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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 29 September 2021

File name

DEC202112636-V_Reg PIL LR 23_1 Chew IE - clean_1632896012.pdf

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 29 September 2021

File name

DEC202112636-V_Reg SPC LR 16_0 20mg Chew IE - clean_1632895973.pdf

Reasons for updating

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

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 7 - Pfizer Healthcare Ireland changed to Upjohn EESV as the MAH, with updated address

Section 8 - updated with new PA number for Upjohn EESV

Updated on 20 September 2021

File name

DEC202112235-V_Reg SPC LR 15_1 20mg Chew IE - clean_1632146383.pdf

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
  • Correction of spelling/typing errors

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

Updated on 20 September 2021

File name

DEC202112235-V_Reg SPC LR 15_1 20mg Chew IE - clean_1632146311.pdf

Reasons for updating

  • Correction of spelling/typing errors

Updated on 31 March 2021

File name

DEC202104589-V_Reg SPC LR 14_1 20mg Chew IE-clean_1617186147.pdf

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 - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic properties

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

Updated on 31 March 2021

File name

DEC202104589-V_Reg SPC LR 14_1 20mg Chew IE-clean_1617186098.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains

Updated on 27 January 2021

File name

DEC202101386-V_Reg PIL LR 19_1 Chew IE-clean_1611759986.pdf

Reasons for updating

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

Updated on 03 September 2020

File name

DEC202046959-V_Reg SPC LR 13_1 20mg Chew IE clean_1599129900.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Updated on 15 June 2020

File name

Reg PIL LR 18_0 Chew UK IE Clean (002)_1592220621.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 19 November 2019

File name

DEC201964482_Reg SPC LR 12_1 20mg Chew IE - Clean_1574176341.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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

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

Updated on 19 November 2019

File name

DEC201964482_Reg PIL LR 18_0 Chew UK IE - Clean_1574175866.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 31 July 2019

File name

DEC201939369_Reg PIL LR 17_2 Chew UK IE _1564571595.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 31 July 2019

File name

DEC201939369_Reg SPC LR 11_2 20mg Chew IE _1564571633.pdf

Reasons for updating

  • 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

SmPC: Updated as follows:

 Section 4.8- updated to include “Muscle rapture” under rare side effects on PRAC recommendation (All strengths).

Updated on 13 May 2019

File name

DEC201924154_Adv PIL LR 12_2 Chew UK IE - Clean_1557732942.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 13 May 2019

File name

DEC201924154_Reg SPC LR 10_1 20mg Chew IE - Clean_1557732985.pdf

Reasons for updating

  • 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

The SPC has been updated as follows: Sections 4.8, 10 has been updated as per the CMDh endorsed PRAC recommendation to include lupus related events.

Updated on 11 January 2019

File name

Adv PIL LR 11_1 Chew UK IE - Clean_1547218144.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 11 January 2019

File name

Reg SPC LR 9_1 20mg Chew IE - Clean_1547219579.pdf

Reasons for updating

  • 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 4.8 – Undesirable effects - how to report a side effect
  • 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

The following changes to the labelling have been approved.  Please refer to attached copy/copies of labelling documentation for full details.

The SPC has been updated as follows: Sections 4.2, 4.3, 4.4, 4.5, 5.1, 5.2 Change in line with PRAC recommendations (drug drug interactions of atorvastatin with HCV protease inhibitor combinations elbasvir/grazoprevir and glecaprevir/pibrentasvir) and section 4.8 ADR reporting

The PIL has been updated to reflect the SPC changes. See PIL tick list for sections updated.

Updated on 28 November 2018

File name

Reg SPC LR 8_1 20mg Chew IE_1543400301.pdf

Reasons for updating

  • Improved presentation of SPC

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

Free text change information supplied by the pharmaceutical company

Improved presentation of SPC uploaded

Updated on 30 August 2018

File name

Reg_SPC_LR_8_1_20mg_Chew_IE_clean_1535636122.pdf

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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

The SPC has been updated as follows:

Section 4.5: a correction to the drug interaction study duration for atorvastatin with colestipol presented in ‘Table 1: Effect of co-administered medicinal products on the pharmacokinetics of atorvastatin’.

Section 5.1: an editorial update to the footnote for Table 3

Updated on 05 June 2018

File name

Reg_SPC_LR_8_1_20mg_Chew_IE_clean.docx

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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

The SPC has been updated as follows:

Section 4.5: a correction to the drug interaction study duration for atorvastatin with colestipol presented in ‘Table 1: Effect of co-administered medicinal products on the pharmacokinetics of atorvastatin’.

Section 5.1: an editorial update to the footnote for Table 3

Updated on 17 February 2017

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Sections 1, 2, 3, 4.6, 5.2, 5.3, 6.4, 6.6 – administrative update

Section 4.2, 4.8, 5.1 - paediatric data update

Section 4.4 – paediatric data update,  CMDh wording for fusidic acid interaction

Section 4.5 - CMDh wording for fusidic acid interaction, harmonised presentation of the drug interaction data

Updated on 17 February 2017

Reasons for updating

  • New SPC for new product

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

Updated on 17 February 2017

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Sections 1, 2, 3, 4.6, 5.2, 5.3, 6.4, 6.6 – administrative update

Section 4.2, 4.8, 5.1 - paediatric data update

Section 4.4 – paediatric data update,  CMDh wording for fusidic acid interaction

Section 4.5 - CMDh wording for fusidic acid interaction, harmonised presentation of the drug interaction data

Updated on 16 February 2017

File name

PIL_15194_725.pdf

Reasons for updating

  • New PIL for new product

Updated on 03 March 2016

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 - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • 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

The SPC has been updated as follows:

Minor updates to the following sections of the  SPC to bring in line with the QRD template:

Section: 2, 4.2, 4.3, 4.4, 4.5, 4.7, 4.8, 5.1, 5.2, 6.1, 6.3, 6.6, 9 and 10

Updated on 03 March 2016

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 - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Minor updates to the following sections of the  SPC to bring in line with the QRD template:

Section: 2, 4.2, 4.3, 4.4, 4.5, 4.7, 4.8, 5.1, 5.2, 6.1, 6.3, 6.6, 9 and 10

Updated on 08 April 2015

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

The SPC has been updated as follows

Section 4.4: Special warnings and precautions for use

Sub-heading: Concomitant treatment with other medicinal products

Update to wording on ‘immune-mediated necrotizing myopathy (IMNM)’ to bring it in line with the PRAC wording.

Section 4.8. Undesirable effects

Sub-heading: Musculoskeletal and connective tissue disorders

Addition of reference to section 4.4.

Updated on 08 April 2015

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows

Section 4.4: Special warnings and precautions for use

Sub-heading: Concomitant treatment with other medicinal products

Update to wording on ‘immune-mediated necrotizing myopathy (IMNM)’ to bring it in line with the PRAC wording.

Section 4.8. Undesirable effects

Sub-heading: Musculoskeletal and connective tissue disorders

Addition of reference to section 4.4.

Updated on 29 May 2014

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

Free text change information supplied by the pharmaceutical company

Update to sections 4.4, 4.5 & 4.8

Updated on 29 May 2014

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

Update to sections 4.4, 4.5 & 4.8

Updated on 07 November 2013

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

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

Free text change information supplied by the pharmaceutical company

changes to section 4.4, 4.5, 4.8

Updated on 07 November 2013

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

Free text change information supplied by the pharmaceutical company

changes to section 4.4, 4.5, 4.8