Verquvo

Država: Evropska unija

Jezik: angleščina

Source: EMA (European Medicines Agency)

Aktivna sestavina:

Vericiguat

Dostopno od:

Bayer AG

Koda artikla:

C01

INN (mednarodno ime):

vericiguat

Terapevtska skupina:

Cardiac therapy

Terapevtsko območje:

Heart Failure

Terapevtske indikacije:

Treatment of symptomatic chronic heart failure

Status dovoljenje:

Authorised

Datum dovoljenje:

2021-07-16

Navodilo za uporabo

39
B. PACKAGE LEAFLET
40
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VERQUVO 2.5 MG FILM-COATED TABLETS
VERQUVO 5 MG FILM-COATED TABLETS
VERQUVO 10 MG FILM-COATED TABLETS
vericiguat
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 Verquvo is and what it is used for
2.
What you need to know before you take Verquvo
3.
How to take Verquvo
4.
Possible side effects
5.
How to store Verquvo
6.
Contents of the pack and other information
1.
WHAT VERQUVO IS AND WHAT IT IS USED FOR
Verquvo contains the active substance vericiguat, which is a type of
heart medicine called soluble
guanylate cyclase stimulator.
Verquvo is used to treat adults with long-term heart failure who
recently have had an increase in heart
failure symptoms. Therefore, you may have gone to hospital and/or
received a medicine (diuretic)
given in a vein to help you pass more urine than usual.
Heart failure is when your heart is weak and cannot pump enough blood
to your body. Some common
symptoms of heart failure are shortness of breath, tiredness, or
swelling caused by a build-up of fluid.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VERQUVO
DO NOT TAKE VERQUVO IF YOU ARE
-
ALLERGIC
to vericiguat or any of the other ingredients of this medicine (listed
in section
6),
-
taking any medicine that contains another
SOLUBLE

Lastnosti izdelka

1
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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
Verquvo 2.5 mg film-coated tablets
Verquvo 5 mg film-coated tablets
Verquvo 10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Verquvo 2.5 mg film-coated tablets
Each film-coated tablet contains 2.5 mg vericiguat.
_Excipient with known effect _
Each film-coated tablet contains 58.14 mg lactose (as monohydrate),
see section 4.4.
Verquvo 5 mg film-coated tablets
Each film-coated tablet contains 5 mg vericiguat.
_Excipient with known effect _
Each film-coated tablet contains 55.59 mg lactose (as monohydrate),
see section 4.4.
Verquvo 10 mg film-coated tablets
Each film-coated tablet contains 10 mg vericiguat.
_Excipient with known effect _
Each film-coated tablet contains 111.15 mg lactose (as monohydrate),
see section 4.4.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Verquvo 2.5 mg film-coated tablets
Round, biconvex, white film-coated tablet with a diameter of 7 mm,
marked with “2.5” on one side
and “VC” on the other side.
Verquvo 5 mg film-coated tablets
Round, biconvex, brown-red film-coated tablet with a diameter of 7 mm,
marked with “5” on one side
and “VC” on the other side.
3
Verquvo 10 mg film-coated tablets
Round, biconvex, yellow-orange film-coated tablet with a diameter of 9
mm, marked with “10” on one
side and “VC” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Verquvo is indicated for the treatment of symptomatic chronic heart
failure in adult patients with
reduced ejection fraction who are stabilised after a recent
decompensation event requiring IV therapy
(see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Vericiguat is administe