Durogesic DTrans 12 micrograms/hour Transdermal Patch

  • Name:

    Durogesic DTrans 12 micrograms/hour Transdermal Patch

  • Company:
    info
  • Active Ingredients:

    Fentanyl

  • 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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Summary of Product Characteristics last updated on medicines.ie: 4/10/2019

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Janssen Sciences Ireland

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Medicine Name DARZALEX 20 mg/mL concentrate for solution for infusion. Active Ingredients Daratumumab
Medicine Name Durogesic DTrans 100 micrograms/hour Transdermal Patch Active Ingredients Fentanyl
Medicine Name Durogesic DTrans 12 micrograms/hour Transdermal Patch Active Ingredients Fentanyl
Medicine Name Durogesic DTrans 25 micrograms/hour Transdermal Patch Active Ingredients Fentanyl
Medicine Name Durogesic DTrans 50 micrograms/hour Transdermal Patch Active Ingredients Fentanyl
Medicine Name Durogesic DTrans 75 micrograms/hour Transdermal Patch Active Ingredients Fentanyl
Medicine Name Durogesic DTrans Transdermal Patch Active Ingredients Fentanyl
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1 - 0 of 55 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 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 SmPC

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 4 October 2019 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container

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

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 SmPC

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 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 SmPC

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 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 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

 

 

Cytochrome P450 3A4 (CYP3A4) Inducers

The concomitant use of transdermal fentanyl with CYP3A4 inducers may result in a decrease in fentanyl plasma concentrations and a decreased therapeutic effect. 

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 SmPC

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 SmPC

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

change of approval date to 08 september 2015

Updated on 11 September 2015 SmPC

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 SmPC

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

 

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

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

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 PIL

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Section 4.8: new HPRA address added

6.6           Special precautions for disposal and other handling

Please refer to Section 4.2 for instructions on how to apply the patch.  There are no safety and pharmacokinetic data available for other application sites.

After removal, the uUsed patches should be folded in half, so that the adhesive side inwards so thatof the patch adheres to itself  the adhesive is not exposed, placed in the original sachet and then they should be safely discarded safely out of reach of children. Unused patches should be returned to the (hospital) pharmacy.

Wash hands with only water only after applying or removing the patch

Updated on 12 August 2014 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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 4.8: new HPRA address added

6.6           Special precautions for disposal and other handling

Please refer to Section 4.2 for instructions on how to apply the patch.  There are no safety and pharmacokinetic data available for other application sites.

After removal, the uUsed patches should be folded in half, so that the adhesive side inwards so thatof the patch adheres to itself  the adhesive is not exposed, placed in the original sachet and then they should be safely discarded safely out of reach of children. Unused patches should be returned to the (hospital) pharmacy.

Wash hands with only water only after applying or removing the patch

Updated on 15 April 2014 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 4.8

addtion to:

Nervous System Disorders: frequency uncommon, Depressed level of consciousness, Loss of consciousness

Eye disorders: frequency uncommon,Vision blurred


adverse drug reaction reproting information

Reporting of suspected adverse reactions

Healthcare professionals are asked to report any suspected adverse reactions preferably through the online reporting option accessible from the IMB homepage. A downloadable report form is also accessible from the IMB website, which may be completed manually and submitted to the IMB via ‘freepost’. Alternatively the traditional post-paid ‘yellow card’ may also continue to be used.

 

FREEPOST

Pharmacovigilance Section

Irish Medicines Board

Kevin O’Malley House

Earlsfort Centre

Earlsfort Terrace

Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.imb.ie

e-mail: imbpharmacovigilance@imb.ie

Updated on 15 April 2014 PIL

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

section 4.8

addtion to:

Nervous System Disorders: frequency uncommon, Depressed level of consciousness, Loss of consciousness

Eye disorders: frequency uncommon,Vision blurred


adverse drug reaction reproting information

Reporting of suspected adverse reactions

Healthcare professionals are asked to report any suspected adverse reactions preferably through the online reporting option accessible from the IMB homepage. A downloadable report form is also accessible from the IMB website, which may be completed manually and submitted to the IMB via ‘freepost’. Alternatively the traditional post-paid ‘yellow card’ may also continue to be used.

