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 this leaflet carefully before using this medicine, because it contains
important information for the patient.

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

Contents of the leaflet

1. What Durogesic is and what it is used for
2. What you need to know 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 chronic severe pain:

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

Durogesic contains fentanyl as the active substance, a potent analgesic belonging to the opioid group of medicines.

2. Important information before using Durogesic

When not to use Durogesic

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

Do not use this medicine 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 take opioid-containing medicines.
• Durogesic is a medicine that may be life-threatening to children, including used patches. The appearance of the patch (used or unused) may attract a child to touch it, stick it on the body, or put it in the mouth, 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.

In case 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 the 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 the patch to another person's skin (especially a child) may result in drug absorption 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 required 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 the disease "myasthenia gravis", in which muscle weakness and fatigue occur.

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 your doctor if the patient experiences breathing problems during sleep.
Opioids such as Durogesic may cause breathing disturbances during sleep, such as sleep apnoea (pauses in breathing during sleep) and nocturnal hypoxia (low oxygen levels in the blood). Inform your 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 your doctor if the patient notices a change in pain perception.
If the patient experiences that:

• pain no longer subsides after applying the patch
• pain worsens
• there is a change in the way pain is felt (e.g. pain is felt in another part of the body)
• touching causes pain that should not be present.

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

Adverse effects of Durogesic

• Durogesic may cause unusual fatigue and slowed, shallow breathing. Very rarely, these breathing disturbances may be life-threatening or fatal, especially in people who have not previously taken 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, particularly 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 using external heat sources such as heated pads, electrically heated blankets, hot water bottles (hot-water bottles), heated beds, heat lamps, or sunbeds. Do not sunbathe or take prolonged warming baths, sauna, 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 it 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 the better option 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 addictive use, 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 addictive use may cause the patient to lose control over how much medicine to take or how often to take 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 addictive use varies between individuals. The risk of dependence on or addictive use of 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 addictive use:

• 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 medicine, the patient feels unwell and feels better when using the medicine again ("withdrawal effect").

If the patient notices any of these symptoms, they should discuss with their doctor the best treatment strategy, 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 a doctor. The doctor will advise how to do this; usually, this is done by gradually reducing the dose to minimize 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 you are using Durogesic.

The treating doctor knows which medicines can be safely used with Durogesic. The patient may require close monitoring when using or stopping some of the medicines listed below, as they may affect the required strength of action 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).
• Medicines that reduce muscle tension (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 to treat 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 antidepressant medicines
The risk of adverse effects increases when used together with certain antidepressants. An interaction between Durogesic and these medicines may occur, leading to changes in mental state such as 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 disturbances, 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 related substances, 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 treatment 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 so they are aware of the above symptoms. If such symptoms occur, contact a doctor.

Do not drink alcohol while using Durogesic unless discussed 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 she may be pregnant, or plans to have a child, she 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, inadequate feeding, and diarrhoea), which may be life-threatening if not recognised and treated. If withdrawal symptoms in the child 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 knows how they react to the medicine.

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
the doctor or pharmacist.
The doctor will decide which Durogesic strength 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 for how long it should be used, 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 directed 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 should 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 the patch to the
  upper back.

• Frequently check whether the patch is properly adhered to the skin.

• It is essential that the child does not remove the patch and put it in their mouth, as this may 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 advise accordingly.

Adults and children
Do not apply the patch:

• To the same site consecutively
• To moving areas (near joints), irritated or damaged skin
• To heavily hairy skin. If hair is present, do not shave it (shaving may irritate 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 packaged in a sealed pouch.
• Tear the pouch at the notch indicated by an arrow.
• Carefully 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 for later use in disposing of the used patch.
• Each patch must be used only once.
• Do not remove the patch from the pouch until ready to apply.
• Check whether the patch is damaged.
• Do not use patches that are cut, broken, or otherwise damaged.
• Never cut or divide the patches.

