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Relifex 1g Tablets

*
Pharmacy Only: Prescription

  • Company:

    Mylan IRE Healthcare Ltd

  • Status:

    Updated

  • Legal Category:

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

  • Active Ingredient(s):

    Nabumetone

    *Additional information is available within the SPC or upon request to the company

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Updated on 06 May 2025

File name

ie-spc-relifex-1g-MAT-clean.pdf

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)

Updated on 06 May 2025

File name

ie-pl-relifex-MAT-clean.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 21 November 2022

File name

ie-pl-relifex-pr2843509-clean.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility

Updated on 21 November 2022

File name

ie-spc-relifex-1g-pr2843509-clean.pdf

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 08 April 2021

File name

ie-spc-relifex-1g-pr1659999-clean (excipient_pi).pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

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

Updated on 08 April 2021

File name

ie-spc-relifex-1g-pr1659999-clean (excipient_pi).pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision

Updated on 21 April 2020

File name

ie-pl-relifex-pr2104671-clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 09 January 2019

File name

ie-pl-relifex-clean-prac.pdf

Reasons for updating

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

Updated on 09 January 2019

File name

ie-spc-relifex-1g-clean-prac.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 July 2018

File name

ie-spc-relifex-1g-mahtransfer-clean.docx

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

Marketing Authorisation Holder Transfer from Meda Health Sales Ireland Limited to Mylan IRE Healthcare Limited

Updated on 02 July 2018

File name

ie-pl-relifex-mahtransfer-clean.pdf

Reasons for updating

  • New PIL for new product

Updated on 14 February 2018

Reasons for updating

  • New SPC for new product

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

Updated on 14 February 2018

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.2 - Posology and method of administration
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • 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

In section 4.2: Information added$0In section 4.3: Contraindications added$0$0In section 4.4: Specials warnings added/expanded$0$0In section 4.5: Medicines added/removed that interaction with Relifex$0$0In section 4.6: Information added$0$0In section 4.7:Information added wrt dizziness and confusion$0$0In section 4.8: Adverse events listed by system organ class and frequency. Undesirable effects added.$0$0In section 4.9: Information added regarding symptoms, signs and treatment$0$0In section 5.1: Pharmacodynamic information added$0$0In section 5.2: Pharmacokinetic information added$0

Updated on 14 February 2018

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.2 - Posology and method of administration
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Free text change information supplied by the pharmaceutical company

In section 4.2: Information added$0In section 4.3: Contraindications added$0$0In section 4.4: Specials warnings added/expanded$0$0In section 4.5: Medicines added/removed that interaction with Relifex$0$0In section 4.6: Information added$0$0In section 4.7:Information added wrt dizziness and confusion$0$0In section 4.8: Adverse events listed by system organ class and frequency. Undesirable effects added.$0$0In section 4.9: Information added regarding symptoms, signs and treatment$0$0In section 5.1: Pharmacodynamic information added$0$0In section 5.2: Pharmacokinetic information added$0

Updated on 04 February 2015

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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)

Free text change information supplied by the pharmaceutical company

In section 2: A small text change as per QRD has been performed

In section 3: The description of the tablets has been expanded

In section 6.1: The excipients have been expanded

In section 10: date of revision has changed

Updated on 04 February 2015

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 2: A small text change as per QRD has been performed

In section 3: The description of the tablets has been expanded

In section 6.1: The excipients have been expanded

In section 10: date of revision has changed

Updated on 11 January 2011

Reasons for updating

  • New SPC for medicines.ie

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 11 January 2011

Reasons for updating

  • New SPC for medicines.ie

Free text change information supplied by the pharmaceutical company

None provided

Mylan IRE Healthcare Ltd

Mylan IRE Healthcare Ltd