Durogesic

Package leaflet: Information for the patient

Durogesic, 12 µg/h, transdermal system, patch
Durogesic, 25 µg/h, transdermal system, patch
Durogesic, 50 µg/h, transdermal system, patch
Durogesic, 75 µg/h, transdermal system, patch
Durogesic, 100 µg/h, transdermal system, patch
fentanyl
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Durogesic is and what it is used for
2. Important information before using Durogesic
3. How to use Durogesic
4. Possible side effects
5. How to store Durogesic
6. Contents of the pack and other information

1. What Durogesic is and what it is used for

The name of this medicine is Durogesic.
Durogesic is indicated for the treatment of severe chronic pain:

• in adults requiring continuous administration of analgesics
• in children over 2 years of age who have already been treated with opioid medicines and require continuous administration of analgesics.

Durogesic contains as the active substance fentanyl, which is a strong-acting analgesic belonging to the group of opioids.

2. Important information before using Durogesic

When not to use Durogesic

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6),
• in the case of short-term, acute or postoperative pain,
• if the patient has severe respiratory depression (marked slowing and shallowing of breathing).

Do not use Durogesic if any of the above situations apply to the patient. If in doubt, consult a doctor or pharmacist before using Durogesic.

Warnings and precautions

• Durogesic may cause life-threatening adverse effects in people who do not regularly use opioid-containing medicines.
• Durogesic is a medicine that may be life-threatening to children, including used patches. Consider that the appearance of the patch (used or unused) may encourage a child to touch it, stick it to the body, put it in the mouth, etc., which may lead to death.
• This medicine must be stored in a safe and secure place inaccessible to others – more information on this can be found in section 5.

If a Durogesic patch adheres to another person's skin
Patches should only be applied to the skin of the person for whom they have been prescribed. There have been reports of accidental adhesion of a patch to another person's skin during close physical contact or while sleeping in the same bed with a person using patches. Accidental adhesion of a patch to another person's skin (especially a child) may result in drug transfer through the skin and cause serious adverse effects such as breathing difficulties with slow and shallow breathing, which may be life-threatening. If this occurs, remove the patch immediately and contact a doctor.

Exercise particular caution when using Durogesic
Talk to your doctor or pharmacist before using this medicine if any of the following situations apply – closer monitoring of the patient may be necessary when:

• the patient has ever had lung disease or breathing difficulties,
• the patient has ever had heart, liver, kidney problems or low blood pressure,
• the patient has ever had a brain tumour,
• the patient has ever had persistent headaches or head injury,
• the patient is elderly – they may be more sensitive to the effects of this medicine,
• the patient has "myasthenia gravis", a condition characterised by muscle weakness and fatigue.

If any of the above situations apply to the patient (or the patient is unsure), talk to a doctor or pharmacist before using Durogesic.

While using the patches, inform the doctor if the patient has breathing problems during sleep.
Opioids such as Durogesic may cause breathing disorders during sleep, such as sleep apnoea (pauses in breathing during sleep) and nocturnal hypoxia (low oxygen levels in the blood). Inform the doctor if the patient, their partner or caregiver notices any of the following symptoms:

• pauses in breathing during sleep
• waking up at night due to breathlessness
• difficulty maintaining sleep
• excessive daytime sleepiness.

The doctor may decide to change the dose of the medicine.

While using the patches, inform the doctor if the patient notices a change in pain perception.
If the patient feels that:

• pain no longer subsides after applying the patch
• pain worsens
• there is a change in the way pain is felt (e.g. the patient feels pain in another part of the body)
• pain occurs on touch where it should not.

Do not change the dose independently. The doctor may decide to change the dose or treatment.

Adverse effects of Durogesic

• Durogesic may cause unusual tiredness and slowed, shallow breathing. Very rarely, these breathing disorders may be life-threatening or lead to death, particularly in people who have not previously used opioid pain medicines (such as Durogesic or morphine). If the patient, partner or caregiver notices that the person using the patches is excessively drowsy and has slow or shallow breathing, they should:
  • remove the patch
  • contact a doctor or go immediately to the nearest hospital
  • encourage the patient to stay awake and talk as much as possible.
• If fever occurs during treatment with Durogesic, talk to a doctor – increased body temperature may significantly increase drug absorption through the skin.
• Durogesic may cause constipation; talk to a doctor or pharmacist about how to prevent or relieve constipation. A full list of adverse effects is provided in section 4.

