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Mylan IRE Healthcare Limited

Newenham Court, Northern Cross, Malahide Road, Dublin 17, Ireland
Medical Information Direct Line: +44 (0)1748828888
Medical Information e-mail: medinfo.shl@mylan.com
Summary of Product Characteristics last updated on medicines.ie: 05/07/2017
SPC Creon 40000 Gastro-resistant Capsules

When a pharmaceutical company changes an SPC or PIL, 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 05/07/2017 and displayed until Current
Reasons for adding or 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
Date of revision of text on the SPC:   30-Jun-2017
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 2010/8/3 2007/3/3

10. DATE OF REVISION OF THE TEXT

 

June 2017

Updated on 30/06/2017 and displayed until 05/07/2017
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Date of revision of text on the SPC:   19-Jun-2017
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 from 3 years to 2 years

Updated on 19/04/2017 and displayed until 30/06/2017
Reasons for adding or 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
Date of revision of text on the SPC:   06-Apr-2017
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 26/04/2016 and displayed until 19/04/2017
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   22-Apr-2016
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 09/04/2015 and displayed until 26/04/2016
Reasons for adding or 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
Date of revision of text on the SPC:   27-Mar-2015
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 05/01/2015 and displayed until 09/04/2015
Reasons for adding or 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
Date of revision of text on the SPC:   04-Dec-2014
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 12/09/2014 and displayed until 05/01/2015
Reasons for adding or updating:
  • Change to MA holder contact details
Date of revision of text on the SPC:   28-Aug-2014
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 04/02/2014 and displayed until 12/09/2014
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   27-Jan-2014
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

 

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 06/08/2013 and displayed until 04/02/2014
Reasons for adding or 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
Date of revision of text on the SPC:   30-Jul-2013
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 29/07/2013 and displayed until 06/08/2013
Reasons for adding or 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
Date of revision of text on the SPC:   18-Jul-2013
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 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 14/07/2011 and displayed until 29/07/2013
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   30-Jun-2011
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 03/09/2009 and displayed until 14/07/2011
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
Date of revision of text on the SPC:   31-May-2009
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 25/02/2009 and displayed until 03/09/2009
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Pancreatin