Procoralan

ivabradine

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About

An overview of Procoralan and why it is authorised in the EU

Procoralan is a heart medicine used to treat the symptoms of long-term stable angina (pains to the chest, jaw and back, brought on by physical effort) in adults with coronary artery disease (disease of the heart caused by the obstruction of the blood vessels that supply blood to the heart muscle).The medicine is used in patients who have a normal heart rhythm, and whose heart rate is at least 70 beats per minute. It is used in those who cannot be treated with beta blockers (another type of medicine to treat angina) or in combination with a beta blocker in patients whose disease is not controlled by beta blockers alone.

Procoralan is also used in patients with long-term heart failure (when the heart cannot pump enough blood to the rest of the body) who have a normal heart rhythm and whose heart rate is at least 75 beats per minute. It is used in combination with standard therapy including beta blockers, or in patients who cannot be treated with beta blockers.

Procoralan contains the active substance ivabradine.

How is Procoralan used?

Procoralan is available as tablets (5 and 7.5 mg) and it can only be obtained with a prescription.

The recommended starting dose is 5 mg twice a day with meals, which the doctor may increase to 7.5 mg twice a day or decrease to 2.5 mg (half a 5-mg tablet) twice a day depending on the patient’s heart rate and symptoms. In patients over 75 years old, a lower starting dose of 2.5 mg twice a day can be used. Treatment must be stopped if the heart rate is persistently below 50 beats per minute or if symptoms of bradycardia (slow heart rate) continue despite dose reduction. When used for angina, treatment should be stopped if symptoms do not improve after 3 months. Also, the doctor should consider stopping treatment if the medicine has only a limited effect on reducing angina symptoms or reducing the heart rate within 3 months.

For more information about using Procoralan, see the package leaflet or contact your doctor or pharmacist.

How does Procoralan work?

The symptoms of angina are caused by the heart not receiving enough oxygenated blood. In stable angina, these symptoms appear during physical effort. The active substance in Procoralan, ivabradine, works by blocking the ‘If currents’ in the sinus node, the ‘pacemaker’ for the heart that controls the heart’s contractions and regulates the heart rate. When these currents are blocked, the heart rate is lowered, so that the heart has less work to do and needs less oxygenated blood. Procoralan therefore reduces or prevents the symptoms of angina.

The symptoms of heart failure are caused by the heart not pumping enough blood around the body. By lowering the heart rate, Procoralan reduces the stress on the heart, thereby slowing the progression of heart failure and improving symptoms.

What benefits of Procoralan have been shown in studies?

Angina

Procoralan was compared with placebo (a dummy treatment) and other treatments in five main studies involving over 4,000 adults with long-term stable angina. The main measure of effectiveness was how long patients could exercise on a bicycle or a treadmill, which was measured at the start and the end of each study. Each study lasted three to four months.

Results showed that the medicine was more effective than placebo in one of the studies in 360 patients. It was as effective as atenolol (a beta blocker) in a study of 939 patients and as effective as amlodipine (another medicine used to treat angina) in a study of 1,195 patients. In a fourth study in 889 patients, Procoralan was more effective than placebo, when both were added to atenolol. However, a fifth study in 728 patients showed that adding Procoralan to amlodipine did not provide an additional benefit.

A sixth study compared Procoralan with placebo in 19,102 patients with coronary artery disease and without clinical heart failure. The main measure of effectiveness was a reduction in the risk of death due to heart problems and non-fatal heart attack.

In this study, a specific subgroup of patients who had symptomatic angina had a small but significant increase in the combined risk of cardiovascular death or non-fatal heart attack with Procoralan compared with placebo (3.4% vs 2.9% yearly incidence rates). However it should be noted that patients in this study were given doses higher than the recommended dose (up to 10 mg twice a day).

Heart failure

Procoralan was compared with placebo in one main study involving over 6,500 patients with long-term moderate to severe heart failure. Results showed that Procoralan was more effective than placebo at preventing death due to disease of the heart or blood vessels or hospitalisation due to worsening heart failure: 24.5% (793 out of 3,241) of patients treated with Procoralan died or were hospitalised due to worsening heart failure, compared with 28.7% (937 out of 3,264) of patients receiving placebo.

What is the risk associated with Procoralan?

The most common side effect with Procoralan (seen in more than 1 patient in 10) is luminous phenomena or ‘phosphenes’ (a temporary brightness in the field of vision). For the full list of all side effects reported with Procoralan, see the package leaflet.