Durogesic, like other opioids, may affect normal hormone production in the body, such as cortisol, prolactin or sex hormones, especially with long-term use of Durogesic. The effects of these hormonal changes may include poor well-being (including nausea), loss of appetite, fatigue, weakness, dizziness, low blood pressure, infertility or reduced sex drive. In women, menstrual cycle changes may occur, and in men, impotence or breast enlargement. If the patient notices any of these symptoms, contact a doctor.

Do not heat the area where the patch is applied with external heat sources such as heated pads, electrically heated blankets, hot water bottles (hot-water bottles), heated beds, heat or sun lamps. Do not sunbathe or take prolonged warming baths, saunas or hydrotherapy baths. In these situations, there is a risk of increased drug release from the patch.

Long-term use and tolerance
This medicine contains fentanyl, which is an opioid. Repeated use of opioid pain medicines may lead to reduced effectiveness of the medicine (the patient becomes accustomed to it, known as tolerance). During treatment with Durogesic, the patient's sensitivity to pain may also increase. This phenomenon is known as hyperalgesia. Increasing the dose of patches may temporarily further reduce pain intensity, but may also be harmful. If the patient notices reduced effectiveness of the medicine, they should consult a doctor. The doctor will decide whether increasing the dose or gradually reducing the use of Durogesic is better for the patient.

Dependence and addiction

This medicine contains fentanyl, which is an opioid. It may cause dependence and/or addiction.
Repeated use of Durogesic may also lead to dependence, abuse and addiction, which may result in life-threatening overdose. The risk of these adverse effects may increase with increasing dose and prolonged duration of use. Dependence or addiction may cause the patient to lose control over how much medicine to use or how often to use it. The patient may feel a need to continue using the medicine, even if it does not help relieve their pain symptoms.

The risk of dependence or addiction varies between individuals. The risk of dependence on or addiction to Durogesic may be higher if:

• the patient or anyone in their family has ever abused or been dependent on alcohol, prescription medicines or illegal substances ("addiction");
• the patient smokes tobacco;
• the patient has ever had mood disorders (depression, anxiety disorders or personality disorders) or has been treated by a psychiatrist for other mental illnesses.

If any of the following symptoms occur during treatment with Durogesic, they may indicate dependence or addiction:

• The patient must take this medicine for longer than prescribed by the doctor.
• The patient must take a higher dose than prescribed.
• The patient uses this medicine for reasons other than those for which the doctor prescribed it, e.g. "to calm down" or "to be able to sleep".
• The patient has made several unsuccessful attempts to stop or control the use of this medicine.
• After stopping the use of this medicine, the patient feels unwell, but feels better when using the medicine again ("withdrawal effect").

If the patient notices any of these symptoms, they should discuss the best treatment strategy with their doctor, including when it is appropriate to stop treatment and how to safely discontinue treatment.

Withdrawal symptoms after stopping Durogesic

Do not suddenly stop using this medicine. Withdrawal symptoms may occur, such as restlessness, difficulty falling asleep, irritability, agitation, anxiety, palpitations, increased blood pressure, nausea or vomiting, diarrhoea, loss of appetite, tremor, chills or sweating. If the patient wishes to stop using this medicine, they should first talk to their doctor. The doctor will advise how to do this; usually, this is done by gradually reducing the dose to minimise any unpleasant withdrawal symptoms.

Durogesic and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This includes all over-the-counter medicines and herbal remedies the patient is taking.

When buying other medicines at the pharmacy, tell the pharmacist that Durogesic is being used.

The treating doctor knows which medicines can be safely used with Durogesic. The patient will require close monitoring if any of the medicines listed below are used or discontinued, as this may affect the required strength of Durogesic.

In particular, tell your doctor or pharmacist if the patient is taking:

