Cataflam 50 mg Coated Tablets
*Company:
Novartis Ireland LimitedStatus:
No Recent UpdateLegal 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
Updated on 05 October 2022
File name
Cataflam 50mg REG SPC PF21-197 & 22-146 27-09-22_clean IPHA.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
Section 4.4: Editorial changes to sucrose warning
Section 4.8: Inclusion of wording describing the risk of oligohydramnios and ductus arteriosus constriction in pregnancy after week 20.
Updated on 05 October 2022
File name
Cataflam REG PIL PF21-197 & 22-146_clean IPHA.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
Free text change information supplied by the pharmaceutical company
Additional recommendations regarding use during pregnancy, particularly after the 20th week.
Updated on 02 December 2021
File name
Cataflam REG PIL PF21-125_clean IPHA.pdf
Reasons for updating
- Change to name of manufacturer
Free text change information supplied by the pharmaceutical company
New manufacturer
Updated on 28 January 2021
File name
Cataflam 50mg REG PIL PF20-188_TBI 21 July 2021_clean IPHA.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.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.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.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.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.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.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
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
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 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
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
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
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
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
Updated on 24 June 2008
Reasons for updating
- Change of inactive ingredient
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
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)
Updated on 24 March 2006
Reasons for updating
- New PIL for medicines.ie