Celebrex 100 mg Capsules, hard

  • Name:

    Celebrex 100 mg Capsules, 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: 16/12/19

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Summary of Product Characteristics last updated on medicines.ie: 16/12/2019

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Pfizer Healthcare Ireland

Pfizer Healthcare Ireland

Company Products

Medicine NameActive Ingredients
Medicine Name Accupro 10 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 20 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 40 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 5 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accuretic 20 mg/12.5 mg Tablets Active Ingredients Hydrochlorothiazide, Quinapril hydrochloride
Medicine Name Aciclovir 25 mg/ml Concentrate for Solution for Infusion. Active Ingredients Aciclovir sodium
Medicine Name Aldactone 100mg film coated tablets Active Ingredients Spironolactone
Medicine Name Aldactone 25mg film-coated tablets Active Ingredients Spironolactone
Medicine Name Aldactone 50 mg Film-coated tablets. Active Ingredients Spironolactone
Medicine Name Amlodipine Pfizer 10 mg Tablets Active Ingredients Amlodipine besilate
Medicine Name Amlodipine Pfizer 5 mg Tablets Active Ingredients Amlodipine besilate
Medicine Name Anugesic HC Cream Active Ingredients Balsam Peru, Benzyl Benzoate, Bismuth Oxide, Hydrocortisone Acetate, Pramocaine Hydrochloride, Zinc Oxide
Medicine Name ARICEPT 10 mg film coated tablets Active Ingredients Donepezil Hydrochloride
Medicine Name ARICEPT 5 mg film coated tablets Active Ingredients Donepezil Hydrochloride
Medicine Name Aromasin 25 mg coated tablets Active Ingredients Exemestane
Medicine Name Arthrotec 50 Active Ingredients Diclofenac Sodium, Misoprostol
Medicine Name Arthrotec 75 modified-release tablets Active Ingredients Diclofenac Sodium, Misoprostol
Medicine Name Ativan 1mg Tablets Active Ingredients Lorazepam
Medicine Name ATIVAN INJECTION Active Ingredients Lorazepam
Medicine Name BeneFIX Active Ingredients nonacog alfa
Medicine Name BESPONSA 1 mg powder for concentrate for solution for infusion Active Ingredients Inotuzumab ozogamicin
Medicine Name Bosulif 100 mg, 400 mg & 500 mg film-coated tablets Active Ingredients Bosutinib monohydrate
Medicine Name Cabaser 1mg Tablet Active Ingredients Cabergoline
Medicine Name Cabaser 2mg Tablet Active Ingredients Cabergoline
Medicine Name CAMPTO 20 mg/ml, concentrate for solution for infusion Active Ingredients Irinotecan hydrochloride trihydrate
1 - 0 of 232 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 16 December 2019 SmPC

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 SmPC

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 18 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 18 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 18 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 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 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 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



Updates to:
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 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



Updates to:
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 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container

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 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container

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 PIL

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

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 SmPC

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 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 29 February 2012 PIL

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

SPC - Sections 7 (MAH name), 8 (MA number), 10 (revision date)

Updated on 29 February 2012 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

SPC - Sections 7 (MAH name), 8 (MA number), 10 (revision date)

Updated on 24 October 2011 PIL

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

SmPC changes to section 7 - MA holder name change and Section 10 – revision date.

Updated on 24 October 2011 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

SmPC changes to section 7 - MA holder name change and Section 10 – revision date.

Updated on 18 November 2010 SmPC

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

Addition of data to section 5.1 of the SmPC

Updated on 18 November 2010 PIL

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

Free text change information supplied by the pharmaceutical company

Addition of data to section 5.1 of the SmPC

Updated on 23 August 2010 PIL

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 4.8 - Undesirable effects
  • 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

Free text change information supplied by the pharmaceutical company

SmPC

4.8 - addition of adverse reactions

6.1 - addition of shellac and propylene glycol as excipients in the Ink (note the excipients have not changed, just the description in the SmPC & PIL)

6.5 - addition of statement indicating that not all pack sizes are marketed

9 - update to date last renewed

10 - date of revision of text updated

Updated on 23 August 2010 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 4.8 - Undesirable effects
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

SmPC

4.8 - addition of adverse reactions

6.1 - addition of shellac and propylene glycol as excipients in the Ink (note the excipients have not changed, just the description in the SmPC & PIL)

