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Xanax 1 mg Tablets

*
Pharmacy Only: Prescription

  • Company:

    Upjohn EESV

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Alprazolam

    *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 24 February 2022

File name

DEC202202014-V_Reg SPC XX 15_0 1 mg 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 1 mg 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 1 mg 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 1 mg 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 1 mg 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 1 mg 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 19 May 2016

File name

PIL_11256_721.pdf

Reasons for updating

  • New PIL for new product

Updated on 19 May 2016

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to instructions about missed dose
  • Change to instructions about overdose
  • Change to drug interactions
  • Change to information about pregnancy or lactation

Updated on 02 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 QRD

Updated on 27 November 2014

Reasons for updating

  • Change to side-effects

Updated on 21 January 2014

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated 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

None provided

Updated on 30 May 2012

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about overdose
  • Change to side-effects
  • Change to further information section
  • Change to date of revision
  • Change to dosage and administration
  • Change to improve clarity and readability
  • Change due to user-testing of patient information

Updated on 09 May 2012

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 04 May 2012

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 14 November 2011

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 15 December 2010

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 14 April 2010

Reasons for updating

  • Change to improve clarity and readability

Updated on 27 February 2008

Reasons for updating

  • Change to packaging
  • Change to date of revision

Updated on 31 October 2006

Reasons for updating

  • Change of manufacturer

Updated on 21 August 2006

Reasons for updating

  • New PIL for new product