Procoralan

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

ivabradine hydrochloride

Διαθέσιμο από:

Les Laboratoires Servier

Φαρμακολογική κατηγορία (ATC):

C01EB17

INN (Διεθνής Όνομα):

ivabradine

Θεραπευτική ομάδα:

Cardiac therapy

Θεραπευτική περιοχή:

Angina Pectoris; Heart Failure

Θεραπευτικές ενδείξεις:

Symptomatic treatment of chronic stable angina pectoris Ivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥ 70 bpm. Ivabradine is indicated :in adults unable to tolerate or with a contraindication to the use of beta-blockersor in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose.Treatment of chronic heart failure Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.

Περίληψη προϊόντος:

Revision: 22

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2005-10-25

Φύλλο οδηγιών χρήσης

28
B. PACKAGE LEAFLET
29
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PROCORALAN 5
MG FILM-COATED TABLETS
PROCORALAN 7.5
MG FILM-COATED TABLETS
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 Procoralan is and what it is used for
2.
What you need to know before you take Procoralan
3.
How to take Procoralan
4.
Possible side effects
5
How to store Procoralan
6.
Contents of the pack and other information
1.
WHAT PROCORALAN IS AND WHAT IT IS USED FOR
Procoralan (ivabradine) is a heart medicine used to treat:
-
Symptomatic stable angina pectoris (which causes chest pain) in adult
patients whose heart rate is
over or equal to 70 beats per minute. It is used in adult patients who
do not tolerate or cannot take
heart medicines called beta-blockers. It is also used in combination
with beta-blockers in adult
patients whose condition is not fully controlled with a beta-blocker.
-
Chronic heart failure in adult patients whose heart rate is over or
equal to 75 beats per minute. It is
used in combination with standard therapy, including beta-blocker
therapy or when beta-blockers
are contraindicated or not tolerated.
About stable angina pectoris (usually referred to as “angina”):
Stable angina is a heart disease which happens when the heart does not
receive enough oxygen. The
most common symptom of angina is chest pain or discomfort.
About chronic heart failure :
Chronic heart failure is a heart disease which happens when your heart
cannot pump enough blood to
the rest of your body. The most c

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Procoralan 5 mg film-coated tablets
Procoralan 7.5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Procoralan 5 mg film-coated tablets
Each film-coated tablet contains 5 mg ivabradine (as hydrochloride).
_Excipient with known effect: _
Each film-coated tablet contains 63.91 mg lactose monohydrate.
Procoralan 7.5 mg film-coated tablets
Each film-coated tablet contains 7.5 mg ivabradine (as hydrochloride).
_Excipient with known effect: _
Each film-coated tablet contains 61.215 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Procoralan 5 mg film-coated tablets
Salmon-coloured, oblong, film-coated tablet scored on both sides,
engraved with “5” on one face
and
on the other face.
The tablet can be divided into equal doses.
Procoralan 7.5 mg film-coated tablets
Salmon-coloured, triangular, film-coated tablet engraved with
“7.5” on one face and
on the other
face.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of chronic stable angina pectoris
Ivabradine is indicated for the symptomatic treatment of chronic
stable angina pectoris in coronary
artery disease adults with normal sinus rhythm and heart rate ≥ 70
bpm. Ivabradine is indicated:
-
in adults unable to tolerate or with a contraindication to the use of
beta-blockers
-
or in combination with beta-blockers in patients inadequately
controlled with an optimal beta-
blocker dose.
3
Treatment of chronic heart failure
Ivabradine is indicated in chronic heart failure NYHA II to IV class
with systolic dysfunction, in adult
patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in
combination with standard therapy
including beta-blocker therapy or when beta-blocker therapy is
contraindicated or not tolerated (see
section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Symptomatic treatment of chronic stable angina pectoris _
It is recommended that the deci