Durogesic

Patient Information Leaflet: Information for the User

DUROGESIC 12 micrograms/hour transdermal patch, 25 micrograms/hour transdermal patch, 50 micrograms/hour transdermal patch, 75 micrograms/hour transdermal patch, 100 micrograms/hour transdermal patch

fentanyl
Please read all of this leaflet carefully before you start using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms seem identical to yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this 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.
The patches help relieve severe and long-lasting pain:

• in adults who require ongoing treatment for pain
• in children over 2 years of age who are already using opioid medicines and who require ongoing treatment for pain.

DUROGESIC contains a medicine called fentanyl, which belongs to a group of strong painkillers called opioids.

2. What you need to know before using DUROGESIC

Do not use DUROGESIC

• If you are allergic to fentanyl or any of the other ingredients of this medicine (listed in section 6).
• If your pain is short-term, such as sudden pain or postoperative pain.
• If you have difficulty breathing, with slow or shallow breathing. Do not use this medicine if any of the above points apply to you or your child. If in doubt, consult your doctor, pharmacist, or nurse before using DUROGESIC.

Warnings and precautions

• DUROGESIC may cause life-threatening side effects in people who are not already regularly using prescribed opioid medicines.
• DUROGESIC is a medicine that could be life-threatening to children, even if the patches have already been used. Please note that a sticky patch (new or used) may attract a child, and if it sticks to the child's skin or if the child puts it in their mouth, the result could be fatal.
• Keep this medicine in a safe and secure place, out of reach of others – see section 5 for more information.

Transfer of the patch to another person
The patch must only be used on the skin of the person for whom it was prescribed. Cases have been reported of accidental adhesion of the patch to a family member during close physical contact or while sharing the same bed with the person using the patch. A patch that accidentally sticks to another person (especially a child) may allow the medicine in the patch to pass through the other person's skin, causing serious side effects such as difficulty breathing, slow and shallow breathing, which can be fatal. If the patch sticks to another person’s skin, remove it immediately and contact a doctor.

Special precautions with DUROGESIC
Consult your doctor or pharmacist before using this medicine if any of the conditions listed below apply to you, as your doctor may need to monitor you more closely.

• If you have ever had lung or breathing problems.
• If you have ever had heart, liver, or kidney problems, or have/have had low blood pressure.
• If you have ever had a brain tumor.
• If you have ever had persistent headaches or a head injury.
• If you are elderly, as you may be more sensitive to the effects of this medicine.
• If you have a condition called 'myasthenia gravis', in which muscles become weak and tire easily.

If any of the conditions listed above apply to you (or if you are unsure), consult your doctor, pharmacist, or nurse before using DUROGESIC.
While using the patch, inform your doctor if you have breathing problems during sleep. Opioids such as DUROGESIC can cause sleep-related breathing disorders such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Inform your doctor if you, your partner, or your caregiver notice any of the following:

• Pauses in breathing during sleep
• Waking up at night due to shortness of breath
• Difficulty staying asleep
• Excessive daytime sleepiness. Your doctor may decide to adjust your dose.

While using the patch, inform your doctor if you notice a change in the pain you feel. If you experience:

• Pain that is no longer relieved by the patch
• Increased pain
• A change in how you feel pain (for example, feeling pain in another part of the body)
• Pain when touched in a way that should not hurt.

Do not change the dose on your own. Your doctor may decide to adjust the dose of the medicine or change your treatment.
Side effects and DUROGESIC

• DUROGESIC may make you unusually drowsy, and can make your breathing slower and more shallow. Very rarely, these breathing problems can be life-threatening or even fatal, especially in people who have never previously used strong opioid painkillers (such as DUROGESIC or morphine). If you or someone else notices that the person using the patch is unusually sleepy, with slow or shallow breathing:
• Remove the patch
• Call your doctor immediately, or go to the nearest hospital
• Try to keep the person moving and talking as much as possible
• If you develop a fever while using DUROGESIC, inform your doctor, as fever can increase the amount of medicine passing through the skin.
• DUROGESIC can cause constipation; consult your doctor or pharmacist for advice on how to prevent or relieve constipation. See section 4 for a complete list of possible side effects.

