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Ikorel Tablets 20mg

  • Name:

    Ikorel Tablets 20mg

  • Company:
    info
  • Active Ingredients:

    Nicorandil

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 12/06/18

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 5/6/2019

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SANOFI

SANOFI

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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 5 June 2019 SmPC

Reasons for updating

  • Improved presentation of SmPC

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

Free text change information supplied by the pharmaceutical company

Update from Word to PDF doc

Updated on 12 June 2018 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Free text change information supplied by the pharmaceutical company

 

Section 1 Wording amended in paragraph

Section 2 Sentence re-formatted Added:-

Excipient(s) with known effect:

This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free’.

Section 3

Rewording of sentence

round replaces circular

inscription replaces marking

doses replaces halves

Section4.4

Spelling amended Desiccant

Capsule replaces tablets as

These tablets replaced with this desiccant capsule

Section 4.5  

Heading wording amended:-

Interactions with Other Medicinal Products and Other Forms of Interaction

Section6.1

Added:-

Grammatical errors amended

(E570)

(E421)

Section 6.3

Added:-

After opening

at below mentioned storage conditions.

Section 6.4 Added and replaces previous wording:-

For each blister strip, there are:

10 cavities containing Ikorel tablets, and

1 bigger cavity containing a silica gel desiccant capsule positioned at one end of the strip.

Each cavity containing Ikorel tablet is connected with the desiccant capsule by a channel.

The desiccant capsule must not be swallowed.

The blister pack is sealed with the aluminium cover foil on the removal side.

Pack sizes available are: 30 or 60 tablets.

Not all pack sizes may be marketed.

Section 6.6  amendment to section title to Special Precautions for Disposal and other Handling

 Added:- Any unused medicinal product or waste material should be disposed of in accordance with local requirements

Updated on 12 June 2018 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - use in children and adolescents
  • Change to section 3 - how to take/use
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product looks like and pack contents

Updated on 27 January 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 27 January 2017 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 20 October 2015 PIL

Reasons for updating

  • Change to date of revision
  • PIL Submitted in error

Updated on 20 October 2015 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 20 October 2015 PIL

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
  • Change to drug interactions

Updated on 20 October 2015 SmPC

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 4.6 - 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5 - Pharmacological properties
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data

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

Free text change information supplied by the pharmaceutical company

4.1 Therapeutic Indications-

Wording of indicated use changed.

4.2 Posology and Method of Administration

Use of the word "bid" removed

Elderly- Recommends use of the lowest effective dose

"Children not recommended" removed

No special dosage requirements stated for patients with hepatic/ renal impairments

Ikorel is not recommended in paediatric patients

Method of administration suggested through oral route.

4.3 Contra-indications

-Hypersentivity to nicorandil or to any of the excipients listen in section 6.1
-Patients with shock, severe hypotension, or left ventricular dysfunction with low filling pressure or cardiac decompensation
-Use of phosphodiesterase 5 inhibitors
-Hypoyolaemia
-Acute pulmonary oedema

4.4 Special warnings and precautions for use

Edited/updated

-Decrease of blood-pressure
-Heart failure
Hyperkalaemia
-Dessicant
-Paediatric population
-G6PD deficiency

4.7 Effects on Ability to Drive and Use Machines

Influence on ability to drive and use machines expanded on further.

4.9, 5.1, 5.2 and 5.3 wording updated


Updated on 2 June 2014 SmPC

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

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

Free text change information supplied by the pharmaceutical company

Type IIC.1.3 variation to update Sections 4.4, 4.5 and 4.8 of the SmPC following completion of the Nicorandil PSUR Work Sharing Procedure AT/H/PSUR/0023/002 in November 2013 and the subsequent submission of   Risk Management Plan in January 2014.

Updated on 27 May 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions

Updated on 19 March 2013 SmPC

Reasons for updating

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

SPC updated in line with CCDS version 5:-

Section 4.4: ‘If ulcerations develop it is recommended to discontinue the nicorandil treatment’ is replaced with ‘If ulcerations develop nicorandil should be discontinued’


Section 4.8: Eye disorders added
 

Section 4.9: Terminology ‘substitution of fluid’ is replaced with ‘fluid resuscitation’.

 

Updated on 18 March 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to further information section
  • Change to marketing authorisation holder

Updated on 20 September 2012 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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 7 updated to include 'T/A SANOFI'

Updated on 1 April 2011 SmPC

Reasons for updating

  • 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

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

Free text change information supplied by the pharmaceutical company

Type Ib  C.I.3.a  variation to align the SPC and Patient information leaflet for Ikorel 10mg and 20mg Tablets, in line  with the harmonised Company Core Safety Information, Version 4, and incorporating the CSP updates from the CSP WSP AT/H/PSUR/0023/001.

Updated on 1 April 2011 PIL

Reasons for updating

  • Change due to harmonisation of PIL

Updated on 16 September 2009 SmPC

Reasons for updating

  • New SPC for medicines.ie

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 7 July 2009 PIL

Reasons for updating

  • Change to improve clarity and readability

Updated on 1 December 2008 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 18 December 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 19 July 2005 PIL

Reasons for updating

  • Change of manufacturer

Updated on 16 December 2004 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 3 December 2004 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 19 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie