Ursofalk 250mg/5ml Suspension
*Company:
DR. FALK PHARMA GMBHStatus:
No Recent UpdateLegal 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
Updated on 15 November 2024
File name
Ursofalk-Suspension-SPC-Nov2024-IE.pdf
Reasons for updating
- 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
To include urticaria and nausea / vomiting under “not known” frequency
Updated on 15 November 2024
File name
Ursofalk-Suspension-PIL-Nov 2024-IE.pdf
Reasons for updating
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
To include urticaria and nausea / vomiting under “not known” frequency
Updated on 12 February 2021
File name
palieuk.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.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.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.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.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.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
File name
PIL_14934_404.pdf
Reasons for updating
- New PIL for new product
Updated on 11 August 2015
Reasons for updating
- Change due to harmonisation of PIL
- Addition of joint PIL covering all presentations
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
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
Updated on 28 March 2011
Reasons for updating
- New PIL for new product