Ivabradine Zentiva
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
13-07-2023
Charakterystyka produktu
(SPC)
13-07-2023
Sprawozdanie z oceny publicznego
(PAR)
08-02-2017
Składnik aktywny:
ivabradine hydrochloride
Dostępny od:
Zentiva, k.s.
Kod ATC:
C01EB17
INN (International Nazwa):
ivabradine
Grupa terapeutyczna:
Cardiac therapy
Dziedzina terapeutyczna:
Angina Pectoris; Heart Failure
Wskazania:
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-blockersorin 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.
Podsumowanie produktu:
Revision: 6
Status autoryzacji:
Authorised
Data autoryzacji:
2016-11-11
Ulotka dla pacjenta
33
B. PACKAGE LEAFLET
34
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IVABRADINE ZENTIVA 5 MG FILM-COATED TABLETS
IVABRADINE ZENTIVA 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 Zentiva is and what it is used for
2.
What you need to know before you take Ivabradine Zentiva
3.
How to take Ivabradine Zentiva
4.
Possible side effects
5.
How to store Ivabradine Zentiva
6.
Contents of the pack and other information
1.
WHAT IVABRADINE ZENTIVA IS AND WHAT IT IS USED FOR
Ivabradine Zentiva (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
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Ivabradine Zentiva 5 mg film-coated tablets
Ivabradine Zentiva 7.5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ivabradine Zentiva 5 mg film-coated tablets
Each film-coated tablet contains 5 mg ivabradine (as hydrochloride).
Ivabradine Zentiva 7.5 mg film-coated tablets
Each film-coated tablet contains 7.5 mg ivabradine (as hydrochloride).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Ivabradine Zentiva 5 mg film-coated tablets
Round, biconvex white tablets with deep breakline on one side and
‘5’ debossing on other side with
diameter 6.5 mm. The tablet can be divided into equal doses.
Ivabradine Zentiva 7.5 mg film-coated tablets
White to off white, round tablets with diameter 7.1 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 beats
per minute (bpm). Ivabradine
is indicated:
‒
in adults unable to tolerate or with a contraindication to the use of
beta-blockers
or
‒
in combination with beta-blockers in patients inadequately controlled
with an optimal beta-blocker
dose.
3
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
_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 sho
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