Procoralan must not be used in patients who have a resting heart rate below 70 beats per minute, very low blood pressure, various types of heart disorder (including cardiogenic shock, rhythm disorders, heart attack, unstable or acute (sudden) heart failure and unstable angina) or severe liver problems. It must not be used in women who are pregnant, breast-feeding or by women who could become pregnant and who are not using appropriate contraceptives. For the full list of restrictions, see the package leaflet.

Caution is needed if Procoralan is taken with some other medicines. See the package leaflet for full details.

What are the risks associated with Procoralan?

The most common side effect with Procoralan (which may affect more than 1 in 10 people) is luminous phenomena or ‘phosphenes’ (a temporary brightness in the field of vision). Bradycardia (slow heart rate) is common (it may affect up to 1 in 10 people). For the full list of all side effects reported with Procoralan, see the package leaflet.

Procoralan must not be used in patients who have a resting heart rate below 70 beats per minute, very low blood pressure, various types of heart disorder (including cardiogenic shock, rhythm disorders, heart attack, unstable or acute (sudden) heart failure and unstable angina) or severe liver problems. It must not be used in women who are pregnant, breast-feeding or by women who could become pregnant and who are not using appropriate contraceptives. Procoralan must not be taken with a number of other medicines.

For the full list of restrictions with Procoralan, see the package leaflet.

Why is Procoralan authorised in the EU?

The European Medicines Agency concluded that Procoralan was shown to be effective in long-term angina with an acceptable safety profile for it to provide an alternative treatment for patients who cannot take beta blockers or whose disease is not controlled with them. It also concluded that Procoralan was effective in long-term heart failure with an acceptable safety profile. The Agency decided that Procoralan’s benefits are greater than its risks and it can be authorised for use in the EU.

For the treatment of angina, Procoralan was originally authorised for patients whose heart rate is at least 60 beats per minute. However, the use was later restricted to patients whose heart rate is at least 70 beats per minute1.


1 In the context of a procedure under Article 20 of Regulation (EC) No 726/2004. More information can be found on Corlentor and Procoralan article 20 referral.

What measures are being taken to ensure the safe and effective use of Procoralan?

The company that markets Procoralan is carrying out a study to assess the way the medicine is used in clinical practice and if measures to minimise risks are adhered to.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Procoralan have also been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Procoralan are continuously monitored. Side effects reported with Procoralan are carefully evaluated and any necessary action taken to protect patients.

Other information about Procoralan

The European Commission granted a marketing authorisation valid throughout the European Union for Procoralan on 25 October 2005.

For more information about treatment with Procoralan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Procoralan : EPAR - Summary for the public BG = bălgarski 2006-07-18 2018-05-04
Procoralan : EPAR - Summary for the public ES = español 2006-07-18 2018-05-04
Procoralan : EPAR - Summary for the public CS = čeština 2006-07-18 2018-05-04
Procoralan : EPAR - Summary for the public DA = dansk 2006-07-18 2018-05-04
Procoralan : EPAR - Summary for the public DE = Deutsch 2006-07-18 2018-05-04
Procoralan : EPAR - Summary for the public ET = eesti keel 2006-07-18 2018-05-04
Procoralan : EPAR - Summary for the public EL = elliniká 2006-07-18 2018-05-04
Procoralan : EPAR - Summary for the public EN = English 2006-07-18 2018-05-04
Procoralan : EPAR - Summary for the public FR = français 2006-07-18 2018-05-04
Procoralan : EPAR - Summary for the public IT = italiano 2006-07-18 2018-05-04
Procoralan : EPAR - Summary for the public LV = latviešu valoda 2006-07-18 2018-05-04
Procoralan : EPAR - Summary for the public LT = lietuvių kalba 2006-07-18 2018-05-04
Procoralan : EPAR - Summary for the public HU = magyar 2006-07-18 2018-05-04
Procoralan : EPAR - Summary for the public MT = Malti 2006-07-18 2018-05-04
Procoralan : EPAR - Summary for the public NL = Nederlands 2006-07-18 2018-05-04
Procoralan : EPAR - Summary for the public PL = polski 2006-07-18 2018-05-04
Procoralan : EPAR - Summary for the public PT = português 2006-07-18 2018-05-04
Procoralan : EPAR - Summary for the public RO = română 2006-07-18 2018-05-04
Procoralan : EPAR - Summary for the public SK = slovenčina 2006-07-18 2018-05-04
Procoralan : EPAR - Summary for the public SL = slovenščina 2006-07-18 2018-05-04
Procoralan : EPAR - Summary for the public FI = suomi 2006-07-18 2018-05-04
Procoralan : EPAR - Summary for the public SV = svenska 2006-07-18 2018-05-04
Procoralan : EPAR - Summary for the public HR = Hrvatski 2006-07-18 2018-05-04

This EPAR was last updated on 04/05/2018 .

