Salofalk 3g prolonged-release granules

*
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):

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

Updated on 03 February 2023

File name

Salofalk granules 3000mg-pil-Jan23.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - duration of treatment
  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

General: removal of term ‘gastro-resistant’

Section 1: addition of term ‘mild to moderate’. 

Section 2: addition of information on urine discolouration due to reaction of mesalazine with toilet bleach. Addition of DRESS adverse reaction.

Section 3: addition of 8-week normal duration of use.

Section 4: addition of rash, pruritus and DRESS reactions.

Updated on 03 February 2023

File name

Salofalk granules 3000mg-SPC-IE-Jan23.pdf

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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
  • 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

1: removal of term ‘gastro-resistant’.

2: correction to quantity of sucrose.

4.1: addition of term ‘mild to moderate’.

4.2: addition of 8-week duration of treatment.

4.4: addition of:

warning to cease use in event of deterioration of renal function.

information on interaction of mesalazine and bleach.

warning on serious blood dyscrasias.

warning on cardiac hypersensitivity.

DRESS adverse reaction.

4.8: addition of rash, pruritus and DRESS reactions.

5.2: updated elimination data.

Updated on 10 December 2021

File name

Salofalk granules 3000mg-PIL-Oct21.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents

Free text change information supplied by the pharmaceutical company

Name change due to excipients guideline

Updated on 10 December 2021

File name

Salofalk granules 3000mg-SPC-IE-Oct21.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

Name change due to excipients guideline

Updated on 26 January 2021

File name

Salofalk Granules 3g ie -smpc-Jan2021.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 Granules 3g UK-IE-PIL-Jan2021.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 Granules 3g UK-IE-PIL-Aug2019.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

Salofalk Granules 3g ie -smpc-Aug2019.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

Salofalk Granules 3g-pil-uk-ie-Feb2019.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

Salofalk Granules 3g IE -smpc-Feb2019.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_15081_1.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 6.3 - Shelf life
  • 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 6.3:  Change from 3 year to 4 year shelf life$0$0Section 10:  Revision date$0$0Minor admin/template/typo updates throughout.$0

Updated on 26 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 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 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 25 July 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 22 July 2011

Reasons for updating

  • New PIL for new product