Relifex Tablets 500 mg
*Company:
Mylan IRE Healthcare LtdStatus:
UpdatedLegal 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 06 May 2025
File name
ie-spc-relifex-500mg-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-500mg-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-500mg-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-pl-relifex-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-500mg- 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-500mg-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-500mg-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 4.2 - 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 4.6 - 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 4.9 - Overdose
- 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 andconfusion$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$0
Updated on 14 February 2018
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 4.6 - 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 4.9 - Overdose
- 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 andconfusion$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$0
Updated on 15 June 2015
Reasons for updating
- 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
In section 6.5: the nature of the container has changed
In section 10: the date of revision has changed
In section 10: the date of revision has changed
Updated on 15 June 2015
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 6.5: the nature of the container has changed
In section 10: the date of revision has changed
In section 10: the date of revision has changed
Updated on 26 January 2011
Reasons for updating
- Change to product name
- 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 4.3 - 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 5.1 - Pharmacodynamic properties
- Change to section 6.1 - List of excipients
- Change to section 6.2 - Incompatibilities
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- 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
Change to product name: name to be extended to full name which is Relifex 500mg Film-coated Tablets
In section 1: name to be extended to full marketing name
In section 2: Additional text is added and also a referral to section 6.1
In section 3: The text 'Film-coated tablet' is added
In section 4.2: Additional text added relating to how indesirable effects may be minimised by using the lowest dose for the shortest time
In section 4.3: Additional contradindications are added - in relation to severe heart failure and use in patients with a history of gastrointestinal bleeding & perforation related to previous NSAID use
In section 4.4: Additional text added in relation to using the lowest dose for the shortest time to minimise undesirable effects. Added warnings about gastrointestinal bleeding, ulceration and perforation, use in elderly, cardiovasular and cerebrovascular effects, female fertility, serious skin reactions, concomitant use of NSAIDs
In section 4.5: Additional warnings regarding anti-coagulants, anti-platelet agents, SSRIs,
In section 4.8: Additional warnings added
In section 5.1: The ATC code is added
In section 6.1: E numbers are added to the excipients
In section 6.4: The storage conditions are changed to instruct to keep the carton in the the outer carton to protect from light
In section 6.5: Description of nature and contents of container have changed
In section 9: Would like to use the new wording for date of first authorisation and date of last renewal
In section 10: Date of revision was chaned to July 2010
In section 1: name to be extended to full marketing name
In section 2: Additional text is added and also a referral to section 6.1
In section 3: The text 'Film-coated tablet' is added
In section 4.2: Additional text added relating to how indesirable effects may be minimised by using the lowest dose for the shortest time
In section 4.3: Additional contradindications are added - in relation to severe heart failure and use in patients with a history of gastrointestinal bleeding & perforation related to previous NSAID use
In section 4.4: Additional text added in relation to using the lowest dose for the shortest time to minimise undesirable effects. Added warnings about gastrointestinal bleeding, ulceration and perforation, use in elderly, cardiovasular and cerebrovascular effects, female fertility, serious skin reactions, concomitant use of NSAIDs
In section 4.5: Additional warnings regarding anti-coagulants, anti-platelet agents, SSRIs,
In section 4.8: Additional warnings added
In section 5.1: The ATC code is added
In section 6.1: E numbers are added to the excipients
In section 6.4: The storage conditions are changed to instruct to keep the carton in the the outer carton to protect from light
In section 6.5: Description of nature and contents of container have changed
In section 9: Would like to use the new wording for date of first authorisation and date of last renewal
In section 10: Date of revision was chaned to July 2010
Updated on 26 January 2011
Reasons for updating
- Change to product name
- 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 4.3 - 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 5.1 - Pharmacodynamic properties
- Change to section 6.1 - List of excipients
- Change to section 6.2 - Incompatibilities
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- 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
Change to product name: name to be extended to full name which is Relifex 500mg Film-coated Tablets
In section 1: name to be extended to full marketing name
In section 2: Additional text is added and also a referral to section 6.1
In section 3: The text 'Film-coated tablet' is added
In section 4.2: Additional text added relating to how indesirable effects may be minimised by using the lowest dose for the shortest time
In section 4.3: Additional contradindications are added - in relation to severe heart failure and use in patients with a history of gastrointestinal bleeding & perforation related to previous NSAID use
In section 4.4: Additional text added in relation to using the lowest dose for the shortest time to minimise undesirable effects. Added warnings about gastrointestinal bleeding, ulceration and perforation, use in elderly, cardiovasular and cerebrovascular effects, female fertility, serious skin reactions, concomitant use of NSAIDs
In section 4.5: Additional warnings regarding anti-coagulants, anti-platelet agents, SSRIs,
In section 4.8: Additional warnings added
In section 5.1: The ATC code is added
In section 6.1: E numbers are added to the excipients
In section 6.4: The storage conditions are changed to instruct to keep the carton in the the outer carton to protect from light
In section 6.5: Description of nature and contents of container have changed
In section 9: Would like to use the new wording for date of first authorisation and date of last renewal
In section 10: Date of revision was chaned to July 2010
In section 1: name to be extended to full marketing name
In section 2: Additional text is added and also a referral to section 6.1
In section 3: The text 'Film-coated tablet' is added
In section 4.2: Additional text added relating to how indesirable effects may be minimised by using the lowest dose for the shortest time
In section 4.3: Additional contradindications are added - in relation to severe heart failure and use in patients with a history of gastrointestinal bleeding & perforation related to previous NSAID use
In section 4.4: Additional text added in relation to using the lowest dose for the shortest time to minimise undesirable effects. Added warnings about gastrointestinal bleeding, ulceration and perforation, use in elderly, cardiovasular and cerebrovascular effects, female fertility, serious skin reactions, concomitant use of NSAIDs
In section 4.5: Additional warnings regarding anti-coagulants, anti-platelet agents, SSRIs,
In section 4.8: Additional warnings added
In section 5.1: The ATC code is added
In section 6.1: E numbers are added to the excipients
In section 6.4: The storage conditions are changed to instruct to keep the carton in the the outer carton to protect from light
In section 6.5: Description of nature and contents of container have changed
In section 9: Would like to use the new wording for date of first authorisation and date of last renewal
In section 10: Date of revision was chaned to July 2010
Updated on 12 November 2003
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 12 November 2003
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Updated on 26 August 2003
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 26 August 2003
Reasons for updating
- Improved electronic presentation
Updated on 22 July 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 22 July 2003
Reasons for updating
- New SPC for medicines.ie
Mylan IRE Healthcare Ltd
Address:
Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, IrelandMedical Information E-mail:
info.ie@viatris.comMedical Information Direct Line:
+44 (0)1707 853000 press 1