Salofalk 1g/Actuation Rectal Foam
*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 January 2024
File name
PA 573_4_5-leaflet-sept2023-clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
4. added rash and itching and re-worded and reorganised the whole section.
Updated on 03 January 2024
File name
Salofalk1gFoam-IE-SmPC-sept2023.pdf
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 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
4.2 added that duration of use is to be determined by physician.
4.4 added to stop use if renal function deteriorates. Added warnings on serious blood dyscrasias and cardiac hypersensitivity reactions.
4.8 added common undesirable effects of rash and pruritus.
Updated on 06 February 2023
File name
Salofalk-1g-foam-leaflet-uk-ie-Jan2023.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
2. addition of:
information on interaction of mesalazine and bleach.
DRESS adverse reaction.
4. addition of symptoms related to DRESS adverse reactions.
Updated on 06 February 2023
File name
Salofalk1gFoamJan2023IESmPC.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
4.4: addition of:
information on interaction of mesalazine and bleach.
DRESS adverse reaction.
4.8: addition of DRESS adverse reactions.
Updated on 26 January 2021
File name
Salofalk-1g-foam-leaflet-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
Salofalk1gFoamJan2021IESmPC.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 11 January 2021
File name
Salofalk-1g-foam-leaflet-uk-ie-Sep2020.pdf
Reasons for updating
- Change to section 2 - excipient warnings
Free text change information supplied by the pharmaceutical company
Section 2: added details on excipients.
Updated on 11 January 2021
File name
Salofalk1gFoamSept20IESmPC.pdf
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 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 2: added quantities to the excipients with known effect.
Section 4.4: updated details on excipients with known effect.
Section 6.5: clarified that 14 actuations equals 7 doses.
Updated on 06 November 2019
File name
Salofalk-1g-foam-leaflet-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
Salofalk1gFoamAug2019IESmPC.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
- 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_14375_152.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 03 March 2014
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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
Updated on 27 February 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 10: Updated revision date
Updated on 05 March 2012
Reasons for updating
- Change to section 10 - Date of revision of the text
- 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
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 "General disorders and administration site conditions", "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 of contraindications
- Change to side-effects
- Change to drug interactions
- Change to date of revision
Updated on 29 November 2010
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
In section 10 - updated revision date.
Updated on 26 November 2010
Reasons for updating
- Change to date of revision
- Change to dosage and administration
Updated on 25 November 2010
Reasons for updating
- Change to date of revision
- Change to dosage and administration
Updated on 27 May 2010
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- 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
4.3 - Removed contraindication concerning use in children
7 - Removed PO Box information
10- Updated revision date
Updated on 20 May 2010
Reasons for updating
- Change of contraindications
- Change to date of revision
- Change to dosage and administration
Updated on 03 February 2010
Reasons for updating
- 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 10: National approval dated the text as Jan 2010.
Updated on 25 January 2010
Reasons for updating
- Introduction of new pack/pack size
Updated on 04 September 2009
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 26 August 2009
Reasons for updating
- New PIL for new product