Authorisation details

Product details

Product details for Procoralan
NameProcoralan
Agency product numberEMEA/H/C/000597
Active substance

ivabradine hydrochloride

International non-proprietary name (INN) or common name

ivabradine

Therapeutic area Heart FailureAngina Pectoris
Anatomical therapeutic chemical (ATC) code C01EB17
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Procoralan
Marketing-authorisation holder

Les Laboratoires Servier

Revision19
Date of issue of marketing authorisation valid throughout the European Union25/10/2005

Contact address:

Les Laboratoires Servier
50, rue Carnot
F-92284 Suresnes Cedex
France

Product information

Product information

11/01/2018  Procoralan -EMEA/H/C/000597 -WS/1180

Name Language First published Last updated
Procoralan : EPAR - Product Information HR = Hrvatski 2009-05-15 2018-05-04
Procoralan : EPAR - Product Information HR = Hrvatski 2009-05-15 2018-05-04
Procoralan : EPAR - Product Information HR = Hrvatski 2009-05-15 2018-05-04
Procoralan : EPAR - Product Information HR = Hrvatski 2009-05-15 2018-05-04
Procoralan : EPAR - Product Information HR = Hrvatski 2009-05-15 2018-05-04
Procoralan : EPAR - Product Information HR = Hrvatski 2009-05-15 2018-05-04
Procoralan : EPAR - Product Information HR = Hrvatski 2009-05-15 2018-05-04
Procoralan : EPAR - Product Information HR = Hrvatski 2009-05-15 2018-05-04
Procoralan : EPAR - Product Information HR = Hrvatski 2009-05-15 2018-05-04
Procoralan : EPAR - Product Information HR = Hrvatski 2009-05-15 2018-05-04
Procoralan : EPAR - Product Information HR = Hrvatski 2009-05-15 2018-05-04
Procoralan : EPAR - Product Information HR = Hrvatski 2009-05-15 2018-05-04
Procoralan : EPAR - Product Information HR = Hrvatski 2009-05-15 2018-05-04
Procoralan : EPAR - Product Information HR = Hrvatski 2009-05-15 2018-05-04
Procoralan : EPAR - Product Information HR = Hrvatski 2009-05-15 2018-05-04
Procoralan : EPAR - Product Information HR = Hrvatski 2009-05-15 2018-05-04
Procoralan : EPAR - Product Information HR = Hrvatski 2009-05-15 2018-05-04
Procoralan : EPAR - Product Information HR = Hrvatski 2009-05-15 2018-05-04
Procoralan : EPAR - Product Information HR = Hrvatski 2009-05-15 2018-05-04
Procoralan : EPAR - Product Information HR = Hrvatski 2009-05-15 2018-05-04
Procoralan : EPAR - Product Information HR = Hrvatski 2009-05-15 2018-05-04
Procoralan : EPAR - Product Information HR = Hrvatski 2009-05-15 2018-05-04
Procoralan : EPAR - Product Information HR = Hrvatski 2009-05-15 2018-05-04
Procoralan : EPAR - Product Information HR = Hrvatski 2009-05-15 2018-05-04
Procoralan : EPAR - Product Information HR = Hrvatski 2009-05-15 2018-05-04

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Procoralan : EPAR - All Authorised presentations HR = Hrvatski 2005-11-04  
Procoralan : EPAR - All Authorised presentations HR = Hrvatski 2005-11-04  
Procoralan : EPAR - All Authorised presentations HR = Hrvatski 2005-11-04  
Procoralan : EPAR - All Authorised presentations HR = Hrvatski 2005-11-04  
Procoralan : EPAR - All Authorised presentations HR = Hrvatski 2005-11-04  
Procoralan : EPAR - All Authorised presentations HR = Hrvatski 2005-11-04  
Procoralan : EPAR - All Authorised presentations HR = Hrvatski 2005-11-04  
Procoralan : EPAR - All Authorised presentations HR = Hrvatski 2005-11-04  
Procoralan : EPAR - All Authorised presentations HR = Hrvatski 2005-11-04  
Procoralan : EPAR - All Authorised presentations HR = Hrvatski 2005-11-04  
Procoralan : EPAR - All Authorised presentations HR = Hrvatski 2005-11-04  
Procoralan : EPAR - All Authorised presentations HR = Hrvatski 2005-11-04  
Procoralan : EPAR - All Authorised presentations HR = Hrvatski 2005-11-04  
Procoralan : EPAR - All Authorised presentations HR = Hrvatski 2005-11-04  
Procoralan : EPAR - All Authorised presentations HR = Hrvatski 2005-11-04  
Procoralan : EPAR - All Authorised presentations HR = Hrvatski 2005-11-04  
Procoralan : EPAR - All Authorised presentations HR = Hrvatski 2005-11-04  
Procoralan : EPAR - All Authorised presentations HR = Hrvatski 2005-11-04  
Procoralan : EPAR - All Authorised presentations HR = Hrvatski 2005-11-04  
Procoralan : EPAR - All Authorised presentations HR = Hrvatski 2005-11-04  
Procoralan : EPAR - All Authorised presentations HR = Hrvatski 2005-11-04  
Procoralan : EPAR - All Authorised presentations HR = Hrvatski 2005-11-04  