Like other opioids, DUROGESIC can affect the normal production of hormones in the body, such as cortisol, prolactin, or sex hormones, especially if you have been taking DUROGESIC for a long time. The effects of these hormonal changes may include feeling nauseous or nausea (including vomiting), loss of appetite, fatigue, weakness, dizziness, low blood pressure, infertility, or reduced sexual desire. In addition, female patients may experience changes in their menstrual cycle, while male patients may experience impotence or breast tissue enlargement. If you notice any of these signs, speak with your doctor.
While wearing the patch, do not expose yourself to direct sources of heat, such as heating pads, electric blankets, hot water bottles, heated water beds, or heat or tanning lamps. Avoid prolonged sun exposure, long hot baths, saunas, or hot whirlpool baths. Doing so may increase the amount of medicine absorbed from the patch.
Long-term use and tolerance
This medicine contains fentanyl, an opioid medicine. Repeated use of opioid painkillers may make the medicine less effective (you become accustomed to it, a phenomenon known as drug tolerance). You may also become more sensitive to pain while using DUROGESIC. This is known as hyperalgesia. Increasing the dose of patches may help reduce pain for a while, but it may also be harmful. If you notice the medicine becoming less effective, consult your doctor. Your doctor will decide whether it is better to increase the dose or gradually reduce the use of DUROGESIC.
Dependence and substance abuse
Repeated use of DUROGESIC may also lead to dependence, abuse, and substance abuse, which may result in potentially fatal overdose. The risk of these side effects may increase with higher doses and prolonged duration of use. Dependence or substance abuse may make you feel that you no longer have control over how much medicine you need or how often you must use it. You may feel the need to continue using the medicine even if it does not help relieve pain.
The risk of developing dependence or substance abuse varies from person to person. You may have a higher risk of becoming dependent on or abusing DUROGESIC if:

• You or a family member has previously suffered from alcohol, prescription medicine, or illegal substance abuse or dependence ("substance abuse").
• You are a smoker.
• You have previously had mood disorders (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

The appearance of any of the following signs during the use of DUROGESIC may indicate dependence or substance abuse.

• You feel the need to use the medicine for longer than prescribed by your doctor
• You feel the need to use a higher dose than recommended
• You use the medicine for reasons other than those prescribed, e.g., "to stay calm" or "to help sleep"
• You have repeatedly tried to stop or control the use of this medicine without success
• You feel unwell when you stop taking the medicine, and feel better when you start again ("withdrawal effects"). If you notice any of these signs, consult your doctor to discuss the best treatment path for you, including cases where it may be appropriate to stop treatment and how to do so safely.

Withdrawal symptoms when stopping DUROGESIC
Do not stop taking this medicine suddenly. Withdrawal symptoms may occur, such as restlessness, difficulty sleeping, irritability, agitation, anxiety, awareness of your heartbeat (palpitations), increased blood pressure, feeling unwell, diarrhea, loss of appetite, tremor, chills, or sweating. If you wish to stop taking this medicine, speak to your doctor first. Your doctor will advise you on how to do this, usually by gradually reducing the dose to minimize unpleasant withdrawal effects.
Other medicines and DUROGESIC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This includes medicines you can buy without a prescription and herbal preparations. In addition, you must inform the pharmacist that you are using DUROGESIC when purchasing any medicine at the pharmacy.
Your doctor will know which medicines are safe to take together with DUROGESIC. If you are starting or stopping any of the medicines listed below, careful monitoring may be needed, as this may affect the dose of DUROGESIC required for you.
In particular, inform your doctor or pharmacist if you are taking:

• Other pain medicines, such as other opioid painkillers (e.g., buprenorphine, nalbuphine, or pentazocine) and some nerve pain medicines (gabapentin and pregabalin).
• Medicines that help you sleep (e.g., temazepam, zaleplon, or zolpidem)
• Medicines for anxiety (tranquilizers such as alprazolam, clonazepam, diazepam, hydroxyzine, or lorazepam) and medicines for mental conditions (antipsychotics such as aripiprazole, haloperidol, olanzapine, risperidone, or phenothiazines)
• Medicines to relax muscles (e.g., cyclobenzaprine or diazepam)
• Some medicines used to treat depression called SSRIs or SNRIs (e.g., citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine) – for more information see below
• Some medicines used to treat depression or Parkinson’s disease called MAOIs (e.g., isocarboxazid, phenelzine, selegiline, or tranylcypromine). You must not use DUROGESIC within 14 days of stopping these medicines – for more information see below
• Some antihistamines, especially those that cause drowsiness (e.g., chlorpheniramine, clemastine, cyproheptadine, diphenhydramine, or hydroxyzine)
• Some antibiotics used to treat infections (e.g., erythromycin or clarithromycin)
• Medicines used to treat fungal infections (e.g., itraconazole, ketoconazole, fluconazole, or voriconazole)
• Medicines used to treat HIV infection (e.g., ritonavir)
• Medicines used to treat arrhythmia (irregular heartbeat) (e.g., amiodarone, diltiazem, or verapamil)
• Medicines used to treat tuberculosis (e.g., rifampicin)
• Some medicines used to treat epilepsy (e.g., carbamazepine, phenobarbital, or phenytoin)
• Some medicines used to treat nausea or motion sickness (e.g., phenothiazines)
• Some medicines used to treat heartburn or ulcers (e.g., cimetidine)
• Some medicines used to treat angina (chest pain) or high blood pressure (e.g., nicardipine)
• Some medicines used to treat blood cancer (e.g., idelalisib).

