Ivabradine Accord
Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Patient Information leaflet
(PIL)
01-03-2022
Summary of Product characteristics
(SPC)
01-03-2022
Public Assessment Report
(PAR)
01-06-2017
Active ingredient:
ivabradine hydrochloride
Available from:
Accord Healthcare S.L.U.
ATC code:
C01EB17
INN (International Name):
ivabradine
Therapeutic group:
Cardiac therapy
Therapeutic area:
Angina Pectoris; Heart Failure
Therapeutic indications:
Symptomatic treatment of chronic stable angina pectorisIvabradine 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 contra-indication to the use of beta-blockers- or in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose.Treatment of chronic heart failureIvabradine 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. (see section 5.1)
Product summary:
Revision: 6
Authorization status:
Authorised
Authorization date:
2017-05-22
Patient Information leaflet
30
B. PACKAGE LEAFLET
31
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IVABRADINE ACCORD 5 MG FILM-COATED TABLETS
IVABRADINE ACCORD 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 Ivabradine Accord is and what it is used for
2.
What you need to know before you take Ivabradine Accord
3.
How to take Ivabradine Accord
4.
Possible side effects
5
How to store Ivabradine Accord
6.
Contents of the pack and other information
1.
WHAT IVABRADINE ACCORD IS AND WHAT IT IS USED FOR
Ivabradine Accord 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 oxygenThe
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 bloo
Read the complete document
Summary of Product characteristics
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Ivabradine Accord 5 mg film-coated tablets
Ivabradine Accord 7.5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Ivabradine Accord 5 mg film-coated tablets
Each film-coated tablet contains 5 mg ivabradine (as hydrochloride).
_Excipient with known effect _
Each 5 mg film-coated tablet contains 72 mg lactose (as anhydrous).
Ivabradine Accord 7.5 mg film-coated tablets
Each film-coated tablet contains 7.5 mg ivabradine (as hydrochloride).
_Excipient with known effect _
Each 7.5 mg film-coated tablet contains 108 mg lactose (as anhydrous).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Ivabradine Accord 5 mg film-coated tablets
Salmon-coloured, oblong shaped, approximately 8.50 mm in length, 4.50
mm in width, film-coated
tablets scored on both sides, debossed with “FK” on one side and
“2” on other side.
The tablet can be divided into equal doses.
Ivabradine Accord 7.5 mg film-coated tablets
Salmon-coloured, triangular shaped, approximately 7.30 mm in length,
6.80 mm in width, film-coated
tablets debossed with “FK” on one side and “1” on other side.
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 New York Heart
Association (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
Read the complete document
