Relpax 40mg Film-Coated Tablets
*Company:
Upjohn EESVStatus:
No Recent UpdateLegal 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 04 March 2024
File name
Summary of Product Characteristics - IE - Relpax 40mg FCT.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 04 March 2024
File name
Patient Information Leaflet - IE - Relpax FCT.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
Updated on 05 July 2023
File name
Patient Information Leaflet - IE - Relpax FCT.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 21 June 2022
File name
DEC202207119-V_REG PIL RP 19_0 IE clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 14 April 2021
File name
DEC202104959-V_Reg SPC RP 16_1 40mg IE Clean.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)
Updated on 14 April 2021
File name
DEC202104959-V_REG PIL RP 18_0 IE Clean.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 03 February 2021
File name
DEC202101772-V_REG PIL RP 17_1 IE - Clean.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 02 February 2021
File name
DEC202101772-V_Reg SPC RP 15_2 40mg IE - Clean.pdf
Reasons for 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
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 01 March 2018
File name
PIL_14146_159.pdf
Reasons for updating
- New PIL for new product
Updated on 01 March 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 01 March 2018
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
A five tablet pack size has been added to section 6.5
Updated on 01 March 2018
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Free text change information supplied by the pharmaceutical company
A five tablet pack size has been added to section 6.5
Updated on 09 September 2014
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.1 - List of excipients
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.3 Contraindications:
inclusion of reference to: Patients with coronary artery vasospasm (Prinzmetal’s angina),
Section 4.8 Undesirable effects:
amendment of bilirubinaemia to hyperbilirubinaemia under hepatobillary disorders and inclusion of reporting of adverse events to HPRA.
Section 5.1: Pharmacodynamic properties:
Removal of statement “The efficacy of RELPAX in the acute treatment of migraine has been evaluated in 10 placebo-controlled trials that included about 5000 patients who received RELPAX” and replaced with “The efficacy and safety of RELPAX in the acute treatment of migraine has been evaluated in 10 placebo-controlled trials involving more than 6000 patients (all treatment groups)….”
Section 6.1 List of Excipients:
Updated on 09 September 2014
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.1 - List of excipients
Free text change information supplied by the pharmaceutical company
Section 4.3 Contraindications:
inclusion of reference to: Patients with coronary artery vasospasm (Prinzmetal’s angina),
Section 4.8 Undesirable effects:
amendment of bilirubinaemia to hyperbilirubinaemia under hepatobillary disorders and inclusion of reporting of adverse events to HPRA.
Section 5.1: Pharmacodynamic properties:
Removal of statement “The efficacy of RELPAX in the acute treatment of migraine has been evaluated in 10 placebo-controlled trials that included about 5000 patients who received RELPAX” and replaced with “The efficacy and safety of RELPAX in the acute treatment of migraine has been evaluated in 10 placebo-controlled trials involving more than 6000 patients (all treatment groups)….”
Section 6.1 List of Excipients:
Updated on 18 September 2013
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- 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
Update to section 1 in line with version 8 QRD
Update to section 2 in line with version 8 QRD
Sections 4.2 - 4.8 updated in line with Core Safety Profile
Sections 5.1 – 5.2 updated in line with version 8 QRD
Updated on 18 September 2013
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- 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
Update to section 1 in line with version 8 QRD
Update to section 2 in line with version 8 QRD
Sections 4.2 - 4.8 updated in line with Core Safety Profile
Sections 5.1 – 5.2 updated in line with version 8 QRD
Updated on 06 September 2012
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
Addition of Medication overuse headache (MOH) to section 4.4 Special Warnings and Precautions for Use
Including angioedema in section 4.8 undesirable effectsUpdated on 06 September 2012
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
Addition of Medication overuse headache (MOH) to section 4.4 Special Warnings and Precautions for Use
Including angioedema in section 4.8 undesirable effectsUpdated on 08 July 2011
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
Section 4.8: Minor changes to the way two current adverse events are described.
Updated on 08 July 2011
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
Section 4.8: Minor changes to the way two current adverse events are described.
Updated on 26 February 2009
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 26 February 2009
Reasons for updating
- New SPC for medicines.ie