• Other opioid pain medicines (such as buprenorphine, nalbuphine or pentazocine) and certain pain medicines used for neuropathic pain (gabapentin and pregabalin).
• Sleeping medicines (such as temazepam, zaleplon or zolpidem).
• Sedatives (such as alprazolam, clonazepam, diazepam, hydroxyzine or lorazepam) and antipsychotic medicines (such as aripiprazole, haloperidol, olanzapine, risperidone or phenothiazines).
• Muscle relaxants (such as cyclobenzaprine or diazepam).
• Certain antidepressants known as SSRIs or SNRIs (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline or venlafaxine) – see below.
• Certain antidepressants or medicines used in Parkinson's disease known as MAOIs (such as isocarboxazid, phenelzine, selegiline or tranylcypromine). Do not use Durogesic for 14 days after stopping these medicines – see below.
• Certain antihistamines, particularly those causing drowsiness (such as chlorpheniramine, clemastine, cyproheptadine, diphenhydramine or hydroxyzine).
• Certain antibiotics (such as erythromycin or clarithromycin).
• Antifungal medicines (such as itraconazole, ketoconazole, fluconazole or voriconazole).
• Medicines used in HIV therapy (such as ritonavir).
• Antiarrhythmic medicines (such as amiodarone, diltiazem or verapamil).
• Antituberculosis medicines (such as rifampicin).
• Certain antiepileptic medicines (such as carbamazepine, phenobarbital or phenytoin).
• Certain medicines used to treat nausea and motion sickness (such as phenothiazines).
• Certain medicines used to treat heartburn and stomach ulcers (such as cimetidine).
• Certain medicines used to treat coronary heart disease (angina pectoris) or high blood pressure (such as nicardipine).
• Certain medicines used to treat blood cancers (such as idelalisib).

Using Durogesic with antidepressants

The risk of adverse effects increases when used together with certain antidepressants. An interaction between Durogesic and these medicines may occur, and the patient may experience changes in mental state, e.g. agitation, hallucinations (seeing, feeling, hearing or smelling things that are not real), and other effects such as blood pressure fluctuations, rapid heart rate, high temperature, exaggerated reflexes, coordination disorders, muscle stiffness, nausea, vomiting and diarrhoea (these may be symptoms of serotonin syndrome). When using these medicines together, the doctor may wish to closely monitor the patient for such adverse effects, especially when starting treatment or changing the dose.

Use with central nervous system depressants, including alcohol and certain narcotic medicines

Concurrent use of Durogesic and sedative medicines, such as benzodiazepines or their derivatives, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and may be life-threatening. For this reason, concurrent use should only be considered if other treatment options are not possible.

If the doctor prescribes Durogesic together with sedative medicines, the dose and duration of combination therapy should be limited by the doctor.

Inform the doctor about all sedative medicines being taken and strictly follow the doctor's instructions regarding dosage. It may be helpful to inform friends or family members to be aware of the above symptoms. If such symptoms occur, contact the doctor.

Do not drink alcohol while using Durogesic without first discussing it with the treating doctor.

Surgical procedures

If the patient suspects they may undergo anaesthesia, inform the doctor or dentist that they are using Durogesic.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine.

Durogesic should not be used during pregnancy unless discussed with a doctor.

Do not use Durogesic around the time of delivery, as it may cause breathing problems in the newborn.

Long-term use of Durogesic during pregnancy may cause withdrawal symptoms in the newborn (such as loud crying, tremor, seizures, poor feeding and diarrhoea), which may be life-threatening if not recognised and treated. If withdrawal symptoms in the baby are suspected, contact a doctor immediately.

Do not use Durogesic during breastfeeding. Do not breastfeed for 3 days after removing the Durogesic patch. The medicine may pass into human milk.

Driving and operating machinery

Durogesic may affect the ability to drive and operate machinery or tools, as it may cause drowsiness and dizziness. If such symptoms occur, do not drive or operate any machinery or use any tools. Do not drive until the patient's reaction to the medicine is known.

Talk to a doctor or pharmacist if the patient is unsure whether they can safely drive while using this medicine.

3. How to use Durogesic

This medicine should always be used exactly as prescribed by the doctor. If in doubt, consult
your doctor or pharmacist.
The doctor will decide which strength of Durogesic is appropriate for the patient, based on an
assessment of pain intensity, the patient's general condition, and previous pain treatment.
Before starting and regularly during treatment, the doctor will also discuss with the patient what
to expect from using Durogesic, when and how long to use it, when to contact the doctor, and when
to stop using the medicine (see also section 2 "Withdrawal symptoms after stopping Durogesic").
Application and changing of patches

• Each patch contains enough medicine for 3 days (72 hours).
• The patch should be changed every third day, unless otherwise instructed by the doctor.
• Always remove the old patch before applying a new one.
• Always change the patch at the same time every 3 days (72 hours).
• If the patient uses more than one patch, all patches must be changed simultaneously.
• It is advisable to record the day, date, and time of patch application to remember when to change it.
• The table below shows when to change the patch:

Patch applied on: Change patch on:
Monday Thursday
Tuesday Friday
Wednesday Saturday
Thursday Sunday
Friday Monday
Saturday Tuesday
Sunday Wednesday
Where to apply the patch
Adults

• Apply the patch to a flat area of the upper body or arm (avoiding joint areas).

