Ivabradine 7.5 mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ivabradine

Available from:

Actavis Group PTC ehf

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:

Authorised

Authorization date:

2017-08-11

Patient Information leaflet

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

Summary of Product characteristics

Health Products Regulatory Authority
29 March 2019
CRN008V5D
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ivabradine 7.5 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film‑coated tablet contains 7.5 mg ivabradine (as
hydrochloride).
Excipient with known effect: 80.48 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White or almost white, triangular, biconvex, film-coated tablet,
marked with “A267” on one side, tablet dimensions 7.5 x 7.2
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 of treatment,
if the patient is still symptomatic, if the initial dose is well
tolerated and if res