Salofalk 500mg 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 03 February 2023
File name
Salofalk granules 500mg-PIL-Jan23.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- 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 500mg-PIL-Jan23.pdf
Reasons for updating
- 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 500mg-SPC-IE-Jan23.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 4.1 - Therapeutic indications
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
SmPC sections:
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 500mg-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 500mg-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-500mg-Granules-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
Salofalk500mgGranuleJan2021ieSmPC.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-500mg-Granules-pil-uk-ie-Aug19.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
Salofalk500mgGranuleAug2019ieSmPC.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
PIL_11597_19.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
Salofalk500mgGranuleApr2019IESmPC.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_11597_19.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 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
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
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 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 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 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
4.5 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 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 4.3 - remove contraindications "pre existing gastric or duodenal ulcer" and "haemorrhagic diathesis"
Section 10 - updated revision date
Updated on 16 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 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 7: Removed phone number
Section 9: Corrected dates
Section 10: Updated date
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
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, peripheral neuropathy and oligospermia added 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)