 

FREEPOST

Pharmacovigilance Section

Irish Medicines Board

Kevin O’Malley House

Earlsfort Centre

Earlsfort Terrace

Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.imb.ie

e-mail: imbpharmacovigilance@imb.ie

Updated on 1 July 2013 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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

section 4.2
addition of:

Conversion to other therapies from Durogesic DTrans using Tables 2 and 3 could overestimate the dose of the new agent resulting in overdosage of the new analgesic agent. For this reason, Table 2 and Table 3 should not be used to convert from Durogesic DTrans to other therapies.

section 4.3
no change to actual  contridications, change to text and layout

Section 4.4

additon of furhter infromation on Accidental exposure bty paych transfet, effect  on Gastrointestinal tract.
IMPORTANT_ new information on serotionin syndrome

Sectiotn 4.5

Addition of interactions with CYP3A4 enzyme inducers e.g. . rifampicin, carbamazepine, phenobarbital, phenytoin) which could result in a decrease in fentanyl plasma concentrations and a decreased therapeutic effect.

Increase risk of serotonin syndrome with tcomcomitant use of serotonergic drugs.

Section 4.8 addition of pyrexia as an ADR -further warning on serotonin syndrome as a result of co-administartion


 

Updated on 1 July 2013 PIL

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

section 4.2
addition of:

Conversion to other therapies from Durogesic DTrans using Tables 2 and 3 could overestimate the dose of the new agent resulting in overdosage of the new analgesic agent. For this reason, Table 2 and Table 3 should not be used to convert from Durogesic DTrans to other therapies.

section 4.3
no change to actual  contridications, change to text and layout

Section 4.4

additon of furhter infromation on Accidental exposure bty paych transfet, effect  on Gastrointestinal tract.
IMPORTANT_ new information on serotionin syndrome

Sectiotn 4.5

Addition of interactions with CYP3A4 enzyme inducers e.g. . rifampicin, carbamazepine, phenobarbital, phenytoin) which could result in a decrease in fentanyl plasma concentrations and a decreased therapeutic effect.

Increase risk of serotonin syndrome with tcomcomitant use of serotonergic drugs.

Section 4.8 addition of pyrexia as an ADR -further warning on serotonin syndrome as a result of co-administartion


 

Updated on 2 December 2011 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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 3 -  Transdermal patch. A rectangular shaped, clear patch with a sticky back so that it can be stuck onto the skin.

Each Durogesic DTrans patch is marked:

       Durogesic

       12, 25, 50, 75 or 100 µg fentanyl/h

       Orange/Red/Green/Blue/Grey printing ink

  • Section 10 - November 2011

Updated on 2 December 2011 PIL

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

  • Section 3 -  Transdermal patch. A rectangular shaped, clear patch with a sticky back so that it can be stuck onto the skin.

Each Durogesic DTrans patch is marked:

       Durogesic

       12, 25, 50, 75 or 100 µg fentanyl/h

       Orange/Red/Green/Blue/Grey printing ink

  • Section 10 - November 2011

Updated on 4 November 2011 PIL

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

  • In section 3 (Pharmaceutical form): addition of  Durogesic DTrans 12 patch: Transdermal patch. A rectangular shaped, clear patch with a sticky back so that it can be stuck onto the skin. Orange printing ink.
  • In section 9 - Date of renewal of authorisation - Date of last renewal: 7 July 2011 has been added
  • In section 10 - Date of revision of the text is October 2011

Updated on 4 November 2011 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 9 - Date of renewal of authorisation
  • 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

  • In section 3 (Pharmaceutical form): addition of  Durogesic DTrans 12 patch: Transdermal patch. A rectangular shaped, clear patch with a sticky back so that it can be stuck onto the skin. Orange printing ink.
  • In section 9 - Date of renewal of authorisation - Date of last renewal: 7 July 2011 has been added
  • In section 10 - Date of revision of the text is October 2011

Updated on 19 September 2011 PIL

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Change to section 4.2- updated wording for discontinuation of Durogesic DTrans

Change to section 4.3 -Durogesic DTrans is contraindicated in patients with known hypersensitivity to fentanyl or to the excipients present in the patch.

Durogesic DTrans is a sustained-release preparation indicated for the treatment of chronic intractable pain in patients requiring opioid analgesia and is contraindicated in acute or postoperative pain because of the lack of opportunity for dosage titration in the short term and the resultant possibility of serious or life threatening respiratory depression.

Change to section 4.4-  

DUROGESIC SHOULD NOT BE USED IN THE MANAGEMENT OF ACUTE OR POSTOPERATIVE PAIN SINCE THERE IS NO OPPORTUNITY FOR DOSE TITRATION DURING SHORT-TERM USE AND BECAUSE SERIOUS OR LIFE‑THREATENING HYPOVENTILATION COULD RESULT.  

