Durogesic DTrans 75 micrograms/hour Transdermal Patch
- Name:
Durogesic DTrans 75 micrograms/hour Transdermal Patch
- Company:
Janssen Sciences Ireland
- 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: 04/10/19
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Janssen Sciences Ireland
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 4 October 2019 PIL
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 4 October 2019
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
Updated on 30 August 2019 PIL
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
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
Updated on 8 April 2019 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 8 April 2019
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Updated on 11 June 2018
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 PIL
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 SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 25 January 2017 SPC
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 25 January 2017 PIL
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
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 PIL
Reasons for updating
- New PIL for new product
Updated on 11 September 2015 PIL
Reasons for updating
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Updated on 11 September 2015 SPC
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 22 July 2015 SPC
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 22 July 2015 PIL
Reasons for updating
- New individual SPC (was previously included in combined SPC)
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.