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Durogesic DTrans 100 micrograms/hour Transdermal Patch

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Pharmacy Only: Prescription

Updated on 15 November 2024

File name

PI-Durogesic DTrans 100 mcg_hr-Ireland-English-II 019+II 021-ERMC-11532+ERMC-12538_EDMS-ERI-147547288_25.0.pdf

Reasons for updating

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

Addition of new warning under section 4.4:

Endocrine effects

Opioids such as fentanyl may influence the hypothalamic-pituitary-adrenal or –gonadal axes, especially after long-term use. Some changes that can be seen include an increase in serum prolactin, and decreases in plasma cortisol and testosterone. Clinical signs and symptoms may manifest from these hormonal changes. If an endocrine effect such as hyperprolactinaemia or adrenal insufficiency is suspected, appropriate laboratory testing is recommended and discontinuation of treatment with DUROGESIC should be considered.

Updated on 15 November 2024

File name

PIL-Durogesic DTrans 12,25,50,75,100 mcg_hr-Ireland-English-II 019+II 021-ERMC-11532+ERMC-12538.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Addition of new warning under section 2: DUROGESIC, like other opioids, may affect the normal production of hormones in the body such as cortisol, prolactin, or sex hormones, particularly if you have taken DUROGESIC for long periods of time. The effects of these hormonal changes may include feeling or being sick (including vomiting), loss of appetite, tiredness, weakness, dizziness, low blood pressure, infertility, or decreased sex drive. In addition, female patients may experience changes in menstrual cycle, while male patients may experience impotence or enlarged breasts. If you notice any of these signs, speak to your doctor.

Updated on 25 October 2024

File name

PI-Durogesic DTrans 100 mcg_hr-Ireland-English-PRAC recommendations related to PSUSA_00001370_202304-II 020 - ERMC-12331_EDMS-ERI-147547288_23.0.pdf

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)

Free text change information supplied by the pharmaceutical company

Summary of Product Characteristics Section 4.8

The following adverse reaction should be added under the SOC Gastrointestinal disorders with a frequency uncommon:

Dysphagia

Updated on 25 October 2024

File name

Durogesic DTrans 12,25,50,75,100 mcg_hr PIL Ireland-PRAC recommendations related to PSUSA_00001370_202304-II 020_EDMS-RIM-1449550_2.0.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to other sources of information section

Free text change information supplied by the pharmaceutical company

Package Leaflet Section 4

The following adverse reaction should be listed under the adverse reactions with a frequency uncommon:

Difficulty in swallowing.

Updated on 27 September 2023

File name

Durogesic DTrans 100 mcg_hr-SmPC Ireland-23-Aug-2023-clean_EDMS-RIM-960522_4.0.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 4.9 - Overdose

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

Free text change information supplied by the pharmaceutical company

Changes to sections 4.2, 4.4, 4.8 and 4.9

Updated on 27 September 2023

File name

Durogesic DTrans 12,25,50,75,100 mcg_hr-PIL Ireland-August 2023-clean_EDMS-RIM-960528_4.0.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Changes to sections 2, 3 and 4 corresponding to SmPC changes

Updated on 09 May 2022

File name

PI-Durogesic DTrans 100 mcg_hr-Ireland-EN-IA 015-PSUSA 00001370202104 outcome.pdf

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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

  • SmPC section 4.5 Interaction with other medicinal products and other forms of interaction and corresponding PIL section, to add additive effect of gabapentinoids on CNS depression

Please note there will be no update to the CCDS in relation to this, since gabapentinoids are already covered by the drug interaction for CNS depressants and therefore would only be another example of a CNS depressant and not a separate drug interaction in the table. The drug interaction table is not meant to be an exhaustive list of CNS depressants, as such it isn’t necessary to update the CCDS with another example of CNS depressants.

Updated on 09 May 2022

File name

PIL-Durogesic DTrans 12,25,50,75,100 mcg_hr-Ireland-EN-IA 015-PSUSA 00001370202104 outcome.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

  • PIL section 3.0 How to use DUROGESIC to add information about lack of efficacy if patch falls off

Please note there will be no update to the CCDS in relation to this, since gabapentinoids are already covered by the drug interaction for CNS depressants and therefore would only be another example of a CNS depressant and not a separate drug interaction in the table. The drug interaction table is not meant to be an exhaustive list of CNS depressants, as such it isn’t necessary to update the CCDS with another example of CNS depressants.

Updated on 16 August 2021

File name

PI-Durogesic Dtrans 100 mcg hr TDP-IE-EN-IA 013.pdf

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
  • 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

Changes to the following sections:

6.5 - Nature and contents of container

10 - Date of revision of the text

Updated on 16 August 2021

File name

PIL-Durogesic Dtrans 12,25,50,75,100 mcg hr TDP-IE-EN-IA 013.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Free text change information supplied by the pharmaceutical company

The following changes to section 6 were made:

-  What the product looks like and pack contents - "The patches come in individually wrapped heat-sealed (acrylonitrile film or cyclic olefin copolymer) pouches, and come in cartons containing 3, 4, 5, 8, 10, 16, 20 or 30 patches."

