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Procoralan film-coated tablets

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  • PROCORALAN 5MG.jpeg
  • PROCORALAN 7.5MG.jpeg

Updated on 23 January 2023

File name

Procoralan SmPC.pdf

Reasons for updating

  • Document format updated

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 10 November 2021

File name

Procoralan PIL.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 05 October 2021

File name

Procoralan SmPC.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 05 October 2021

File name

Procoralan PIL.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 09 December 2020

File name

Procoralan PIL.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 14 January 2019

File name

emea-combined-h-597-bg-Final Report DUS 107 -PIL.pdf

Reasons for updating

  • Removal of Black Inverted Triangle

Updated on 11 January 2019

File name

emea-combined-h-597-bg-Final Report DUS 107 - SmPC.pdf

Reasons for updating

  • Removal of Black Inverted Triangle

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 24 October 2018

File name

Procoralan film coated tablets PIL.pdf

Reasons for updating

  • Removal of Black Inverted Triangle

Updated on 24 October 2018

File name

Procoralan film coated tablets SmPC.pdf

Reasons for updating

  • Removal of Black Inverted Triangle

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

  • Removing the black triangle about additional monitoring

Updated on 06 March 2018

File name

PIL_10629_80.pdf

Reasons for updating

  • New PIL for new product

Updated on 06 March 2018

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 18 January 2018

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 18 January 2018

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

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4.8 Undesirable effects

Updated on 07 December 2016

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 26 May 2016

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may be renewed (B)

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results of clinical study CL3-16257-067 (Ivabradine Ophthalmic Safety Study).


Sections 4.4 and 5.1 have been updated to reflect the new information on retinal safety.

Updated on 24 May 2016

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • SPC submitted in error

Legal category:Product subject to medical prescription which may be renewed (B)

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Sections 4.4 & 5.1 have been updated to reflect the new information on retinal safety. Results of clinical study CL3-16257-067 (Ivabradine Ophthalmic Safety Study)

Updated on 13 April 2015

Reasons for updating

  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties

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$0$0In section 4.2 (Posology and method ofadministration), 'Paediatric population', the following has been added:"The safety and efficacy of ivabradine in the treatment ofchronic heart failure in children aged below 18 years have not beenestablished. Availabledata are described in sections 5.1 and 5.2 but no recommendation on aposology can be made."$0$0In section 5.1 (Pharmacodynamic properties), details of a paediatric study have been added.$0$0In section 5.2 (Pharmacokinetic properties), paediatric data has been added$0$0

Updated on 26 February 2015

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

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In section 5.1 (Pharmacodynamic properties), addition of the results from the report of clinical study CL3-16257-068 on the "Evaluation of the anti-anginal efficacy and safety oforal administration of ivabradine compared to placebo".$0$0

Updated on 04 February 2015

Reasons for updating

  • Addition of black triangle
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Addition of manufacturer
  • Change to MA holder contact details

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

-In section 4.8: Addition of a sentence at the beginning of the paragraph dedicated to atrial fibrillation (to reflect incidence in SIGNIFY)$0-Implementation of notification 61(3) to declare change of local representative name in Cyprus$0$0-Implementation of the recently approved type 1B variation aiming at declaring Madrid as manufacturing site$0$0-In section 4.4 of Procoralan 7.5mg only- change in the threshold of HR in paragraph "patients with a low HR"$0$0$0$0

Updated on 19 January 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Changes to therapeutic indications
  • Addition of black triangle

Updated on 08 September 2014

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

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Section 4.8, addition of the uncommon side effect, abdominal pain

Updated on 29 August 2014

Reasons for updating

  • Change to side-effects

Updated on 27 January 2014

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

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4.3: Addition of a contra-indication for women of child-bearing potential not using appropriate contraceptive measures (with corresponding modification in section 4.6)$04.8: Addition of visual impairment and diplopia.$04.8: Extension of the description of luminous phenomena.$04.8: information on reporting a suspected adverse reaction$0

Updated on 07 November 2012

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to improve clarity and readability

