Opsumit

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Macitentan

Available from:

Janssen-Cilag International N.V.  

ATC code:

C02KX04

INN (International Name):

macitentan

Therapeutic group:

Antihypertensives,

Therapeutic area:

Hypertension, Pulmonary

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.

Product summary:

Revision: 23

Authorization status:

Authorised

Authorization date:

2013-12-20

Patient Information leaflet

24
B. PACKAGE LEAFLET
25
PACKAGE LEAFLET: INFORMATION FOR THE USER
OPSUMIT 10 MG FILM-COATED TABLETS
macitentan
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 Opsumit is and what it is used for
2.
What you need to know before you take Opsumit
3.
How to take Opsumit
4.
Possible side effects
5.
How to store Opsumit
6.
Contents of the pack and other information
1.
WHAT OPSUMIT IS AND WHAT IT IS USED FOR
Opsumit contains the active substance macitentan, which belongs to the
class of medicines called
“endothelin receptor antagonists”.
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).
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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE OPSUMIT
DO NOT TAKE OPSUMIT

if you are allergic to macitentan, soya or any of the other
ingredients of this medicine (listed in
section 6).

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 (contracept

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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).
3
_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 pati