Children

• To minimize the risk of the child touching or removing the patch, apply it to the upper back.

• Frequently check that the patch remains properly attached to the skin.

• It is essential that the child does not remove the patch and put it in their mouth, as this could be life-threatening or fatal.

• The child should be closely observed for 48 hours after:

  • Application of the first patch
  • Application of a patch with higher strength.

• The effect of the patch may be delayed after the first dose. Therefore, until the full effect of the medicine becomes apparent, the child may receive additional pain-relieving medicines. The doctor will provide information about this.

Adults and children
Do not apply the patch:

• In the same place consecutively
• On mobile areas (near joints), irritated or damaged skin
• On heavily hairy skin. If hair is present, do not shave (shaving irritates the skin). Instead, trim the hair as close to the skin as possible.

Applying the patch
Step 1: Preparing the skin

• Ensure the skin is completely dry, clean, and cool before applying the patch
• If the skin needs cleaning, use cool water only
• Do not use soap or other cleansing agents, oils, creams, balms, or talcum powder before applying the patch
• Do not apply the patch immediately after a hot bath or shower.

Step 2: Opening the pouch

• Each patch is individually sealed in a pouch
• Tear the pouch at the notch indicated by the arrow
• Carefully and completely peel or cut open one edge of the pouch (if using scissors, cut close to the edge to avoid damaging the patch)

• Hold both sides of the opened pouch and pull apart
• Remove the patch and apply it immediately
• Keep the empty pouch to later dispose of the used patch
• Each patch must be used only once
• Do not remove the patch from the pouch until ready to apply
• Check that the patch is not damaged
• Do not use patches that are cut, torn, or otherwise damaged
• Never divide or cut patches.

Step 3: Unfolding the patch and applying it to the skin

• Ensure clothing at the application site will be loose; do not wear tight elastic bands or bandages
• Carefully peel off one half of the shiny protective liner from the center of the patch. Avoid touching the adhesive layer of the patch
• Apply the adhesive side of the patch to the skin
• Remove the second part of the protective liner and press the entire patch firmly onto the skin with the palm of the hand
• Hold in place for at least 30 seconds. Ensure the patch adheres completely, especially at the edges.

Step 4: Removing the patch

• Immediately after removing the patch, fold it in half so that the adhesive sides stick together
• Place it in the original pouch and dispose of it according to the pharmacist's instructions
• Used patches must be stored out of sight and out of reach of children—used patches still contain medicine that may be harmful and potentially fatal to children.

Step 5: Washing hands

• Always wash hands with clean water only after applying or removing the patch.

Additional information on using Durogesic
Daily activities while using patches

• Patches are water-resistant
• Showering or bathing is allowed, but avoid rubbing the patch
• With the doctor's approval, physical exercise or sports may be performed while using the patch
• Swimming is also permitted while wearing the patch, but:
  • Do not use prolonged hot baths or saunas
  • Do not wear tight elastic bands or bandages at the patch site
• Do not heat the patch application site with external heat sources such as heating pads, electrically heated blankets, hot water bottles (hot-water bags), heated beds, heat lamps, or sunlamps. Do not sunbathe or use prolonged hot baths or saunas. In these situations, there is a risk of increased drug release from the patch.

How quickly will the patch work?

• Maximum effect from the first patch may be delayed.
• During the initial phase of treatment, the doctor may prescribe additional pain-relieving medicines.
• After the initial treatment phase, the patch should provide continuous pain relief, allowing other pain medicines to be discontinued. However, the doctor may occasionally recommend additional pain-relieving medicines.

How long will the patient use patches?

• Durogesic patches are used to treat chronic pain. The treating doctor will inform the patient about the expected duration of therapy.

In case of increased pain

• If pain suddenly worsens after applying the last patch, check the patch. If it is no longer adhering properly or has fallen off, replace it (see also section If the patch detaches).
• If pain increases over time during patch use, the treating doctor may recommend a patch with higher strength and/or additional pain-relieving medicines.
• If increasing the patch strength does not improve pain control, the doctor may decide to discontinue patch treatment.