PATIENTS WHO HAVE EXPERIENCED SERIOUS ADVERSE EVENTS SHOULD BE MONITORED FOR UP TO 24 HOURS AFTER DUROGESIC REMOVAL SINCE SERUM FENTANYL CONCENTRATIONS DECLINE GRADUALLY AND ARE REDUCED BY ABOUT 50% 17 (RANGE 13-22) HOURS LATER (see Section 5.2, Pharmacokinetic Properties)

Patients who have experienced serious adverse events should be monitored for up to 24 hours after Durogesic DTrans removal since serum fentanyl concentrations decline gradually with mean half-life ranging from 20-27 hours.

 

Do not cut Durogesic DTrans patches should not be cut.. A patch that has been divided, cut or damaged in any way should not be used.

Drug dependence and potential for abuse

Tolerance, physical dependence and psychological dependence may develop upon repeated administration of opioids.  Iatrogenic addiction following opioid administration is rare. Patients with a prior history of drug dependence/alcohol abuse are more at risk to develop dependence and abuse in opioid treatment. Patients at increased risk of opioid abuse may still be appropriately treated with modified-release opioid formulations; however, these patients will require intensive monitoring for signs of misuse, abuse or addiction. Fentanyl can be abused in a manner similar to other opioid agonists.  Abuse or intentional misuse of Durogesic DTrans may result in overdose and/or death. Patients at increased risk of opioid abuse may still be appropriately treated with modified-release opioid formulations, however, these patients will require intensive monitoring for signs of misuse, abuse or addiction.

Opioids may cause hypotension, especially in patients with acute hypovolaemia. Underlying, symptomatic hypotension and/or hypovolaemia should be corrected before treatment with fentanyl transdermal patches is initiated

 

Patients with fever/external heat

A pharmacokinetic model suggests that serum fentanyl concentrations may increase by about one-third if the skin temperature increases to 40° C. Therefore, patients with fever should be monitored for opioid side effects and the Durogesic DTrans dose should be adjusted if necessary. There is a potential for temperature-dependent increases in fentanyl released from the system resulting in possible overdose and death.  A clinical pharmacology trial conducted in healthy adult subjects has shown that the application of heat over the Durogesic DTrans transdermal system increased mean fentanyl AUC values by 120% and mean Cmax values by 61%.

Patients who develop fever should be monitored for opioid side effects since significant increases in body temperature can potentially increase fentanyl delivery rate.

 

Interactions with other Medicinal Products:

Interactions with CYP3A4 inhibitors

The concomitant use of Durogesic DTrans with cytochrome P450 3A4 (CYP3A4) inhibitors (e.g. ritonavir, ketoconazole, itraconazole, troleandomycin clarithromycin, nelfinavir, nefazodone, verapamil, diltiazem, and amiodarone) may result in an increase in fentanyl plasma concentrations, which could increase or prolong both the therapeutic and adverse effects, and may cause serious respiratory depression.  In this situation special patient care and observation are appropriate.  Therefore, the concomitant use of transdermal fentanyl and CYP3A4 inhibitors is not recommended unless the patient is closely monitored.  Patients, especially those who are receiving Durogesic DTrans and CYP3A4 inhibitors, should be monitored for signs of respiratory depression and dosage adjustments should be made if warranted.

Concomitant use of mixed agonists/antagonists

The concomitant use of buprenorphine, nalbuphine or pentazocine is not recommended (see also Section 4.5). 

Use in Elderly Patients

Data from intravenous studies with fentanyl suggest that elderly patients may have reduced clearance, a prolonged half-life, and they may be more sensitive to the drug than younger patients. If elderly patients receive Durogesic, they should be observed carefully for signs of fentanyl toxicity and the dose reduced if necessary (see Section 5.2, Pharmacokinetic properties).

Lactation

As fentanyl is excreted into breast milk, breastfeeding should be discontinued during treatment with Durogesic (see also Section 4.6).

Patients with myasthenia gravis

Non-epileptic (myo)clonic reactions can occur. Caution should be exercised when treating patients with myasthenia gravis. 

Change to section 4.5- The concomitant use of other CNS depressants, including opioids, sedatives, anxiolytics, hypnotics, general anaesthetics, phenothiazines, tranquilisers, antipsychotics, skeletal muscle relaxants, sedating antihistamines and alcoholic beverages may produce additive depressant effects; hypoventilation, hypotension and profound sedation, coma or death may occur.  Therefore, the use of any of these drugs concomitantly with Durogesic DTrans requires special care and observation.

 

 

Itraconazole (a potent CYP3A4 inhibitor) at 200 mg/day given orally for 4 days had no significant effect on the pharmacokinetics of IV fentanyl.  Oral ritonavir (one of the most potent CYP3A4 inhibitors) reduced the clearance of IV fentanyl by two thirds.

