Salofalk 1g/Actuation Rectal Foam
- Name:
Salofalk 1g/Actuation Rectal Foam
- Company:
DR. FALK PHARMA GMBH
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 26/01/21
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DR. FALK PHARMA GMBH
Company Products
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 PIL
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 SPC
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 PIL
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 SPC
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 6 November 2019 PIL
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 6 November 2019 SPC
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 SPC
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 SPC
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 PIL
Reasons for updating
- New PIL for new product
Updated on 12 January 2018 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 3 March 2014 SPC
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 PIL
Reasons for updating
- Change to storage instructions
- Change to date of revision
Updated on 3 August 2012 SPC
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 5 March 2012 PIL
Reasons for updating
- Change of contraindications
- Change to side-effects
- Change to drug interactions
- Change to date of revision
Updated on 5 March 2012 SPC
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 29 November 2010 SPC
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 PIL
Reasons for updating
- Change to date of revision
- Change to dosage and administration
Updated on 25 November 2010 PIL
Reasons for updating
- Change to date of revision
- Change to dosage and administration
Updated on 27 May 2010 SPC
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 PIL
Reasons for updating
- Change of contraindications
- Change to date of revision
- Change to dosage and administration
Updated on 3 February 2010 SPC
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 PIL
Reasons for updating
- Introduction of new pack/pack size
Updated on 4 September 2009 SPC
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 PIL
Reasons for updating
- New PIL for new product