CENTRAX Tablets
*Company:
Pfizer Healthcare IrelandStatus:
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 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
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 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 4.5 - 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)