Opsumit 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Macitentan

Available from:

Actelion Pharmaceuticals UK Ltd

ATC code:

C02KX04

INN (International Name):

Macitentan

Dosage:

10mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02050100; GTIN: 7640111931102

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
OPSUMIT 10 MG FILM-COATED TABLETS
macitentan
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 or any of the other ingre

Summary of Product characteristics

OBJECT 1
OPSUMIT (MACITENTAN) 10 MG
Summary of Product Characteristics Updated 22-Feb-2018 | Actelion
Pharmaceuticals UK Ltd
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
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 lecithin (soya) (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
Opsumit is to be taken orally at a dose of 10 mg once daily, with or
without food. The film-coated tablets
are not breakable and are to be swallowed whole, with water.
Opsumit should be taken every day at about the same time. If the
patient misses a dose of Opsumit, the
patient should be told to take it as soon as possible and then take
the next dose at the regularly scheduled
time. The patient should be told not to take two doses at the same
time if a dose has been missed.
Elderly
No dose adjustment is required in patients ove