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Budenofalk 3mg gastro-resistant capsules *
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):

    Budesonide

    *Additional information is available within the SPC or upon request to the company

Updated on 13 January 2020

File name

Budenofalk-capsules-leaflet-uk-ie -dec2019_1578933145.pdf

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

File name

Budenofalk-capsules-SmPC-IE-Dec2019_1578932996.pdf

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

File name

Budenofalk-capsules-leaflet-uk-ie -nov18_1552316799.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 11 March 2019

File name

pa573-2-1-spc-nov18_1552316688.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

New ADR

Updated on 18 May 2017

Reasons for updating

  • New SPC for new product

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

Updated on 18 May 2017

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

4.4 Added:$0Patients with liver function disorders$0$0Based on the experience with patients suffering from late stage primary biliary cirrhosis (PBC) with hepatic cirrhosis an increased systemic availability of budesonide in all patients with severely impaired hepatic function is to be expected.$0$0However, in patients with liver disease without hepatic cirrhosis budesonide in daily doses of 9 mg was safe and well tolerated. There is no evidence that a specific dose recommendation for patients with non-cirrhotic liver diseases or only slightly impaired liver function is necessary.$0$0Visual disturbance$0$0Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.$0$04.5 Added:$0$0Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.$0$0Because adrenal function may be suppressed by treatment with budesonide, an ACTH stimulation test for diagnosing pituitary insufficiency might show false results (low values).$0$04.6  Reworded/expanded:$0$0Pregnancy$0$0Administration during pregnancy should be avoided unless there are compelling reasons for therapy with Budenofalk 3mg. There are few data of pregnancy outcomes after oral administration of budesonide in humans. Although data on the use of inhaled budesonide in a large number of exposed pregnancies indicate no adverse effect, the maximal concentration of budesonide in plasma has to be expected to be higher in the treatment with Budenofalk 3mg compared to inhaled budesonide. In pregnant animals, budesonide, like other glucocorticosteroids, has been shown to cause abnormalities of fetal development (see section 5.3). The relevance of this to man has not been established.$0$0Breast-feeding$0$0Budesonide is excreted in human milk (data on excretion after inhalative use is available).  However, only minor effects on the breast-fed child are anticipated after Budenofalk 3mg intake within the therapeutic range. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from budesonide therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.$0$04.8 Added$0$0Blurred vision.  Aggression, psychomotor hyperactivity, anxiety, headache$0

Updated on 17 May 2017

File name

PIL_12226_812.pdf

Reasons for updating

  • New PIL for new product

Updated on 17 May 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Updated on 05 August 2016

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

Change to no special store condition

Updated on 04 August 2016

Reasons for updating

  • Change to storage instructions
  • Change to date of revision

Updated on 28 April 2015

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

1.  To introduce once daily dosing in Crohn's disease and collagenous colitis.$02.  To modify the indication for collagenous colits from "symptomatic relief of chronic diarrhoea due to collagenous colits" to "Induction of remission in patients with active collagenous colitis"$0$03.  To update in line with the QRD template$0$04.  Addition of information on fertility in section 4.6.$0$05.  Update section 5.1 with clinical efficacy and safety information in Crohn's disease$0

Updated on 24 April 2015

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

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

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 03 February 2010

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 04 September 2009

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 6.1:  Removed water from list
Section 10:  Updated date of revision

Updated on 26 July 2007

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

 
Replacement of the excipient Dibutyl phthalate with Triethyl citrate.

Updated on 26 July 2007

Reasons for updating

  • New PIL for medicines.ie

Updated on 10 October 2006

Reasons for updating

  • New SPC for medicines.ie

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