In case of applying more patches than recommended or a patch with an incorrect dose
If too many patches are applied or a patch with an incorrect dose is used, remove the patches
immediately and contact a doctor as soon as possible.
Symptoms of overdose include breathing difficulties or shallow breathing, fatigue, extreme
drowsiness, inability to think clearly, walk or speak properly, and feelings of faintness, dizziness, or confusion. Overdose may also cause brain disorders known as toxic leukoencephalopathy.
If the patient forgets to change the patch

• Change the patch as soon as remembered and record the day and time. The next patch should be changed after 3 days (72 hours) as usual.
• If a significant delay has occurred since the last patch change, consult the doctor, as additional pain-relieving medicines may be needed; however, do not apply an extra patch.

If the patch detaches

• If the patch detaches before the scheduled change time, apply a new patch immediately and record the day and time. Apply the new patch to a different site:
  • On the upper body or arm
  • On the upper back—for children
• Inform the doctor and continue wearing the patch for 3 days (72 hours) or as directed by the doctor until the next scheduled change
• If repeated early detachment occurs, contact the doctor, pharmacist, or nurse.

Stopping the use of patches

• Do not stop using this medicine suddenly. If the patient wishes to discontinue treatment, they should first consult the doctor. The doctor will advise on how to do this—usually by gradually reducing the dose to minimize any unpleasant withdrawal symptoms. See also section 2 "Withdrawal symptoms after stopping Durogesic".
• After stopping patch treatment, do not restart therapy without consulting the doctor. In such cases, a different dose of medicine may be required.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient, partner or caregiver notices any of the following symptoms in a person using the patches,
the patch should be removed immediately and the doctor contacted or the nearest hospital visited
without delay. Intensive medical care may be required.

• Excessive drowsiness, excessive slowing or shallowness of breathing. Follow the advice above and encourage the patient to move and talk as much as possible. Very rarely, these breathing disturbances may be life-threatening or lead to death, particularly in people who have not previously taken strong opioid painkillers (such as Durogesic or morphine). (Uncommon, may occur in less than 1 in 100 people)
• Sudden swelling of the face or throat, severe irritation, redness or blisters on the skin. These may be symptoms of a severe allergic reaction. (Frequency cannot be determined from available data)
• Seizures (Uncommon, may occur in less than 1 in 100 people)
• Reduced consciousness or loss of consciousness (Uncommon, may occur in less than 1 in 100 people).

The following adverse reactions have also been reported:
Very common adverse reactions (may occur in more than 1 in 10 people):

• nausea, vomiting, constipation
• drowsiness
• dizziness
• headache.

Common adverse reactions (may occur in less than 1 in 10 people):

• allergic reaction
• loss of appetite
• insomnia
• depression
• feeling anxious or confused
• seeing, feeling, hearing, or smelling things that are not there (hallucinations)
• trembling or muscle spasms
• disturbances in sensation, tingling, burning skin (paraesthesia)
• dizziness
• fast heartbeat or palpitations
• high blood pressure
• shortness of breath
• diarrhoea
• dry mouth
• abdominal pain or indigestion
• excessive sweating
• itching, rash, redness of the skin
• difficulty passing urine or completely emptying the bladder
• feeling tired, weak, or generally unwell
• feeling cold
• peripheral swelling in the limbs.

Uncommon adverse reactions (may occur in less than 1 in 100 people):

• restlessness or disorientation
• unnatural state of elation and increased activity (euphoria)
• reduced sensation, especially of the skin (hypoesthesia)
• memory loss
• blurred vision
• slow heartbeat or low blood pressure
• lack of oxygen (cyanosis)
• intestinal obstruction (ileus)
• itchy rash, allergic reaction or other skin disorders at the site of patch application
• influenza-like symptoms
• sensation of body temperature changes
• fever
• muscle twitching
• erectile dysfunction (impotence) or disturbances in sexual function
• difficulty swallowing.

Rare adverse reactions (may occur in less than 1 in 1000 people):

• pinpoint pupils (miosis)
• periodic breathing pauses (apnoea)

The following adverse reactions have also been reported, although their exact frequency is unknown:

• deficiency of male sex hormones (androgen deficiency)
• delirium (symptoms may include restlessness, anxiety, disorientation, confusion, fear, seeing or hearing things that are not there, sleep disturbances, nightmares)
• patients may become dependent on Durogesic (see section 2).

