Uptravi 400microgram tablets

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Selexipag

Commercializzato da:

Actelion Pharmaceuticals UK Ltd

Codice ATC:

B01AC27

INN (Nome Internazionale):

Selexipag

Dosaggio:

400microgram

Forma farmaceutica:

Tablet

Via di somministrazione:

Oral

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 02050100; GTIN: 7640111931898

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
UPTRAVI 200 MICROGRAM FILM-COATED TABLETS
UPTRAVI 400 MICROGRAM FILM-COATED TABLETS
UPTRAVI 600 MICROGRAM FILM-COATED TABLETS
UPTRAVI 800 MICROGRAM FILM-COATED TABLETS
UPTRAVI 1,000 MICROGRAM FILM-COATED TABLETS
UPTRAVI 1,200 MICROGRAM FILM-COATED TABLETS
UPTRAVI 1,400 MICROGRAM FILM-COATED TABLETS
UPTRAVI 1,600 MICROGRAM FILM-COATED TABLETS
Selexipag
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 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 nurse.
-
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 have any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet (see section 4).
WHAT IS IN THIS LEAFLET
1.
What Uptravi is and what it is used for
2.
What you need to know before you take Uptravi
3.
How to take Uptravi
4.
Possible side effects
5.
How to store Uptravi
6.
Contents of the package and other information
1.
WHAT UPTRAVI IS AND WHAT IT IS USED FOR
Uptravi is a medicine that contains the active substance selexipag. It
acts on blood vessels in a similar
way to the natural substance prostacyclin, making them relax and
widen.
Uptravi is used for the long-term treatment of pulmonary arterial
hypertension (PAH) in adult patients
insufficiently controlled with other types of medicines for PAH known
as endothelin receptor
antagonists and phosphodiesterase type 5 inhibitors. Uptravi can be
used on its own if the patient is
not a candidate for these medicines.
PAH is high blood pressure in the blood vessels that carry blood from
the heart to the lungs (the
pulm

Scheda tecnica

OBJECT 1
UPTRAVI
Summary of Product Characteristics Updated 18-Apr-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
Uptravi 200 microgram film-coated tablets.
Uptravi 400 microgram film-coated tablets.
Uptravi 600 microgram film-coated tablets.
Uptravi 800 microgram film-coated tablets.
Uptravi 1,000 microgram film-coated tablets.
Uptravi 1,200 microgram film-coated tablets.
Uptravi 1,400 microgram film-coated tablets.
Uptravi 1,600 microgram film-coated tablets.
2. Qualitative and quantitative composition
Uptravi 200 microgram film-coated tablets
Each film-coated tablet contains 200 micrograms of selexipag.
Uptravi 400 microgram film-coated tablets
Each film-coated tablet contains 400 micrograms of selexipag.
Uptravi 600 microgram film-coated tablets
Each film-coated tablet contains 600 micrograms of selexipag.
Uptravi 800 microgram film-coated tablets
Each film-coated tablet contains 800 micrograms of selexipag.
Uptravi 1,000 microgram film-coated tablets
Each film-coated tablet contains 1,000 micrograms of selexipag.
Uptravi 1,200 microgram film-coated tablets
Each film-coated tablet contains 1,200 micrograms of selexipag.
Uptravi 1,400 microgram film-coated tablets
Each film-coated tablet contains 1,400 micrograms of selexipag.
Uptravi 1,600 microgram film-coated tablets
Each film-coated tablet contains 1,600 micrograms of selexipag.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
Uptravi 200 microgram film-coated tablets
Round, light-yellow, film-coated tablets with “2” debossed on one
side.
Uptravi 400 microgram film-coated tablets
Round, red, film-coated tablets with “4” debossed on one side.
Uptravi 600 microgram film-coated tablets
Round, light-violet, film-coated tablets with “