Salofalk 1g/Actuation Rectal Foam

  • Name:

    Salofalk 1g/Actuation Rectal Foam

  • Company:
    info
  • Active Ingredients:

    Mesalazine

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 11/01/21

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Summary of Product Characteristics last updated on medicines.ie: 11/1/2021

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DR. FALK PHARMA GMBH

Company Products

Medicine NameActive Ingredients
Medicine Name Budenofalk 2mg/dose rectal foam Active Ingredients Budesonide
Medicine Name Budenofalk 3mg gastro-resistant capsules Active Ingredients Budesonide
Medicine Name Budenofalk 9mg gastro-resistant granules Active Ingredients Budesonide
Medicine Name Salofalk 1.5g gastro-resistant prolonged-release granules Active Ingredients Mesalazine
Medicine Name Salofalk 1000mg gastro-resistant prolonged-release granules Active Ingredients Mesalazine
Medicine Name Salofalk 1g Suppositories Active Ingredients Mesalazine
Medicine Name Salofalk 1g/Actuation Rectal Foam Active Ingredients Mesalazine
Medicine Name Salofalk 250mg gastro-resistant tablets Active Ingredients Mesalazine
Medicine Name Salofalk 250mg Suppositories Active Ingredients Mesalazine
Medicine Name Salofalk 3g Gastro-resistant prolonged-release granules Active Ingredients Mesalazine
Medicine Name Salofalk 4g/60ml Enema Active Ingredients Mesalazine
Medicine Name Salofalk 500mg gastro-resistant prolonged-release granules Active Ingredients Mesalazine
Medicine Name Ursofalk 250mg Hard Capsules Active Ingredients Ursodeoxycholic Acid
Medicine Name Ursofalk 250mg/5ml Suspension Active Ingredients Ursodeoxycholic Acid
Medicine Name Ursofalk 500mg film-coated tablets Active Ingredients Ursodeoxycholic Acid
1 - 0 of 15 items.Total: Infinity pages

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 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

Added photosensitivity as possible side effect

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

Storage conditions changed from 20 - 25C to 20 - 30C.

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 7:  Removed MAH phone number
Section 10:  Updated revision date

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

4.3 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 "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 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 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 4.8 added emphasis to use the product at room temperature.
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

4.2 - Updated information concerning use in children
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 6.5:  Added details of a bundle pack of 4 cans.
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

None provided

Updated on 26 August 2009 PIL

Reasons for updating

  • New PIL for new product