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Celebrex 200 mg capsule, hard

*
Pharmacy Only: Prescription

  • Company:

    Upjohn EESV

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

  • Active Ingredient(s):

    Celecoxib

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

Updated on 14 November 2023

File name

Patient Information Leaflet - IE - Celebrex - Klocke 14Nov2023.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents

Updated on 11 July 2023

File name

Patient Information Leaflet - Malta LENC - clean.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 17 March 2022

File name

DEC202202890-V_Reg SPC CB 26_0 200mg clean.pdf

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 4.6 – updated wording related to oligohydramnios risk with the use of NSAIDs in the 2nd and 3rd trimester; ‘upon discontinuation’ added.

Updated on 04 August 2021

File name

DEC202110079-V_Reg SPC CB 25_0 200mg 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 be renewed (B)

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 04 August 2021

File name

DEC202110079-V_Reg PIL CB 28_1 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

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 21 April 2021

File name

DEC202105563-V_Reg SPC CB 24_3 200mg IE - clean.pdf

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Updated inline with QRD template and/or excipient guideline

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: 

  • Update to name of the medicinal product in Section 1 and 3 of the SPC
  • Addition of Celebrex contains sodium subsection with information related to sodium as excipient in section 4.4 of the SPC
  • Addition of influence on driving and use of machines in section 4.7 of the SPC

Minor editorial changes throughout the SPC and QRD alignment

Updated on 21 April 2021

File name

DEC202105563-V_Reg PIL CB 27_3 IE - clean.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • 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
  • Change to other sources of information section

Updated on 09 October 2020

File name

Reg PIL CB 26_0 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 16 December 2019

File name

DEC201970444_Reg SPC CB 23_3 200mg IE-clean.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 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

In Section 4.4 Special warnings and precautions of use, antiplatelet drugs have been added under the sub section Gastrointestinal(GI) effects.

Minor formatting updates have been made to sections 4.2, 4.4 and 4.5.

Updated on 16 December 2019

File name

DEC201970444_Reg PIL CB 24_0 IE-clean.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 14 November 2019

File name

DEC201963772_Reg SPC CB 22_1 200mg IE.pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

All SPCs - Section 5.1 – Precision study results have been added.

Updated on 31 July 2018

File name

Reg PIL CB 23_0 IE _1-clean.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 05 June 2018

File name

Reg PIL CB 22_1 IE clean (2).pdf

Reasons for updating

  • New PIL for new product

Updated on 17 October 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 17 October 2017

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 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

·         Section 4.4 updated to clarify that the increase in risk for cardiovascular (CV) thromboembolic events associated with non-aspirin NSAIDs use occurs irrespective of the presence of underlying cardiovascular disease (CVD) or CV risk factors. This update is based on the results of a comprehensive assessment of medical literature and safety database.

·         Section 4.6 updated with oligohydramnios risk associated with the use of NSAIDs in the second and third trimester of pregnancy.

·         Sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 6.6 – editorial/QRD changes including spelling of sulphonamide to sulfonamide

Updated on 17 October 2017

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 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • 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 updated to clarify that the increase in risk for cardiovascular (CV) thromboembolic events associated with non-aspirin NSAIDs use occurs irrespective of the presence of underlying cardiovascular disease (CVD) or CV risk factors. This update is based on the results of a comprehensive assessment of medical literature and safety database.

·         Section 4.6 updated with oligohydramnios risk associated with the use of NSAIDs in the second and third trimester of pregnancy.

·         Sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 6.6 – editorial/QRD changes including spelling of sulphonamide to sulfonamide

Updated on 15 April 2016

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 5.3 - updated in order to provide greater granularity of information which could be of relevance for the prescriber, in recognising the safety profile of the medicinal product used for the authorised indications. This change does not impact the PIL.

Sections 2, 4.1, 4.2, 4.3, 4.4, 4.5, 4.8, 5.1, 5.2, 6.1 – updated in line with QRD v9.1 and minor editorial changes.

Updated on 15 April 2016

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 5.3 - updated in order to provide greater granularity of information which could be of relevance for the prescriber, in recognising the safety profile of the medicinal product used for the authorised indications. This change does not impact the PIL.

