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Salofalk 250mg gastro-resistant tablets

*
Pharmacy Only: Prescription

  • Company:

    DR. FALK PHARMA GMBH

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Mesalazine

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

Updated on 03 January 2024

File name

Salofalk 250mg tablets IE SmPC-sept2023.pdf

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 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

4.2 added that duration of use is to be determined by physician.

4.4 added to stop use if renal function deteriorates. Added warnings on serious blood dyscrasias and cardiac hypersensitivity reactions.

4.8 added common undesirable effects of rash and pruritus.

Updated on 03 January 2024

File name

Salofalk-250mg-tablet-PILsept2023.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

4. added rash and itching and re-worded and reorganized the whole section. 

Updated on 03 February 2023

File name

Salofalk-250mg-tablet-PIL-Jan2023.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

addition of:

information on interaction of mesalazine and bleach.

DRESS adverse reaction.

addition of symptoms related to DRESS adverse reactions.

Updated on 03 February 2023

File name

Salofalk 250mg tablets IE SmPCJan2023.pdf

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 on interaction of mesalazine and bleach.

DRESS adverse reaction.

4.8: addition of DRESS adverse reactions.

Updated on 01 February 2022

File name

Salofalk-250mg-tablet-PIL-Jan2022.pdf

Reasons for updating

  • Change to section 6 - what the product contains

Free text change information supplied by the pharmaceutical company

Delete anhydrous from sodium carbonate name

Updated on 01 February 2022

File name

Salofalk 250mg tablets IE SmPCJan2022.pdf

Reasons for updating

  • 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

Delete anhydrous from sodium carbonate name

Updated on 26 January 2021

File name

Salofalk-250mg-tablet-PIL-Jan2021 - clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Implementation of Type IAIN variation C.1.3.a to update the SmPC/PIL due to the outcome of PSUSA/00001990/202002 adopted by the PRAC committee and CMDh position of 10/2020 relating to mesalazine and side effects of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)

Updated on 26 January 2021

File name

Salofalk 250mg tablets IE SmPCJan2021.pdf

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

Section 4.4 added warning on severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)

Section 4.8 added Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN) under the SOC Skin and subcutaneous tissue disorders with a frequency unknown.  Added summary of safety profile - severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in association with mesalazine treatment (see section 4.4).

Updated on 06 November 2019

File name

Salofalk-250mg-tablet-PIL-Nov19.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Warning and possible adr relating to nephrolithiasis

Updated on 06 November 2019

File name

Salofalk 250mg tablets IE SmPCNov19.pdf

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

Warning and possible adr relating to nephrolithiasis

Updated on 18 June 2019

File name

Salofalk-250mg-tablet-PIL-Feb19.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 18 June 2019

File name

Salofalk 250mg tablets IE SmPC Feb19.pdf

Reasons for updating

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

Update to information on sodium content.  Update to frequencies of possible side effects.

Updated on 01 December 2017

Reasons for updating

  • New SPC for new product

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

Updated on 01 December 2017

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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

Addition of side effect according to PRAC recommendations

Updated on 29 November 2017

File name

PIL_11596_815.pdf

Reasons for updating

  • New PIL for new product

Updated on 29 November 2017

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 03 June 2015

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 - how to report a side effect
  • 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

All QRD template updates and minor admin, spelling, changes and corrections

Updated on 29 May 2015

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.
  • Correction of spelling/typing errors

Updated on 07 March 2012

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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 4.9 - Overdose
  • 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

4.3 Contraindications - removed contraindications relating to ulcers and haemorrhagic diathesis
4.5 Interactions - removed majority of contraindications.  Added contraindications relating to thioguanine and warfarin.
4.8 Undesirable effects - added effects under "cardiac disorders", Respiratory, thoracic and mediastinal disorders" and "gastrointestinal disorders"
4.9 Overdose - new advice
10  Approved Feb 2012

Updated on 05 March 2012

Reasons for updating

  • Change of contraindications
  • Change to instructions about overdose
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision

Updated on 01 August 2011

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change due to user-testing of patient information

Updated on 23 May 2011

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 5.3 - Preclinical safety data
  • 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

4.2 updated concerning dosing in children.  4.3 - 5.3 updated in full to bring into line with more up to date information in Salofalk 1g Suppositories. 

Updated on 07 May 2010

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 2:  Added:  Excipient:  Each tablet contains 48mg sodium.

Section 10:  Changed to April 2010

Updated on 26 July 2007

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • 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

Removal of the excipient Dibutyl phthalate in section 6.1 and addition of Cholestatic hepatitis to section 4.8.

Updated on 26 July 2007

Reasons for updating

  • Change of inactive ingredient

Updated on 14 November 2006

Reasons for updating

  • New PIL for medicines.ie

Updated on 10 October 2006

Reasons for updating

  • New SPC for medicines.ie

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