Procoralan

Țară: Uniunea Europeană

Limbă: engleză

Sursă: EMA (European Medicines Agency)

Cumpara asta acum

Prospect Prospect (PIL)
12-10-2021

Ingredient activ:

ivabradine hydrochloride

Disponibil de la:

Les Laboratoires Servier

Codul ATC:

C01EB17

INN (nume internaţional):

ivabradine

Grupul Terapeutică:

Cardiac therapy

Zonă Terapeutică:

Angina Pectoris; Heart Failure

Indicații terapeutice:

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-blockersor 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.

Rezumat produs:

Revision: 22

Statutul autorizaţiei:

Authorised

Data de autorizare:

2005-10-25

Prospect

                                28
B. PACKAGE LEAFLET
29
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PROCORALAN 5
MG FILM-COATED TABLETS
PROCORALAN 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 Procoralan is and what it is used for
2.
What you need to know before you take Procoralan
3.
How to take Procoralan
4.
Possible side effects
5
How to store Procoralan
6.
Contents of the pack and other information
1.
WHAT PROCORALAN IS AND WHAT IT IS USED FOR
Procoralan (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 body. The most c
                                
                                Citiți documentul complet
                                
                            

Caracteristicilor produsului

                                1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Procoralan 5 mg film-coated tablets
Procoralan 7.5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Procoralan 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.
Procoralan 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.
Procoralan 5 mg film-coated tablets
Salmon-coloured, oblong, film-coated tablet scored on both sides,
engraved with “5” on one face
and
on the other face.
The tablet can be divided into equal doses.
Procoralan 7.5 mg film-coated tablets
Salmon-coloured, triangular, film-coated tablet engraved with
“7.5” on one face and
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
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 deci
                                
                                Citiți documentul complet
                                
                            

Documente în alte limbi

Prospect Prospect bulgară 12-10-2021
Caracteristicilor produsului Caracteristicilor produsului bulgară 12-10-2021
Raport public de evaluare Raport public de evaluare bulgară 26-02-2019
Prospect Prospect spaniolă 12-10-2021
Caracteristicilor produsului Caracteristicilor produsului spaniolă 12-10-2021
Raport public de evaluare Raport public de evaluare spaniolă 26-02-2019
Prospect Prospect cehă 12-10-2021
Caracteristicilor produsului Caracteristicilor produsului cehă 12-10-2021
Raport public de evaluare Raport public de evaluare cehă 26-02-2019
Prospect Prospect daneză 12-10-2021
Caracteristicilor produsului Caracteristicilor produsului daneză 12-10-2021
Raport public de evaluare Raport public de evaluare daneză 26-02-2019
Prospect Prospect germană 12-10-2021
Caracteristicilor produsului Caracteristicilor produsului germană 12-10-2021
Raport public de evaluare Raport public de evaluare germană 26-02-2019
Prospect Prospect estoniană 12-10-2021
Caracteristicilor produsului Caracteristicilor produsului estoniană 12-10-2021
Raport public de evaluare Raport public de evaluare estoniană 26-02-2019
Prospect Prospect greacă 12-10-2021
Caracteristicilor produsului Caracteristicilor produsului greacă 12-10-2021
Raport public de evaluare Raport public de evaluare greacă 26-02-2019
Prospect Prospect franceză 12-10-2021
Caracteristicilor produsului Caracteristicilor produsului franceză 12-10-2021
Raport public de evaluare Raport public de evaluare franceză 26-02-2019
Prospect Prospect italiană 12-10-2021
Caracteristicilor produsului Caracteristicilor produsului italiană 12-10-2021
Raport public de evaluare Raport public de evaluare italiană 26-02-2019
Prospect Prospect letonă 12-10-2021
Caracteristicilor produsului Caracteristicilor produsului letonă 12-10-2021
Raport public de evaluare Raport public de evaluare letonă 26-02-2019
Prospect Prospect lituaniană 12-10-2021
Caracteristicilor produsului Caracteristicilor produsului lituaniană 12-10-2021
Raport public de evaluare Raport public de evaluare lituaniană 26-02-2019
Prospect Prospect maghiară 12-10-2021
Caracteristicilor produsului Caracteristicilor produsului maghiară 12-10-2021
Raport public de evaluare Raport public de evaluare maghiară 26-02-2019
Prospect Prospect malteză 12-10-2021
Caracteristicilor produsului Caracteristicilor produsului malteză 12-10-2021
Raport public de evaluare Raport public de evaluare malteză 26-02-2019
Prospect Prospect olandeză 12-10-2021
Caracteristicilor produsului Caracteristicilor produsului olandeză 12-10-2021
Raport public de evaluare Raport public de evaluare olandeză 26-02-2019
Prospect Prospect poloneză 12-10-2021
Caracteristicilor produsului Caracteristicilor produsului poloneză 12-10-2021
Raport public de evaluare Raport public de evaluare poloneză 26-02-2019
Prospect Prospect portugheză 12-10-2021
Caracteristicilor produsului Caracteristicilor produsului portugheză 12-10-2021
Raport public de evaluare Raport public de evaluare portugheză 26-02-2019
Prospect Prospect română 12-10-2021
Caracteristicilor produsului Caracteristicilor produsului română 12-10-2021
Raport public de evaluare Raport public de evaluare română 26-02-2019
Prospect Prospect slovacă 12-10-2021
Caracteristicilor produsului Caracteristicilor produsului slovacă 12-10-2021
Raport public de evaluare Raport public de evaluare slovacă 26-02-2019
Prospect Prospect slovenă 12-10-2021
Caracteristicilor produsului Caracteristicilor produsului slovenă 12-10-2021
Raport public de evaluare Raport public de evaluare slovenă 26-02-2019
Prospect Prospect finlandeză 12-10-2021
Caracteristicilor produsului Caracteristicilor produsului finlandeză 12-10-2021
Raport public de evaluare Raport public de evaluare finlandeză 26-02-2019
Prospect Prospect suedeză 12-10-2021
Caracteristicilor produsului Caracteristicilor produsului suedeză 12-10-2021
Raport public de evaluare Raport public de evaluare suedeză 26-02-2019
Prospect Prospect norvegiană 12-10-2021
Caracteristicilor produsului Caracteristicilor produsului norvegiană 12-10-2021
Prospect Prospect islandeză 12-10-2021
Caracteristicilor produsului Caracteristicilor produsului islandeză 12-10-2021
Prospect Prospect croată 12-10-2021
Caracteristicilor produsului Caracteristicilor produsului croată 12-10-2021
Raport public de evaluare Raport public de evaluare croată 26-02-2019

Căutați alerte legate de acest produs

Vizualizați istoricul documentelor