- Last date of revision of the text

Updated on 26 May 2021

File name

PIL-Durogesic Dtrans-12,25,50,75,100 mcg hr TDP-IE-EN-II 011_II 012-clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - how to take/use
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Correction of spelling/typing errors

Updated on 26 May 2021

File name

PI-Durogesic Dtrans-100 mcg hr TDP-IE-EN-II 011_II 012_EDMS-RIM-372559_4.0.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

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

Updated on 20 January 2021

File name

PIL-Durogesic DTrans-12,25,50,75,100mcghr-TDP-Ireland-English-NLH3915001-005II007G-clean.pdf

Reasons for updating

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

Updated on 20 January 2021

File name

PI-Durogesic DTrans-100mcghr-TDP-Ireland-English-NLH3915001-005II007G-clean.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)

Updated on 04 October 2019

File name

IE_Durogesic DTrans PIL Clean.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 04 October 2019

File name

Durogesic-DTrans SPC_100-27-Sep-19 Clean.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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 30 August 2019

File name

IRE_Durogesic DTrans PIL clean.pdf

Reasons for updating

  • Change to section 5 - how to store or dispose
  • 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 30 August 2019

File name

Durogesic-DTrans SPC_100-clean.pdf

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 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • 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 08 April 2019

File name

IRE_Durogesic DTrans PIL C20_clean.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 08 April 2019

File name

Durogesic DTrans SPC_100-C22_clean.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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 11 June 2018

File name

Durogesic-DTrans SPC_100-_Clean.docx

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 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

4.4       Special warnings and precautions for use

Respiratory depression

Some patients may experience significant respiratory depression with Durogesic DTrans; patients must be observed for these effects.  Respiratory depression may persist beyond the removal of the Durogesic DTrans patch.  The incidence of respiratory depression increases as the Durogesic DTrans dose is increased (see section 4.9).  Central nervous system depressants may increase the respiratory depression (see section 4.5).

Central Nervous System (CNS) Depressants, including Alcohol and CNS Depressant Narcotic Drugs

Concomitant use of Durogesic DTrans with CNS depressants, including alcohol and CNS depressant narcotic drugs, may increase the undesirable effects of Durogesic DTrans; concomitant use should be avoided (see section 4.5). If concomitant use of Durogesic DTrans with a CNS depressant is clinically necessary, prescribe the lowest effective dosages and minimum duration for both drugs, and follow patients closely for signs of respiratory depression and sedation.

4.5       Interaction with other medicinal products and other forms of interaction

Pharmacodynamic-related interactions

Centrally-acting medicinal products/Central Nervous System (CNS) depressants, includingand alcohol and CNS depressant narcotic drugs

The concomitant use of Durogesic DTrans with other central nervous system depressants (including benzodiazepines and other sedatives/ hypnotics, opioids, sedatives, hypnotics, general anaesthetics, phenothiazines, tranquilisers, sedating antihistamines, and alcoholic beverages and CNS depressant narcotic drugs) and skeletal muscle relaxants may produce additive disproportionately increase the CNS depressant effects such as respiratory depressionhypoventilation, hypotension, profound sedation, coma or death may occur. Therefore, the use of any of these medicinal products concomitantly with Durogesic DTrans requires special patient care and observation.

 

Cytochrome P450 3A4 (CYP3A4) Inhibitors

Fentanyl, a high clearance active substance, is rapidly and extensively metabolised mainly by CYP3A4.

 

Cytochrome P450 3A4 (CYP3A4) Inducers

 

Updated on 11 June 2018

File name

IRE_Durogesic DTrans PIL C19_Clean.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 25 January 2017

Reasons for updating

  • New SPC for new product

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

Updated on 25 January 2017

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 4.5 - 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
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

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

Free text change information supplied by the pharmaceutical company

Change due to harmonisation of Summary of Product Characteristics in Europe (implementation of the outcome of a referral procedure under Article 30 of Directive 2001/83/EC).

Updated on 24 January 2017

File name

PIL_10567_425.pdf

Reasons for updating

  • New PIL for new product

Updated on 24 January 2017

Reasons for updating

  • Change to section 1 - what the product is used for
  • 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 2 - driving and using machines
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - duration of treatment
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 11 September 2015

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

change of approval date to 08 september 2015

Updated on 22 July 2015

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

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

Free text change information supplied by the pharmaceutical company

Durogesic DTrans combined SmPC is no longer published, SmPC for each strength is now available

 

Changes to the SmPC

 

Section 4.4: Special warnings and precautions for use

 

 

Gastrointestinal tract

 

Opioids increase the tone and decrease the propulsive contractions of the smooth muscle of the gastrointestinal tract. The resultant prolongation in gastrointestinal transit time may be responsible for the constipating effect of fentanyl. Patients should be advised on to take measures to prevent constipation and prophylactic laxative use should may be considered in some situations. Extra caution should be used in patients with chronic constipation. If paralytic ileus is present or suspected, treatment with Durogesic DTrans should be reviewed taking into account the overall risk-benefit for the patient.

Updated on 12 August 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to further information section
  • Change to date of revision

Updated on 15 April 2014

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 01 July 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision

Updated on 09 September 2011

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision

Updated on 14 December 2010

Reasons for updating

  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 27 October 2010

Reasons for updating

  • Change to, or new use for medicine
  • Change to date of revision

Updated on 02 August 2010

Reasons for updating

  • Change to, or new use for medicine
  • Change to date of revision

Updated on 21 June 2010

Reasons for updating

  • Change due to user-testing of patient information

Updated on 08 June 2010

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 04 September 2008

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder address

Updated on 06 August 2008

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to dosage and administration

Updated on 19 June 2007

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to dosage and administration
  • Change to date of revision

Updated on 17 May 2007

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 27 November 2006

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 12 October 2006

Reasons for updating

  • Change to, or new use for medicine
  • Change to date of revision

Updated on 05 September 2006

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 21 November 2005

Reasons for updating

  • New PIL for new product