrate

Therapeutic group:

Other antihypertensives

Therapeutic area:

Hypertension, Pulmonary; Scleroderma, Systemic

Therapeutic indications:

Treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity and symptoms in patients with World Health Organization (WHO) functional class III. Efficacy has been shown in:primary (idiopathic and familial) PAH;PAH secondary to scleroderma without significant interstitial pulmonary disease;PAH associated with congenital systemic-to-pulmonary shunts and Eisenmenger’s physiology.Some improvements have also been shown in patients with PAH WHO functional class II.Stayveer is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital-ulcer disease.

Product summary:

Revision: 15

Authorization status:

Authorised

Authorization date:

2013-06-24

Patient Information leaflet

43
B. PACKAGE LEAFLET
44
PACKAGE LEAFLET: INFORMATION FOR THE USER
STAYVEER 62.5 MG FILM-COATED TABLETS
STAYVEER 125 MG FILM-COATED TABLETS
bosentan
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, please ask your doctor or
pharmacist.
-
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 or pharmacist. This
includes any possible side effects
not listed in this leaflet.
WHAT IS IN THIS LEAFLET
1.
What STAYVEER is and what it is used for
2.
What you need to know before you take STAYVEER
3.
How to take STAYVEER
4.
Possible side effects
5.
How to store STAYVEER
6.
Contents of the pack and other information
1.
WHAT STAYVEER IS AND WHAT IT IS USED FOR
STAYVEER tablets contain bosentan, which blocks a naturally occurring
hormone called endothelin-1
(ET-1), which causes blood vessels to narrow. STAYVEER therefore
causes blood vessels to expand and
belongs to the class of medicines called “endothelin receptor
antagonists”.
STAYVEER is used to treat:

PULMONARY ARTERIAL HYPERTENSION (PAH): PAH is a disease of severe
narrowing of the blood
vessels in the lungs resulting in high blood pressure in the blood
vessels (the pulmonary arteries)
that carry blood from the heart to the lungs. This pressure reduces
the amount of oxygen that can
get into the blood in the lungs, making physical activity more
difficult. STAYVEER widens the
pulmonary arteries, making it easier for the heart to pump blood
through them. This lowers the
blood pressure and relieves the symptoms.
STAYVEER is used to treat patients with class III PAH to improve
exercise capacity (the ability to carry
out physical activity) and symptoms. The ‘class’ reflects the
seriousness of the disease: ‘class III’ involves
marked limitation of physical

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
STAYVEER 62.5 mg film-coated tablets
STAYVEER 125 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
STAYVEER 62.5 mg film-coated tablets
Each film-coated tablet contains 62.5 mg bosentan (as monohydrate).
STAYVEER 125 mg film-coated tablets
Each film-coated tablet contains 125 mg bosentan (as monohydrate).
Excipient with known effect
This medicine contains less than 1 mmol sodium (23 mg) per tablet,
that is to say essentially
‘sodium-free’.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablets):
STAYVEER 62.5 mg film-coated tablets
Orange-white, round, biconvex, film-coated tablets, embossed with
“62,5” on one side.
STAYVEER 125 mg film-coated tablets
Orange-white, oval, biconvex, film-coated tablets, embossed with
“125” on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of pulmonary arterial hypertension (PAH) to improve exercise
capacity and symptoms in
patients with WHO functional class III. Efficacy has been shown in:

Primary (idiopathic and heritable) pulmonary arterial hypertension

Pulmonary arterial hypertension secondary to scleroderma without
significant interstitial pulmonary
disease

Pulmonary arterial hypertension associated with congenital
systemic-to-pulmonary shunts and
Eisenmenger’s physiology
Some improvements have also been shown in patients with pulmonary
arterial hypertension WHO
functional class II (see section 5.1).
STAYVEER is also indicated to reduce the number of new digital ulcers
in patients with systemic
sclerosis and ongoing digital ulcer disease (see section 5.1).
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration
Tablets are to be taken orally morning and evening, with or without
food. The film-coated tablets are to be
swallowed with water.
Patients should be advised not to swallow the desiccant found in the
white high-density polyethylene
bottles.
Posology
Pulmonary arterial