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Skudexa 75 mg/25 mg film-coated tablets

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 10/12/20

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Summary of Product Characteristics last updated on medicines.ie: 10/12/2020
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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A. Menarini Pharmaceuticals Ireland Ltd

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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 10 December 2020 SPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Changes to side effect reporting details for the HPRA

Changes to "what Skudexa contains" (Opadry II white 85F1842 composed byOpadry II white 85F1842)

 

Updated on 10 December 2020 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision
  • Change to other sources of information section

Free text change information supplied by the pharmaceutical company

Changes to side effect reporting details for the HPRA

Changes to "what Skudexa contains" (Opadry II white 85F1842 composed byOpadry II white 85F1842)

Changes to member states 

 

Updated on 14 January 2020 SPC

Reasons for updating

  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to section 5.3 with the results of Environmental Risk Assessment (ERA) studies for dexketoprofen.

Updated on 20 March 2019 SPC

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 25 October 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 25 October 2018 SPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

New product