IVABRADINE 5 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

IVABRADINE

Available from:

Clonmel Healthcare Ltd

ATC code:

C01EB17

INN (International Name):

IVABRADINE

Dosage:

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:

2017-02-16

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
[PRODUCT NAME] 2.5 MG FILM-COATED TABLETS
[PRODUCT NAME] 5 MG FILM-COATED TABLETS
[PRODUCT NAME] 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. 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 [Product name] is and what it is used for
2.
What you need to know before you take [Product name]
3.
How to take [Product name]
4.
Possible side effects
5.
How to store [Product name]
6.
Contents of the pack and other information
1
WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR
[Product name] (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 i

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ivabradine 5 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 5 mg of ivabradine (equivalent to
5.390 mg ivabradine hydrochloride).
Excipient(s) with known effect: 1.344 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablet
Pink, round, film-coated tablet of approximately 8.7 mm, debossed with
‘I9VB’ and score line on one side and ‘5’ on
the other side.
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 2.5 mg, 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 hea