Ursofalk 250mg/5ml Suspension *
Pharmacy Only: Prescription

  • Company:

    DR. FALK PHARMA GMBH
  • Status:

    No Recent Update
  • Legal 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

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 12 February 2021

File name

palieuk_1613140330.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - excipient warnings
  • Change to section 3 - dose and frequency

Free text change information supplied by the pharmaceutical company

Section 1 and 3

primary biliary cirrhosis cholangitis

Section 2

Added: Ursofalk 250mg/5ml suspension contains benzoic acid, propylene glycol and sodium

Updated on 12 February 2021

File name

spcie_1613140045.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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

Section 2

Added excipients with known effect:

5 ml of Ursofalk Suspension contain 7.5 mg benzoic acid, 50 mg propylene glycol and 11 mg

sodium.

 

Section 4.1, 4.2, 4.4, 4.8

primary biliary cirrhosis cholangitis

 

Section 4.4

Added: This medicinal product contains 7.5 mg benzoic acid in each 5 ml of suspension. Benzoic acid may increase jaundice in neonates. This medicinal product contains 50 mg propylene glycol in each 5 ml of suspension. May induce serious adverse effects in neonates. This medicinal product contains 11 mg sodium per 5 ml of suspension, equivalent to 0.6 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.

Updated on 12 February 2021

File name

palieuk_1613139797.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

Section 2

Added excipients with known effect:

5 ml of Ursofalk Suspension contain 7.5 mg benzoic acid, 50 mg propylene glycol and 11 mg

sodium.

 

Section 4.1, 4.2, 4.4, 4.8

primary biliary cirrhosis cholangitis

 

Section 4.4

Added: This medicinal product contains 7.5 mg benzoic acid in each 5 ml of suspension. Benzoic acid may increase jaundice in neonates. This medicinal product contains 50 mg propylene glycol in each 5 ml of suspension. May induce serious adverse effects in neonates. This medicinal product contains 11 mg sodium per 5 ml of suspension, equivalent to 0.6 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.

Updated on 03 February 2021

File name

Ursofalk-Suspension-Oct2020-IE SmPC_1612361877.pdf

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)

Updated on 02 November 2020

File name

PL10341-0007 UKIE PIL_1604309363.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents

Free text change information supplied by the pharmaceutical company

Change to include description of pouring device.

Updated on 02 November 2020

File name

PL10341-0007 UKIE SmPC_1604309293.pdf

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

Update to include description of pouring device.

Updated on 11 August 2015

Reasons for updating

  • Change due to harmonisation of PIL
  • Addition of joint PIL covering all presentations

Updated on 11 August 2015

File name

PIL_14934_404.pdf

Reasons for updating

  • New PIL for new product

Updated on 05 February 2015

Reasons for updating

  • New SPC for new product

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

Updated on 05 February 2015

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

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 date of revision
  • Change to dosage and administration
  • Changes to therapeutic indications

Updated on 30 March 2011

Reasons for updating

  • Deletion of a pack size
  • Presentation currently not marketed.

Updated on 29 March 2011

Reasons for updating

  • New SPC for new product
  • Presentation currently not marketed.

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 28 March 2011

Reasons for updating

  • New PIL for new product