BuTrans 15 microgram/hour transdermal patch * Pharmacy Only: Prescription
Company:
Mundipharma Pharmaceuticals Limited - Formerly Napp LaboratoriesStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 27 April 2023
File name
644a8cf6d6045.pdf
Reasons for updating
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 April 2023
File name
642da6104379d.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 April 2023
File name
642da5f54d420.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 28 September 2021
File name
spc 15 mg_1632838370.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 4.8 – Undesirable effects - how to report a side effect
- 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: Updated information on titration process, information about hyperalgesia, patch application and the use of hot water bottles.
Section 4.4: Reformatting into a bulleted list, addition of constipation. Addition of warning statements regarding signs of respiratory depression, tolerance, opioid use disorder, withdrawal, skin reactions and sleep apnoea.
Section 4.8: Addition of hyperalgesia and drug tolerance. Additional information about application site reactions.
Section 5.1: Clarification of action of buprenorphine at different opioid receptors.
Updated on 28 September 2021
File name
pil_1632838130.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: Wording changes to improve clarity, addition of constipation, smoking, mental illnesses. Additional information about application site reactions and hyperalgesia.
Section 4: Addition of hyperalgesia and drug tolerance.
Updated on 08 September 2021
File name
spc 15 mg_1631109705.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
Section 4.4: re-wording of section on sleep-related breathing disorders
Section 4.8: addition of dermatitis contact and skin discolouration
Updated on 08 September 2021
File name
pil_1631109638.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 what you need to know… : re-wording of section on sleep-related breathing disorders
Section 4 possible side effects: addition of dermatitis contact and skin discolouration
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
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
Updated on 18 April 2016
Reasons for updating
- New PIL for new product