Ivabradine Rowex 7.5 mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ivabradine

Available from:

Rowex Ltd

ATC code:

C01EB; C01EB17

INN (International Name):

Ivabradine

Dosage:

7.5 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Other cardiac preparations; ivabradine

Authorization status:

Marketed

Authorization date:

2016-02-10

Patient Information leaflet

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

Summary of Product characteristics

Health Products Regulatory Authority
26 February 2021
CRN00C3H7
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ivabradine Rowex 7.5 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 7.5 mg of ivabradine (as oxalate).
Excipient with known effect
Each film-coated tablet contains 106.449 mg of lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Orange-yellow coloured, round (6.5 mm), biconvex, film-coated tablets
debossed with ´7.5´ on one 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 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
of treatment, if the patient is still symptomatic, if the initial dose
is well tolerated and if resting he