Durogesic

B. PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: patient information

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

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Durogesic and what is it used for

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

• in adults who require continuous treatment with painkillers
• in children over 2 years of age who have already used opioid painkillers and require continuous treatment with painkillers.

Durogesic contains the active substance fentanyl, which is a strong painkiller belonging to the opioid group.

2. Important information before using Durogesic

When not to use Durogesic

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6),
• for short-term, sudden, or post-operative pain,
• if you have severe respiratory depression (significant slowing and shallowing of breathing). Do not use this medicine if any of the above situations apply to you. If in doubt, consult your doctor or pharmacist before using Durogesic.

Warnings and precautions

• Durogesic may cause life-threatening side effects in people who do not regularly use opioid painkillers.
• Durogesic is a medicine that can be life-threatening to children. This also applies to used patches. It should be considered that the appearance of the patch (used or not) may encourage a child to touch it, stick it to their body, put it in their mouth, etc., which can lead to death.
• This medicine should be stored in a safe and protected place, inaccessible to other people - more information on this can be found in section 5.

In case of accidental patch attachment to another person's skin

Patches should only be applied to the skin of the person they have been prescribed for. There have been reports of accidental attachment of a patch to another person's skin during close physical contact or while sleeping in the same bed with the person using the patches. Accidental attachment of a patch to another person's skin (especially a child) can cause the medicine to be absorbed through the skin and cause severe side effects, such as breathing difficulties with slow and shallow breathing, which can be life-threatening. If such a situation occurs, the patch should be removed immediately and a doctor should be consulted.

Be careful when using Durogesic

Consult your doctor or pharmacist before using this medicine if

any of the following situations apply- you may need closer monitoring: when:

• you have had lung disease or breathing difficulties,
• you have had heart, liver, kidney problems, or low blood pressure,
• you have had a brain tumor,
• you have had persistent headaches or head injuries,
• you are elderly - you may be more sensitive to the effects of this medicine,
• you have a condition called "myasthenia gravis" with muscle weakness and fatigue.

If any of the above situations apply to you (or you are not sure), consult your doctor or pharmacist before using Durogesic.

Tell your doctor if you experience breathing problems during sleep.

Breathing difficulties during sleep.Opioids, such as Durogesic, can cause breathing difficulties during sleep, such as sleep apnea (pauses in breathing during sleep) and nocturnal hypoxemia (low oxygen levels in the blood). Tell your doctor if you, your partner, or caregiver notice any of the following symptoms:

• pauses in breathing during sleep
• nighttime awakenings due to shortness of breath
• difficulty staying asleep
• excessive daytime sleepiness. Your doctor may decide to adjust the dose of the medicine.

Tell your doctor if you notice a change in pain perception.

Pain perception.If you feel that:

• the pain is no longer relieved after applying the patch
• the pain is getting worse
• there is a change in the way the pain is perceived (e.g., you feel pain in a different part of the body)
• there is pain upon touch, which should not be there. Do not change the dose yourself. Your doctor may decide to change the dose or treatment.

Side effects of Durogesic

• Durogesic may cause unnatural fatigue and slowed and shallow breathing. Very rarely, these breathing difficulties can be life-threatening or lead to death, especially in people who have not previously used opioid painkillers (such as Durogesic or morphine). If you, your partner, or caregiver notice that the person using the patches is excessively sleepy and has slow or shallow breathing, you should:
• remove the patch
• call a doctor or go to the nearest hospital immediately
• encourage the patient to move and talk as much as possible.
• If you develop a fever while using Durogesic, consult your doctor - an increase in body temperature can significantly increase the absorption of the medicine through the skin.
• Durogesic may cause constipation; consult your doctor or pharmacist on how to prevent or alleviate constipation. A full list of side effects can be found in section 4.

Durogesic, like other opioids, may affect the normal production of hormones in the body, such as cortisol, prolactin, or sex hormones, especially with long-term use. The consequences of these hormonal changes may include malaise (including nausea), loss of appetite, fatigue, weakness, dizziness, low blood pressure, infertility, or decreased sex drive. Additionally, women may experience changes in their menstrual cycle, and men may experience impotence or breast enlargement. If you notice any of these symptoms, consult your doctor.
Do not heat the patch attachment site with external heat sources, such as: heated pads, electrically heated blankets, hot water bottles (thermoses), heated beds, heat lamps, or tanning lamps. Do not sunbathe or use prolonged warming baths, saunas, or whirlpool baths. In these situations, there is a risk of increased release of the medicine from the patch.