6.5 - addition of statement indicating that not all pack sizes are marketed

9 - update to date last renewed

10 - date of revision of text updated

Updated on 3 August 2009 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Section 6.5 - addition of a bulk pack size

Section 10 - date last updated

Updated on 3 August 2009 PIL

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Section 6.5 - addition of a bulk pack size

Section 10 - date last updated

Updated on 22 January 2009 PIL

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

4.4: addition of information about reported cases of severe hepatic reactions

4.8 addition of post-marketing adverse drug reactions: fulminant hepatitis, liver necrosis, acute generalised exanthematous pustulosis and expansion of hepatic failure text to include sometimes fatal or requiring liver transplant

Updated on 22 January 2009 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

4.4: addition of information about reported cases of severe hepatic reactions

4.8 addition of post-marketing adverse drug reactions: fulminant hepatitis, liver necrosis, acute generalised exanthematous pustulosis and expansion of hepatic failure text to include sometimes fatal or requiring liver transplant

Updated on 12 May 2008 PIL

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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
  • 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
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

 

2 – addition of quantity of lactose monohydrate

4.2 – addition of advice for CYP2C9 poor metabolisers

4.4 – advice to monitor blood pressure as celecoxib can lead to onset of new or worsening of existing hypertension, advice to monitor patients at greatest risk of renal toxicity

4.5 – addition of results from interaction study with lisinopril, ciclosporin spelling updated, advice for CYP2C9 poor metabolisers

4.6 – administration of celecoxib to a limited number of lactating women has shown a very low rate of transfer of celecoxib into breast milk

4.8 – extensively rewritten to include adverse events from PSUR11, PreSAP  and APC trials

5.1 – addition of Pharmacotherapeutic group, addition of data from PreSAP, APC and ADAPT trials

5.2 – addition of CYP2C9 data

6.1 – administrative update

9 – addition of date of last renewal

10 – update to date last updated

Updated on 12 May 2008 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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
  • 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
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

 

2 – addition of quantity of lactose monohydrate

4.2 – addition of advice for CYP2C9 poor metabolisers

4.4 – advice to monitor blood pressure as celecoxib can lead to onset of new or worsening of existing hypertension, advice to monitor patients at greatest risk of renal toxicity

4.5 – addition of results from interaction study with lisinopril, ciclosporin spelling updated, advice for CYP2C9 poor metabolisers

4.6 – administration of celecoxib to a limited number of lactating women has shown a very low rate of transfer of celecoxib into breast milk

4.8 – extensively rewritten to include adverse events from PSUR11, PreSAP  and APC trials

5.1 – addition of Pharmacotherapeutic group, addition of data from PreSAP, APC and ADAPT trials

5.2 – addition of CYP2C9 data

6.1 – administrative update

9 – addition of date of last renewal

10 – update to date last updated

Updated on 5 April 2007 PIL

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

Free text change information supplied by the pharmaceutical company

 
Section 5.1 Wording updated to "Celecoxib was evaluated for the symptomatic treatment of ankylosing spondylitis in 896 patients in placebo and active controlled trials of up to 12 weeks duration."

Updated on 5 April 2007 SmPC

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

 
Section 5.1 Wording updated to "Celecoxib was evaluated for the symptomatic treatment of ankylosing spondylitis in 896 patients in placebo and active controlled trials of up to 12 weeks duration."

Updated on 9 March 2007 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

 
Section 4.1  addition of ankylosing spondylitis as a new indication

Section 4.2  dosing instructions for AS indication

Section 5.1  new information relating to AS
 
Section 10  Change to date of revision of the text

Updated on 9 March 2007 PIL

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

 
Section 4.1  addition of ankylosing spondylitis as a new indication

Section 4.2  dosing instructions for AS indication

Section 5.1  new information relating to AS
 
Section 10  Change to date of revision of the text

Updated on 19 April 2006 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

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

Updated on 19 April 2006 PIL

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Updated on 11 May 2005 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

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

Updated on 11 May 2005 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

Updated on 12 July 2004 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

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

Updated on 12 July 2004 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

Updated on 18 March 2004 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

Updated on 18 March 2004 PIL

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Updated on 3 July 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 3 July 2003 PIL

Reasons for updating

  • New SPC for medicines.ie