Adempas 1.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Riociguat

Available from:

Merck Sharp & Dohme Ltd

ATC code:

C02KX05

INN (International Name):

Riociguat

Dosage:

1.5mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02050100; GTIN: 5010605333125 5010605333071

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ADEMPAS 0.5 MG FILM-COATED TABLETS
ADEMPAS 1 MG FILM-COATED TABLETS
ADEMPAS 1.5 MG FILM-COATED TABLETS
ADEMPAS 2 MG FILM-COATED TABLETS
ADEMPAS 2.5 MG FILM-COATED TABLETS
Riociguat
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 Adempas is and what it is used for
2.
What you need to know before you take Adempas
3.
How to take Adempas
4.
Possible side effects
5.
How to store Adempas
6.
Contents of the pack and other information
1.
WHAT ADEMPAS IS AND WHAT IT IS USED FOR
Adempas contains the active substance riociguat. Riociguat is a type
of medicine called a guanylate
cyclase (sGC)-stimulator. It works by widening the pulmonary arteries
(the blood vessels that connect
the heart to the lungs), making it easier for the heart to pump blood
through the lungs. Adempas can
be used to treat adults with certain forms of pulmonary hypertension,
a condition in which these blood
vessels become narrowed, making it harder for the heart to pump blood
through them and leading to
high blood pressure in the vessels. Because the heart must work harder
than normal, people with
pulmonary hypertension feel tired, dizzy and short of breath. By
widening the narrowed arteries,
Adempas leads to an improvement in your ability to carry out physical
activity.

Summary of Product characteristics

OBJECT 1
ADEMPAS 0.5 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 13-Mar-2018 | Merck Sharp &
Dohme Limited
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
Adempas® 0.5 mg film-coated tablets
Adempas® 1 mg film-coated tablets
Adempas® 1.5 mg film-coated tablets
Adempas® 2 mg film-coated tablets
Adempas® 2.5 mg film-coated tablets
2. Qualitative and quantitative composition
Adempas 0.5 mg: Each film-coated tablet contains 0.5 mg of riociguat.
Adempas 1 mg: Each film-coated tablet contains 1 mg of riociguat.
Adempas 1.5 mg: Each film-coated tablet contains 1.5 mg of riociguat.
Adempas 2 mg: Each film-coated tablet contains 2 mg of riociguat.
Adempas 2.5 mg: Each film-coated tablet contains 2.5 mg of riociguat.
Excipients with known effect:
Each 0.5 mg film-coated tablet contains 37.8 mg lactose (as
monohydrate),
Each 1 mg film-coated tablet contains 37.2 mg lactose (as
monohydrate),
Each 1.5 mg film-coated tablet contains 36.8 mg lactose (as
monohydrate),
Each 2 mg film-coated tablet contains 36.3 mg lactose (as
monohydrate),
Each 2.5 mg film-coated tablet contains 35.8 mg lactose (as
monohydrate).
See section 4.4.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Adempas is a film-coated tablet.
• _0.5 mg tablet_: 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.
• _1 mg tablet_: 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.
• _1.5 mg tablet_: 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.
• _2 mg tablet_: pale orange, round, biconvex tablets of 6 mm,
marked with the Bayer cross on one side a