Salofalk 1000mg gastro-resistant prolonged-release granules

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

SalofalkGranules1g-IE-smpc-Jan2021_1611669796.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 26 January 2021

File name

Salofalk-1000mg-granules-leaflet-uk-ie-Jan21_1611669730.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 06 November 2019

File name

Salofalk-1000mg-granules-leaflet-uk-ie-Aug19_1573031842.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

SalofalkGranules1g-IE-smpc-Aug19_1573031786.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 23 April 2019

File name

SalofalkGranules1g-pil-uk-ie-Feb2019_1556029685.pdf

Reasons for updating

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

Updated on 23 April 2019

File name

SalofalkGranules1g-IE-smpc-Feb2019_1556029156.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

Updated warnings on aspartame and sodium.  Updated possible ADRs

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 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 12 January 2018

File name

PIL_11598_781.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 06 November 2017

Reasons for updating

  • Change to section 9 - Date of first authorisation/renewal of the 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

Renewal date added

Updated on 29 July 2014

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

Corrected HPRA address details.

Updated on 24 July 2014

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 27 June 2014

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

$0Section 2:  Addition of sucrose as excipient$0$0Section 4.4:  Warning for those with fructose intolerance,glucose galactose malabsorption or sucrose-isomaltase insufficiency.$0$0Section 4.8:  Addition of ADR reporting information$0$0Section 6.1:  Addition of sucrose as excipient$0$0Section 10:  Revision date$0$0Minor admin/template/typo updates throughout.$0

Updated on 27 June 2014

Reasons for updating

  • Change of inactive ingredient
  • Change to warnings or special precautions for use
  • Change to further information section
  • Change to date of revision
  • Addition of information on reporting a side effect.
  • Correction of spelling/typing errors

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 11 April 2012

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 4.2 - Addition of 3g strength option.  Addition that when taken once daily, ideally it should be in the morning.  Addition that duration of treatment is determined by the physician.
Section 5.1 - Updated the pharmacotherapeutic group.
Section 6.5 - Added weight of granules in each sachet.
General minor, typographical changes throughout

Updated on 04 April 2012

Reasons for updating

  • Change to date of revision
  • Change due to harmonisation of PIL
  • Correction of spelling/typing errors

Updated on 06 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 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 16 November 2010

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.2 - updated dosage for maintenance of remission
Section 4.3 - remove contraindications "pre existing gastric or duodenal ulcer" and "haemorrhagic diathesis"
Section 10 - updated revision date

Updated on 09 November 2010

Reasons for updating

  • Change of contraindications
  • Change to date of revision
  • Change to dosage and administration

Updated on 01 June 2010

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 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

4.2  Posology and method of administration

Updated information concerning use in children.

 

4.4  Special warnings and precautions for use

Deleted statement concerning use in children.

 

9  Date of first authorisation/renewal of the authorisation

Corrected date of authorisation

 

10  Date of revision of the text

Updated date

Updated on 27 May 2010

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change to dosage and administration

Updated on 25 January 2010

Reasons for updating

  • Change to dosage and administration

Updated on 04 September 2009

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 6.5 - Nature and contents of container
  • Change to section 7 - Marketing authorisation holder
  • 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

Section 4.5:  1000mg added after Salofalk
Section 6.5:  Pack sizes of 20 and 60 added
Section 7:  Telephone number removed
Section 9:  Dates corrected
Section 10:  Date updated

Updated on 16 January 2008

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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

Change to add once daily dosage for acute treatment of ulcerative colitis.

Updated on 26 July 2007

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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

Removal of "in sachets" from the name of the product, addition of peripheral neuropathy and oligospermia to section 4.8.

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)