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 all the information in this 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 questions, 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 someone else, 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.

Table of 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 opioid analgesic therapy
• in children over 2 years of age who are already receiving opioid analgesics and require continuous pain relief.

Durogesic contains, as the active substance, fentanyl, a potent analgesic 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 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. The appearance of the patch (used or unused) may attract a child to touch it, stick it on the body, or place 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 is provided 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 were 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 severe 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 special caution when using Durogesic
Talk to your doctor or pharmacist before using this medicine if any of the following apply – closer monitoring of the patient may be required:

• 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", which causes 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 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 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 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)
• touch 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 tiredness and slowed or shallow breathing. Very rarely, these breathing disturbances 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, their partner or caregiver notices that the person using the patches is excessively sleepy 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 move and speak as much as possible.
• If fever occurs during treatment with Durogesic, talk to the doctor – increased body temperature may significantly increase drug absorption through the skin.
• Durogesic may cause constipation; talk to the 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 may occur. If the patient notices any of these symptoms, contact the doctor.

Do not heat the patch application site 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 it may also be harmful. If the patient notices reduced effectiveness of the medicine, they should consult the 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, misuse and addiction, which may result in life-threatening overdose. The risk of these adverse effects may increase with increasing dose and 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 the 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 misused 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, this 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 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, 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 this; usually this is done by gradually reducing the dose to minimize any unpleasant withdrawal symptoms.

Durogesic and other medicines

Tell the 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 may require close monitoring when using some of the medicines listed below or when stopping some of the medicines listed below, as this may affect the required strength of Durogesic.

In particular, tell the 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).
• Tranquillisers (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 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 state, e.g. agitation, hallucinations (seeing, feeling, hearing or smelling things that are not real), and other effects such as blood pressure fluctuations, rapid heartbeat, high temperature, excessive 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, particularly 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 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 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 is planning 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 baby are suspected, contact the 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 the 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 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 important 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 crucial 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 on this.

Adults and children
Do not apply the patch:

• To the same site consecutively
• To mobile areas (around 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: Skin preparation

• 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 may 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, broken, or otherwise damaged
• Never divide or cut 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 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 should be stored out of sight and out of reach of children – even 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
• You may take a shower or bath, but avoid rubbing the patch
• With your doctor's approval, you may perform physical exercise or engage in sports while using the patch
• Swimming is also permitted while wearing the patch, however:
  • Do not use 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 (thermophores), 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 treatment period, the doctor may prescribe additional pain-relieving medicines
• After the initial treatment 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 If the patch comes off).
• 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 the patches.

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 your 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 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 you remember and record the day and time. The next patch should be changed after 3 days (72 hours) as usual.
• If a longer period has passed since the last patch change, consult your doctor, as additional pain-relieving medicines may be needed; however, do not apply an extra patch.

If the patch comes off

• If the patch comes off 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 your 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 repeated early detachment of the patch occurs, contact your 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 their doctor. The doctor will advise on how to do this; usually, this involves gradually reducing the dose to minimize any unpleasant 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 than previously used 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, their 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 person should go straight away to the nearest hospital. Intensive medical care may be required.

• Excessive drowsiness, slowed or shallow 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 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 estimated 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 real (hallucinations)
• muscle tremors or spasms
• disturbances in sensation, tingling, burning skin (paraesthesia)
• dizziness
• fast heartbeat or palpitations
• high blood pressure
• shortness of breath
• diarrhoea
• dry mouth
• stomach pain or indigestion
• excessive sweating
• itching, rash, redness of the skin
• difficulty passing urine or completely emptying the bladder
• feeling tired, weak, 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 1,000 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 disappear after removing the patch. If they do not resolve, 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 if 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 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 to 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 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 pose serious risks and can lead to death in individuals who may 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.
After the expiry date has passed, 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—whether unused or used—to another person’s skin, especially in children, 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 out of sight and out of reach of others, especially children, until it is disposed of. 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, 12 µg/h patch contains 2.1 mg of fentanyl and releases the drug at a rate of 12 micrograms per hour. Durogesic transdermal system, 25 µg/h patch contains 4.2 mg of fentanyl and releases the drug at a rate of 25 micrograms per hour. Durogesic transdermal system, 50 µg/h patch contains 8.4 mg of fentanyl and releases the drug at a rate of 50 micrograms per hour. Durogesic transdermal system, 75 µg/h patch contains 12.6 mg of fentanyl and releases the drug at a rate of 75 micrograms per hour. Durogesic transdermal system, 100 µg/h patch contains 16.8 mg of fentanyl and releases the drug at a rate 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).

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, please 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 for sale 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