Transtec transdermal patch

  • Name:

    Transtec transdermal patch

  • Company:
    info
  • Active Ingredients:

    Buprenorphine

  • 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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Summary of Product Characteristics last updated on medicines.ie: 23/10/2019

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Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories

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Company Products

Medicine NameActive Ingredients
Medicine Name Adizem-SR Capsules Active Ingredients Diltiazem Hydrochloride
Medicine Name ADIZEM-XL Capsules Active Ingredients Diltiazem Hydrochloride
Medicine Name BuTrans 15 microgram/hour transdermal patches Active Ingredients Buprenorphine
Medicine Name BuTrans transdermal patches Active Ingredients Buprenorphine
Medicine Name Flutiform 50 microgram/5 microgram, 125 microgram/5 microgram and 250 micorgram/10 microgram per metered dose pressurised inhalation, suspension. Active Ingredients Fluticasone Propionate, Formoterol fumarate dihydrate
Medicine Name Flutiform K-haler 50 microgram /5 microgram, 125 microgram /5 microgram per actuation pressurised inhalation, suspension. Active Ingredients Fluticasone Propionate, Formoterol fumarate dihydrate
Medicine Name Herzuma 150 mg and 420 mg powder for concentrate for solution for infusion Active Ingredients Trastuzumab
Medicine Name Invokana 100 mg and 300 mg film-coated tablets Active Ingredients Canagliflozin hemihydrate
Medicine Name Levact 25mg and 100 mg powder for concentrate for solution for infusion Active Ingredients Bendamustine Hydrochloride
Medicine Name MST Continus Suspension Active Ingredients Morphine sulfate
Medicine Name MST Continus Tablets Active Ingredients Morphine sulfate
Medicine Name Nyxoid 1.8 mg nasal spray Active Ingredients Naloxone Hydrochloride dihydrate
Medicine Name OxyContin prolonged release tablets Active Ingredients Oxycodone Hydrochloride
Medicine Name OxyNorm 10 mg/ml solution for Injection or Infusion Active Ingredients Oxycodone Hydrochloride
Medicine Name OxyNorm 50 mg/ml, solution for injection or infusion Active Ingredients Oxycodone Hydrochloride
Medicine Name OxyNorm Capsules Active Ingredients Oxycodone Hydrochloride
Medicine Name OxyNorm Concentrate Active Ingredients Oxycodone Hydrochloride
Medicine Name OxyNorm Dispersa 5, 10, 20 mg orodispersible tablets Active Ingredients Oxycodone Hydrochloride
Medicine Name OxyNorm liquid 1 mg/ml oral solution Active Ingredients Oxycodone Hydrochloride
Medicine Name PALLADONE Capsules Active Ingredients Hydromorphone Hydrochloride
Medicine Name Palladone SR Capsules Active Ingredients Hydromorphone Hydrochloride
Medicine Name Pelmeg 6 mg solution for injection in pre-filled syringe Active Ingredients Pegfilgrastim
Medicine Name PHYLLOCONTIN CONTINUS Tablets Active Ingredients Aminophylline Hydrate
Medicine Name SEVREDOL Tablets Active Ingredients Morphine sulfate
Medicine Name Targin 15 mg/7.5 mg and 30 mg/15 mg prolonged-release tablets Active Ingredients Naloxone Hydrochloride dihydrate, Oxycodone Hydrochloride
1 - 0 of 31 items.Total: Infinity pages

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

Section 6.5

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

Change to formatting

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

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 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

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

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)