Opsumit ® 10mg Film-Coated Tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Macitentan

Boleh didapati daripada:

JOHNSON & JOHNSON SDN. BHD.

INN (Nama Antarabangsa):

Macitentan

Unit dalam pakej:

30 Tablets

Dikeluarkan oleh:

Excella GmbH & Co.KG

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
OPSUMIT® 10MG FILM-COATED TABLETS
Macitentan (10mg)
1
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
11.
Serial Number
WHAT OPSUMIT IS USED FOR
Opsumit
is
used
for
the
long-term
treatment
of
pulmonary
arterial
hypertension (PAH) in adults; it can be
used on its own or with other medicines
for PAH. PAH is high blood pressure in
the blood vessels that carry blood from
the heart to the lungs (the pulmonary
arteries).
HOW OPSUMIT WORKS
Opsumit contains the active substance
macitentan, which belongs to the class of
medicines
called
“endothelin
receptor
antagonists”.
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, relieves the symptoms
and improves the course of the disease.
BEFORE YOU USE OPSUMIT
-
_When you must not take it _
•
If you are allergic to macitentan, soya
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
(contraception).
See
section
‘Things
you must do’.
•
If you are breastfeeding. See section
‘Things you must do’.
•
If you have liver disease or if you have
very high levels of liver enzymes in
your blood. Talk to your doctor, who
will decide whether this medicine is
suitable for you.
If any of these apply to you, please tell
your doctor.
-
_Before you start to use it_
Talk to your doctor or pharmacist before
taking Opsumit.
This medicine has been prescribed for
you only. Do not pass it on to others. It
may harm t

Ciri produk

1
1.
NAME OF THE MEDICINAL PRODUCT
Opsumit
®
10 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg macitentan.
Excipients with known effect:
Each film-coated tablet contains approximately 37 mg of lactose (as
monohydrate) and approximately
0.06 mg of soya bean lecithin (E322).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
5.5 mm, round, biconvex, white to off-white film-coated tablets,
debossed with “10” on both sides.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Opsumit, as monotherapy or in combination, is indicated for the
long-term treatment of pulmonary
arterial hypertension (PAH) in adult patients of WHO Functional Class
(FC) II to III.
Efficacy has been shown in a PAH population including idiopathic and
heritable PAH, PAH
associated with connective tissue disorders, and PAH associated with
corrected simple congenital
heart disease (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should only be initiated and monitored by a physician
experienced in the treatment of PAH.
Posology
The recommended dose is 10 mg once daily.
Special populations
_Elderly _
No dose adjustment is required in patients over the age of 65 years
(see section 5.2).
_Hepatic impairment _
Based on pharmacokinetic (PK) data, no dose adjustment is required in
patients with mild, moderate
or severe hepatic impairment (see sections 4.4 and 5.2). However,
there is no clinical experience with
the use of macitentan in PAH patients with moderate or severe hepatic
impairment. Opsumit must not
be initiated in patients with severe hepatic impairment, or clinically
significant elevated hepatic
aminotransferases (greater than 3 times the Upper Limit of Normal (> 3
× ULN); see sections 4.3 and
4.4).
2
_Renal impairment _
Based on PK data, no dose adjustment is required in patients with
renal impairment. There is no
clinical experience with the use of macitentan in PAH patients with
severe renal impairment. Th