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

$0In sections 4.4 & 4.5 informationhas been updated regarding use in combination with potassium-depletingdiuretics and use in patients with QT prolongation. In section 4.8 “ECG prolonged QT interval” has been addedunder uncommon undesirable effects.In section 5.1 two corrections have beenmade and new information has been added under the heading paediatricpopulation. The entire PI has also been updated in line with new QRDtemplate.$0

Updated on 31 October 2012

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Correction of spelling/typing errors

Updated on 12 March 2012

Reasons for updating

  • Change to, or new use for medicine

Updated on 17 February 2012

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

$0In section 4.1 Therapeutic indications:$0$0The following has been added: $0$0Treatment ofcoronary artery disease $0$0Treatment ofchronic heart failure$0$0Ivabradine isindicated in chronic heart failure NYHA II to IV class with systolicdysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, incombination with standard therapy including beta-blocker therapy or whenbeta-blocker therapy is contraindicated or not tolerated. (see section 5.1)$0$0In section 4.2Posology and method of administration:$0$0The followinghas been added: $0$0Treatment ofcoronary artery disease $0$0Treatment ofchronic heart failure$0$0The treatment hasto be initiated only in patient with stable heart failure. It is recommendedthat the treating physician should be experienced in the management of chronicheart failure.$0$0The usualrecommended starting dose of ivabradine is 5 mg twice daily. After two weeks oftreatment, the dose can be increased to 7.5 mg twice daily if resting heartrate is persistently above 60 bpm or decreased to 2.5 mg twice daily (one half5 mg tablet twice daily) if resting heart rate is persistently below 50bpm or in case of symptoms related to bradycardia such as dizziness, fatigue orhypotension. If heart rate is between 50 and 60 bpm, the dose of 5 mg twice dailyshould be maintained.$0$0If duringtreatment, heart rate decreases persistently below 50 beats per minute (bpm) atrest or the patient experiences symptoms related to bradycardia, the dose mustbe titrated downward to the next lower dose in patients receiving 7.5 mg twicedaily or 5 mg twice daily. If heart rate increases persistently above 60 beatsper minute at rest, the dose can be up titrated to the next upper dose inpatients receiving 2.5 mg twice daily or 5 mg twice daily.$0$0Treatment must bediscontinued if heart rate remains below 50 bpm or symptoms of bradycardiapersist (see section 4.4).$0$0The followinghas been deleted: 'Since ivabradine has been studied in alimited number of' and replaced by 'in'$0$0In section 4.3Contraindications:$0$0The followinghas been deleted: $0$0Heart failurepatients with NYHA functional classification III-IV$0$0The followinghas been added: $0$0-                 Unstable or acute heart failure$0$0-                 Pacemaker dependent (heart rateimposed exclusively by the pacemaker) $0$0In section 4.4 Special warnings and precautions for use:$0$0The following has been added: $0$0 The risk ofdeveloping atrial fibrillation may be higher in chronic heart failure patientstreated with ivabradine. Atrial fibrillation has been more common in patientsusing concomitantly amiodarone or potent class I anti-arrhythmics.$0$0Chronic heartfailure patients with intraventricular conduction defects (bundle branch blockleft, bundle branch block right) and ventricular dyssynchrony should bemonitored closely.$0$0Heart failure mustbe stable before considering ivabradine treatment. Ivabradine should be usedwith caution in heart failure patients with NYHA functional classification IVdue to limited amount of data in this population.$0$0Hypertensivepatients requiring blood pressure treatment modifications.$0$0In the SHIFT trialmore patients experienced episodes of increased blood pressure while treatedwith ivabradine (7.1%) compared to patients treated with placebo (6.1%). Theseepisodes occurred most frequently shortly after blood pressure treatment wasmodified, were transient, and did not affect the treatment effect ofivabradine. When treatment modifications are made in chronic heart failurepatients treated with ivabradine blood pressure should be monitored at anappropriate interval (see section 4.8).$0$0The following has been deleted: $0$0Heart failure must be appropriately controlled before consideringivabradine treatment. The use of ivabradine is contra-indicated in heartfailure patients with NYHA functional classification III-IV and should be usedwith caution in heart failure patients with NYHA functional classification I-II(see section 4.)$0$0In section 4.5 Interaction with other medicinal productsand other forms of interaction:$0$0The following has been deleted/added: $0$0In pivotal phase III clinical trials the following medicinal products were not restricted and therefore were routinely combined withivabradine with no evidence of safety concerns: angiotensin converting enzymeinhibitors, angiotensin II antagonists, beta-blockers,diuretics, anti-aldosteroneagents....