Creon 25000 Gastro-resistant Capsules
*Company:
Mylan IRE Healthcare LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 04 July 2023
File name
ie-pl-Creon10000-25000-PR3083478-maht-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 04 July 2023
File name
ie-smpc-Creon25000-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 05 December 2022
File name
IE-PIL-Creon10000-25000-PR2751623-clean.pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 05 December 2022
File name
ie-smpc-Creon25000-2010_8_2-PR2751623-clean.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- 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)
Updated on 27 April 2021
File name
IE-PIL-Creon10000-25000-26Apr2021-At613-clean.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.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.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.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.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.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
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 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 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 5.1 - Pharmacodynamic properties
Free text change information supplied by the pharmaceutical company
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
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
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
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 - 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
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
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
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 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 6.4:
Do not store above
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
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
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
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
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)