Long-term use and tolerance

This medicine contains fentanyl, which is an opioid painkiller. Repeated use of opioid painkillers can lead to decreased effectiveness of the medicine (the patient becomes accustomed to it, which is known as tolerance to the medicine). During the use of Durogesic, the patient's sensitivity to pain may also increase. This phenomenon is known as hyperalgesia.
Increasing the patch dose may temporarily reduce the intensity of the pain, but it can also be harmful. If you notice a decrease in the effectiveness of the medicine, you should consult your doctor. Your doctor will decide whether it is better for you to increase the dose or gradually reduce the use of Durogesic.

Dependence and addictive use

Repeated use of Durogesic can also lead to dependence, abuse, and addictive use, which can result in life-threatening overdose. The risk of these side effects may increase with increasing dose and duration of use. Dependence or addictive use can cause the patient to feel a loss of control over the amount of medicine used or how often it is taken. The patient may feel the need to continue using the medicine, even if it no longer helps to relieve their pain.
The risk of dependence or addictive use varies from person to person. The risk of dependence on Durogesic or its addictive use may be higher if:

• you or someone in your family has ever abused or been dependent on alcohol, prescription drugs, or illegal substances ("dependence");
• you smoke;
• you have ever had mood disorders (depression, anxiety disorders, or personality disorders) or have been treated by a psychiatrist for other mental illnesses.

If you experience any of the following symptoms while using Durogesic, it may indicate dependence or addictive use.

• You need to take the medicine for a longer period than prescribed by your doctor.
• You need to take a higher dose than prescribed.
• You use the medicine for reasons other than those for which your doctor prescribed it, such as "to calm down" or "to fall asleep".
• You have repeatedly tried to stop or control the use of the medicine but failed.
• After stopping the use of the medicine, you feel unwell, and your condition improves when you take the medicine again ("withdrawal effect").

If you notice any of these symptoms, you should discuss the best treatment strategy with your doctor, including determining when it is appropriate to stop the treatment and how to safely stop the treatment.

Withdrawal symptoms after stopping Durogesic

Do not stop using this medicine suddenly. Withdrawal symptoms may occur, such as anxiety, difficulty sleeping, irritability, restlessness, anxiety, palpitations, increased blood pressure, nausea, vomiting, diarrhea, loss of appetite, tremors, chills, or sweating. If you want to stop using this medicine, you should first consult your doctor. Your doctor will inform you how to do it; usually, it is done by gradually reducing the dose, so that any unpleasant withdrawal symptoms are minimized. See also section 2 "Withdrawal symptoms after stopping Durogesic".

Durogesic and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take. This includes all over-the-counter medicines and herbal medicines.
When buying other medicines at a pharmacy, tell the pharmacist that you are using Durogesic.
Your doctor knows which medicines can be safely used with Durogesic. You will need close monitoring if you use any of the following medicines or stop using any of the following medicines, as it may affect the required strength of Durogesic.
In particular, tell your doctor or pharmacist if you are taking:

• Other opioid painkillers (such as buprenorphine, nalbuphine, or pentazocine) and some painkillers used for neuropathic pain (gabapentin and pregabalin).
• Sleeping pills (such as temazepam, zaleplon, or zolpidem).
• Tranquilizers (such as alprazolam, clonazepam, diazepam, hydroxyzine, or lorazepam) and antipsychotic medicines (such as aripiprazole, haloperidol, olanzapine, risperidone, or phenothiazines).
• Muscle relaxants (such as cyclobenzaprine or diazepam).
• Certain antidepressants called SSRI or SNRI (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine) - see below.
• Certain antidepressants or medicines used to treat Parkinson's disease called IMAO (such as isocarboxazid, phenelzine, selegiline, or tranylcypromine). Do not use Durogesic for 14 days after stopping these medicines - see below.
• Certain antihistamines, especially those that cause 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 to treat HIV infection (such as ritonavir).
• Anti-arrhythmic 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 artery 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 side effects increases when used with certain antidepressants. There may be an interaction between Durogesic and these medicines, and the patient may experience changes in mental state, such as agitation, hallucinations, and other effects, such as changes in blood pressure, rapid heart rate, high temperature, excessive reflexes, coordination disorders, muscle stiffness, nausea, vomiting, and diarrhea (these may be symptoms of serotonin syndrome). If used together, your doctor may want to closely monitor you for such side effects, especially when starting treatment or when changing the dose of the medicine.

