Creon 25000 Gastro-resistant Capsules

Product Information *

  • Company:

    Mylan IRE Healthcare Limited
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

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

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 April 2021

File name

IE-PIL-Creon10000-25000-26Apr2021-At613-clean_1619550551.pdf

Reasons for updating

  • Removal of one or more presentations from joint PIL

Updated on 02 March 2021

File name

ie-smpc-Creon25000-2010_8_2_TIBExcipients_clean_1614693072.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-10_25_40-TIBexcipients-clean_1614692336.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 17 February 2020

File name

IE_MT_Creon 100002500040000_PIL_AddMT_13Feb2020_eMC_1581951252.pdf

Reasons for updating

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

Updated on 30 August 2019

File name

1871729_Creon 10000_25000_40000_02Aug2019-CRN008LL2-approved-eMC_1567171481.pdf

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 30 August 2019

File name

ie-SmPC-Creon25000-02Aug2019-crn008LL2-clean_1567171515.pdf

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)

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 2010/8/2 2007/3/2

10. DATE OF REVISION OF THE TEXT

 

June 2017

 

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

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 2010/8/3 2007/3/3

10. DATE OF REVISION OF THE TEXT

 

June 2017

Updated on 30 June 2017

File name

PIL_15808_65.pdf

Reasons for updating

  • New PIL for new product

Updated on 30 June 2017

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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

Section 6.3: Shelf life changed form 3 years to 2 years

Storage conditions updated to add the following statement:  
Keep container tightly closed in order to protect from moisture.

Updated on 30 June 2017

Reasons for updating

  • Change to section 6.3 - Shelf life

Free text change information supplied by the pharmaceutical company

Section 6.3: Shelf life changed from 3 years to 2 years

Updated on 19 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

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 12 April 2017

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 10 - Date of revision of the text
  • 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

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 26 April 2016

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

Free text change information supplied by the pharmaceutical company

Section 5.1: Addition of text: “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 26 April 2016

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 4.1: Change from ‘PE Deficiency' to ‘PE Insufficiency'
Section 5.1: Addition of text: “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 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 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

Free text change information supplied by the pharmaceutical company

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

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 - how to report a side effect
  • Change to section 10 - Date of revision of the text

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 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 12 September 2014

Reasons for updating

  • Change to MA holder contact details

Free text change information supplied by the pharmaceutical company

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

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 February 2014

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

Section 4.2                   Posology and method of administration
Initially one or two capsule with meals

Updated on 04 February 2014

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Free text change information supplied by the pharmaceutical company

Section 4.2                          Posology and method of administration

 

Adults (including the elderly) and children:

Creon 40000 should only be used if the patient requires equal to or more than 40,000 lipase units per meal or snack.  

Initially one or two capsules with meals.  The capsules should be swallowed whole, without crushing or chewing, with enough fluid during or after each meal or snack.  Dose adjustments, if required, should be done slowly, with careful monitoring of response and symptomatology.

Updated on 06 August 2013

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 1 - Addition of 'gastro-resistant' to name of product
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

  • 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

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 29 July 2013

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container

Free text change information supplied by the pharmaceutical company

Section 1 - Addition of 'gastro-resistant' to product name
Section 3 - Addition of 'gastro-resistant' to description
Section 6.4 - Change to storage conditions
Section 6.5 - Addition of 'gastro-resistant' to description

Updated on 01 October 2012

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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

Section 6.3:

2 3 years


Section 6.4:

Do not store above 30C  25C

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

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 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 04 September 2009

Reasons for updating

  • 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 6.1 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.

 

Updated on 03 September 2009

Reasons for updating

  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage

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 6.1 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.

 

Updated on 25 February 2009

Reasons for updating

  • New SPC for medicines.ie

Updated on 27 August 2008

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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 3 Capsule, hard changed to
Gastro-resistant capsule, hard.
 
section 9: 24th April 1997/21st March 2002 changes to
 

Date of first authorisation: 24th April 1997

Date of last renewal: 21st March 2007

 
 
 

Updated on 28 August 2007

Reasons for updating

  • Change to section 6.1 - List of excipients
  • 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

6.1        List of Excipients

 

Capsules:  Gelatin, Red and Yellow Iron Oxides (E172), Titanium Dioxide (E171), sodium lauryl sulphate.

 

 

6.5.       Nature and Contents of Container

 

HDPE container with polypropylene closure, containing 50 or 100 capsules.

 

10.        Date of Revision of the Text

 

            March 2007

Updated on 23 May 2005

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation

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

Updated on 11 March 2005

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Updated on 05 May 2004

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation

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

Updated on 27 June 2003

Reasons for updating

  • New SPC for new product

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