The concomitant use of transdermal fentanyl with cytochrome P450 3A4 (CYP3A4) inhibitors (e.g. ritonavir, ketoconazole, itraconazole, fluconazole, voriconazole,  troleandomycin, clarithromycin, nelfinavir, nefazodone, verapamil, diltiazem, and amiodarone) may result in an increase in fentanyl plasma concentrations, which could increase or prolong both the therapeutic and adverse effects, and may cause serious respiratory depression. In this situation, special patient care and observation are appropriate. The concomitant use of CYP3A4 inhibitors and transdermal fentanyl is not recommended, unless the patient is closely monitored for an extended period of time and dosage adjustments made if warranted (See also 4.4 Special Warnings and Precautions for Use).

Concomitant use of mixed agonists/antagonists

The concomitant use of buprenorphine, nalbuphine or pentazocine is not recommended. They have high affinity to opioid receptors with relatively low intrinsic activity and therefore partially antagonise the analgesic effect of fentanyl and may induce withdrawal symptoms in opioid dependent patients (see also Section 4.4).

Change to section 4.6- There are no adequate data from the use of Durogesic in pregnant women. Studies in animals have shown some reproductive toxicity (see Section 5.3, preclinical safety data).  The potential risk for humans is unknown, although fentanyl as an IV anesthetic has been found to cross the placenta in early human pregnancies.  .  Neonatal withdrawal syndrome has been reported in newborn infants with chronic maternal use of Durogesic DTrans during pregnancy.  Durogesic DTrans should not be used during pregnancy unless clearly necessary.

 

Use of Durogesic DTrans during childbirth is not recommended because it should not be used in the management of acute or postoperative pain (see section 4.3 Contraindications and 4.4, Special Warning and Precautions).

Change to section 4.7-Durogesic DTrans may impair the mental and/or physical ability required to perform potentially hazardous tasks such as driving a car or operating machinery.

Change to section 4.8-Addition of paediatric wording and updated paediatric table

Change to section 4.9-

Symptoms:

The manifestations of fentanyl overdosage are an extension of its pharmacological actions, the most serious effect being respiratory depression.

Treatment:

For management of respiratory depression, immediate countermeasures include removing Durogesic DTrans and physically or verbally stimulating the patient. These actions can be followed by administration of a specific opioid antagonist such as naloxone. Respiratory depression following an overdose may outlast the duration of action of the opioid antagonist. The interval between IV antagonist doses should be carefully chosen because of the possibility of re-narcotization after the patch is removed; repeated administration or a continuous infusion of naloxone may be necessary. Reversal of the narcotic effect may result in acute onset of pain and release of catecholamines.

If the clinical situation warrants, a patent airway should be established and maintained, possibly with an oropharyngeal airway or endotracheal tube and oxygen should be administered and respiration assisted or controlled, as appropriate.  Adequate body temperature and fluid intake should be maintained

Change to section 5.2-

Elimination

After Durogesic DTrans is removed, serum fentanyl concentrations decline gradually, falling about 50% in about 17 (range 13-22) hours following a 24-hour application. Following a 72-hour application, the mean half-life ranges from 20-27 hours. 

 

Updated on 19 September 2011 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic 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

Change to section 4.2- updated wording for discontinuation of Durogesic DTrans

Change to section 4.3 -Durogesic DTrans is contraindicated in patients with known hypersensitivity to fentanyl or to the excipients present in the patch.

Durogesic DTrans is a sustained-release preparation indicated for the treatment of chronic intractable pain in patients requiring opioid analgesia and is contraindicated in acute or postoperative pain because of the lack of opportunity for dosage titration in the short term and the resultant possibility of serious or life threatening respiratory depression.

Change to section 4.4-  

DUROGESIC SHOULD NOT BE USED IN THE MANAGEMENT OF ACUTE OR POSTOPERATIVE PAIN SINCE THERE IS NO OPPORTUNITY FOR DOSE TITRATION DURING SHORT-TERM USE AND BECAUSE SERIOUS OR LIFE‑THREATENING HYPOVENTILATION COULD RESULT.  

PATIENTS WHO HAVE EXPERIENCED SERIOUS ADVERSE EVENTS SHOULD BE MONITORED FOR UP TO 24 HOURS AFTER DUROGESIC REMOVAL SINCE SERUM FENTANYL CONCENTRATIONS DECLINE GRADUALLY AND ARE REDUCED BY ABOUT 50% 17 (RANGE 13-22) HOURS LATER (see Section 5.2, Pharmacokinetic Properties)

Patients who have experienced serious adverse events should be monitored for up to 24 hours after Durogesic DTrans removal since serum fentanyl concentrations decline gradually with mean half-life ranging from 20-27 hours.