$0$0In section 4.7 Effects on ability to drive and usemachines:$0$0The following has been added/deleted: $0$0However, in post-marketing experience, cases of impaired drivingability due to visual symptoms have been reported.Ivabradine has noinfluence on the ability to drive and use machines. However, Ivabradinemay cause transient luminous phenomena consisting mainly of phosphenes$0$0Ivabradine has no influence on the abilityto use machines.$0$0Ivabradine has been studied in clinicaltrials involving nearly 14,000 participants. Approximately2,900 patients have been treated with ivabradine in phase II-III studies $0$0$0$0$0$0Cardiac disorders  $0$0$0$0Very rare  $0$0$0$0Atrial fibrillation,  $0$0AV 2nd degree block, $0$0 AV 3rd degreeblock , $0$0Sick sinus syndrome  $0$0$0$0$0$0Vascular disorders$0$0$0$0Common$0$0$0$0Uncontrolled blood pressure$0$0$0$0$0$0 $0$0I$0$0In section 5.1Pharmacodynamic properties: $0$0The following was added:$0$0The SHIFT studywas a large multicentre, international, randomised double-blind placebocontrolled outcome trial conducted in 6505 adult patients with stable chronicCHF (for ³ 4 weeks), NYHA class II to IV, with areduced left ventricular ejection fraction (LVEF £ 35%)and a resting heart rate ³ 70 bpm.$0$0Patients receivedstandard care including beta-blockers (89 %), ACE inhibitors and/or angiotensinII antagonists (91 %), diuretics (83 %), and anti-aldosterone agents (60 %). Inthe ivabradine group, 67% of patients were treated with 7.5 mg twice a day. Themedian follow-up duration was 22.9 months. Treatmentwith ivabradine was associated with an average reduction in heart rate of 15bpm from a baseline value of 80 bpm. The difference in heart rate betweenivabradine and placebo arms was 10.8 bpm at 28 days, 9.1 bpm at 12 months and8.3 bpm at 24 months.$0$0 $0$0The studydemonstrated a clinically and statistically significant relative risk reductionof 18% in the rate of the primary composite endpoint of cardiovascularmortality and hospitalisation for worsening heart failure (hazard ratio: 0.82,95%CI [0.75;0.90] – p<0.0001) apparent within 3 months of initiationof treatment. The absolute risk reduction was 4.2%. The results on the primaryendpoint are mainly driven by the heart failure endpoints, hospitalisation forworsening heart failure (absolute risk reduced by 4.7 %) and deaths from heartfailure (absolute risk reduced by 1.1 %).$0$0 $0$0Treatment effecton the primary composite endpoint, its components and secondary endpoints$0$0 $0$0$0$0$0$0 $0$0$0$0Ivabradine$0$0(N=3241)$0$0n (%)$0$0$0$0Placebo$0$0(N=3264)$0$0n (%)$0$0$0$0Hazard ratio$0$0[95% CI]$0$0$0$0p-value$0$0$0$0$0$0Primary composite endpoint$0$0$0$0793(24.47)$0$0$0$0937 (28.71)$0$0$0$00.82 [0.75; 0.90]$0$0$0$0<0.0001$0$0$0$0$0$0Components of the composite:$0$0- CV death$0$0- Hospitalisation for worsening HF$0$0$0$0 $0$0449 (13.85)$0$0514 (15.86)$0$0 $0$0$0$0 $0$0491 (15.04)$0$0672 (20.59)$0$0 $0$0$0$0 $0$00.91 [0.80; 1.03]$0$00.74 [0.66; 0.83]$0$0 $0$0$0$0 $0$00.128$0$0<0.0001$0$0 $0$0$0$0$0$0Other secondary endpoints:$0$0- All cause death$0$0- Death from HF$0$0- Hospitalisation for anycause$0$0- Hospitalisation for CVreason$0$0$0$0 $0$0503 (15.52)$0$0113 (3.49)$0$01231 (37.98)$0$0977 (30.15)$0$0$0$0 $0$0552 (16.91)$0$0151 (4.63)$0$01356 (41.54)$0$01122 (34.38)$0$0$0$0 $0$00.90 [0.80; 1.02]$0$00.74 [0.58;0.94]$0$00.89 [0.82;0.96]$0$00.85 [0.78; 0.92]$0$0$0$0 $0$00.092$0$00.014$0$00.003$0$00.0002$0$0$0$0$0$0 $0$0The reduction inthe primary endpoint was observed consistently irrespective of gender, NYHAclass, ischaemic or non-ischaemic heart failure aetiology and of backgroundhistory of diabetes or hypertension.$0$0 $0$0In the subgroup ofpatients with HR ≥ 75 bpm (n=4150), a greater reduction was observed in theprimary composite endpoint of 24 % (hazard ratio: 0.76, 95%CI [0.68;0.85] – p<0.0001)and for other secondary endpoints, including all cause death (hazard ratio:0.83, 95%CI [0.72;0.96] – p=0.0109) and CV death (hazard ratio: 0.83,95%CI [0.71;0.97] – p=0.0166). In this subgroup of patients, the safetyprofile of ivabradine is in line with the one of the overall population.$0$0 $0$0A significanteffect was observed on the primary composite endpoint in the overall group ofpatients receiving beta blocker therapy (hazard ratio: 0.82, 95%CI[0.76;0.94]). In the subgroup of patients with HR ≥ 75 bpm and on therecommended target dose of beta-blocker, no statistically significant benefitwas observed on the primary composite endpoint (hazard ratio: 0.97, 95%CI[0.74;1.28]) and other secondary endpoints, including hospitalisation forworsening heart failure (hazard ratio: 0.79, 95% CI [0.56;1.10]) or death fromheart failure (hazard ratio: 0.69, 95% CI [0.31;1.56]).$0$0 $0$0There was a significant improvement in NYHA class atlast recorded value, 887 (28%) of patients on ivabradine improved versus 776(24%) of patients on placebo (p=0.001).$0$0 $0

