Cataflam 50 mg Coated Tablets *

  • Company:

    Novartis Ireland Limited
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may be renewed (B)
  • Active Ingredient(s):

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

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 28 January 2021

File name

Cataflam 50mg REG PIL PF20-188_TBI 21 July 2021_clean IPHA_1611825263.pdf

Reasons for updating

  • Change to section 2 - excipient warnings

Free text change information supplied by the pharmaceutical company

Addition of sodium free statement. 

Updated on 28 January 2021

File name

Cataflam 50mg REG SPC PF20-188 Jan 2021 clean IPHA_1611823648.pdf

Reasons for updating

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

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

Free text change information supplied by the pharmaceutical company

Addition of sodium free statement

Updated on 18 November 2019

File name

Cataflam 50mg REG SPC PF19-119 November 2019 clean IPHA_1574074509.pdf

Reasons for updating

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

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

Free text change information supplied by the pharmaceutical company

  • Section 4.4: Addition of wording regarding increased risk of gastro-intestinal anastomotic leak associated with NSAID use
  • Section 4.4: Addition of wording regarding hypersensitivity reactions progressing to Kounis syndrome, a serious allergic reaction that can result in myocardial infarction

Updated on 18 November 2019

File name

Cataflam 50mg REG PIL PF19-119 September 2019 clean_1574074445.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 10 January 2019

File name

Cataflam 50mg REG PIL PF18-039 clean_1547132723.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 4 - possible side effects

Updated on 10 January 2019

File name

Cataflam 50mg REG SPC PF18-039 January 2019 clean IPHA_1547129753.pdf

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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

  • Section 4.4 has been updated to include the following text “CYP2C9 inducers: Caution is recommended when co-prescribing diclofenac with CYP2C9 inducers (such as rifampicin), which could result in a significant decrease in plasma concentration and exposure to diclofenac”.|
  • Section 4.8 has been updated the include “Kounis syndrome” with a Frequency “Not known”

 

Updated on 21 August 2018

File name

Cataflam REG PIL 1815655 PF18-183 Brexit TBI 29 December 2018 IPHA_1534850412.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 18 July 2018

File name

Cataflam 50 REG SPC PF18-183 July 2018 clean IPHA.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 29 November 2016

File name

PIL_10791_648.pdf

Reasons for updating

  • New PIL for new product

Updated on 29 November 2016

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects

Updated on 25 October 2016

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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

Update Section 4.5: Deletion of the word “isolated” when describing reports of interaction between diclofenac and anticoagulants

Update Section 4.8: Addition of “ischemic colitis” as an adverse reaction with frequency “not known”

Updated on 25 October 2016

Reasons for updating

  • New SPC for new product

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

Updated on 16 September 2015

Reasons for updating

  • Discontinuation of one or more strengths
  • Addition of information on reporting a side effect.

Updated on 28 July 2015

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

Change IMB to HPRA

Updated on 27 March 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions

Updated on 25 March 2014

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 5.3 - Preclinical safety data

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

Free text change information supplied by the pharmaceutical company

Section 4.2: A dosage recommendation has been added for special populations (renal and hepatic impaired patients)

Section 4.3: Established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease added as contraindications

Section 4.4: Warning that patients with significant risk factors for cardiovascular events should only be treated with diclofenac after careful consideration for the shortest duration possible and at the lowest effective daily dose

Section 4.4: Warning to alert the patients to the signs and symptoms of the serious arteriothrombotic events

Section 4.5: A new interaction between systemic diclofenac containing products and drugs known to cause hyperkalemia has been included

Section 4.8: The frequency of cardiac disorders is changed from very rare to uncommon

Section 4.8:  Revision of the adverse drug reactions according to the last MedDRA terms and reporting requirements for suspected adverse events added.

Section 5.3: Addition of nonclinical data regarding the contraindication during the third trimester

Updated on 26 September 2013

Reasons for updating

  • 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

Inclusion of the limited clinical trial experience of the use of diclofenac in Juvenile Rheumatoid Arthritis (JRA)/Juvenile Idiopathic Arthritis (JIA) paediatric patients

Updated on 04 July 2013

Reasons for updating

  • Change to drug interactions
  • Change due to user-testing of patient information

Updated on 06 March 2013

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 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

·         Update SPC Section 4.5 to include new interactions between systemic diclofenac containing products and potent CYP2C9 inhibitors, as well as phenytoin

 

·         Update SPC Sections 4.3, 4.4, 4.5, 4.6 and 4.8  to align with the CCDS and CSP that was agreed during PSUR worksharing

Updated on 27 April 2011

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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

Changes due to approval of renewal

Updated on 23 March 2011

Reasons for updating

  • Change to improve clarity and readability
  • Change to product name

Updated on 20 May 2009

Reasons for updating

  • 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

Addition of hepatic failure and hepatic necrosis as very rare ADRs to the existing description of hepatic events in the section 4.8

Updated on 20 May 2009

Reasons for updating

  • Change to side-effects
  • Improved electronic presentation

Updated on 15 May 2009

Reasons for updating

  • Change to side-effects

Updated on 25 June 2008

Reasons for updating

  • Change to section 3 - Pharmaceutical form

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

Free text change information supplied by the pharmaceutical company

Changes to Section 3: Removal of tablet markings

Updated on 24 June 2008

Reasons for updating

  • Change of inactive ingredient

Updated on 24 June 2008

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 3 - Pharmaceutical form

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

Free text change information supplied by the pharmaceutical company

Change to Section 3 - removal of tablet markings
Change to Section 6 - reduction o fshelf-life from 5 to 3 years

Updated on 13 April 2007

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 14 December 2006

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data

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

Free text change information supplied by the pharmaceutical company

The changes follow a BPI update

Updated on 24 March 2006

Reasons for updating

  • New PIL for medicines.ie

Updated on 24 March 2006

Reasons for updating

  • New SPC for medicines.ie

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