 

Do not cut Durogesic DTrans patches should not be cut.. A patch that has been divided, cut or damaged in any way should not be used.

Drug dependence and potential for abuse

Tolerance, physical dependence and psychological dependence may develop upon repeated administration of opioids.  Iatrogenic addiction following opioid administration is rare. Patients with a prior history of drug dependence/alcohol abuse are more at risk to develop dependence and abuse in opioid treatment. Patients at increased risk of opioid abuse may still be appropriately treated with modified-release opioid formulations; however, these patients will require intensive monitoring for signs of misuse, abuse or addiction. Fentanyl can be abused in a manner similar to other opioid agonists.  Abuse or intentional misuse of Durogesic DTrans may result in overdose and/or death. Patients at increased risk of opioid abuse may still be appropriately treated with modified-release opioid formulations, however, these patients will require intensive monitoring for signs of misuse, abuse or addiction.

Opioids may cause hypotension, especially in patients with acute hypovolaemia. Underlying, symptomatic hypotension and/or hypovolaemia should be corrected before treatment with fentanyl transdermal patches is initiated

 

Patients with fever/external heat

A pharmacokinetic model suggests that serum fentanyl concentrations may increase by about one-third if the skin temperature increases to 40° C. Therefore, patients with fever should be monitored for opioid side effects and the Durogesic DTrans dose should be adjusted if necessary. There is a potential for temperature-dependent increases in fentanyl released from the system resulting in possible overdose and death.  A clinical pharmacology trial conducted in healthy adult subjects has shown that the application of heat over the Durogesic DTrans transdermal system increased mean fentanyl AUC values by 120% and mean Cmax values by 61%.

Patients who develop fever should be monitored for opioid side effects since significant increases in body temperature can potentially increase fentanyl delivery rate.

 

Interactions with other Medicinal Products:

Interactions with CYP3A4 inhibitors

The concomitant use of Durogesic DTrans with cytochrome P450 3A4 (CYP3A4) inhibitors (e.g. ritonavir, ketoconazole, itraconazole, troleandomycin clarithromycin, nelfinavir, nefazodone, verapamil, diltiazem, and amiodarone) may result in an increase in fentanyl plasma concentrations, which could increase or prolong both the therapeutic and adverse effects, and may cause serious respiratory depression.  In this situation special patient care and observation are appropriate.  Therefore, the concomitant use of transdermal fentanyl and CYP3A4 inhibitors is not recommended unless the patient is closely monitored.  Patients, especially those who are receiving Durogesic DTrans and CYP3A4 inhibitors, should be monitored for signs of respiratory depression and dosage adjustments should be made if warranted.

Concomitant use of mixed agonists/antagonists

The concomitant use of buprenorphine, nalbuphine or pentazocine is not recommended (see also Section 4.5). 

Use in Elderly Patients

Data from intravenous studies with fentanyl suggest that elderly patients may have reduced clearance, a prolonged half-life, and they may be more sensitive to the drug than younger patients. If elderly patients receive Durogesic, they should be observed carefully for signs of fentanyl toxicity and the dose reduced if necessary (see Section 5.2, Pharmacokinetic properties).

Lactation

As fentanyl is excreted into breast milk, breastfeeding should be discontinued during treatment with Durogesic (see also Section 4.6).

Patients with myasthenia gravis

Non-epileptic (myo)clonic reactions can occur. Caution should be exercised when treating patients with myasthenia gravis. 

Change to section 4.5- The concomitant use of other CNS depressants, including opioids, sedatives, anxiolytics, hypnotics, general anaesthetics, phenothiazines, tranquilisers, antipsychotics, skeletal muscle relaxants, sedating antihistamines and alcoholic beverages may produce additive depressant effects; hypoventilation, hypotension and profound sedation, coma or death may occur.  Therefore, the use of any of these drugs concomitantly with Durogesic DTrans requires special care and observation.

 

 

Itraconazole (a potent CYP3A4 inhibitor) at 200 mg/day given orally for 4 days had no significant effect on the pharmacokinetics of IV fentanyl.  Oral ritonavir (one of the most potent CYP3A4 inhibitors) reduced the clearance of IV fentanyl by two thirds.

