Salofalk 1.5g prolonged-release granules
*Company:
DR. FALK PHARMA GMBHStatus:
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 21 February 2023
File name
Salofalk granules 1500mg-SPC-IE-Jan23.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Correction of typo in name
Updated on 03 February 2023
File name
Salofalk granules 1500mg-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 03 February 2023
File name
Salofalk granules 1500mg-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 10 December 2021
File name
Salofalk granules 1500mg-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 1500mg-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 1500mg-pil-uk-ie-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 26 January 2021
File name
Salofalk Granules 1500mg IE smpc-Jan21.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 Granules 1500mg-pil-uk-ie-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 1500mg 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 1500mg-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 1500mg 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
Updated on 12 January 2018
File name
PIL_16068_851.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
Updated on 14 August 2014
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
Updated on 11 August 2014
Reasons for updating
- New PIL for new product