Seroxat 30mg Tablets
*Company:
GlaxoSmithKline (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 06 December 2023
File name
ie-pil-seroxattabsissue15draft1-master.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - marketing authorisation holder
Free text change information supplied by the pharmaceutical company
Section 4: Addition of 'Reduction in white blood cell count'
Section 6: Removal of United Kingdom (Northern Ireland) following the withdrawal from the MRP.
Leaflet revision date updated to October 2023
Updated on 06 December 2023
File name
ie-spc-seroxat30mgissue12draft1-master.pdf
Reasons for updating
- 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
In section 4.8: The following adverse reaction(s) have been added under the 'Blood and lymphatic system disorders' subheading, with a frequency Uncommon: Leukopenia
In section 10: updated to 01 December 2023
Updated on 13 February 2023
File name
ie-spc-seroxat30mgissue11draft2 - clean.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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.2 - Pharmacokinetic properties
- 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 13 February 2023
File name
ie-pl-seroxattabsissue14draft3 - clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 12 July 2022
File name
ie-pil-seroxattabsissue13draft1.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 17 February 2021
File name
ie-spc-seroxat30mgissue10draft2.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 4.6 - Pregnancy and lactation
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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 addition of warning relating to postpartum haemorrhage in relation to SSRIs/SNRIs.
Section 4.5 Addition of buprenorphine under Serotonergic drugs section
Section 4.6 addition of information relating to increased risk of postpartum haemorrhage following SSRI/SNRI exposure within month prior to birth
Section 4.8 addition of postpartum haemorrhage under frequency not known
Updated on 17 February 2021
File name
ie-pil-seroxattabsissue12draft2.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 03 September 2020
File name
ie-pil-seroxattabsissue11draft1-medicines.ie.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
Update to section 2 – addition of warning on sodium content
Update to section 4 – addition of Inflammation of the colon (causing diarrhoea) to frequency not known
The MAH has taken the opportunity to align to the EMA product Information template for products authorized via the MR procedure (QRD v 4.1) – minor editorial updates throughout the Leaflet.
Updated on 03 September 2020
File name
ie-spc-seroxat30mgissue9draft1-medicines.ie.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
Section 4.4 Addition of warning on sodium content
Section 4.8 Addition of microscopic colitis to Gastrointestinal disorders under frequency not known
Update to section 4.8 reporting of suspected adverse reactions
The MAH has taken the opportunity to align to the EMA product Information template for products authorized via the MR procedure (QRD v 4.1) – minor editorial updates throughout the SPC.