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Creon for Children 5000 Gastro-resistant Granules

*
Pharmacy Only: Prescription

  • Company:

    Mylan IRE Healthcare Ltd

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Pancreatin

    *Additional information is available within the SPC or upon request to the company

Updated on 04 July 2023

File name

ie-pl-Creon-5000-PR3083478-maht-clean.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 04 July 2023

File name

ie-smpc-Creon5000-maht-clean.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 04 April 2022

File name

SmPC-5000-TIAIN-dosingspoon-IE.pdf

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

Updated on 02 March 2021

File name

ie-smpc-Creon-5000_2010_8_4-TIBExcipients_clean.pdf

Reasons for updating

  • 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 02 March 2021

File name

ie-pl-Creon-5000-TIBexcipients-clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 10 October 2019

File name

1911336_Creon5000_07Oct2019_CRN008ZWJ_eMC.pdf

Reasons for updating

  • Change to section 5 - how to store or dispose

Free text change information supplied by the pharmaceutical company

Section 5: Update

From: Do not store above 30°C. After opening use within 3 weeks.

To: Do not store above 25°C. After opening use within 12 weeks.

Updated on 10 October 2019

File name

ie-SmPC-Creon5000_CRN008ZWJ-07Oct2019-clean-eMC.pdf

Reasons for updating

  • Change to section 6 - Pharmaceutical particulars

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

Free text change information supplied by the pharmaceutical company

Update to section 6.5, storage conditions

From: Do not store above 30C

To: Do not store above 25C

Updated on 05 July 2017

Reasons for updating

  • New SPC for new product

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

Updated on 05 July 2017

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • 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

7.  MARKETING AUTHORISATION HOLDER

Mylan IRE Healthcare Limited

Unit 35/36

Grange Parade

Baldoyle Industrial Estate

Dublin 13

Ireland

BGP Products Ireland Limited

4051 Kingswood Drive,

Citywest Business Campus,

Dublin 24

8. MARKETING AUTHORISATION NUMBER

 

PA 2010/8/4 2007/3/4

10. DATE OF REVISION OF THE TEXT

 

June 2017

Updated on 30 June 2017

File name

PIL_11636_545.pdf

Reasons for updating

  • New PIL for new product

Updated on 30 June 2017

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 12 April 2017

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • 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

An update to SPC section 4.2 to clarify Creon should be taken ‘during or immediately after’ a meal

and section 4.6 to state that Creon can be prescribed to pregnant women and can be used during breast-feeding

Updated on 10 April 2017

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - what you need to know - contraindications
  • Change to section 6 - date of revision

Updated on 08 November 2016

Reasons for updating

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

Updated on 26 April 2016

Reasons for updating

  • 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

Addition of text to section 5.1: “Treatment with Creon improves the symptoms of pancreatic exocrine insufficiency including stool consistency, abdominal pain, flatulence and stool frequency, independent of the underlying disease.”

Updated on 14 May 2015

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

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

Free text change information supplied by the pharmaceutical company

Article 46 Paediatric: method of administration in infants

Updated on 11 May 2015

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration

Updated on 09 April 2015

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
  • Change to marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

Transfer of MAH from Abbott to BGP with change in PA no. also

Updated on 09 April 2015

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 05 January 2015

Reasons for updating

  • 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)

Free text change information supplied by the pharmaceutical company

CCDS approved Dec 2014

4.4 Special Warning and Precautions 

The warning on the theoretical risk for transmission of viral disease is removed fro.

 

4.8 Undesirable effects

Include details of reporting suspected adverse reactions

 

5.1 Pharmacodynamic properties (Editorial change)

Updated on 22 December 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 11 September 2014

Reasons for updating

  • 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

Section 7: AHPL address change  from S'hampton to Maidenhead

Updated on 04 September 2014

Reasons for updating

  • Change to further information section
  • Change to MA holder contact details

Updated on 12 August 2013

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.9 - Overdose
  • 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

Section 2 - Addition of 'Produced from porcine pancreatic tissue'
Section 4.2 - Changes to text regarding method of administration
Section 4.3 - Update in line with QRD template
Section 4.4 - Extensive updates throughout the section
Section 4.5 - Rewording of this section
Section 4.7 - Rewording of this section
Section 4.8 - Extensive updates throughout the section and addition of adverse events table
Section 4.9 - Changes to text regarding overdose
Section 5.1 - Extensive updates throughout the section

Updated on 06 August 2013

Reasons for updating

  • Correction of spelling/typing errors

Updated on 01 August 2013

Reasons for updating

  • Change to dosage and administration

Updated on 15 November 2012

Reasons for updating

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

Updated on 01 October 2012

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation

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

Free text change information supplied by the pharmaceutical company

Section 2: Sentence amended to: "For a full list of excipients, see section 6.1"

Section 6.5: Details regarding the dosing spoon added to this section.

Section 9: Date of Renewal updated to 23 June 2011

Updated on 21 December 2011

Reasons for updating

  • Change due to user-testing of patient information

Updated on 14 July 2011

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

Due to the recent acquisition of Solvay Pharmaceuticals by Abbott there will be a change in the MAH name(only) from Solvay Healthcare Ltd. to Abbott Healthcare Products Ltd.  Implementation date 30 Jun 2011

Updated on 13 July 2011

Reasons for updating

  • Change to marketing authorisation holder
  • Change to name of manufacturer

Updated on 14 April 2010

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

In section 6.5, the container has been changed to a glass bottle. This change is purely administrative.

Updated on 20 October 2009

Reasons for updating

  • Improved electronic presentation
  • Change of active ingredient
  • Change of inactive ingredient
  • Change to storage instructions

Updated on 03 September 2009

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage

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

Free text change information supplied by the pharmaceutical company

Following approval of the DBP free formulation the following sections of the SPC have been changed;

In section 2

the amount of pancreatin has been changed from 60.36mg to 60.12mg.

the amount of pancreatin has been changed from 60.36mg to 60.12mg.

In section 4.6

wording has been harmonised for all strengths. For Creon for Children 5000, the final sentence has been updated from "Creon should not be used during pregnancy or lactation unless clearly necessary" to "Creon should not be used during pregnancy or lactation unless clearly necessary, but if required should be used in doses providing adequate nutritional status (see warnings about high dose sections 4.2 & 4.8.)."

wording has been harmonised for all strengths. For Creon for Children 5000, the final sentence has been updated from "Creon should not be used during pregnancy or lactation unless clearly necessary" to "Creon should not be used during pregnancy or lactation unless clearly necessary, but if required should be used in doses providing adequate nutritional status (see warnings about high dose sections 4.2 & 4.8.)."

In section 6.1

the excipient dibutylphthalate and liquid paraffin have been removed and replaced with cetyl alcohol and triethyl citrate.

the excipient dibutylphthalate and liquid paraffin have been removed and replaced with cetyl alcohol and triethyl citrate.

In section 6.4

storage conditions have been changed from 25 to 30 degrees C.

storage conditions have been changed from 25 to 30 degrees C.

Updated on 13 November 2006

Reasons for updating

  • New SPC for new product

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

Updated on 13 November 2006

Reasons for updating

  • New PIL for new product