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Ikorel Tablets 10mg

Name:
Ikorel Tablets 10mg
Company:
SANOFI
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

(Click to Download)

XPIL

PATIENT INFORMATION LEAFLET

1. What Ikorel is and what it is used for

2. What you need to know before you take Ikorel

3. How to take Ikorel

4. Possible side effects

5. How to store Ikorel

6. Contents of the pack and other Information

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

Click on this link to Download PDF directly

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1 - 0 of 176 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 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 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
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 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 PIL

Reasons for updating

Change due to harmonisation of PIL

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 16 September 2009 SmPC

Reasons for updating

Improved electronic presentation

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

Free text change information supplied by the pharmaceutical company

Improved electronic presentation

Updated on 7 July 2009 PIL

Reasons for updating

Change to improve clarity and readability

Updated on 19 March 2009 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 4.8 - Undesirable effects
Change to section 4.9 - Overdose

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

Free text change information supplied by the pharmaceutical company

Update sections 4.3, 4.4, 4.5, 4.8, 4.9 of SPC

Updated on 1 December 2008 PIL

Reasons for updating

Improved electronic presentation

Updated on 12 June 2008 SmPC

Reasons for updating

Improved electronic presentation

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

Updated on 9 November 2007 SmPC

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

Update Section 3 - Information on breakability

Updated on 6 November 2007 SmPC

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

Update section 3 - information on breaking of tablet.

Updated on 18 December 2006 PIL

Reasons for updating

Improved electronic presentation

Updated on 18 December 2006 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

Update Section

7 - Change MAH to sanofi-aventis Ireland Ltd.

10 - Date of Revision

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 3 December 2004 SmPC

Reasons for updating

Change to section 4.3 - Contraindications
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 10 - Date of revision of the text

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

Updated on 19 August 2004 PIL

Reasons for updating

New PIL for medicines.ie

Updated on 21 June 2004 SmPC

Reasons for updating

Change to section 3 - Pharmaceutical form

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

Updated on 3 December 2003 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)

Updated on 17 November 2003 SmPC

Reasons for updating

Improved electronic presentation

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

Updated on 23 June 2003 SmPC

Reasons for updating

Improved electronic presentation

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

Updated on 11 June 2003 SmPC

Reasons for updating

New SPC for medicines.ie

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