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 all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• 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 someone else, even if their symptoms are the same.
• If you experience any side effects, 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 administration of pain-relieving medicines
• in children over 2 years of age who have already been treated with opioid medicines and require continuous pain relief.

Durogesic contains the active substance fentanyl, a potent pain-relieving medicine belonging to the opioid group.

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 cases 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 attract a child to touch it, stick it to 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 such a situation 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 diseases 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 characterized 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 patches, inform the doctor if the patient experiences 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
• nocturnal awakenings due to breathlessness
• difficulty maintaining sleep
• excessive daytime sleepiness.

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

While using patches, inform the doctor if the patient notices any 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. pain is felt in another part of the body)
• pain occurs upon touch where it should not.

Do not change the dose on your own. The doctor may decide to adjust the dose or treatment.

Adverse effects of Durogesic

• Durogesic may cause unusual tiredness and slowed or shallow breathing. Very rarely, these breathing disorders may be life-threatening or fatal, 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 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. For a full list of adverse effects, see 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 using external heat sources such as heated pads, electrically heated blankets, hot water bottles (hot-water bottles), heated beds, heating or tanning lamps. 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, 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 better for the patient.

Dependence and addiction

This medicine contains fentanyl, 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 higher doses and longer 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 no longer helps relieve their pain.

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, it 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 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, rapid heartbeat (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 it; usually, this is done by gradually reducing the dose so that any unpleasant withdrawal symptoms are minimized.

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 using.

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 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, especially 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, leading to changes in mental status 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
Concomitant 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. Therefore, concomitant 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 combined 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 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 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, poor feeding, and diarrhoea), which may be life-threatening if not recognized 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 the doctor or pharmacist.
The doctor will decide which strength of Durogesic is appropriate for the patient, based on an assessment of the intensity of pain, 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 discontinue 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 of day, 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 following table 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 is evident, the child may receive additional pain-relieving medicines as advised by the doctor.

Adults and children
Do not apply the patch:

• In the same spot consecutively
• On mobile areas (near joints), irritated or damaged skin
• On 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 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 gently pull apart.
• Remove the patch and apply it immediately.
• Keep the empty pouch to use later for safe disposal 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 cut or divide 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 off one half of the shiny protective liner from the center of the patch. Avoid touching the adhesive layer.
• Apply the adhesive side of the patch to the skin.
• Remove the second half 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 — even used patches contain residual 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.
• Showers or baths are permitted, 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 site with external heat sources such as heating pads, electric blankets, hot water bottles (thermophores), heated beds, heat lamps, 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 from the first patch may be delayed.
• During the initial treatment period, the doctor may prescribe additional pain-relieving medicines.
• After the initial period, the patch should provide continuous pain relief, allowing discontinuation of other pain medicines. 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 recommend a higher-strength patch 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 using more patches than recommended or a patch with an incorrect dose
If too many patches are used or a patch with an incorrect dose is applied, 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, fainting, 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 note the day and time. The next patch should be changed after 3 days (72 hours) as usual.
• If a significant delay occurs in changing the patch, 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 immediately and record the date 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 keep the new patch in place 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 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 withdrawal symptoms. See also section 2 "Withdrawal symptoms after stopping Durogesic".
• If patch treatment is stopped, do not restart therapy without consulting the doctor. In such cases, a different dose from the previous one 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 may cause adverse reactions, although not everyone experiences them.
If the patient, their partner or caregiver notices any of the following symptoms in a person using the patches, the patch should be removed immediately and the patient should contact their doctor or go immediately to the nearest hospital. Intensive medical care may be required.

• Excessive drowsiness, excessive slowing or shallowing of breathing. Follow the advice above and encourage the patient to move and speak as much as possible. Very rarely, these breathing problems can be life-threatening or lead to death, particularly in people who have not previously used 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 of anxiety or confusion
• seeing, feeling, hearing, or smelling things that are not real (hallucinations)
• trembling or muscle spasms
• disturbances in sensation, tingling, burning skin (paresthesia)
• 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 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, but 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 real, 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 removing the patch. If they persist or the patch causes significant skin irritation, inform the doctor.
With repeated use of the patches, the medicine's effectiveness 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 treatment with Durogesic is suddenly stopped, 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 used Durogesic chronically during pregnancy.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform the doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 the medicine.

5. How to store Durogesic

Where to store the patches
Unused and used Durogesic patches must be stored in a place invisible and inaccessible to children.
Store in the original packaging to protect from light.
There are no special storage temperature requirements for this medicine.
The medicine must be stored in a secure and protected place, out of reach of other people. It may pose serious risks and may result in death of individuals who might accidentally or intentionally use this medicine 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 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 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—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 the original pouch, and then stored in a place invisible and inaccessible to others, especially children, until disposal. Ask your pharmacist how to properly dispose of medicines no longer in use.
Medicines must not be disposed of via sewage systems or household waste bins. Proper disposal helps protect the environment.

6. Contents of the Package 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 dose of 12 micrograms per hour. Durogesic transdermal system, patch 25 \μg/h contains 4.2 mg of fentanyl and releases the drug at a dose of 25 micrograms per hour. Durogesic transdermal system, patch 50 \μg/h contains 8.4 mg of fentanyl and releases the drug at a dose of 50 micrograms per hour. Durogesic transdermal system, patch 75 \μg/h contains 12.6 mg of fentanyl and releases the drug at a dose of 75 micrograms per hour. Durogesic transdermal system, patch 100 \μg/h contains 16.8 mg of fentanyl and releases the drug at a dose of 100 micrograms per hour.

Other components (excipients) of the patch are:
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 film).

Marketing Authorization 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 Authorization Holder:
Janssen-Cilag Polska Sp. z o.o.
Tel. +48 22 237 60 00

This medicine is authorized in the Member States of 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