Celebrex 200 mg capsule, hard

  • Name:

    Celebrex 200 mg capsule, hard

  • Company:
    info
  • Active Ingredients:

    Celecoxib

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 31/07/18

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Summary of Product Characteristics last updated on medicines.ie: 17/10/2017
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Pfizer Healthcare Ireland

Pfizer Healthcare Ireland

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1 - 0 of 231 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 31 July 2018 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 5 June 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 17 October 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 17 October 2017 SmPC

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 PIL

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 SmPC

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 PIL

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 SmPC

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 PIL

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 9 September 2014 SmPC

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 9 September 2014 PIL

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 PIL

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 26 February 2014 SmPC

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 6 February 2013 SmPC

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 6 February 2013 PIL

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 SmPC

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 PIL

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.