Ivabradine Krka 5 mg Film-coated Tablets

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Ivabradine

Dostupné z:

KRKA, d.d., Novo mesto

ATC kód:

C01EB; C01EB17

INN (Medzinárodný Name):

Ivabradine

Dávkovanie:

5 milligram(s)

Forma lieku:

Film-coated tablet

Typ predpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

Other cardiac preparations; ivabradine

Stav Autorizácia:

Marketed

Dátum Autorizácia:

2017-03-01

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IVABRADINE KRKA 5 MG FILM-COATED TABLETS
IVABRADINE KRKA 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 Krka is and what it is used for
2.
What you need to know before you take Ivabradine Krka
3.
How to take Ivabradine Krka
4.
Possible side effects
5.
How to store Ivabradine Krka
6.
Contents of the pack and other information
1.
WHAT IVABRADINE KRKA IS AND WHAT IT IS USED FOR
Ivabradine Krka (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. The
most common symptom of angina is chest pain or discomfort.
About chronic heart failure:
Chronic heart failure is a heart disease which happens when your heart
cannot pump enough blood to
the rest of your bo

Súhrn charakteristických

Health Products Regulatory Authority
16 January 2024
CRN00F25H
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ivabradine Krka 5 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg ivabradine (as ivabradine
hydrochloride).
Excipient with known effect
Each film-coated tablet contains 45.36 mg lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Pale pinkish orange, rectangular, slightly biconvex film-coated
tablets with a score line on one side, dimensions 8 mm x 4.5 mm.
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 adult 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