Pharmacotherapeutic group

Cardiac therapy

Therapeutic indication

Treatment of coronary-artery disease

Symptomatic treatment of chronic stable angina pectoris in coronary-artery-disease patients with normal sinus rhythm. Ivabradine is indicated:

- in patients 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 and whose heart rate is > 60 beats per minute (bpm).

Treatment of chronic heart failure

Ivabradine is indicated in chronic heart failure New York Heart Association 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.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Procoralan : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2009-05-15 2018-05-04
Procoralan : EPAR - Paediatric investigation plan compliance statement HR = Hrvatski 2015-05-07  
Procoralan-H-C-597-A20-1404 : EPAR - Assessment Report - Article 20 HR = Hrvatski 2015-02-10  
Procoralan : EPAR - Scientific Conclusion HR = Hrvatski 2015-02-10  
Procoralan : EPAR - Scientific Conclusion HR = Hrvatski 2015-02-10  
Procoralan : EPAR - Scientific Conclusion HR = Hrvatski 2015-02-10  
Procoralan : EPAR - Scientific Conclusion HR = Hrvatski 2015-02-10  
Procoralan : EPAR - Scientific Conclusion HR = Hrvatski 2015-02-10  
Procoralan : EPAR - Scientific Conclusion HR = Hrvatski 2015-02-10  
Procoralan : EPAR - Scientific Conclusion HR = Hrvatski 2015-02-10  
Procoralan : EPAR - Scientific Conclusion HR = Hrvatski 2015-02-10  
Procoralan : EPAR - Scientific Conclusion HR = Hrvatski 2015-02-10  
Procoralan : EPAR - Scientific Conclusion HR = Hrvatski 2015-02-10  
Procoralan : EPAR - Scientific Conclusion HR = Hrvatski 2015-02-10  
Procoralan : EPAR - Scientific Conclusion HR = Hrvatski 2015-02-10  
Procoralan : EPAR - Scientific Conclusion HR = Hrvatski 2015-02-10  
Procoralan : EPAR - Scientific Conclusion HR = Hrvatski 2015-02-10  
Procoralan : EPAR - Scientific Conclusion HR = Hrvatski 2015-02-10  
Procoralan : EPAR - Scientific Conclusion HR = Hrvatski 2015-02-10  
Procoralan : EPAR - Scientific Conclusion HR = Hrvatski 2015-02-10  
Procoralan : EPAR - Scientific Conclusion HR = Hrvatski 2015-02-10  
Procoralan : EPAR - Scientific Conclusion HR = Hrvatski 2015-02-10  
Procoralan : EPAR - Scientific Conclusion HR = Hrvatski 2015-02-10  
Procoralan : EPAR - Scientific Conclusion HR = Hrvatski 2015-02-10  
Procoralan : EPAR - Scientific Conclusion HR = Hrvatski 2015-02-10  
Procoralan : EPAR - Scientific Conclusion HR = Hrvatski 2015-02-10  
Procoralan-H-C-597-PSUV-0031 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation HR = Hrvatski 2014-09-11  
Procoralan-H-C-597-II-0029 : EPAR - Assessment Report - Variation HR = Hrvatski 2014-03-19  
CHMP post-authorisation summary of positive opinion for Procoralan HR = Hrvatski 2013-11-22  
Procoralan-H-C-597-II-0018 : EPAR - Assessment Report - Variation HR = Hrvatski 2012-03-27  
CHMP post-authorisation positive summmary of opinion for Procoralan HR = Hrvatski 2011-12-16  

Initial marketing-authorisation documents

Name Language First published Last updated
Procoralan : EPAR - Procedural steps taken before authorisation HR = Hrvatski 2005-11-04  
Procoralan : EPAR - Scientific Discussion HR = Hrvatski 2005-11-04  

Authorised

This medicine is approved for use in the European Union

More information on Procoralan