Opsumit 10mg Film-Coated Tablets

Negara: Malaysia

Bahasa: Inggris

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

Bahan aktif:

Macitentan

Tersedia dari:

DKSH MALAYSIA SDN BHD

INN (Nama Internasional):

Macitentan

Unit dalam paket:

30tablet Tablets

Diproduksi oleh:

PATHEON ITALIA S.P.A.

Selebaran informasi

OPSUMIT® 10MG FILM-COATED TABLETS
Macitentan (10mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1. What Opsumit is used for
2. How Opsumit works
3. Before you use Opsumit
4. How to use Opsumit
5. While you are using it
6. Side effects
7. Storage and Disposal of Opsumit
8. Product Description
9. Manufacturer and Product Registration
Holder
10. Date of revision
WHAT OPSUMIT IS USED FOR
Opsumit
is
used
for
the
long-term
treatment
of
pulmonary
arterial
hypertension (PAH), it can be used on its
own or with other drugs for PAH.
HOW OPSUMIT WORKS
Opsumit
contains
the
active
substance
macitentan, which belongs to the group
of
substances
known
as
endothelin
receptor antagonists.
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.
Opsumit widens the pulmonary arteries,
making it easier for the heart to pump
blood
through
them.
This
lowers
the
blood
pressure
and
both
relieves
the
symptoms and improves the course of
the disease.
BEFORE YOU USE OPSUMIT
-
_When you must not take it _

If
you
are
hypersensitive
to
macitentan
or
any
of
the
other
ingredients of Opsumit.

If
you
are
pregnant,
if
you
are
planning to become pregnant, or if
you could become pregnant because
you
are
not
using
reliable
birth
control.

If before the start of treatment your
liver enzymes are greatly elevated
-
_Before you start to use it_
Read this package leaflet carefully before
you take the medicine.
This medicine has been prescribed for
you,
and
you
must
not
pass
it
on
to
others. The medicine could harm them,
even if their symptoms are the same as
yours.
Keep this leaflet; you may want to read it
again later.
If you have anaemia (a reduced number
of red blood cells).
Before you start treatment with Opsumit
and
during
treatment
your
doctor
will
take blood tests to control the