Ranexa prolonged-release tablets

  • Name:

    Ranexa prolonged-release tablets

  • Company:
    info
  • Active Ingredients:

    Ranolazine

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 27/10/20

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 27/10/2020

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A. Menarini Pharmaceuticals Ireland Ltd

A

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Medicine Name Ranexa prolonged-release tablets Active Ingredients Ranolazine
1 - 0 of 32 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 27 October 2020 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

The main changes are as follows:
  • 4. Possible side effects – muscle weakness included as an uncommon side-effect, myoclonus added with the frequency ‘not known’.

Updated on 27 October 2020 SPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

The main changes are as follows:
  • Section 4.8 Undesirable Effects - inclusion of myoclonus as an adverse event with the frequency ‘not known’
  • Section 4.9 Overdose - addition of a sentence on the cases of intentional overdose.

Updated on 20 April 2020 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 25 April 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 25 April 2019 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

The changes are to update the SmPC to include additional pre-clinical data (sections 4.6 fertility, pregnancy and lactation and 5.3 pre-clinical safety data) and to implement the warning on sodium (section 4.4 special warnings and precautions for use).

Updated on 11 December 2018 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 11 December 2018 SPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

4.2       Posology and method of administration

Updated to remove reference to the Patient Alert Card following its removal as an additional Risk Minimization Measure in Risk the Management Plan.

4.4       Special warnings and precautions for use

QT prolongation

Information added - Ranolazine blocks IKr and prolongs the QTc interval in a dose-related manner. 

 

Updated on 16 February 2017 SPC

Reasons for updating

  • New SPC for new product

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

Updated on 16 February 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 16 February 2017 SPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

The following sections have been updated:

 

Section 4.8 Undesirable effects

The following paragraph has been added:

An increased incidence of adverse events was seen among ranolazine treated patients in the RIVER-PCI trial (see section 5.1) where patients with incomplete revascularization post-PCI were given ranolazine up to 1000 mg twice daily or placebo for approximately 70 weeks. In this study, there was a higher reporting rate for congestive heart failure in the ranolazine group (2.2% vs 1.0% in placebo). Also, transient ischemic attack occurred more frequently in patients treated with ranolazine 1000 mg twice daily compared with placebo (1.0% vs 0.2%, respectively); however, the incidence of stroke was similar between treatment groups (ranolazine 1.7% vs placebo 1.5%).

 

 

Section 5.1 Pharmacodynamic properties

The following paragraph has been added:

In a phase 3, double-blind, placebo-controlled, event-driven trial (RIVER-PCI) in 2604 patients aged ≥18 years with a history of chronic angina and incomplete revascularisation after percutaneous coronary intervention (PCI) patients were up-titrated to 1000 mg twice daily*. No significant difference occurred in the composite primary endpoint (time to first occurrence of ischaemia-driven revascularisation or ischaemia-driven hospitalisation without revascularisation) in the ranolazine group (26.2%) versus the placebo group (28.3%), hazard ratio 0.95, 95% CI 0.82-1.10 p= 0.48. The risk of all cause mortality, CV death or major adverse cardiovascular events (MACE) and heart failure hospitalisation was similar between treatment groups in the overall population; however, MACE were reported more frequently in patients 75 years treated with ranolazine compared with placebo (17.0% vs 11.3%, respectively); in addition there was a numerical increase in all cause mortality in patients 75 years (9.2% vs. 5.1%, p = 0.074). 

*dosage not approved in the current SmPC

Updated on 16 February 2017 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 3 December 2015 PIL

Reasons for updating

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

Updated on 1 December 2015 SPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Section 4.8 Undesirable effects Add hyponatremia as a rare side-effect under Metabolism and nutrition disorders
  • Section 10 Date of Revision of the text Updated to November 2015

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

Free text change information supplied by the pharmaceutical company

  • Section 4.8 Undesirable effects
    Add hyponatremia as a rare side-effect under Metabolism and nutrition disorders
  • Section 10 Date of Revision of the text
    Updated to November 2015
  • Updated on 19 August 2014 SPC

    Reasons for updating

    • Change to section 3 - Pharmaceutical form
    • Change to Section 4.8 – Undesirable effects - how to report a side effect
    • Change to section 10 - Date of revision of the text

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

    Free text change information supplied by the pharmaceutical company

    Section 3 Pharmaceutical Form

    Remove CVT 375/500/750 from the tablet descriptions.

