IVABRADINE TEVA 7.5 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

IVABRADINE ADIPATE

Available from:

Teva B.V.

ATC code:

C01EB17

INN (International Name):

IVABRADINE ADIPATE

Dosage:

7.5 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Other cardiac preparations

Authorization status:

Authorised

Authorization date:

2016-12-16

Patient Information leaflet

IVABRADINE TEVA 5 MG
FILM-COATED TABLETS
IVABRADINE TEVA 7.5 MG
FILM-COATED TABLETS
IVABRADINE
PACKAGE LEAFLET:
INFORMATION FOR THE PATIENT
READ ALL OF THIS LEAFL ET CAREFULLY BEFORE YOU 
START TAKING THIS MEDICINE BECAUSE IT 
CONTAINS IMPORTANT INFORMATION FOR YOU.
•  Keep this leafl et. 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 
leafl et. 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 

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ivabradine Teva 7.5 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
Beige to pale-orange round, biconvex film-coated tablet with embossing “7.5” on one side. Diameter approx. 8 mm.
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.
_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 or ambulatory 24-hour monitoring.
The starting dose of ivabradine should not exceed 5 mg twice daily in patients aged below 75 years. After three to four
weeks