Ivabradine Anpharm
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
28-02-2023
Charakterystyka produktu
(SPC)
28-02-2023
Sprawozdanie z oceny publicznego
(PAR)
25-02-2019
Składnik aktywny:
ivabradine
Dostępny od:
"Anpharm" Przedsiębiorstwo Farmaceutyczne S.A.
Kod ATC:
C01EB17
INN (International Nazwa):
ivabradine
Grupa terapeutyczna:
Other cardiac preparations
Dziedzina terapeutyczna:
Angina Pectoris; Heart Failure
Wskazania:
Symptomatic treatment of chronic stable angina pectorisIvabradine 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-blockersor in combination with beta-blockers in patients inadequately controlled with an optimal betablocker dose.Treatment of chronic heart failureIvabradine 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: 9
Status autoryzacji:
Authorised
Data autoryzacji:
2015-09-08
Ulotka dla pacjenta
28
Classified as confidential by the European Medicines Agency
B. PACKAGE LEAFLET
29
Classified as confidential by the European Medicines Agency
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IVABRADINE ANPHARM 5
MG FILM-COATED TABLETS
IVABRADINE ANPHARM 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 Anpharm is and what it is used for
2.
What you need to know before you take Ivabradine Anpharm
3.
How to take Ivabradine Anpharm
4.
Possible side effects
5
How to store Ivabradine Anpharm
6.
Contents of the pack and other information
1.
WHAT IVABRADINE ANPHARM IS AND WHAT IT IS USED FOR
Ivabradine Anpharm (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 che
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Charakterystyka produktu
1
Classified as confidential by the European Medicines Agency
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
Classified as confidential by the European Medicines Agency
1.
NAME OF THE MEDICINAL PRODUCT
Ivabradine Anpharm 5 mg film-coated tablets
Ivabradine Anpharm 7.5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Ivabradine Anpharm 5 mg film-coated tablets
Each film-coated tablet contains 5 mg ivabradine (as hydrochloride).
_Excipient with known effect: _
Each film-coated tablet contains 63.91 mg lactose monohydrate.
Ivabradine Anpharm 7.5 mg film-coated tablets
Each film-coated tablet contains 7.5 mg ivabradine (as hydrochloride).
_Excipient with known effect: _
Each film-coated tablet contains 61.215 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Ivabradine Anpharm 5 mg film-coated tablets
Salmon-coloured, oblong, film-coated tablet scored on both sides,
engraved with “5” on one face and
“S” on the other face.
The tablet can be divided into equal doses.
Ivabradine Anpharm 7.5 mg film-coated tablets
Salmon-coloured, triangular, film-coated tablet engraved with
“7.5” on one face and “S” on the other
face.
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 contraindication to the use of
beta-blockers
-
or in combination with beta-blockers in patients inadequately
controlled with an optimal beta-
blocker dose.
3
Classified as confidential by the European Medicines Agency
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 be
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