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Pharmacy Only: Prescription

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 20 September 2021

File name

DEC202112235-V_Reg SPC LR 31_1 40mg IE - clean_1632149894.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 31_1 40mg IE - clean_1632149800.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 PIL LR 35_1 IE - clean_1632149759.pdf

Reasons for updating

  • Correction of spelling/typing errors

Updated on 31 March 2021

File name

DEC202104589-V_Reg SPC LR 30_2 40mg IE-clean_1617186445.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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
  • Change to section 6.1 - List of excipients

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

Updated on 31 March 2021

File name

DEC202104589-V_Reg PIL LR 34_0 IE-clean_1617186391.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 06 October 2020

File name

Reg PIL LR 32_0 IE Clean_1601978561.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder

Updated on 19 November 2019

File name

DEC201964482_Reg SPC LR 29_1 40mg IE - Clean_1574176920.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 31_1 IE - Clean_1574176836.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 30_2 IE _1564571755.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 28_2 40mg IE_1564571935.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_Reg PIL LR 29_1 IE - Clean_1557734041.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 27_1 40mg IE - Clean_1557734095.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

Reg PIL LR 28_1 IE - Clean_1547219750.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 26_1 40mg IE- Clean_1547219979.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 25_1 40mg IE_1543400379.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_25_1_40mg_IE_clean_1535636197.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_25_1_40mg_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_8757_784.pdf

Reasons for updating

  • New PIL for new product

Updated on 04 January 2016

Reasons for updating

  • 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 4.3 - 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
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • 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

updates to sections:

2, 3, 4.2, 4.3, 4.4, 4.5, 4.8, 5.2, 6.1. 9 and 10 - to bring in line with QRD template

Updated on 04 January 2016

Reasons for updating

  • 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 4.3 - 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
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • 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

updates to sections:

2, 3, 4.2, 4.3, 4.4, 4.5, 4.8, 5.2, 6.1. 9 and 10 - to bring in line with QRD template

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 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 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 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 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