At the site where the patch is applied to the skin, a rash, redness or mild itching may occur.
These reactions are usually mild and resolve after removal of the patch. If they persist or the patch causes significant skin irritation, inform the doctor.
With repeated use of the patches, the effectiveness of the medicine may decrease (tolerance to the medicine may develop or sensitivity to pain may increase), or the patient may become dependent on it.
When switching from other painkillers to Durogesic or when Durogesic is stopped abruptly, the patient may experience withdrawal symptoms such as nausea, vomiting, diarrhoea, restlessness and chills. These symptoms should be reported to the doctor immediately.
Cases of withdrawal symptoms have been observed in newborns whose mothers used Durogesic chronically during pregnancy.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Durogesic

Where to store the patches
Unused and used Durogesic patches must be stored in a place that is out of sight and out of reach of children.
Store in the original packaging to protect from light.
There are no special requirements regarding storage temperature.
The medicine should be stored in a safe and secure place inaccessible to others. It may cause serious harm or even death in individuals who use this medicine accidentally or intentionally when it has not been prescribed for them.

How long can Durogesic be stored
Do not use this medicine after the expiry date stated on the protective pouch of the patch and on the outer packaging following EXP. The expiry date refers to the last day of the stated month.
If the medicine expires, return any unused patches to a pharmacy.
The medicine should be stored in closed pouches within the original packaging, with no special requirements.

How to dispose of used and unused patches
Accidental application of a patch—unused or used—to another person’s skin, especially a child, may result in death.
A used patch should be folded in half with the adhesive sides pressed together, placed back into its original pouch, and then stored in a place that is out of sight and out of reach of others, particularly children, until it can be properly disposed of. Ask your pharmacist how to dispose of medicines that are no longer needed.
Medicines must not be disposed of via wastewater or household waste. Proper disposal helps protect the environment.

6. Contents of the pack and other information

What Durogesic contains

• The active substance is fentanyl. Durogesic transdermal system, patch 12 µg/h contains 2.1 mg of fentanyl and releases the drug at a rate of 12 micrograms per hour. Durogesic transdermal system, patch 25 µg/h contains 4.2 mg of fentanyl and releases the drug at a rate of 25 micrograms per hour. Durogesic transdermal system, patch 50 µg/h contains 8.4 mg of fentanyl and releases the drug at a rate of 50 micrograms per hour. Durogesic transdermal system, patch 75 µg/h contains 12.6 mg of fentanyl and releases the drug at a rate of 75 micrograms per hour. Durogesic transdermal system, patch 100 µg/h contains 16.8 mg of fentanyl and releases the drug at a rate of 100 micrograms per hour.

Other components (excipients) of the patch: Outer layer, film: copolymer of polyester and ethyl vinyl acetate.
Protective layer, film: silicone-coated polyester.
Drug-containing layer: polyacrylate adhesive.
Printing inks (on the outer layer):
Durogesic 12 µg/h also contains orange printing ink.
Durogesic 25 µg/h also contains red printing ink.
Durogesic 50 µg/h also contains green printing ink.
Durogesic 75 µg/h also contains blue printing ink.
Durogesic 100 µg/h also contains grey printing ink.

What Durogesic looks like and contents of the pack
Durogesic 12 µg/h
Durogesic is a semi-transparent, rectangular patch with rounded corners. Each patch has a surface area of 5.25 cm² and features an orange border and the printed text "DUROGESIC 12 µg fentanyl/h".
Durogesic 25 µg/h
Durogesic is a semi-transparent, rectangular patch with rounded corners. Each patch has a surface area of 10.5 cm² and features a red border and the printed text "DUROGESIC 25 µg fentanyl/h".
Durogesic 50 µg/h
Durogesic is a semi-transparent, rectangular patch with rounded corners. Each patch has a surface area of 21.0 cm² and features a green border and the printed text "DUROGESIC 50 µg fentanyl/h".
Durogesic 75 µg/h
Durogesic is a semi-transparent, rectangular patch with rounded corners. Each patch has a surface area of 31.5 cm² and features a blue border and the printed text "DUROGESIC 75 µg fentanyl/h".
Durogesic 100 µg/h
Durogesic is a semi-transparent, rectangular patch with rounded corners. Each patch has a surface area of 42.0 cm² and features a grey border and the printed text "DUROGESIC 100 µg fentanyl/h".
The medicine is supplied in cardboard boxes containing 5 individually packaged patches in heat-sealed pouches (made of acrylonitrile film or cyclic olefin copolymer).

Marketing Authorisation Holder:
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Manufacturer:
Janssen-Pharmaceutica NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

For further information about this medicine, contact the local representative of the Marketing Authorisation Holder:
Janssen-Cilag Polska Sp. z o.o.
tel. +48 22 237 60 00

This medicine is authorised for marketing in the European Economic Area under the following names:

Other sources of information
Detailed information about this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products www.urpl.gov.pl