Celebrex 200 mg capsule, hard
- Name:
Celebrex 200 mg capsule, hard
- Company:
Pfizer Healthcare Ireland
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 09/10/20
(Click to Download)Click on this link to Download PDF directly
Pfizer Healthcare Ireland
Company Products
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 9 October 2020 PIL
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 SPC
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 PIL
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 SPC
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 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 SPC
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 SPC
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 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 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 15 April 2016 SPC
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 27 August 2015 SPC
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 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
Updated on 9 September 2014 SPC
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
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
Updated on 26 February 2014 SPC
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
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 6.5: clarification of blister type
Updated on 6 February 2013 SPC
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 6.5: clarification of blister type
Updated on 17 January 2013 SPC
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
Updated on 17 January 2013 PIL
Reasons for updating
- New individual SPC (was previously included in combined SPC)