Transtec transdermal patch
- Name:
Transtec transdermal patch
- 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: 23/10/19
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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 23 October 2019 PIL
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 SmPC
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 PIL
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 SmPC
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 PIL
Reasons for updating
- New PIL for new product
Updated on 19 February 2018 PIL
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 3 December 2015 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Addition of information on alternative format leaflets
Updated on 24 April 2015 SmPC
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 24 April 2015 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 10 April 2015 PIL
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 SmPC
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 a pack size of 11 patches
Updated on 24 January 2012 PIL
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 SmPC
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
Updated on 27 March 2009 PIL
Reasons for updating
- Change to information about driving or using machinery
Updated on 26 March 2009 SmPC
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
Updated on 22 June 2007 SmPC
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
Updated on 5 June 2006 SmPC
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 5 June 2006 PIL
Reasons for updating
- Change to date of revision
- Change to dosage and administration
- Change to packaging
Updated on 26 August 2004 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 4 July 2003 SmPC
Reasons for updating
- Correction of spelling/typing errors
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 4 July 2003 SmPC
Reasons for updating
- Improved electronic presentation
Legal category: Product subject to medical prescription which may not be renewed (A)