Xanax 500 microgram Tablets
*Company:
Upjohn EESVStatus:
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 11 January 2024
File name
ie-pl-clean-Dec2023_Xanax.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
- Addition of manufacturer
Updated on 22 May 2023
File name
Patient Information Leaflet - 002990072.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
Updated on 24 February 2022
File name
DEC202202014-V_Reg SPC XX 15_0 500 mcg Tab IE - Clean.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
- Update to section 4.1 - Therapeutic indications
- Update to section 4.2 – Posology and method of administration
- Update to section 4.4 - Special warnings and precautions for use
- Update to section 4.8 - ADR reporting
Updated on 24 February 2022
File name
DEC202202014-V_Reg PIL XX 19_2 tabs IE - Clean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - duration of treatment
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 21 December 2021
File name
Reg PIL XX 18_1 tabs IE - clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 09 November 2021
File name
DEC202114551-V_Reg SPC XX 14_0 500 mcg Tab 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Section 7 - Pfizer Healthcare Ireland changed to Upjohn EESV as the MAH, with updated address
Section 8 - updated with new PA number for Upjohn EESV
Updated on 09 November 2021
File name
DEC202114551-V_Reg PIL XX 18_0 tabs 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 23 December 2020
File name
DEC202052422-V_Reg SPC XX 12_0 500 mcg Tab IE-clean.pdf
Reasons for updating
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 December 2019
File name
DEC201968219_Reg PIL XX 15_1 tabs IE.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - duration of treatment
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 06 December 2019
File name
DEC201968219_Reg SPC XX 11_2 500 mcg Tab IE.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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 not be renewed (A)
Updated on 27 February 2019
File name
DEC201909741_Reg SPC XX 10_2 500 mcg Tab IE.pdf
Reasons for updating
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 5.3 Preclinical safety data is updated to include text related to neurotoxic effects of anesthetic and sedation drugs used in young children and pregnant women.
Updated on 12 October 2018
File name
Reg PIL XX 14_7 tabs IE.pdf
Reasons for updating
- Change to section 2 - use in children and adolescents
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - excipient warnings
- Change to section 3 - how to take/use
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 12 October 2018
File name
Reg SPC XX 9_3 500 mcg Tab IE.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- 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 4.7 - Effects on ability to drive and use machines
- Change to section 5.3 - Preclinical safety data
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
- Section 2 Addition of excipient with known effect
- Section 4.4 Addition of warning
- Section 4.5 Addition of rug interaction text related to benzodiazepine/opioid interaction
Sections 4.2, 4.7, 5.3 and 6.5: QRD updates
Updated on 23 May 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 23 May 2016
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 4.7 - Effects on ability to drive and use machines
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
· Section 4.4: Warning added for elderly patients that Benzodiazepines and related products should be used with caution due to the risk of sedation and / or musculoskeletal weakness that can promote falls, often with serious consequences in this population.
Sections 2, 4.2, 4.3, 4.4, 4.6, 4.7, 6.5 and 6.6: updated in line with QRD v9.1
Updated on 23 May 2016
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 4.7 - Effects on ability to drive and use machines
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
· Section 4.4: Warning added for elderly patients that Benzodiazepines and related products should be used with caution due to the risk of sedation and / or musculoskeletal weakness that can promote falls, often with serious consequences in this population.
Sections 2, 4.2, 4.3, 4.4, 4.6, 4.7, 6.5 and 6.6: updated in line with QRD v9.1
Updated on 19 May 2016
File name
PIL_11256_721.pdf
Reasons for updating
- New PIL for new product
Updated on 01 December 2014
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.8: Revision of the ADRs and frequencies table to align with the CDS
Update to include HPRA details for reporting of suspected adverse reactions.
Section 6.6: Revision of section title in line with QRDUpdated on 01 December 2014
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.6 - Special precautions for disposal and other handling
Free text change information supplied by the pharmaceutical company
Section 4.8: Revision of the ADRs and frequencies table to align with the CDS
Update to include HPRA details for reporting of suspected adverse reactions.
Section 6.6: Revision of section title in line with QRDUpdated on 20 January 2014
Reasons for updating
- New individual SPC (was previously included in combined SPC)
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 20 January 2014
Reasons for updating
- New individual SPC (was previously included in combined SPC)