Carivalan 25mg/7.5mg Film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CARVEDILOL, IVABRADINE HYDROCHLORIDE

Available from:

Les Laboratoires Servier 50 Rue Carnot, 92284 Suresnes Cedex, France

ATC code:

C07F

INN (International Name):

CARVEDILOL 25 mg IVABRADINE HYDROCHLORIDE 8.085 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

CARVEDILOL 25 mg IVABRADINE HYDROCHLORIDE 8.085 mg

Prescription type:

POM

Therapeutic area:

BETA BLOCKING AGENTS

Authorization status:

Withdrawn

Authorization date:

2017-03-17

Patient Information leaflet

PAGE 1 OF 9
PACKAGE LEAFLET
PAGE 2 OF 9
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CARIVALAN 6.25 MG/5 MG FILM-COATED TABLETS
CARIVALAN 6.25 MG/7.5 MG FILM-COATED TABLETS
CARIVALAN 12.5 MG/5 MG FILM-COATED TABLETS
CARIVALAN 12.5 MG/7.5 MG FILM-COATED TABLETS
CARIVALAN 25 MG/5 MG FILM-COATED TABLETS
CARIVALAN 25 MG/7.5 MG FILM-COATED TABLETS
Carvedilol/ivabradine
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 Carivalan is and what it is used for
2.
What you need to know before you take Carivalan
3.
How to take Carivalan
4.
Possible side effects
5.
How to store Carivalan
6.
Contents of the pack and other information
1.
WHAT CARIVALAN
IS AND WHAT IT IS USED FOR
Carivalan is used in adult patients to treat:
•
Symptomatic stable angina pectoris (which causes chest pain).
•
Chronic heart failure.
Instead of taking carvedilol and ivabradine as separate tablets, you
will receive one tablet of Carivalan which
contains both ingredients at the same strength.
Carivalan is a combination of two active ingredients, carvedilol and
ivabradine. Carvedilol is a beta-blocker.
Beta-blockers slow the heartbeat, lessen the force with which the
heart muscle contracts and reduces the
blood vessel contraction in the heart, brain and throughout the body.
Ivabradine works mainly by reducing
the heart rate by a few beats per minute. This lowers the heart’s
need for oxygen especially in the situations
when an angina attack is more likely to happen. In this way,
carvedilol and ivabradine help to control and
r

Summary of Product characteristics

Page 1 of 27
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Carivalan 6.25 mg/5 mg film-coated tablets
[Carivalan 6.25 mg/7.5 mg film-coated tablets]
[Carivalan 12.5 mg/5 mg film-coated tablets]
[Carivalan 12.5 mg/7.5 mg film-coated tablets]
[Carivalan 25 mg/5 mg film-coated tablets]
[Carivalan 25 mg/7.5 mg film-coated tablets]
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 6.25 mg of carvedilol and 5 mg of
ivabradine (equivalent to 5.390
mg ivabradine as hydrochloride).
[Each film-coated tablet contains 6.25 mg of carvedilol and 7.5 mg of
ivabradine (equivalent to
8.085 mg ivabradine as hydrochloride]
[Each film-coated tablet contains 12.5 mg of carvedilol and 5 mg of
ivabradine (equivalent to 5.390
mg ivabradine as hydrochloride]
[Each film-coated tablet contains 12.5 mg of carvedilol and 7.5 mg of
ivabradine (equivalent to
8.085 mg ivabradine as hydrochloride]
[Each film-coated tablet contains 25 mg of carvedilol and 5 mg of
ivabradine (equivalent to 5.390
mg ivabradine as hydrochloride]
[Each film-coated tablet contains 25 mg of carvedilol and 7.5 mg of
ivabradine (equivalent to 8.085
mg ivabradine as hydrochloride]
Excipient with known effect: lactose monohydrate (68.055 mg for
Carivalan 6.25/5 mg, 65.360 mg
for Carivalan 6.25/7.5 mg, 78.710 mg for Carivalan 12.5/5 mg, 76.015
mg for Carivalan 12.5/7.5
mg, 85.530 mg for Carivalan 25/5 mg and 82.835 mg for Carivalan 25/7.5
mg).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White, hexagonal, film-coated tablet (6.25/5 mg) (longest diagonal 7.3
mm) engraved with CI2 on
one face and
on the other face.
[Yellow, hexagonal, film-coated tablet (6.25/7.5 mg) (longest diagonal
7.3 mm) engraved with CI3
on one face and
on the other face.]
[White, elliptic, film-coated tablet (12.5/5 mg) (10.6 mm x 5.3 mm)
engraved with CI4 on one face
and
on the other face.]
[Yellow, elliptic, film-coated tablet (12.5/7.5 mg) (10.6 mm x 5.3 mm)
engraved with CI5 on one
face and
on the other