DUROGESIC with antidepressants
The risk of side effects increases if you are taking medicines such as certain antidepressants. DUROGESIC can interact with these medicines, and changes in mental status may occur, such as feeling agitated, seeing things or hearing or smelling things that are not real (hallucinations), and other effects such as changes in blood pressure, rapid heartbeat, high body temperature, hyperreflexia (excessive reflexes), lack of coordination, muscle stiffness, nausea, vomiting, and diarrhea (these could be signs of Serotonin Syndrome). If used together, your doctor may wish to monitor you closely for such side effects, especially when starting treatment or when changing the dose of the medicine.
Use with central nervous system depressants, including alcohol and certain narcotic medicines
Concomitant use of DUROGESIC and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are possible.
However, if your doctor prescribes DUROGESIC together with sedative medicines, the dose and duration of concomitant treatment must be limited by your doctor.
Inform your doctor about all sedative medicines you are taking and follow your doctor’s dose recommendations carefully. It may be helpful to inform friends or family members to be aware of the signs and symptoms listed above. Contact your doctor if these symptoms occur. Do not consume alcohol while using DUROGESIC unless you have spoken with your doctor.
Surgery
If you think you may need anesthesia, inform your doctor or dentist that you are using DUROGESIC.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
DUROGESIC must not be used during pregnancy unless you have discussed it with your doctor.
DUROGESIC must not be used during childbirth, as the medicine may affect the newborn’s breathing.
Prolonged use of DUROGESIC during pregnancy may cause withdrawal symptoms in the newborn (such as high-pitched crying, restlessness, seizures, poor feeding, and diarrhea), which may be potentially fatal if not recognized and treated. Inform your doctor immediately if you think your baby may have withdrawal symptoms.
Do not use DUROGESIC if you are breastfeeding. You must not breastfeed for 3 days after removing the DUROGESIC patch. This is because the medicine can pass into breast milk.
Driving and using machines
DUROGESIC may impair your ability to drive or use machines or tools, as it may cause drowsiness or dizziness. If this occurs, do not drive or operate any tools or machinery. Do not drive while using this medicine until you know how it affects you.
Consult your doctor or pharmacist if you have any doubts about whether it is safe to drive while using this medicine.

3. How to use DUROGESIC

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Your doctor will decide which dose of DUROGESIC is most suitable for you, taking into account the intensity of your pain, your general health condition, and the type of pain treatment you have previously received.
Before starting treatment and regularly during treatment, your doctor will also discuss with you what you can expect from using DUROGESIC, when and for how long it should be used, when to contact your doctor, and when treatment should be stopped (see also section 2, Withdrawal symptoms when stopping DUROGESIC).

Application and replacement of the patch

• Each patch contains enough medicine for 3 days (72 hours).
• You must change the patch every third day, unless otherwise instructed by your 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 you are using more than one patch, change all patches at the same time.
• Record the day, date, and time when you apply a patch so you can remember when to replace it.
• The following table shows when to change the patch:

If you apply the patch on Change the 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 trunk or upper arm (not over a joint).

Children

• Always apply the patch to the upper back to make it difficult for the child to touch or remove it.
• Nevertheless, check frequently to ensure the patch remains properly adhered to the skin.
• It is important that the child does not remove the patch or put it in their mouth, as this could be life-threatening or even fatal.
• Closely observe the child for 48 hours after:
• the first patch has been applied
• a patch with a higher dose has been applied
• The patch may take some time to reach its full effect. Therefore, the child may need to use other painkillers until the patch becomes effective. Your doctor will discuss this with you.

Adults and children:
Do not apply the patch

• To the same site two times in a row.
• On areas that move a lot (joints), irritated skin, or skin with wounds.
• On areas with excessive hair. Do not shave the hair (shaving irritates the skin); instead, cut it as close to the skin as possible using scissors.

How to apply the patch
Step 1: Prepare the skin

• Ensure the skin is completely dry, clean, and intact before applying the patch.
• If necessary, clean the skin using only cool water.
• Do not use soap or any other detergent, nor creams, moisturizing lotions, oils, or talcum powder before applying the patch.
• Do not apply a patch immediately after a hot bath or shower.

Step 2: Open the pouch

• Each patch is sealed in its individual pouch.
• Tear or cut the pouch open at the notch indicated by the arrow.
• Carefully tear or cut completely along the edge of the pouch (if using scissors, cut close to the sealed edge to avoid damaging the patch).