     

    Section 4.8 Undesirable effects

    Add details on Reporting of suspected adverse reactions

     

    Section 10 Date of Revision of the text

    Updated to July 2014

    Updated on 19 August 2014 PIL

    Reasons for updating

    • Change to date of revision
    • Change to appearance of the medicine
    • Addition of information on reporting a side effect.

    Updated on 13 May 2014 SPC

    Reasons for updating

    • Change to section 6.5 - Nature and contents of container
    • Change to section 10 - Date of revision of the text

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

    Free text change information supplied by the pharmaceutical company

    Changes are made to the number of tablets per blister card as follows:

    Section 6.5        Nature and contents of container


    PVC/PVDC/Aluminium blisters of 15 or 20 tablets per blister card. Each carton contains 2, 3, or 5 blister cards (30, 60 or 100 tablets) or one HDPE bottle containing 60 tablets. 

    Updated on 6 May 2014 PIL

    Reasons for updating

    • Change of manufacturer

    Updated on 26 November 2013 SPC

    Reasons for updating

    • 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)

    Free text change information supplied by the pharmaceutical company

    Section 4.8 – Musculoskeletal and connective tissue disorders

    add ‘muscular weakness as an uncommon side-effect’

     

    Section 10 – Date of revision updated to 13 November 2013

    Updated on 26 November 2013 PIL

    Reasons for updating

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

    Updated on 17 October 2013 PIL

    Reasons for updating

    • Change to further information section
    • Change to date of revision

    Updated on 28 May 2013 PIL

    Reasons for updating

    • Change to side-effects
    • Change to drug interactions
    • Change to information about driving or using machinery

    Updated on 28 May 2013 SPC

    Reasons for updating

    • 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 10 - Date of revision of the text

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

    Free text change information supplied by the pharmaceutical company

    • Section 4.5 Interactions: update the information on simvastatin, add information on atorvastatin, other statins and drugs transported by Organic Cation Transporter-2 (OCT2) - metformin
    • Section 4.7 Effects on ability to drive and use machines: add diplopia and coordination abnormal
    • Section 4.8 Undesirable effects: add paresthesia, coordination abnormal, gait disturbance, diplopia, urinary retention.
    • Typographical updates to align to current template

    Updated on 19 March 2013 SPC

    Reasons for updating

    • Change to section 9 - Date of renewal of authorisation
    • Change to section 10 - Date of revision of the text

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

    Free text change information supplied by the pharmaceutical company

    Change to section 9 -date of last renewal added

    Updated on 24 April 2012 SPC

    Reasons for updating

    • Change to section 6.3 - Shelf life
    • Change to section 10 - Date of revision of the text

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

    Free text change information supplied by the pharmaceutical company

    Section 6.3 Shelf life

    Blister pack: shelf life extended from 4 to 5 years
    Bottle pack: 4°years

    Updated on 30 March 2012 PIL

    Reasons for updating

    • Change to drug interactions
    • Change to information about driving or using machinery
    • Change to further information section
    • Change to instructions about missed dose
    • Change to storage instructions
    • Change to side-effects

    Updated on 29 March 2012 SPC

    Reasons for updating

    • Change to section 4.1 - Therapeutic indications
    • Change to section 4.2 - Posology and method of administration
    • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
    • Change to section 4.6 - Pregnancy and lactation
    • 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
    • Change to section 5.2 - Pharmacokinetic properties
    • Change to section 5.3 - Preclinical safety data
    • Change to section 10 - Date of revision of the text

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

    Free text change information supplied by the pharmaceutical company

    Section 4.5 Interactions

    Effects of ranolazine on other medicinal products  - new paragraph added:

    Dose adjustment of sensitive CYP3A4 substrates (e.g., simvastatin, lovastatin) and CYP3A4 substrates with a narrow therapeutic range (e.g., ciclosporin, tacrolimus, sirolimus, everolimus) may be required as RANEXA may increase plasma concentrations of these drugs.

     

    Simvastatin: additional information added:

    Rhabdomyolysis has been associated with high doses of simvastatin and cases of rhabdomyolysis have been observed in patients receiving Ranexa and simvastatin, in postmarketing experience. Limit the dose of simvastatin to 20 mg once daily in patients taking any dose of Ranexa. Dose limitation of other statins, metabolised by CYP3A4 (lovastatin), may be considered in patients taking Ranexa.

