Adempas 1.5mg film-coated tablet

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

Riociguat

Boleh didapati daripada:

BAYER CO. (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

Riociguat

Unit dalam pakej:

56tablet Tablets; 14tablet Tablets; 42 (3 x 14's)tablet Tablets

Dikeluarkan oleh:

BAYER AG

Risalah maklumat

ADEMPAS
®
Riociguat (0.5 mg film-coated tablets,1.0 mg film-coated tablets,1.5
mg film-coated tablets,2.0 mg film-coated tablets,2.5 mg film-coated
tablets)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_Adempas_
is used for
2.
How
_Adempas_
works
3.
Before you use
_Adempas_
4.
How to use
_Adempas_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Adempas_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _ADEMPAS_ IS USED FOR
_Chronic-thromboembolic _
_pulmonary _
_hypertension (CTEPH, WHO Group 4) _
_Adempas_
is used to treat adult patients
with CTEPH, a disease where high blood
pressure
in
lung
vessels
(pulmonary
arteries) is caused by fixed blood clots
narrowing or blocking the blood flow.
High pulmonary blood pressure in the
lung vessels means that the heart needs
to work harder to pump blood through
the
lungs.
This
causes
people
to
feel
tired, dizzy and short of breath.
_Adempas_
is intended for use in patients
with
CTEPH
who
cannot
be
operated
(inoperable CTEPH) or in patients with
persistent or recurrent
high pulmonary
blood pressure after surgical treatment.
_Adempas_
lowers high blood pressure in
the lung vessels and leads to an increase
in
exercise
capacity
(will
increase
a
patient’s ability to walk further).
_ _
_Pulmonary arterial hypertension (PAH, _
_WHO Group 1) _
_Adempas_
is used to treat adult patients
with
PAH,
a
disease
characterized
by
high blood pressure in blood vessels (the
pulmonary arteries) that carry blood from
the heart to the lungs. In patients 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.
_Adempas_
lowers the high blood pressure
in
the
lung
vessels
and
leads
to
an
increase
in
exercise
capacity
(will
increase
a
patient’s
ability
to
walk
further).
_Adempas_
can be taken alone or together
with certain medicines used to treat PAH
(endothelin
receptor
antagonists
or

Ciri produk

ADEMPAS
®
FILM-COATED TABLET
1.
NAME OF THE MEDICINAL PRODUCT
Adempas 0.5 mg film-coated tablets
Adempas 1.0 mg film-coated tablets
Adempas 1.5 mg film-coated tablets
Adempas 2.0 mg film-coated tablets
Adempas 2.5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains either 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg
and 2.5 mg riociguat.
For the full list of excipient(s) see section ’list of
excipients’.
3.
PHARMACEUTICAL FORM
Adempas 0.5 mg film-coated tablets:
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.
Adempas 1.0 mg film-coated tablets:
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.
Adempas 1.5 mg film-coated tablets:
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.
Adempas 2.0 mg film-coated tablets:
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.
Adempas 2.5 mg film-coated tablets:
Red-orange, round, biconvex tablets of 6 mm, marked with the Bayer
cross on one side and 2.5 and an “R”
on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Chronic thromboembolic pulmonary hypertension (CTEPH)
Adempas is indicated for the treatment of adult patients with WHO
Functional Class (FC) II to III with
•
inoperable CTEPH,
•
persistent or recurrent CTEPH after surgical treatment,
to improve exercise capacity (see section 5.1).
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 (