Transtec transdermal patch *
Pharmacy Only: Prescription

Updated on 28 January 2022

File name

spc_1643370189.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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

Addition of contact dermatitis and application skin discolouration as possible side effects. Update to HPRA contact details.

Updated on 28 January 2022

File name

pil_1643370039.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Free text change information supplied by the pharmaceutical company

Section 2 - Update to wording on sleep-related breathing disorders.

Section 4 - Addition of contact dermatitis and application skin discolouration as possible side effects. Update to HPRA contact details.

Updated on 26 October 2020

File name

spc_1603727512.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 26 October 2020

File name

pil_1603727483.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 31 March 2020

File name

spc_1585645215.pdf

Reasons for updating

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

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

Free text change information supplied by the pharmaceutical company

Introduction of a new warning for all opioids (sleep-related breathing disorders)

Updated on 31 March 2020

File name

pil_1585645164.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Free text change information supplied by the pharmaceutical company

Introduction of a new warning for all opioids (sleep-related breathing disorders)

Updated on 23 October 2019

File name

pil_1571845232.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - how to take/use

Free text change information supplied by the pharmaceutical company

Section 2 updated to include CMDh recommended wording on interaction with benzodiazepines.

Section 3 updated with new pictogram.

Updated on 23 October 2019

File name

spc_1571845090.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
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data

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

Free text change information supplied by the pharmaceutical company

Sections 4.4 and 4.5 updated to include CMDh recommended wording on interactions with benzodiazepines.

Section 4.6 information on fertility updated

Section 5.3 updated for fetotoxicity and postimplantation loss

Updated on 22 January 2019

File name

Transtec PIL text 30 October 2018 - to upload to medicine_1548169062.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 22 January 2019

File name

Transtec SmPC text 30 October 2018 - to upload to medicine_1548169002.pdf

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • 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 to sachet - Child-resistant

Updated on 19 February 2018

File name

PIL_8302_515.pdf

Reasons for updating

  • New PIL for new product

Updated on 19 February 2018

Reasons for updating

  • Change to section 2 - driving and using machines
  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 03 December 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Addition of information on alternative format leaflets

Updated on 24 April 2015

Reasons for updating

  • New SPC for new product

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

Updated on 24 April 2015

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • 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

Section 4.2 - 'Patients under 18 year of age" has been replaced with 'Paediatric population,

Section 4.3 - 'listed in section 6.1' has been added

Section 4.4 - 'Athletes should be aware that this medicine may cause a positive reaction to sports doping control tests' has been added. 

'Paediatric population has been added.

Section 4.6

'Lactation' heading has been replaced with 'Breast-feeding'

The following has been added ' Fertility An effect of buprenorphine on fertility in animals is not known (see section 5.3).

Section 4.8 the following has been added

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard


Updated on 10 April 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to storage instructions
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Addition of information on reporting a side effect.

Updated on 18 July 2012

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

Section 6.5

Addition of a pack size of 11 patches

Updated on 24 January 2012

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to information about drinking alcohol
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to further information section
  • Change to date of revision

Updated on 21 October 2010

Reasons for updating

  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

Change to formatting

Updated on 27 March 2009

Reasons for updating

  • Change to information about driving or using machinery

Updated on 26 March 2009

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • 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

Section 4.1 Deleted:  Treatment of severe opioid responsive pain conditions which are not adequately responding to non-opioid analgesia.
 
TRANSTEC is not suitable for the treatment of acute pain has been moved from section 4.2.
 
4.3 - opioid dependent patients and for narcotic withdrawal treatment (this has been rewritten)
 
4.8  This section has been reformatted and re-written.
 
6.1  Has be reformatted and spelling errors corrected.
 

Updated on 22 June 2007

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • 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

Section 4.2 conversion table removed
 
Section 5.1 section updated in line wiht current literature

Updated on 05 June 2006

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.5 - Nature and contents of container
  • 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 05 June 2006

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration
  • Change to packaging

Updated on 26 August 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 04 July 2003

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 04 July 2003

Reasons for updating

  • Improved electronic presentation

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