Updated on 15 February 2012

Reasons for updating

  • Change to MA holder contact details

Updated on 08 December 2011

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may be renewed (B)

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In Section 7: Marketing Authorisation Holder

Change from

LES LABORATOIRES SERVIER

22, rue Garnier

92200 Neuilly-sur-Seine

France

to

Les Laboratoires Servier

50, rue Carnot

92284 Suresnes cedex

France

Updated on 23 September 2011

Reasons for updating

  • Change to side-effects

Updated on 10 December 2010

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 09 December 2010

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

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Section 4.8:

new adverse events reported during the post-marketing experience (frequency unknown). :

- rash, erythema, pruritis

- hypotension, malaise, syncope (possibly linked to bradycardia).

 

 

 

Updated on 05 March 2010

Reasons for updating

  • Change to, or new use for medicine
  • Change to date of revision

Updated on 23 November 2009

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

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The update concerns sections 4.1, 4.3, 4.4, 4.8 and 5.1 of the SPC, the labelling and the Package Leaflet. The results of a supporting large safety study, Beautiful, are also introduced in section 5.1.

Updated on 17 November 2009

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects

Updated on 06 August 2009

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

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The text in bold has been added

Section 4.8

Cardiac disorders
Common:
AV 1st degree block (ECG prolonged PQ interval)

Updated on 28 August 2007

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

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Changes to Sections 2, 3, 4.2 and 4.8.

Updated on 28 August 2007

Reasons for updating

  • Change to date of revision

Updated on 16 April 2007

Reasons for updating

  • Change of manufacturer

Updated on 01 February 2006

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 03 January 2006

Reasons for updating

  • New PIL for new product