Using Durogesic with medicines that act on the central nervous system, including alcohol and certain narcotics

Concomitant use of Durogesic and tranquilizers, such as benzodiazepines or derivatives, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, concomitant use should only be considered when other treatment options are not possible.
If your doctor prescribes Durogesic with tranquilizers, the dose and duration of concomitant treatment should be limited by your doctor.
Tell your doctor about all tranquilizers you are taking and strictly follow your doctor's dosage recommendations. It may be helpful to inform friends or relatives to be aware of the above symptoms. If such symptoms occur, consult your doctor.
Do not drink alcohol while using Durogesic unless you have discussed it with your doctor.

Surgical procedures

If you think you may have anesthesia, tell your doctor or dentist that you are using Durogesic.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Durogesic should not be used during pregnancy, unless discussed with your doctor.
Durogesic should not be used during the perinatal period, as it may cause breathing difficulties in the newborn.
Long-term use of Durogesic during pregnancy may cause withdrawal symptoms in the newborn (such as loud crying, trembling, seizures, poor feeding, and diarrhea), which can be life-threatening if not recognized and treated. If suspected, consult your doctor immediately.
Durogesic should not be used during breastfeeding. Do not breastfeed for 3 days after removing the Durogesic patch. The medicine may pass into breast milk.

Driving and using machines

Durogesic may affect your ability to drive and use machines, as it can cause drowsiness and dizziness. If you experience these symptoms, do not drive or operate any machines or tools. Do not drive until you know how the medicine affects you.
Consult your doctor or pharmacist if you are not sure whether you can drive safely while using this medicine.

3. How to use Durogesic

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Your doctor will decide which strength of Durogesic is suitable for you, based on the severity of your pain, your overall condition, and any previous pain treatment you have used.
Before starting and regularly during treatment, your doctor will also discuss with you what to expect from using Durogesic, when and for how long to use it, when to consult your doctor, and when to stop using the medicine (see also section 2 "Withdrawal symptoms after stopping Durogesic").

Using and changing patches

• Each patch contains enough medicine for 3 days (72 hours).
• Change the patch every third day, unless your doctor advises otherwise.
• Always remove the old patch beforeapplying a new one.
• Always change the patch at the same timeevery 3 days (72 hours).
• If you use more than 1 patch, change all patches at the same time.
• Make a note of the day, date, and time you apply the patch, so you can remember when to change it.
• The following table shows when to change the patch:

Patch applied on: Patch change on:

Monday
Thursday
Tuesday
Friday
Wednesday
Saturday
Thursday
Sunday
Friday
Monday
Saturday
Tuesday
Sunday
Wednesday

Where to apply the patch

Adults

• Apply patches to a flat area of the upper body or arm (avoiding joints).

Children

• To minimize the risk of the child touching or removing the patch, apply the patch to the upper back.
• Check frequently to ensure the patch is properly attached to the skin.
• It is essential that the child does not remove the patch and put it in their mouth, as this can be life-threatening or fatal.
• Monitor the child closely for 48 hours after:
• applying the first patch
• applying a patch with a higher dose.
• The effect of the patch may be delayed after the first dose is applied. Therefore, before the full effect of the medicine is apparent, the child may need to take additional painkillers. Your doctor will inform you about this.

Adults and children

Do not apply the patch:

• to the same spot twice in a row
• to areas with movement (joints), irritated, or damaged skin
• to very hairy skin. If there is hair, do not shave it (shaving irritates the skin). Instead, cut the hair as close to the skin as possible.

Applying the patch

Step 1: Prepare the skin

• Make sure the skin is completely dry, clean, and cool before applying the patch
• If the skin needs to be cleaned, do so with cold water
• Do not use soap or other cleansing products, oils, creams, lotions, or talcum powder before applying the patch
• Do not apply the patch immediately after a hot bath or shower.

Step 2: Open the pouch

• Each patch is in an individual pouch
• Tear the pouch at the notch indicated by the arrow
• Gently, completely tear or cut off one edge of the pouch (if using scissors, cut close to the edge to avoid damaging the patch)

• Hold the opened pouch by both edges and stretch
• Remove the patch and apply it immediately
• Keep the empty pouch to use later to dispose of the used patch
• Each patch can only be used once
• Do not remove the patch from the pouch until you are ready to apply it
• Check the patch for damage
• Do not use patches that are cut, broken, or damaged in any way
• Never divide or cut patches.

