Ivabradine Teva 5 mg Film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

IVABRADINE ADIPATE

Available from:

Teva B.V. Swensweg 5, 2031 GA Haarlem, Netherlands

ATC code:

C01EB17

INN (International Name):

IVABRADINE ADIPATE 5 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

IVABRADINE ADIPATE 5 mg

Prescription type:

POM

Therapeutic area:

CARDIAC THERAPY

Authorization status:

Withdrawn

Authorization date:

2016-11-15

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IVABRADINE TEVA 5 MG FILM-COATED TABLETS
IVABRADINE TEVA 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 Teva is and what it is used for
2.
What you need to know before you take Ivabradine Teva
3.
How to take Ivabradine Teva
4.
Possible side effects
5.
How to store Ivabradine Teva
6.
Contents of the pack and other information
1.
WHAT IVABRADINE TEVA IS AND WHAT IT IS USED FOR
Ivabradine Teva 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
faster in situations such as
exercise,

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ivabradine Teva 5 mg Film-coated Tablets
Ivabradine Teva 7.5 mg Film-coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg ivabradine (equivalent to 6.56
mg ivabradine adipate)
Each film-coated tablet contains 7.5 mg ivabradine (equivalent to 9.84
mg ivabradine adipate)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
5 mg: Beige to pale-orange oval, biconvex film-coated tablet with
breaking score on one side and
embossing “5” on other side. Dimensions approx. 9 mm x 4.5 mm.
7.5 mg: Beige to pale-orange round, biconvex film-coated tablet with
embossing “7.5” on one side.
Diameter approx. 8 mm.
5 mg: The tablet can be divided into equal doses.
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 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 (see
section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For the different doses, film-coated tablets containing 5 mg and 7.5
mg ivabradine are available.
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_Symptomatic treatment of chronic stable angina pectoris _
It is recommended that the decision to initiate or titrate treatment
takes place with the availability of
serial heart rate measurements, ECG