The concomitant use of transdermal fentanyl with cytochrome P450 3A4 (CYP3A4) inhibitors (e.g. ritonavir, ketoconazole, itraconazole, fluconazole, voriconazole,  troleandomycin, clarithromycin, nelfinavir, nefazodone, verapamil, diltiazem, and amiodarone) may result in an increase in fentanyl plasma concentrations, which could increase or prolong both the therapeutic and adverse effects, and may cause serious respiratory depression. In this situation, special patient care and observation are appropriate. The concomitant use of CYP3A4 inhibitors and transdermal fentanyl is not recommended, unless the patient is closely monitored for an extended period of time and dosage adjustments made if warranted (See also 4.4 Special Warnings and Precautions for Use).

Concomitant use of mixed agonists/antagonists

The concomitant use of buprenorphine, nalbuphine or pentazocine is not recommended. They have high affinity to opioid receptors with relatively low intrinsic activity and therefore partially antagonise the analgesic effect of fentanyl and may induce withdrawal symptoms in opioid dependent patients (see also Section 4.4).

Change to section 4.6- There are no adequate data from the use of Durogesic in pregnant women. Studies in animals have shown some reproductive toxicity (see Section 5.3, preclinical safety data).  The potential risk for humans is unknown, although fentanyl as an IV anesthetic has been found to cross the placenta in early human pregnancies.  .  Neonatal withdrawal syndrome has been reported in newborn infants with chronic maternal use of Durogesic DTrans during pregnancy.  Durogesic DTrans should not be used during pregnancy unless clearly necessary.

 

Use of Durogesic DTrans during childbirth is not recommended because it should not be used in the management of acute or postoperative pain (see section 4.3 Contraindications and 4.4, Special Warning and Precautions).

Change to section 4.7-Durogesic DTrans may impair the mental and/or physical ability required to perform potentially hazardous tasks such as driving a car or operating machinery.

Change to section 4.8-Addition of paediatric wording and updated paediatric table

Change to section 4.9-

Symptoms:

The manifestations of fentanyl overdosage are an extension of its pharmacological actions, the most serious effect being respiratory depression.

Treatment:

For management of respiratory depression, immediate countermeasures include removing Durogesic DTrans and physically or verbally stimulating the patient. These actions can be followed by administration of a specific opioid antagonist such as naloxone. Respiratory depression following an overdose may outlast the duration of action of the opioid antagonist. The interval between IV antagonist doses should be carefully chosen because of the possibility of re-narcotization after the patch is removed; repeated administration or a continuous infusion of naloxone may be necessary. Reversal of the narcotic effect may result in acute onset of pain and release of catecholamines.

If the clinical situation warrants, a patent airway should be established and maintained, possibly with an oropharyngeal airway or endotracheal tube and oxygen should be administered and respiration assisted or controlled, as appropriate.  Adequate body temperature and fluid intake should be maintained

Change to section 5.2-

Elimination

After Durogesic DTrans is removed, serum fentanyl concentrations decline gradually, falling about 50% in about 17 (range 13-22) hours following a 24-hour application. Following a 72-hour application, the mean half-life ranges from 20-27 hours. 

 

Updated on 21 December 2010 PIL

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Section 4.2 - Addition of equianalgesic potency conversion information.

Section 4.4 - Addition of - do not divide or cut patches, damaged patches should not be used. Information on temperature dependent increases int he release of fentanyl.

Section 4.5 - Addition of - Coadminstration with agents that induce CYP3A4 activity may reduce the efficacy of Durogesic DTrans.

Therefore, Durogesic DTrans should not be used within 14 days after discontinuation of treatment with MAOIs.


Section 4.6 - Addition of - Breastfeeding should therefore be discontinued during treatment with Durogesic and for at least 72 hours after removal of the patch.

Section 5.2 - Addition of information to the following sub-sections: Adults, Distribution, Metabolism, Elimination, Special Populations, Hepatic Impairment and Renal Impairment.

Updated on 21 December 2010 SmPC

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • 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 - Addition of equianalgesic potency conversion information.

Section 4.4 - Addition of - do not divide or cut patches, damaged patches should not be used. Information on temperature dependent increases int he release of fentanyl.

Section 4.5 - Addition of - Coadminstration with agents that induce CYP3A4 activity may reduce the efficacy of Durogesic DTrans.

Therefore, Durogesic DTrans should not be used within 14 days after discontinuation of treatment with MAOIs.


Section 4.6 - Addition of - Breastfeeding should therefore be discontinued during treatment with Durogesic and for at least 72 hours after removal of the patch.

Section 5.2 - Addition of information to the following sub-sections: Adults, Distribution, Metabolism, Elimination, Special Populations, Hepatic Impairment and Renal Impairment.