Step 3: Peel off the patch and apply it to the skin

• Make sure the clothing covering the patch site is loose; do not wear tight, elastic bands or bandages
• Carefully peel off one half of the shiny protective layer from the center of the patch. Avoid touching the adhesive layer of the patch
• Apply the adhesive layer of the patch to the skin
• Remove the second part of the protective layer and press the entire patch firmly onto the skin with your hand
• Hold for at least 30 seconds. Make sure the patch is fully attached, especially at the edges.

Step 4: Removing the patch

• Immediately after removing the patch, fold it in half, so the adhesive layers stick together
• Put it back in the original pouch and dispose of it according to the pharmacist's instructions
• Keep used patches out of sight and reach of children - even used patches still contain medicine that can be harmful to children and life-threatening.

Step 5: Washing hands

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

Additional information about using Durogesic

Daily activities while using patches

• Patches are waterproof
• You can shower or bathe, but do not rub the patch
• You can exercise or play sports with your doctor's permission while using the patch
• You can also swim while wearing the patch, but:
• Do not use prolonged warming baths or saunas
• Do not wear tight, elastic bands or bandages over the patch site
• While using the patch, do not heat the patch attachment site with external heat sources, such as: heated pads, electrically heated blankets, hot water bottles (thermoses), heated beds, heat lamps, or tanning lamps. Do not sunbathe or use prolonged warming baths, saunas, or whirlpool baths. In these situations, there is a risk of increased release of the medicine from the patch.

How quickly will the patch work?

• The maximum effect of the first patch may be delayed.
• During the initial treatment period, your doctor may prescribe additional painkillers
• After the initial treatment period, the patch should provide constant pain relief, so you can stop taking other painkillers. However, your doctor may occasionally recommend additional painkillers.

How long will you use the patches?

• Durogesic patches are used to treat chronic pain. Your doctor will inform you about the expected duration of treatment.

If the pain worsens

• If the pain suddenly worsens after applying the last patch, check the patch. If it is no longer attached well or has fallen off, replace it (see also the section "If the patch comes off").
• If the pain worsens over time while using the patches, your doctor may prescribe a patch with a higher dose and (or) additional painkillers
• If increasing the patch dose does not improve the pain, your doctor may decide to stop using the patches.

If you use more patches than prescribed or a patch with the wrong dose

If you use too many patches or a patch with the wrong dose, remove the patches immediately and consult your doctor as soon as possible.
Overdose symptoms include breathing difficulties or shallow breathing, fatigue, extreme sleepiness, inability to think clearly, difficulty walking or talking, and feeling faint, dizziness, or confusion. Overdose can also cause brain disorders called toxic leukoencephalopathy.

If you forget to change the patch

• Change the patch as soon as you remember and make a note of the day and time. Change the next patch at the usual time, after 3 days (72 hours).
• If more time has passed since the patch change, consult your doctor, as you may need to take additional painkillers, but do notapply an extra patch.

If the patch comes off

• If the patch comes off before the required change time, apply a new one in its place and make a note of the day and time. Apply the patch to a different area:
• on the upper body or arm
• on the upper back - in children
• Tell your doctor and leave the patch on for 3 days (72 hours)or as advised by your doctor, until the next scheduled patch change
• If the patch comes off repeatedly, consult your doctor, pharmacist, or nurse.

Stopping the patches

• Do not stop using this medicine suddenly. If you want to stop using this medicine, consult your doctor first. Your doctor will inform you how to do it; usually, it is done by gradually reducing the dose, so that any unpleasant withdrawal symptoms are minimized. See also section 2 "Withdrawal symptoms after stopping Durogesic".
• When stopping the patches, do not restart treatment without consulting your doctor. In such a situation, a different dose than before may be required.

If you have any further questions about using the medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Durogesic can cause side effects, although not everybody gets them.

If you, your partner, or caregiver notice any of the following symptoms in the person using the patches, remove the patch and consult your doctor or go to the hospital immediately. Intensive medical care may be necessary.

Medical care.

• Feeling overly sleepy, slow, or shallow breathing. Very rarely, these breathing difficulties can be life-threatening or lead to death, especially in people who have not previously used strong opioid painkillers (such as Durogesic or morphine). Follow the above advice and encourage the patient to move and talk as much as possible. (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 the available data)
• Seizures (Uncommon, may occur in less than 1 in 100 people)
• Decreased consciousness or loss of consciousness (Uncommon, may occur in less than 1 in 100 people).

