Ursofalk 250mg Hard Capsules

  • Name:

    Ursofalk 250mg Hard Capsules

  • Company:
    info
  • Active Ingredients:

    Ursodeoxycholic Acid

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 11/01/16

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Summary of Product Characteristics last updated on medicines.ie: 6/11/2015
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DR. FALK PHARMA GMBH

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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 2016 PIL

Reasons for updating

  • Change to drug interactions

Updated on 11 January 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 6 November 2015 SmPC

Reasons for updating

  • 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

Preparation of combined UK/IE pack. 60 capsule pack listed on SmPC . Not all packs may be marketed.

Updated on 6 November 2015 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 23 October 2015 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Addition of marketing authorisation holder

Updated on 3 February 2015 SmPC

Reasons for updating

  • Change to paediatric information
  • Change to section 4 - Clinical particulars
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 template.
Additional paediatric indication.
Updated safety information.

Updated on 27 January 2015 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to dosage and administration
  • Changes to therapeutic indications

Updated on 8 January 2013 PIL

Reasons for updating

  • Change to storage instructions
  • Change to further information section
  • Change to date of revision

Updated on 21 December 2011 PIL

Reasons for updating

  • Change to dosage and administration
  • Correction of spelling/typing errors

Updated on 23 May 2011 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

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

Free text change information supplied by the pharmaceutical company

In section 4.2, The dosing for Primary Biliary Cirrhosis (PBC), following 3 month improvements in the liver values, has been changed to once daily in the evening.

Updated on 18 May 2011 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to date of revision

Updated on 6 December 2010 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • 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

Change to section 4.3 - Contraindications
Change to section 4.4 - Special warnings and precautions for use
Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Change to section 4.6 - Pregnancy and lactation
Change to section 4.7 - Effects on ability to drive and use machines 
Change to section 4.8 - Undesirable effects
Change to section 4.9 - Overdose
Change to section 10 - Date of revision of the text 

Updated on 14 January 2010 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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

1.  Changed name from Ursofalk 250mg Capsules to Ursofalk 250mg Hard Capsules

2.  For excipients, see 6.1  changed to For a full list of excipients, see section 6.1.

6.1.  Added ‘Capsule Shell’ and changed Sodium dodecyl sulphate to Sodium laurilsulphate

10.  Updated revision date.

Updated on 7 January 2010 PIL

Reasons for updating

  • Change to date of revision
  • Change to product name

Updated on 14 November 2006 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 10 October 2006 SmPC

Reasons for updating

  • New SPC for medicines.ie

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