Updated on 29 October 2010 SmPC

Reasons for updating

  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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 to section 6.6 - Special precautions for disposal and other handling: Wash hands with water only after applying or removing the patch.

Updated on 29 October 2010 PIL

Reasons for updating

  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Change to section 6.6 - Special precautions for disposal and other handling: Wash hands with water only after applying or removing the patch.

Updated on 4 August 2010 PIL

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Change to section 4.1 - addition of paediatric data
Change to section 4.2 - addition of paediatric data
Change to section 10 - July 2010

Updated on 4 August 2010 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • 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 to section 4.1 - addition of paediatric data
Change to section 4.2 - addition of paediatric data
Change to section 10 - July 2010

Updated on 11 June 2010 SmPC

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

Change to section 10 - Date of revision of the text

June 2010

Change to section 4.8 - Undesirable effects

Updated into MedRA format.

Updated on 11 June 2010 PIL

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Change to section 10 - Date of revision of the text

June 2010

Change to section 4.8 - Undesirable effects

Updated into MedRA format.

Updated on 4 September 2008 PIL

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Change to section 7 – Marketing Authorisation Holder

Change of address

Change to section 10 – Date of revision of text

August 2008

Updated on 4 September 2008 SmPC

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)

Free text change information supplied by the pharmaceutical company

Change to section 7 – Marketing Authorisation Holder

Change of address

Change to section 10 – Date of revision of text

August 2008

Updated on 7 August 2008 PIL

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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Change to section 4.2 – Posology and Method of Administration

Information added regarding application and removal of patches.

Change to section 4.4 – Special Warnings and Precautions for Use

Information added to sections “Drug dependence and potential for abuse” and “Patients with fever/external heat”.

Change to section 4.6 – Pregnancy and Lactation

Information added regarding use in pregnancy, childbirth and breast feeding.

Change to section 4.8 – Undesirable effects

Information added regarding neonatal withdrawal syndrome.

Change to section 5.3 - Preclinical Safety Data

Information added regarding in vitro and in vivo studies.

Change to section 10 – Date of revision of text

July 2008

Updated on 7 August 2008 SmPC

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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data
  • 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 to section 4.2 – Posology and Method of Administration

Information added regarding application and removal of patches.

Change to section 4.4 – Special Warnings and Precautions for Use

Information added to sections “Drug dependence and potential for abuse” and “Patients with fever/external heat”.

Change to section 4.6 – Pregnancy and Lactation

Information added regarding use in pregnancy, childbirth and breast feeding.

Change to section 4.8 – Undesirable effects

Information added regarding neonatal withdrawal syndrome.

Change to section 5.3 - Preclinical Safety Data

Information added regarding in vitro and in vivo studies.

Change to section 10 – Date of revision of text

July 2008

Updated on 3 July 2008 SmPC

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation
  • 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 to section 9 – Date of Renewal of Authorisation

Change to section 10 – Date of revision of text

Updated on 3 July 2008 PIL

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Change to section 9 – Date of Renewal of Authorisation

Change to section 10 – Date of revision of text

Updated on 22 June 2007 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 22 June 2007 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 18 June 2007 SmPC

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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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

REASON(S) FOR SUBMISSION

Change

IPHA – Fragments submitted to IMB

Change to section 4.2 – Posology and |Method of Administration

Addition of paediatric Posology

Change to section 4.4 – Special Warnings and Precautions for Use

Addition of paediatric information. Wording included on accidental ingestion.

Change to section 4.8 – Undesirable effects

Addition of AEs in children and adolescents

Change to section 5.1 - Pharmacodynamic properties

Addition of Clinical Trial data on paediatric patients

Change to section 5.2 - Pharmacokinetic properties

Addition of paediatric PK information

Change to section 6.6 –  Instructions for use, handling and disposal

Addition of wording informing there is no safety and PK data available for other application sites.

Change to section 10 – Date of revision of text

 

Updated on 18 June 2007 PIL

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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

REASON(S) FOR SUBMISSION

Change

IPHA – Fragments submitted to IMB

Change to section 4.2 – Posology and |Method of Administration

Addition of paediatric Posology

Change to section 4.4 – Special Warnings and Precautions for Use

Addition of paediatric information. Wording included on accidental ingestion.

Change to section 4.8 – Undesirable effects

Addition of AEs in children and adolescents

Change to section 5.1 - Pharmacodynamic properties

Addition of Clinical Trial data on paediatric patients

Change to section 5.2 - Pharmacokinetic properties

Addition of paediatric PK information

Change to section 6.6 –  Instructions for use, handling and disposal

Addition of wording informing there is no safety and PK data available for other application sites.

