Uptravi 200 microgram Film-coated tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Selexipag

Boleh didapati daripada:

JOHNSON & JOHNSON SDN. BHD.

INN (Nama Antarabangsa):

Selexipag

Unit dalam pakej:

140 Tablets; 60 Tablets

Dikeluarkan oleh:

Excella GmbH & Co.KG

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
UPTRAVI® FILM-COATED TABLETS
Selexipag (200mcg, 400mcg, 600mcg, 800mcg, 1000mcg, 1200mcg, 1400mcg,
1600mcg)
1
WHAT IS IN THIS LEAFLET
1.
What UPTRAVI is used for
2.
How UPTRAVI works
3.
Before you use UPTRAVI
4.
How to use UPTRAVI
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
UPTRAVI
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT UPTRAVI IS USED FOR
UPTRAVI 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
narrow, so the heart has to work
harder to pump blood through them.
This may cause people to feel tired,
dizzy, short of breath, or experience
other symptoms.
Ask your doctor if you have any
questions about why it has been
prescribed for you.
HOW UPTRAVI WORKS
UPTRAVI contains the active
substance selexipag. It is a medicine
that acts on a receptor that is the target
of a natural substance called
"prostacyclin".
UPTRAVI widens the pulmonary
arteries and reduces their hardening.
This makes it easier for the heart to
pump blood through the pulmonary
arteries. It relieves the symptoms of
PAH and improves the course of the
disease.
BEFORE YOU USE UPTRAVI
-
_When you must not use it_
Do not take UPTRAVI if
1.
You have ever had an allergic
reaction to selexipag or any of the
ingredients listed at the end of this
leaflet.
Please consult your doctor
immediately if you experience
any signs or symptoms of a
serious allergic reaction:
•
Wheezing
•
Swelling of the
lips/mouth/throat/face
•
Difficulty in breathing or
tightness in the throat
•
Hives or rash
•
Fainting
2.
You have severe liver problems
(Child-Pugh Class C)
3.
You have had a stroke within the
last 3 months
4.
You have severe coronary heart
disease or unstable angin

Ciri produk

1
PRODUCT INFORMATION
UPTRAVI
®
(SELEXIPAG)
FILM-COATED TABLET
1
NAME OF THE MEDICINE
UPTRAVI selexipag
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Selexipag is a pale yellow crystalline powder that is practically
insoluble in water. In the solid state
selexipag is very stable, is not hygroscopic, and is not light
sensitive.
Each round film-coated tablet contains 200 micrograms or multiples
thereof (respectively 400, 600,
800, 1000, 1200, 1400, or 1600 micrograms) selexipag. The film-coated
tablets are not light
sensitive.
Refer to Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
UPTRAVI 200 micrograms, light yellow, debossed with '2', round,
film-coated tablet.
UPTRAVI 400 micrograms, red, debossed with '4', round, film-coated
tablet.
UPTRAVI 600 micrograms, light violet, debossed with '6', round,
film-coated tablet.
UPTRAVI 800 micrograms, green, debossed with '8', round, film-coated
tablet.
UPTRAVI 1000 micrograms, orange, debossed with '10', round,
film-coated tablet.
UPTRAVI 1200 micrograms, dark violet, debossed with '12', round,
film-coated tablet.
UPTRAVI 1400 micrograms, dark yellow, debossed with '14', round,
film-coated tablet
UPTRAVI 1600 micrograms, brown, debossed with '16', round, film-coated
tablet
Refer to Section 6.5 NATURE AND CONTENTS OF CONTAINER.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Uptravi is indicated for the long-term treatment of pulmonary arterial
hypertension (PAH) in adult
patients with WHO functional class (FC) II–III, either as
combination therapy in patients insufficiently
controlled with an endothelin receptor antagonist (ERA) and/or a
phosphodiesterase type 5 (PDE-5)
inhibitor, or as monotherapy in patients who are not candidates for
these therapies.
2
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.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Treatment should only be initiated and monitored by a physician
experien