     

    New paragraph added:

    Tacrolimus, ciclosporin, sirolimus, everolimus: Increased plasma concentrations of tacrolimus, a CYP3A4 substrate, have been observed in patients after ranolazine administration. It is recommended that tacrolimus blood levels are monitored when co-administering Ranexa and tacrolimus and that tacrolimus dosage is adjusted accordingly. This is also recommended for other CYP3A4 substrates with a narrow therapeutic range (e.g., ciclosporin, sirolimus, everolimus).

     

    Section 4.6 Fertility, pregnancy and lactation

    New paragraph added:

    Fertility: In animals, reproduction studies indicated no adverse effects on fertility (see section 5.3). The effect of ranolazine on human fertility is unknown.


    Section 4.7 Effects on ability to drive and use machines
    Confusional state and hallucination added to wording.

    Section 4.8 Undesirable effects
    Acute renal failure added as a rare side-effect.

    Section 5.3 Preclinical safety data

    New sentence added:

    Animal studies do not indicate direct or indirect harmful effects of ranolazine with respect to male or female fertility.

     

    Other sections 4.1, 4.2, 5.1, 5.2, 10 - amendments made for clarification

    Updated on 28 June 2011 SPC

    Reasons for updating

    • 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)

    Free text change information supplied by the pharmaceutical company

    Update to section 4.8 Undesirable effects to add confusional state and hallucination.

    Updated on 24 June 2011 PIL

    Reasons for updating

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

    Updated on 17 March 2011 SPC

    Reasons for updating

    • 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)

    Free text change information supplied by the pharmaceutical company

    Section 4.8 Undesirable effects
    - Add angioedema as a side effect.

    Updated on 10 August 2010 SPC

    Reasons for updating

    • Change to section 3 - Pharmaceutical form

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

    Free text change information supplied by the pharmaceutical company

    Section 3 Pharmaceutical form

    Alternative engraving mark added for the tablets.

    Updated on 22 July 2010 PIL

    Reasons for updating

    • Change to appearance of the medicine

    Updated on 1 June 2010 SPC

    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 4.5 - Interaction with other medicinal products and other forms of interaction
    • Change to section 5.1 - Pharmacodynamic properties
    • Change to section 6.1 - List of excipients
    • Change to section 10 - Date of revision of the text

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

    Free text change information supplied by the pharmaceutical company

    Section 2. Qualitative and quantative composition

     

    - 500 mg tablet: Azo colouring agent E110 removed as an excipient.

    Section 4.4 Special warnings and precuations

    - 500 mg tablet: Azo colouring agent E110 removed as an excipient.


    Please note that stock of Ranexa 500 mg tablets containing E110 may still be in the distribution chain.

     

    Section 4.5

    • Interactions add information on the effect of Ranolazine 750 mg twice daily on the pharmacokinetics of metoprolol. Add further details regarding other CYP2D6 substrates.
    • Delete "quinidine" as it is already included in the section 4.3 Contraindications

     Section 5.1 Pharmacodynamic properties

    • Amendment of a mistake as regards the incidence of arrhythmia in the MERLIN-TIMI 36 study

     Section 6.1

    • List of excipients updated.

     Section 10

    • Date of revision of the text updated.

    Updated on 25 May 2010 PIL

    Reasons for updating

    • Change of inactive ingredient
    • Change to drug interactions
    • Change to date of revision

    Updated on 15 September 2009 SPC

    Reasons for updating

    • 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)

    Free text change information supplied by the pharmaceutical company

    In section 4.8, two additional statements added regarding acute renal failure:

    The adverse event profile was generally similar in the MERLIN-TIMI 36 study. In this long term study, acute renal failure was also reported with an incidence less than 1% in placebo and ranolazine patients.... 

    .......

    Post-marketing experience: In post-marketing experience, there have been reports of acute renal failure, including in patients with pre-existing mild to moderate renal impairment and/or taking concomitant medications that are known to interact with ranolazine (see section 4.4 and 4.5).

    Updated on 8 September 2009 PIL

    Reasons for updating

    • Change to side-effects
    • Addition of manufacturer

    Updated on 22 May 2009 SPC

    Reasons for updating

    • New SPC for new product

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

    Free text change information supplied by the pharmaceutical company

    None provided

    Updated on 22 May 2009 PIL

    Reasons for updating

    • New PIL for new product