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

• Ensure clothing over the application site will be loose; do not wear tight elastic bands or bandages.
• Carefully peel back half of the shiny protective liner from the center of the patch. Avoid touching the adhesive surface.
• 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 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 reach of children — even used patches contain medicine that may be harmful and potentially life-threatening 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

• The patches are water-resistant.
• You may take a shower or bath, but do not rub the patch.
• With the doctor's approval, physical exercise or sports may be performed while using the patch.
• Swimming is allowed during patch use, but:
  • Avoid prolonged hot baths or saunas.
  • Do not wear tight elastic bands or bandages over the patch site.
• Do not heat the patch application site with external heat sources such as heating pads, electric blankets, hot water bottles (hot water bags), heated beds, heating or tanning lamps. Do not sunbathe or use prolonged hot baths or saunas. In such situations, there is a risk of increased drug release from the patch.

How quickly will the patch work?

• Maximum effect of 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, so other pain medicines may be discontinued. However, the doctor may occasionally recommend additional pain-relieving medicines.

How long will the patient use the 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 In case of patch detachment).
• If pain increases over time during patch use, the treating doctor may prescribe 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 the 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 the standard interval of 3 days (72 hours).
• If a longer time has passed since the last patch change, consult the doctor, as additional pain-relieving medicines may be needed. However, do not apply an extra patch.

In case of patch detachment

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

Stopping the use of patches

• Do not stop using this medicine abruptly. 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 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 medicinal product may cause adverse reactions, although not everyone will experience them.
If the patient, their partner or caregiver notices any of the following symptoms in a person using the patches, the patch must be removed immediately and the doctor should be contacted or the patient should go immediately to the nearest hospital. Intensive medical care may be required.

• Excessive drowsiness, excessive slowing or shallow breathing. Follow the advice above and encourage the patient to move and speak as much as possible. Very rarely, these breathing problems 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 level of 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 of anxiety or confusion
• seeing, feeling, hearing, or smelling things that are not there (hallucinations)
• muscle tremors or spasms
• disturbances in sensation, tingling, burning of the 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 inability to completely empty the bladder
• feeling tired, weak, or generally unwell
• feeling cold
• peripheral swelling of the limbs.

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

• restlessness or disorientation
• unnatural state of euphoria 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
• flu-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):

• constricted pupils
• 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)
• the patient may become dependent on Durogesic (see section 2).

At the site where the patch is applied to the skin, rash, redness or mild itching may occur.
These reactions are usually mild and resolve after removal of the patch. If they persist or if 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 abruptly discontinuing Durogesic, the patient may experience withdrawal symptoms such as nausea, vomiting, diarrhoea, restlessness and chills. Inform the doctor immediately if such symptoms occur.
Cases of withdrawal symptoms have been observed in newborns whose mothers chronically used Durogesic during pregnancy.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform the doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 marketing authorisation holder.
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.
Keep them in the original packaging to protect from light.
There are no special storage temperature requirements for this medicine.
The medicine should be stored in a secure and protected place, inaccessible to others. It may cause serious harm or even death in individuals who accidentally or intentionally use it when it has not been prescribed to them.

How long can Durogesic be stored
Do not use this medicine after the expiry date stated on the protective pouch and outer packaging following EXP. The expiry date refers to the last day of the mentioned month.
If the medicine has expired, return any unused patches to a pharmacy.
The medicine should be stored in sealed 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—onto 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 inaccessible and invisible to others, especially children, until properly disposed of. Ask your pharmacist how to dispose of medicines no longer in use.
Medicines must not be disposed of via sewage systems or household waste. Doing so 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 fentanyl and releases the drug at a dose of 12 micrograms per hour. Durogesic transdermal system, patch 25 µg/h contains 4.2 mg fentanyl and releases the drug at a dose of 25 micrograms per hour. Durogesic transdermal system, patch 50 µg/h contains 8.4 mg fentanyl and releases the drug at a dose of 50 micrograms per hour. Durogesic transdermal system, patch 75 µg/h contains 12.6 mg fentanyl and releases the drug at a dose of 75 micrograms per hour. Durogesic transdermal system, patch 100 µg/h contains 16.8 mg fentanyl and releases the drug at a dose of 100 micrograms per hour.

Other components (excipients) of the patch:

Outer layer, film: copolymer of polyester and ethylene 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 packed patches in heat-sealed pouches (made of acrylonitrile film or cyclic olefin copolymer film).

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 on 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 medicinal product is authorised in the European Economic Area countries 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