Budenofalk 2mg/dose rectal foam *

  • 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

Budenofalk-foam-PIL-UK-IE-Feb21_1613132919.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 3 - how to take/use

Free text change information supplied by the pharmaceutical company

To update excipients and related warnings

Updated on 12 February 2021

File name

Budenofalk-Foam-SmPC-IE-Feb21_1613132808.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use

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

Free text change information supplied by the pharmaceutical company

To update excipients and related warnings.

Updated on 13 January 2020

File name

Budenofalk-Foam-SmPC-IE-May2017_1578933455.pdf

Reasons for updating

  • Other

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

Free text change information supplied by the pharmaceutical company

SmPC added back into the system as it was missing after previous system changes by IPHA.

Updated on 19 May 2017

Reasons for updating

  • New SPC for new product

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

Updated on 19 May 2017

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 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

$0$0$04.3Deletion: $0$0Hepaticcirrhosis with signs ofportal hypertension eg late stage primary biliary cirrhosis$0$04.4Added:$0$0Systemic effects of glucocorticosteroidsmay occur, particularly when prescribed at high doses and for prolongedperiods. Such effects may include Cushing’s syndrome, adrenal suppression,growth retardation, decreased bone mineral density, cataract, glaucoma and awide range of psychiatric/behavioural effects (see section 4.8).$0$0Patients with liver function disorders$0$0Based onthe experience with patients suffering from late stage primary biliarycirrhosis (PBC) with hepatic cirrhosis an increased systemic availability ofbudesonide in all patients with severely impaired hepatic function is to beexpected.$0$0However,in patients with liver disease without hepatic cirrhosis budesonide in dailydoses of 9 mg was safe and well tolerated. There is no evidence that aspecific dose recommendation for patients with non-cirrhotic liver diseases oronly slightly impaired liver function is necessary.$0$0Visual disturbance$0$0Visualdisturbance may be reported with systemic and topical corticosteroid use. If apatient presents with symptoms such as blurred vision or other visualdisturbances, the patient should be considered for referral to anophthalmologist for evaluation of possible causes which may include cataract,glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) whichhave been reported after use of systemic and topical corticosteroids.$0$04.5Added:$0$0Co-treatmentwith CYP3A inhibitors, including cobicistat-containing products, is expected toincrease the risk of systemic side-effects. The combination should be avoidedunless the benefit outweighs the increased risk of systemic corticosteroidside-effects, in which case patients should be monitored for systemiccorticosteroid side-effects.$0$0Because adrenal function may be suppressed by treatment withbudesonide, an ACTH stimulation test for diagnosing pituitary insufficiencymight show false results (low values).$0$04.6  Reworded/expanded:$0$0Pregnancy$0$0Administration during pregnancy should be avoided unless there arecompelling reasons for therapy with Budenofalk 3mg. There are few data ofpregnancy outcomes after oral administration of budesonide in humans. Althoughdata on the use of inhaled budesonide in a large number of exposed pregnanciesindicate no adverse effect, the maximal concentration of budesonide in plasmahas to be expected to be higher in the treatment with Budenofalk 3mg comparedto inhaled budesonide. In pregnant animals, budesonide, like otherglucocorticosteroids, has been shown to cause abnormalities of fetaldevelopment (see section 5.3). The relevance of this to man has not beenestablished.$0$0Breast-feeding$0$0Budesonide is excreted in human milk (data on excretion afterinhalative use is available).  However, only minor effects on thebreast-fed child are anticipated after Budenofalk 3mg intake within thetherapeutic range. A decision must be made whether to discontinuebreast-feeding or to discontinue/abstain from budesonide therapy taking intoaccount the benefit of breast-feeding for the child and the benefit of therapyfor the woman.$0$04.8 Added$0$0$0$0Blurred vision.  Aggression, psychomotor hyperactivity,anxiety$0$0$0

Updated on 18 May 2017

File name

PIL_14701_400.pdf

Reasons for updating

  • New PIL for new product

Updated on 18 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 12 January 2015

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • 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 - 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

To update to requirements of QRD template

Updated on 08 January 2015

Reasons for updating

  • Addition of information on reporting a side effect.
  • Correction of spelling/typing errors

Updated on 17 June 2014

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

changed store condition to 25C

Updated on 13 June 2014

Reasons for updating

  • Change to storage instructions
  • Change to date of revision

Updated on 05 March 2012

Reasons for updating

  • Change to date of revision
  • Addition of joint PIL covering all presentations

Updated on 30 January 2012

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

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

Free text change information supplied by the pharmaceutical company

Addition of warning regarding potential for local skin reactions due to cetyl alcohol or propylene glycol

Updated on 01 June 2010

Reasons for updating

  • New SPC for new product

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 01 June 2010

Reasons for updating

  • New PIL for new product