Salofalk 1.5g gastro-resistant prolonged-release granules

  • Name:

    Salofalk 1.5g gastro-resistant prolonged-release granules

  • 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: 06/11/19

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Summary of Product Characteristics last updated on medicines.ie: 6/11/2019

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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 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 SmPC

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 PIL

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 SmPC

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 SmPC

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 15 January 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

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 12 January 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 6 November 2017 SmPC

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

Renewal date added

Updated on 14 August 2014 SmPC

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 11 August 2014 PIL

Reasons for updating

  • New PIL for new product