Procoralan

ivabradine

Overview
Authorisation details
Product information
Assessment history

Authorised

This medicine is authorised for use in the European Union.

Overview

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.

: 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.

: 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.

: 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.

: 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.

: 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 minute.1

: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Procoralan have 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.

: Procoralan received a marketing authorisation valid throughout the EU on 25 October 2005.

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Procoralan : EPAR - Summary for the public (PDF/87.47 KB)

First published: 18/07/2006
Last updated: 26/02/2019
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Procoralan : EPAR - Risk-management-plan summary (PDF/216.57 KB)

First published: 17/12/2021

This EPAR was last updated on 17/12/2021

Authorisation details

Product details
Name	Procoralan
Agency product number	EMEA/H/C/000597
Active substance	ivabradine hydrochloride
International non-proprietary name (INN) or common name	ivabradine
Therapeutic area (MeSH)	Angina Pectoris Heart Failure
Anatomical therapeutic chemical (ATC) code	C01EB17

Publication details
Marketing-authorisation holder	Les Laboratoires Servier
Revision	22
Date of issue of marketing authorisation valid throughout the European Union	25/10/2005
Contact address	50, rue Carnot F-92284 Suresnes Cedex France

Product information

30/09/2021 Procoralan - EMEA/H/C/000597 - WS/2050/G

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Procoralan : EPAR - Product Information (PDF/445.73 KB)

First published: 15/05/2009
Last updated: 12/10/2021
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Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

Product information documents contain:

summary of product characteristics (annex I);
manufacturing authorisation holder responsible for batch release (annex IIA);
conditions of the marketing authorisation (annex IIB);
labelling (annex IIIA);
package leaflet (annex IIIB).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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Procoralan : EPAR - All Authorised presentations (PDF/12.85 KB)

First published: 04/11/2005
Last updated: 04/11/2005
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  (PDF/96.7 KB)
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Pharmacotherapeutic group

Cardiac therapy

Therapeutic indication

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.

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.

Assessment history

Changes since initial authorisation of medicine

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Procoralan : EPAR - Procedural steps taken and scientific information after authorisation (PDF/232.53 KB)

First published: 15/05/2009
Last updated: 12/10/2021
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Procoralan-H-C-N-PSR-S-0019 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s) (PDF/65.37 KB)

First published: 26/02/2019
EMA/798331/2018
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Procoralan : EPAR - Paediatric investigation plan compliance statement (PDF/66.01 KB)

First published: 07/05/2015
Last updated: 07/05/2015
EMA/285905/2015
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Procoralan : EPAR - Scientific Conclusion (PDF/57.56 KB)

First published: 10/02/2015
Last updated: 10/02/2015
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  (PDF/93.15 KB)
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  (PDF/74.15 KB)
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  (PDF/84.43 KB)
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  (PDF/56.52 KB)
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  (PDF/57.8 KB)
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  (PDF/54.66 KB)
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  (PDF/52.01 KB)
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  (PDF/55.63 KB)
- German
  (PDF/49.96 KB)
- Greek
  (PDF/90.67 KB)
- Hungarian
  (PDF/67.46 KB)
- Italian
  (PDF/42.9 KB)
- Latvian
  (PDF/88.9 KB)
- Lithuanian
  (PDF/91.35 KB)
- Maltese
  (PDF/90.56 KB)
- Polish
  (PDF/91.13 KB)
- Portuguese
  (PDF/56.62 KB)
- Romanian
  (PDF/88.43 KB)
- Slovak
  (PDF/84.08 KB)
- Slovenian
  (PDF/106.03 KB)
- Spanish
  (PDF/54.61 KB)
- Swedish
  (PDF/51.41 KB)
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Procoralan-H-C-597-A20-1404 : EPAR - Assessment Report - Article 20 (PDF/384.79 KB)

Adopted

First published: 10/02/2015
Last updated: 10/02/2015
EMA/734305/2014
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Procoralan-H-C-597-PSUV-0031 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/66.94 KB)

First published: 11/09/2014
Last updated: 11/09/2014
EMA/373632/2014
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Procoralan-H-C-597-II-0029 : EPAR - Assessment Report - Variation (PDF/223.52 KB)

Adopted

First published: 19/03/2014
Last updated: 19/03/2014
EMA/696794/2013
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CHMP post-authorisation summary of positive opinion for Procoralan (PDF/71.73 KB)

Adopted

First published: 22/11/2013
Last updated: 22/11/2013
EMA/CHMP/712673/2013
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Procoralan-H-C-597-II-0018 : EPAR - Assessment Report - Variation (PDF/1.03 MB)

Adopted

First published: 27/03/2012
Last updated: 27/03/2012
EMA/194513/2012
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CHMP post-authorisation positive summary of opinion for Procoralan (PDF/72.96 KB)

Adopted

First published: 16/12/2011
Last updated: 16/12/2011
EMA/CHMP/963751/2011

Procoralan

Table of contents

Overview

Procoralan : EPAR - Summary for the public (PDF/87.47 KB)

Procoralan : EPAR - Risk-management-plan summary (PDF/216.57 KB)

Authorisation details

Product information

Procoralan : EPAR - Product Information (PDF/445.73 KB)

Procoralan : EPAR - All Authorised presentations (PDF/12.85 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Procoralan : EPAR - Procedural steps taken and scientific information after authorisation (PDF/232.53 KB)

Procoralan-H-C-N-PSR-S-0019 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s) (PDF/65.37 KB)

Procoralan : EPAR - Paediatric investigation plan compliance statement (PDF/66.01 KB)

Procoralan : EPAR - Scientific Conclusion (PDF/57.56 KB)

Procoralan-H-C-597-A20-1404 : EPAR - Assessment Report - Article 20 (PDF/384.79 KB)

Procoralan-H-C-597-PSUV-0031 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/66.94 KB)

Procoralan-H-C-597-II-0029 : EPAR - Assessment Report - Variation (PDF/223.52 KB)

CHMP post-authorisation summary of positive opinion for Procoralan (PDF/71.73 KB)

Procoralan-H-C-597-II-0018 : EPAR - Assessment Report - Variation (PDF/1.03 MB)

CHMP post-authorisation positive summary of opinion for Procoralan (PDF/72.96 KB)

Initial marketing-authorisation documents

Procoralan : EPAR - Procedural steps taken before authorisation (PDF/18.9 KB)

Procoralan : EPAR - Scientific Discussion (PDF/411.81 KB)

News

More information on Procoralan

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