Adempas

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

riociguat

Διαθέσιμο από:

Bayer AG

Φαρμακολογική κατηγορία (ATC):

C02KX05

INN (Διεθνής Όνομα):

riociguat

Θεραπευτική ομάδα:

Antihypertensives for pulmonary arterial hypertension

Θεραπευτική περιοχή:

Hypertension, Pulmonary

Θεραπευτικές ενδείξεις:

Chronic thromboembolic pulmonary hypertension (CTEPH) Adempas is indicated for the treatment of adult patients with WHO Functional Class (FC) II to III withinoperable CTEPH,persistent or recurrent CTEPH after surgical treatment,to improve exercise capacity. Pulmonary arterial hypertension (PAH) Adempas, as monotherapy or in combination with endothelin receptor antagonists, is indicated for the treatment of adult patients with pulmonary arterial hypertension (PAH) with WHO Functional Class (FC) II to III to improve exercise capacity. Efficacy has been shown in a PAH population including aetiologies of idiopathic or heritable PAH or PAH associated with connective tissue disease.

Περίληψη προϊόντος:

Revision: 9

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2014-03-26

Φύλλο οδηγιών χρήσης

30
B. PACKAGE LEAFLET
31
PACKAGE LEAFLET: INFORMATION FOR THE USER
ADEMPAS 0.5 MG FILM-COATED TABLETS
ADEMPAS 1 MG FILM-COATED TABLETS
ADEMPAS 1.5 MG FILM-COATED TABLETS
ADEMPAS 2 MG FILM-COATED TABLETS
ADEMPAS 2.5 MG FILM-COATED TABLETS
riociguat
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 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. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Adempas is and what it is used for
2.
What you need to know before you take Adempas
3.
How to take Adempas
4.
Possible side effects
5.
How to store Adempas
6.
Contents of the pack and other information
1.
WHAT ADEMPAS IS AND WHAT IT IS USED FOR
Adempas contains the active substance riociguat. Riociguat is a type
of medicine called a guanylate
cyclase (sGC)-stimulator. It works by widening the pulmonary arteries
(the blood vessels that connect
the heart to the lungs), making it easier for the heart to pump blood
through the lungs. Adempas can be
used to treat adults with certain forms of pulmonary hypertension, a
condition in which these blood
vessels become narrowed, making it harder for the heart to pump blood
through them and leading to
high blood pressure in the vessels. Because the heart must work harder
than normal, people with
pulmonary hypertension feel tired, dizzy and short of breath. By
widening the narrowed arteries,
Adempas leads to an improvement in your ability to carry out physical
activity.
Adempas is used in either of two types of pulmonary hypertension:

CHRONIC THROMBOEMBOLIC PULMONARY HYPERTENSION (CTEPH)
.
In CTEPH, the blood vessels of the lung are blocked or narrowed with
blood c

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Adempas 0.5 mg film-coated tablets
Adempas 1 mg film-coated tablets
Adempas 1.5 mg film-coated tablets
Adempas 2 mg film
-
coated tablets
Adempas 2.5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Adempas 0.5 mg film-coated tablets
Each film-coated tablet contains 0.5 mg of riociguat.
Adempas 1 mg film-coated tablets
Each film-coated tablet contains 1 mg of riociguat.
Adempas 1.5 mg film-coated tablets
Each film-coated tablet contains 1.5 mg of riociguat.
Adempas 2 mg film-coated tablets
Each film-coated tablet contains 2 mg of riociguat.
Adempas 2.5 mg film-coated tablets
Each film-coated tablet contains 2.5 mg of riociguat.
Excipient with known effect
_Adempas 0.5 mg film-coated tablets _
Each 0.5 mg film-coated tablet contains 37.8 mg lactose (as
monohydrate).
_Adempas 1 mg film-coated tablets _
Each 1 mg film-coated tablet contains 37.2 mg lactose (as
monohydrate).
_Adempas 1.5 mg film-coated tablets _
Each 1.5 mg film-coated tablet contains 36.8 mg lactose (as
monohydrate).
_Adempas 2 mg film-coated tablets _
Each 2 mg film-coated tablet contains 36.3 mg lactose (as
monohydrate).
_Adempas 2.5 mg film-coated tablets _
Each 2.5 mg film-coated tablet contains 35.8 mg lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).

_0.5 mg tablet:_
white, round, biconvex tablets of 6 mm, marked with the Bayer cross on
one side
and 0.5 and an “R” on the other side.

_1 mg tablet:_
pale yellow, round, biconvex tablets of 6 mm, marked with the Bayer
cross on one
side and 1 and an “R” on the other side.

_1.5 mg tablet:_
yellow-orange, round, biconvex tablets of 6 mm, marked with the Bayer
cross on
one side and 1.5 and an “R” on the other side.
3

_2 mg tablet:_
pale orange, round, biconvex tablets of 6 mm, marked with the Bayer
cross on one
side and 2 and an “R” on the other side.

_2.5 mg tablet:_
red-orange, round, biconv