BuTrans 15 microgram/hour transdermal patches

Product Information *

  • Company:

    Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

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 01 February 2021

File name

pil_1612197151.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

Addition of warnings regarding sleep apnoea

Updated on 01 February 2021

File name

spc 15 mg_1612197088.pdf

Reasons for updating

  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Addition of warnings regarding sleep apnoea

Updated on 23 December 2020

File name

spc 15 mg_1608731068.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - 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 - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.2 - Addition of clarification that no dose adjustment is required for patients with mild to moderate hepatic impairment.

Section 4.4 - Addition of warnings regarding dependence and withdrawal syndrome. Addition of warnings regarding the potential for buprenorphine to impact the hypothalamic-pituitary-adrenal or -gonadal axes.

Section 4.5 - Addition of examples of sedative medicines.

Section 4.6 - Clarification regarding use during pregnancy and breast feeding.

Section 4.8 - Minor administrative changes.

Section 4.9 - Clarification of statement regarding apnoea.

Section 5.1 - Deletion of section on the endocrine system (relocated to section 4.4). Addition of statements regarding immunological effects and risk of respiratory depression.

Updated on 23 December 2020

File name

pil_1608729668.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - how to take/use

Free text change information supplied by the pharmaceutical company

Section 2 - Addition of warnings regarding hormone production. Addition of warnings regarding concomitant use of benzodiazepines. Addition of clarification on use during pregnancy and breast feeding.

Section 3 - Addition of instructions regarding use of two patches where necessary. Replacement of instructions for tearing the pouch with instructions for cutting with scissors.

Section 4 - Correction of side effect frequencies. Addition of mood swings as a possible side effect.

Updated on 16 October 2020

File name

spc 15_1602842962.pdf

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

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

 

Addition of warnings regarding serotonin syndrome following PRAC recommendation.

Updated on 16 October 2020

File name

pil_1602842875.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink

Free text change information supplied by the pharmaceutical company

 

Addition of warnings regarding serotonin syndrome following PRAC recommendation.

Updated on 29 June 2020

File name

pil_1593444575.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Addition of warnings in relation to concomitant use with benzodiazepines.

Updates to descriptions of frequencies of side effects.

Updated on 29 June 2020

File name

spc_1593444320.pdf

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

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Addition of warnings in relation to concomitant use with benzodiazepines.

Updated on 11 February 2019

File name

Approved_package_leaflet_clean_English_BuTrans_IE_medicines ie_1549890807.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - what the product looks like and pack contents

Updated on 11 February 2019

File name

Approved_SPC_clean_Transdermal_Patch_English_BuTrans_15_mg IE_medicines ie_1549890582.pdf

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Addition of details of child resistant packaging

Updated on 02 February 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 02 February 2017

Reasons for updating

  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.5

The following has been replaced with (added text in red)

Benzodiazepines: This combination can potentiate respiratory depression of central origin, with risk of death in case of overdose (see section 4.4).


Benzodiazepines: This combination can potentiate respiratory depression of central origin(see section 4.4).

Section 4.6

The following has been changed (text in red has been added)

Prolonged use Long term administration  of buprenorphine during the last three months of pregnancy can result in neonatal opioid may cause a withdrawal syndrome. in the neonate.

Section 4.8

 (Psychiartic disorders) Affect lability has been changed from liability. Libido decreased has been changed from Decreased Libido.

(Nervous system disorders)  Seizures has been added. Abnormal co-ordination has been changed to Co-ordination abnormal.

Renal and urinary disorders - Urinary incontinence has been added.  Urinary hesitation has been added. Micturtion disorder has been removed.

General disorders and administration site conditions - Drug withdrawal syndrome neonatal has been added.

Updated on 26 January 2017

File name

PIL_16696_292.pdf

Reasons for updating

  • New PIL for new product

Updated on 26 January 2017

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects

Updated on 04 May 2016

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 18 April 2016

Reasons for updating

  • New PIL for new product