Budenofalk 3mg gastro-resistant capsules
- Name:
Budenofalk 3mg gastro-resistant capsules
- Company:
DR. FALK PHARMA GMBH
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 13/01/20

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DR. FALK PHARMA GMBH
Company Products
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 13 January 2020 PIL
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - excipient warnings
- Change to section 3 - dose and frequency
- Change to section 3 - how to take/use
- Change to section 3 - duration of treatment
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
To change indication from collagenous colitis to microscopic colitis with consequential changes to other sections.
Updated on 13 January 2020 SPC
Reasons for updating
- 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 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
- 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
To change indication from collagenous colitis to microscopic colitis with associated changes to othere sections. Section 4.4 updated with regards to Lapp lactase deficiency. Section 5.3 updated for environmental risk.
Updated on 11 March 2019 PIL
Reasons for updating
- Change to section 4 - possible side effects
Updated on 11 March 2019 SPC
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
New ADR
Updated on 18 May 2017 SPC
Reasons for updating
- 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
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 18 May 2017 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 17 May 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 17 May 2017 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 5 August 2016 SPC
Reasons for updating
- 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
Updated on 4 August 2016 PIL
Reasons for updating
- Change to storage instructions
- Change to date of revision
Updated on 28 April 2015 SPC
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 4.3 - Contraindications
- Change to section 4.6 - Pregnancy and lactation
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- 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 on 24 April 2015 PIL
Reasons for updating
- Change to date of revision
- Change to dosage and administration
- Changes to therapeutic indications
- Addition of information on reporting a side effect.
Updated on 14 January 2011 SPC
Reasons for updating
- 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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- 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 4.1. Therapeutic indications
Addition of autoimmune hepatitis indication.
Section 4.2. Posology and method of administration
Addition of posology and duration of treatment for the autoimmune hepatitis indication.
Details on paediatric use added.
Section 4.3. Contra-indications
Removed reference to portal hypertension.
Section 4.4. Special warnings and special precautions for use
Information on changing from systemically acting corticosteroids, particularly in adolescents.
Section 4.8. Undesirable Effects
Added reference to effects in paediatrics when taken for autoimmune hepatitis.
Added section “Side effects in clinical studies with paediatric patients:“
Section 5.1. Pharmacodynamic Properties
Added clinical efficacy and safety information from clinical studies in patients with autoimmune hepatitis.
Added paediatric information.
Section 5.2. Pharmacokinetic Properties
Updated the section: Specific patient populations - Liver diseases.
Added section on Paediatric patients:
Section 10. Date of (partial) revision of the text
Updated
Updated on 12 January 2011 PIL
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change to side-effects
- Change to drug interactions
- Change to date of revision
Updated on 3 February 2010 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.4 - Special warnings and precautions for use
- 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 2: Added: Excipients: Each capsule contains 240mg Sucrose and 12mg Lactose Monohydrate.
Section 3: Added: (gastro-resistant capsules)
Section 4.4: Added: Information on the systemic effects of corticosteroids (2nd paragraph)
Section 10: Changed: October 2006 to April 2009
Updated on 4 September 2009 SPC
Reasons for updating
- 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
Section 10: Updated date of revision
Updated on 26 July 2007 SPC
Reasons for updating
- 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
Updated on 26 July 2007 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 10 October 2006 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)