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CENTRAX Tablets

*
Pharmacy Only: Prescription

  • Company:

    Pfizer Healthcare Ireland

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Prazepam

    *Additional information is available within the SPC or upon request to the company

Updated on 30 May 2023

File name

RegSPCCE151IEclean.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
  • 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 following changes to the labelling have been approved.

The SPC has been updated as follows:

Section 4.2 updated to include:

• Information on the risk of dependence increasing with dose and duration of treatment and the lowest effective dose and duration should therefore be used. Cross reference to section 4.4 added.

• Information on precipitation of withdrawal reactions with abrupt discontinuation or rapid dose reduction. Recommndation for gradual tapering added.

• Duration of treatment section has been added and is stated as "Treatment should be as short as possible". 

Section 4.4 updated to include:

• The statement "Tolerance to benzodiazepines may develop from continued therapy".

• Statements on abrupt termination of treatment or rapid dose reduction has been expanded to include additional withdrawal symptoms.

• Statements on drug abuse added and recommnedations provided for reducing the risks.

Section 4.8 updated to inlcude:

• Drug abuse, Drug dependence and Drug withdrawal syndrome added as side effects (frequency unknown) with cross reference to Section 4.4.

• Cross reference to Section 4.4 added in relation to dependence and drug abuse.

• Updated adverse event reporting requirements 


Updated on 30 May 2023

File name

RegPILCE171IEclean.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 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 13 February 2023

File name

DEC202060480_Reg SPC CE 14_1 IE - clean.pdf

Reasons for updating

  • Document format updated

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

Updated on 11 September 2020

File name

DEC202060480_Reg SPC CE 14_1 IE - clean.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • 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 11 September 2020

File name

DEC202060480_Reg PIL CE 16_1 IE - clean.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 30 January 2018

Reasons for updating

  • New SPC for new product

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

Updated on 30 January 2018

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

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 SPC with the addition of warning (section 4.4) and drug interaction text (section 4.5) related to benzodiazepine/opioid interaction in line with Company Core Data Sheet (CDS).

Updated on 29 January 2018

File name

PIL_8703_213.pdf

Reasons for updating

  • New PIL for new product

Updated on 29 January 2018

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 01 November 2017

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 19 July 2017

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 12 May 2016

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.2 - Incompatibilities

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

Free text change information supplied by the pharmaceutical company

Update to Summary of Product Characteristics in line with QRD Template Version 9.1.

QRD changes to sections 2, 3, 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 5.1 and 6.2.

 

Updated on 07 January 2015

Reasons for updating

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

Updated on 16 September 2014

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

The SPC has been updated to include Nonclinical information on carcinogenesis, mutagenesis, and impairment of fertility. Updates to sections 4.6 Fertility, pregnancy, and lactation and 5.3 Preclinical Safety Data. Section 4.8 Undesirable effects: Reporting of suspected adverse reactions- was updated with the HPRA details

Updated on 10 September 2014

Reasons for updating

  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 09 September 2014

Reasons for updating

  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 31 July 2014

Reasons for updating

  • Change to side-effects
  • Change to further information section
  • Change to date of revision
  • Change to improve clarity and readability
  • Deletion of a pack size
  • Improved electronic presentation

Updated on 27 March 2013

Reasons for updating

  • Change to section 4.3 - Contraindications

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

Free text change information supplied by the pharmaceutical company

Removal of the glaucoma contraindication) section 4.3.

Updated on 27 March 2013

Reasons for updating

  • Change of contraindications
  • Change to date of revision

Updated on 07 April 2011

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • 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

Updates to sections 2 (Qualitative and Quantitative Composition) and 3 (Pharmaceutical form). Update to the SPC and PIL following the IMB request (also includes CDS updates)
Updates to sections 4.4 (Special warnings and precautions for use), 4.6 (Pregnancy and lactation), 4.8 (Undesirable effects), 4.9 (Overdose) and 5.3 (Preclinical safety data).

Updated on 05 April 2011

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to date of revision
  • Change of special precautions for disposal

Updated on 24 March 2010

Reasons for updating

  • Change due to user-testing of patient information

Updated on 17 March 2010

Reasons for updating

  • Change due to user-testing of patient information

Updated on 15 April 2009

Reasons for updating

  • Change to improve clarity and readability

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

Free text change information supplied by the pharmaceutical company

There are no changes to the SPC content

Updated on 23 September 2008

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions

Updated on 19 September 2008

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

section 4.3 - Section updated due to Type II Variation

section 4.5 - Section updated due to Type II Variation

section 5.1 - Section updated due to Type II Variation

Updated on 12 June 2006

Reasons for updating

  • Correction of spelling/typing errors

Updated on 06 February 2006

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 10 - Date of revision of the text

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

Updated on 03 November 2005

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 28 October 2005

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 9 - Date of renewal of authorisation
  • 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 28 October 2005

Reasons for updating

  • Change to marketing authorisation holder
  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to date of revision
  • Change to appearance of the medicine

Updated on 27 October 2005

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients

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

Updated on 13 September 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 14 May 2004

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients

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

Updated on 16 March 2004

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 27 June 2003

Reasons for updating

  • New SPC for medicines.ie

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