The following side effects have also been reported

Very common side effects (may occur in more than 1 in 10 people):

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

Common side effects (may occur in less than 1 in 10 people):

• allergic reaction
• loss of appetite
• insomnia
• depression
• feeling anxious or confused
• seeing, feeling, hearing, smelling things that are not there (hallucinations)
• tremors or muscle spasms
• disorders of sensation, tingling, burning skin (paresthesia)
• dizziness
• rapid heart rate or palpitations
• high blood pressure
• shortness of breath
• diarrhea
• dry mouth
• abdominal pain or indigestion
• excessive sweating
• itching, rash, redness of the skin
• difficulty urinating or completely emptying the bladder
• feeling tired, weak, unwell
• feeling cold
• peripheral edema on limbs.

Uncommon side effects (may occur in less than 1 in 100 people):

• agitation or disorientation
• unusual state of happiness and increased activity (euphoria)
• decreased sensation, especially skin (hypoesthesia)
• memory loss
• blurred vision
• slow heart rate or low blood pressure
• hypoxia (cyanosis)
• intestinal obstruction (ileus)
• itchy rash, allergic reaction, or other skin disorders at the patch application site
• flu-like symptoms
• feeling changes in body temperature
• fever
• muscle tremors
• erectile dysfunction or sexual function disorders
• difficulty swallowing.

Rare side effects (may occur in less than 1 in 1000 people):

• pupil constriction
• periodic breathing pauses (apnea)

The following side effects have also been reported, but their frequency is unknown:

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

A rash, redness, or mild itching may occur at the patch application site on the skin. These reactions are usually mild and resolve after the patch is removed. If they do not resolve or the patch causes significant skin irritation, tell your doctor.
Repeated use of patches may lead to decreased effectiveness of the medicine (tolerance to the medicine may develop) or you may become dependent on it.
After switching from other painkillers to Durogesic or suddenly stopping Durogesic, you may experience withdrawal symptoms, such as nausea, vomiting, diarrhea, anxiety, and chills. Tell your doctor immediately if you experience such symptoms.
In newborns whose mothers have used Durogesic for a long time during pregnancy, cases of withdrawal symptoms have been observed.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Durogesic

Where to store the patches

Unused and used Durogesic patches should be kept out of sight and reach of children.
Store 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 safe and protected place, inaccessible to other people. It can cause serious harm and lead to death if used accidentally or intentionally by someone who has not been prescribed it.

How long can you store Durogesic

Do not use this medicine after the expiry date stated on the patch pouch and outer packaging after EXP. The expiry date refers to the last day of the month stated.
If the expiry date has passed, return unused patches to the pharmacy.
The medicine should be stored in closed pouches in the original packaging, without special requirements.

How to dispose of used and unused patches

Accidental attachment of a used or unused patch to another person's skin, especially a child, can be fatal.
A used patch should be folded in half, with the adhesive sides together, placed in the original pouch, and then placed in a location out of sight and reach of others, especially children, until disposal. Ask your pharmacist how to dispose of medicines that are no longer needed.
Do not throw away medicines down the drain or in household waste. This will help protect the environment.

6. Contents of the pack and other information

What Durogesic contains

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

Other ingredients (excipients) of the patch are:

Outer layer, foil: polyester-ethyl vinyl acetate copolymer.
Protective layer, foil: siliconized polyester.
Layer containing the active substance: acrylic 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 gray 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 an area of 5.25 cm and has an orange border printed with "DUROGESIC 12 µg fentanyl/h".
Durogesic 25 µg/h
Durogesic is a semi-transparent, rectangular patch with rounded corners. Each patch has an area of 10.5 cm and has a red border printed with "DUROGESIC 25 µg fentanyl/h".
Durogesic 50 µg/h
Durogesic is a semi-transparent, rectangular patch with rounded corners. Each patch has an area of 21.0 cm and has a green border printed with "DUROGESIC 50 µg fentanyl/h".
Durogesic 75 µg/h
Durogesic is a semi-transparent, rectangular patch with rounded corners. Each patch has an area of 31.5 cm and has a blue border printed with "DUROGESIC 75 µg fentanyl/h".
Durogesic 100 µg/h
Durogesic is a semi-transparent, rectangular patch with rounded corners. Each patch has an area of 42.0 cm and has a gray border printed with "DUROGESIC 100 µg fentanyl/h".
The medicine is supplied in cardboard boxes containing 5 individually packaged patches in heat-sealable pouches (made of acrylonitrile film or cyclic olefin copolymer).

Marketing authorization holder:

Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Manufacturer:

Janssen-Pharmaceutica NV
Turnhoutseweg 30
B-2340 Beerse
Belgium
To obtain more detailed information on this medicine, please 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

Economically and in the United Kingdom (Northern Ireland) under the following names:

Date of the last update of the leaflet: 10/2024

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