Skudexa 75 mg/25 mg film-coated tablets
*Company:
A. Menarini Pharmaceuticals Ireland LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 17 January 2023
File name
ie-spc Skudexa Tabs Clean Dec 22.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- 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
Section 4.6 - Pregnancy Warnings updated
Section 10 - Date of Revision updated
Updated on 17 January 2023
File name
ie-pl Skudexa Tabs Clean Dec 22.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to date of revision
Free text change information supplied by the pharmaceutical company
Section 2 - Pregnancy warnings updated
Section 6 - Date of revision updated
Updated on 10 October 2022
File name
ie-spc Skudexa Tabs Clean Approved Oct 22.pdf
Reasons for updating
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Black Triangle Removed
Updated on 10 October 2022
File name
ie-pl Skudexa Tabs Clean Approved Oct 22.pdf
Reasons for updating
- Removal of Black Inverted Triangle
Free text change information supplied by the pharmaceutical company
Removal of Black Triangle
Updated on 20 January 2022
File name
ie-spc Skudexa Tabs Clean - Approved Jan 22.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 4.6 - Pregnancy and lactation
- 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
Section 4.2 - "dysfunction" replaced with "impairment"
Section 4.3 - "dysfunction" replaced with "impairment"
Section 4.4 - new section added - "Masking of symptoms of underlying infections" and other minor amends
Section 4.6 - "dysfunction" replaced with "impairment"
Section 6.1 - Typo amended
Section 10 - Date of revision updated
Updated on 20 January 2022
File name
ie-pl Skudexa Tabs Clean - Approved Jan 22.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Section 2 - warnings and precautions - information on infections added
Section 3 - Dosing information updated and information on infections added
Section 10 - date of revision updated
Updated on 09 August 2021
File name
ie-spc Skudexa Tabs Clean - Approved August 21 - Serotonin PRAC.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
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- 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
Section 4.4 - New section on Serotonin Syndrome added
Section 4.5 - Combinations requiring precautions updated for serotonin syndrome warning
Section 4.8 - Serotonin syndrome added as a new adverse event (frequency not known)
Section 4.9 - Serotonin syndrome added to Tramadol section
Section 10 - Date of revision updated
Updated on 09 August 2021
File name
ie-pl Skudexa Tabs Clean - Approved August 21 - Serotonin PRAC.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Section 2 - Information on serotonin syndrome added
Section 4 - serotonin syndrome added as an adverse event
section 6 - date of revision updated
Updated on 13 July 2021
File name
ie-spc Skudexa tabs clean approved June 21.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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.4 - warnings for adrenal insuficciency and sleep related breating disorders added
Section 4.8 - Hiccups added as a side effect (frequency unknown) and how to report a side effect HPRA reporting details updated
Section 10 - date of revision updated
Updated on 13 July 2021
File name
ie-pl Skudexa tabs clean approved June 21.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Section 2 - warnings for adrenal insuficciency and sleep related breating disorders added
Section 4 - Hiccups added as a side effect (frequency unknown) and how to report a side effect HPRA reporting details updated
Section 6 - date of revision updated
Updated on 02 May 2021
File name
ie-spc Skudexa tabs clean April 21.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- 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
Section 6.3 - information on different types of blisters deleted and shelf life increased from 23/36 months to 5 years
Section 10 - date of revision updated
Updated on 10 December 2020
File name
ie-spc Skudexa tabs clean 19-10-20.pdf
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
File name
ie-pl Skudexa Clean 9-11-20.pdf
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
File name
ie-spc Skudexa tabs clean 30-10-19.pdf
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
File name
ie-spc Skudexa 18-1-19 clean.pdf
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
File name
ie-pl Skudexa black triangle clean 28-9-18.pdf
Reasons for updating
- New PIL for new product
Updated on 25 October 2018
File name
ie-spc Skudexa 28-9-18 clean.pdf
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