Ivabradine JensonR

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

ivabradine hydrochloride

Available from:

JensonR+ Limited

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 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 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.,

Authorization status:

Withdrawn

Authorization date:

2016-11-11

Patient Information leaflet

30
B.
PACKAGE LEAFLET
Medicinal product no longer authorised
31
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IVABRADINE JENSONR 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 JensonR is and what it is used for
2.
What you need to know before you take Ivabradine JensonR
3.
How to take Ivabradine JensonR
4.
Possible side effects
5.
How to store Ivabradine JensonR
6.
Contents of the pack and other information
1.
WHAT IVABRADINE JENSONR IS AND WHAT IT IS USED FOR
Ivabradine JensonR (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. It usually
appears between 40 and 50 years of age. The most common symptom of
angina is chest pain or discomfort.
Angina is more likely to happen when the heart beats fa

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Ivabradine JensonR 5 mg film-coated tablets
Ivabradine JensonR 7.5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ivabradine JensonR 5 mg film-coated tablets
Each film-coated tablet contains 5 mg ivabradine (as hydrochloride).
Excipient with known effect
Each film-coated tablet contains 36.73 mg lactose (as anhydrous).
Ivabradine JensonR 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 55.09 mg lactose (as anhydrous).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Ivabradine JensonR 5 mg film-coated tablets
Pink colour, oval shape, biconvex film-coated scored tablets,
approximately 7.9 mm by 4.15 mm debossed
with “Ι 5” on one side and “M” on other side of the tablet.
The tablet can be divided into equal doses.
Ivabradine JensonR 7.5 mg film-coated tablets
Pink colour, round, beveled edge, biconvex film-coated tablets,
approximately 6.65 mm in diameter
debossed with “Ι 7” on one side and “M” on other side of the
tablet.
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.
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 contra