Change to section 10 – Date of revision of text

 

Updated on 14 May 2007 PIL

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Change to section 4.2 – Posology and |Method of Administration

Further details added for application site, use in opioid tolerant patients, use in opioid-naive patients, withdrawal symptoms.

Change to section 4.3 – Contra-indications

- Change in wording regarding respiratory depression.

Change to section 4.4 – Special Warnings and Precautions for Use

- Addition of paragraph for "Opioid-naïve and not opioid-tolerant states"

- Addition of text regarding potential for abuse, misuse or addiction of product

- Addition of paragraph regarding "Interactions with CYP3A4 Inhibitors"

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

- Further details added for concomitant use with CNS depressants, potent CYP3A4 inhibitors.

- Addition of paragraph regarding "Monoamine Oxidase Inhibitors

Change to section 4.8 – Undesirable effects

- Information added for Clinical Trials and Postmarketing Experience.

Change to section 10 – Date of revision of text

May 2007

Updated on 14 May 2007 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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

Change to section 4.2 – Posology and |Method of Administration

Further details added for application site, use in opioid tolerant patients, use in opioid-naive patients, withdrawal symptoms.

Change to section 4.3 – Contra-indications

- Change in wording regarding respiratory depression.

Change to section 4.4 – Special Warnings and Precautions for Use

- Addition of paragraph for "Opioid-naïve and not opioid-tolerant states"

- Addition of text regarding potential for abuse, misuse or addiction of product

- Addition of paragraph regarding "Interactions with CYP3A4 Inhibitors"

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

- Further details added for concomitant use with CNS depressants, potent CYP3A4 inhibitors.

- Addition of paragraph regarding "Monoamine Oxidase Inhibitors

Change to section 4.8 – Undesirable effects

- Information added for Clinical Trials and Postmarketing Experience.

Change to section 10 – Date of revision of text

May 2007

Updated on 21 November 2006 SmPC

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

4.4

Special Warnings and Precautions for Use

Text added advising that patients should not be changed from one brand of fentanyl transdermal patches to another without specific counselling on the change from their healthcare professionals.

 

10.

DATE OF REVISION OF THE TEXT

 

November 2006

 

Updated on 21 November 2006 PIL

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

4.4

Special Warnings and Precautions for Use

Text added advising that patients should not be changed from one brand of fentanyl transdermal patches to another without specific counselling on the change from their healthcare professionals.

 

10.

DATE OF REVISION OF THE TEXT

 

November 2006

 

Updated on 20 October 2006 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 20 October 2006 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 10 October 2006 PIL

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 8 - MA number
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

1.

NAME OF THE MEDICINAL PRODUCT

Addition of 12 microgram/hour information to the SmPC

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Addition of 12 microgram/hour information to the SmPC

4.2

Posology and method of administration

Addition of 12 microgram/hour information to the SmPC

4.4

Special Warnings and Precautions for Use

Addition of 12 microgram/hour information to the SmPC

5.2

Pharmacokinetic properties

Addition of 12 microgram/hour information to the SmPC

6.1

List of excipients

Addition of 12 microgram/hour information to the SmPC

8.

MARKETING AUTHORISATION NUMBER(S)

Addition of 12 microgram/hour information to the SmPC

9.

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Addition of 12 microgram/hour information to the SmPC

10.

DATE OF REVISION OF THE TEXT

September 2006

 

Updated on 10 October 2006 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 8 - MA number
  • Change to section 9 - Date of renewal of authorisation
  • 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

1.

NAME OF THE MEDICINAL PRODUCT

Addition of 12 microgram/hour information to the SmPC

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Addition of 12 microgram/hour information to the SmPC

4.2

Posology and method of administration

Addition of 12 microgram/hour information to the SmPC

4.4

Special Warnings and Precautions for Use

Addition of 12 microgram/hour information to the SmPC

5.2

Pharmacokinetic properties

Addition of 12 microgram/hour information to the SmPC

6.1

List of excipients

Addition of 12 microgram/hour information to the SmPC

8.

MARKETING AUTHORISATION NUMBER(S)

Addition of 12 microgram/hour information to the SmPC

9.

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Addition of 12 microgram/hour information to the SmPC

10.

DATE OF REVISION OF THE TEXT

September 2006

 

Updated on 18 November 2005 SmPC

Reasons for updating

  • New SPC for new product

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

Updated on 18 November 2005 PIL

Reasons for updating

  • New SPC for new product