Salofalk 1g Suppositories

Product Information *

  • Company:

    DR. FALK PHARMA GMBH
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

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

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 26 January 2021

File name

Salofalk-1g-suppositories-leaflet-uk-ie-Jan2021_1611670511.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

Salofalk1gSuppositoriesJan2021ieSmPC_1611670444.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-1g-suppositories-leaflet-uk-ie-Aug2019_1573032273.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

New warning and possible adr concerning nephrolithiasis

Updated on 06 November 2019

File name

Salofalk1gSuppositoriesAug2019ieSmPC_1573032238.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

New warning and possible adr concerning nephrolithiasis

Updated on 15 January 2018

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

Added photosensitivity as possible side effect

Updated on 15 January 2018

Reasons for updating

  • New SPC for new product

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

Updated on 12 January 2018

File name

PIL_14997_322.pdf

Reasons for updating

  • New PIL for new product

Updated on 12 January 2018

Reasons for updating

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

Updated on 21 October 2015

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 21 October 2015

Reasons for updating

  • 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

General updates to conform with the QRD template, particularly addition of ADR reporting address.

Updated on 20 May 2014

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • 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

Changed store condition from 25C to 30C

Updated on 16 May 2014

Reasons for updating

  • Change to storage instructions
  • Change to date of revision

Updated on 03 August 2012

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

Section 7:  Removed MAH phone number
Section 10:  Updated revision date

Updated on 06 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 Jan 2012

Updated on 05 March 2012

Reasons for updating

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

Updated on 31 May 2011

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 25 May 2011

Reasons for updating

  • New PIL for new product