Sections 2, 4.1, 4.2, 4.3, 4.4, 4.5, 4.8, 5.1, 5.2, 6.1 – updated in line with QRD v9.1 and minor editorial changes.

Updated on 27 August 2015

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Sections 4.1, 4.3, 5.1 - editorial changes
Section 4.2 - safety related information pertaining to an alternative method of administration for patients who have difficulty swallowing capsules.
Section 4.4 - safety related information pertaining to the risk of lower gastrointestinal events in patients treated with celecoxib, and interaction of NSAIDs with glucocorticoids, with alcohol and with oral anticoagulants.
Section 4.5 - safety related information pertaining to diminished antihypertensive effect with concomitant use of NSAIDs with antihypertensive drugs (i.e., angiotensin converting enzyme inhibitors [ACEIs], angiotensin II antagonists [ARB], diuretics and beta-blockers) and interaction with ciclosporin. In addition changes are proposed for the current text regarding CYP2D6 inhibition.
Section 4.8 -  addition of pneumonitis as ADR plus an update of ADR terms from non MedDRA PT to MedDRA PT terms.
Section 5.2 - information related to absorption of celecoxib and the alternative method of administration for patients who have difficulty swallowing capsules.
Some editorial changes were made to other sections of the SPC.

Updated on 27 August 2015

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Free text change information supplied by the pharmaceutical company

Sections 4.1, 4.3, 5.1 - editorial changes
Section 4.2 - safety related information pertaining to an alternative method of administration for patients who have difficulty swallowing capsules.
Section 4.4 - safety related information pertaining to the risk of lower gastrointestinal events in patients treated with celecoxib, and interaction of NSAIDs with glucocorticoids, with alcohol and with oral anticoagulants.
Section 4.5 - safety related information pertaining to diminished antihypertensive effect with concomitant use of NSAIDs with antihypertensive drugs (i.e., angiotensin converting enzyme inhibitors [ACEIs], angiotensin II antagonists [ARB], diuretics and beta-blockers) and interaction with ciclosporin. In addition changes are proposed for the current text regarding CYP2D6 inhibition.
Section 4.8 -  addition of pneumonitis as ADR plus an update of ADR terms from non MedDRA PT to MedDRA PT terms.
Section 5.2 - information related to absorption of celecoxib and the alternative method of administration for patients who have difficulty swallowing capsules.
Some editorial changes were made to other sections of the SPC.

Updated on 09 September 2014

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.8 - ADR ‘accidental injury (injury)’ added as common; frequencies of several other ADRs changed; HPRA details added for reporting of adverse reactions due to IMB name change

Updated on 09 September 2014

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Free text change information supplied by the pharmaceutical company

Section 4.8 - ADR ‘accidental injury (injury)’ added as common; frequencies of several other ADRs changed; HPRA details added for reporting of adverse reactions due to IMB name change

Updated on 26 February 2014

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 1, Section 2, Section 4.1, Section 4.2, Section 4.3, Section 4.4, Section 4.5, Section 4.6, Section 4.8,  Section 5.1,  Section 5.2, Section 6.1:   

Updated on 26 February 2014

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients

Free text change information supplied by the pharmaceutical company

Section 1, Section 2, Section 4.1, Section 4.2, Section 4.3, Section 4.4, Section 4.5, Section 4.6, Section 4.8,  Section 5.1,  Section 5.2, Section 6.1:   

Updated on 06 February 2013

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.1 - List of excipients

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 6.1: editorial changes to list of excipients;
Section 6.5: clarification of blister type

Updated on 06 February 2013

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.1 - List of excipients

Free text change information supplied by the pharmaceutical company

Section 6.1: editorial changes to list of excipients;
Section 6.5: clarification of blister type

Updated on 17 January 2013

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Sections 4.4 & 4.5: information on interaction of NSAIDs with ACE inhibitors added; Section 4.8: Drug rash with eosinophilia and systemic symptoms (DRESS) or hypersensitivity syndrome added as ADR.

Updated on 17 January 2013

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

Free text change information supplied by the pharmaceutical company

Sections 4.4 & 4.5: information on interaction of NSAIDs with ACE inhibitors added; Section 4.8: Drug rash with eosinophilia and systemic symptoms (DRESS) or hypersensitivity syndrome added as ADR.