BuTrans transdermal patches * 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 28 September 2021
File name
spc 5 10 20 mg_1632837971.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
- 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_1632837842.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
pil_1631109560.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 08 September 2021
File name
spc 5 10 20 mg_1631109483.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 01 February 2021
File name
pil_1612197225.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 5 10 20 mg_1612197195.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 5 10 20 mg_1608730596.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 use in patients with problems with drug or alcohol abuse or serious mental illness. Addition of warnings regarding dependence and withdrawal syndrome. Addition of warnings regarding concomitant use of benzodiazepines. Addition of warnings regarding respiratory depression. Addition of warnings regarding the potential for buprenorphine to impact the hypothalamic-pituitary-adrenal or -gonadal axes.
Section 4.5 - Addition of warnings regarding concomitant use of benzodiazepines.
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_1608729861.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
- Change to section 4 - possible side effects
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 5, 10, 20_1602843071.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_1602843020.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 24 January 2019
File name
Approved_Leaflet_cleanbutrans5101520mcghtdpen_child resistant packaging_1548328312.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 24 January 2019
File name
Approved_SPC_clean_Butrans_5_10_20_child resistant packaging_medicines_ie_1548328076.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
Update to section 6.5 of the SPC to include wording in relation to 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 4.6 - Pregnancy and lactation
- Change to Section 4.8 – Undesirable effects - how to report a side effect
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 updated due to CCDS changes
Prolonged use of buprenorphine during pregnancy can result in neonatal opioid withdrawal syndrome.
Section 4.8
Changes to Psychiatric disorders due to CCDS changes
Changes to Nervous system disorders due to CCDS changes
Changes to Renal and urinary disorders due to CCDS changes
Changes to General disorders and administration site conditions due to CCDS changes
Updated on 26 January 2017
File name
PIL_10489_347.pdf
Reasons for updating
- New PIL for new product
Updated on 26 January 2017
Reasons for updating
- Change to section 4 - possible side effects
Updated on 20 May 2016
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- 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 4.5 - Interaction with other medicinal products and other forms of interaction
- 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
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.5 - Nature and contents of container
- Change to section 11 - Dosimetry
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Sections 1, 2, 3, 4.1, 4.2, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3, 6.5 and 11 due to CCDS changes
Updated on 11 May 2016
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to drug interactions
- Change to information about drinking alcohol
- Change to information about pregnancy or lactation
- Change to information about driving or using machinery
- Change to date of revision
Updated on 05 August 2015
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 29 January 2013
Reasons for updating
- Change to date of revision
- Addition of manufacturer
Updated on 03 June 2011
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Marketing Authorisation Holder has been changed to
Mundipharma Pharmaceuticals Ltd
Millbank House
Arkle Road
Sandyford
Dublin 18
Ireland
Section 8
Marketing Authorisation number has been changed to PA 1688/2/1
Updated on 01 June 2011
Reasons for updating
- Change to date of revision
- Change to marketing authorisation holder
Updated on 27 March 2009
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- 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
Updated on 27 March 2009
Reasons for updating
- Change to, or new use for medicine
- Change to information about pregnancy or lactation
- Change to side-effects
- Correction of spelling/typing errors
Updated on 19 July 2007
Reasons for updating
- Change to warnings or special precautions for use
- Change to information about pregnancy or lactation
- Change to side-effects
- Change to date of revision
Updated on 14 November 2006
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 24 January 2006
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 22 December 2005
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 25 October 2005
Reasons for updating
- Correction of spelling/typing errors
Updated on 18 October 2005
Reasons for updating
- New PIL for new product
Updated on 12 October 2005
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)