BuTrans 15 microgram/hour transdermal patches
- Name:
BuTrans 15 microgram/hour transdermal patches
- Company:
Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 01/02/21
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Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories
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 1 February 2021 PIL
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 1 February 2021 SPC
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 SPC
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 PIL
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 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
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 PIL
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 PIL
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 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
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 PIL
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 SPC
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 2 February 2017 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 2 February 2017 SPC
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 PIL
Reasons for updating
- New PIL for new product
Updated on 26 January 2017 PIL
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
Updated on 4 May 2016 SPC
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 PIL
Reasons for updating
- New PIL for new product