• Gently pull apart both sides of the opened pouch.
• Remove the patch and use it immediately.
• Keep the empty pouch to dispose of the used patch later.
• Use each patch only once.
• Do not remove the patch from the pouch until you are ready to use it.
• Inspect the patch to check if it is damaged.
• Do not use the patch if it has been divided, cut, or appears damaged.
• Never divide or cut the patch.

Step 3: Peel and press

• Make sure the patch will be covered by comfortable clothing and not constricted under tight or elastic bandages.
• Carefully peel off half of the shiny plastic liner starting from the center of the patch. Try not to touch the adhesive side of the patch.
• Press this adhesive part of the patch onto the skin.
• Remove the other half of the plastic liner and press the entire patch onto the skin with the palm of your hand.
• Maintain pressure for at least 30 seconds, ensuring the patch adheres well, especially along the edges.

Step 4: Dispose of the patch

• Immediately after removing a patch, fold it firmly in half so that the adhesive side sticks to itself.
• Place it back into the original pouch and dispose of the pouch according to the pharmacist’s instructions.
• Keep used patches out of sight and reach of children, as even used patches contain some medicine that could be dangerous or even fatal to children.

Step 5: Wash

• After touching the patch, always wash your hands using only running water.

Additional information for using DUROGESIC
Daily activities while using the patch

• The patch is waterproof.
• You may take a shower or bath while wearing the patch, but do not rub it.
• If approved by your doctor, you may exercise or engage in sports while wearing the patch.
• You may also swim while wearing the patch, but:
• do not use hot water jets or thermal baths
• do not place tight or elastic bandages over the patch
• While wearing the patch, do not expose it to direct heat sources such as heating pads, electric blankets, hot water bottles, heated water beds, heat lamps, or sunbeds. Avoid prolonged sun exposure, hot baths, or saunas, as this may increase the amount of medicine released from the patch.

How quickly does the patch work?

• The first patch may take some time to reach its full effect.
• Your doctor will provide you with additional painkillers for the first day or as long as needed.
• After this period, the patch should help relieve pain continuously, allowing you to stop other analgesics. However, your doctor may occasionally prescribe additional painkillers.

How long should you use the patches?

• DUROGESIC patches are indicated for long-term pain. Your doctor will be able to advise how long they expect you to use the patches.

If pain worsens

• If pain suddenly worsens after applying your last patch, check the patch. If it is not adhering properly or has detached, replace it (See also section "If a patch comes off").
• If pain worsens over time while using these patches, your doctor may try a stronger-dose patch or prescribe additional painkillers (or both).
• If increasing the patch dose does not help, your doctor may decide to discontinue the use of patches.

If you use too many patches or a patch with the wrong dose
If you have applied too many patches or a patch with the wrong dose, remove the patch immediately and contact your doctor without delay.
Signs of overdose include: difficulty breathing or shallow breathing, fatigue, extreme drowsiness, inability to think clearly, walk or speak normally, and feelings of faintness, dizziness, or confusion. Overdose may also cause a brain disorder known as toxic leukoencephalopathy.

If you forget to change the patch

• If you forget, change the patch as soon as you remember, and note the day and time. Then change the patch again after 3 days (72 hours) as usual.
• If you are significantly late in changing the patch, contact your doctor, as you may need additional painkillers, but do not apply an extra patch.

If the patch comes off

• If a patch comes off before it needs to be changed, apply a new one immediately and note the day and time. Apply it to a new skin site on:
• the trunk or upper arm
• the upper back (in a child).
• Inform your doctor about what happened and leave the new patch in place for 3 days (72 hours) or as directed by your doctor before changing it as usual.
• If patches continue to fall off, speak to your doctor, pharmacist, or nurse.

If you want to stop using the patches

• Do not stop using this medicine abruptly. If you wish to stop using this medicine, talk to your doctor first. Your doctor will advise you on how to do this, usually by gradually reducing the dose to minimize any unpleasant withdrawal effects. See also section 2, Withdrawal symptoms when stopping DUROGESIC.
• If you stop using the patches, do not restart without first consulting your doctor. You may need a patch with a different dose when restarting.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you, or someone else, notice that the person using the patch shows any of the following
symptoms, remove the patch immediately and contact a doctor or go to the nearest hospital,
as they may need urgent medical treatment.

• Unusual drowsiness, with breathing slower or shallower than normal. Follow the recommendations given above and keep the person using the patch as active as possible and encourage them to talk. Very rarely, these breathing difficulties can be life-threatening or even fatal, especially in people who have never previously used strong opioid analgesics (such as DUROGESIC or morphine). (Uncommon, may affect up to 1 in 100 people)
• Sudden redness of the face or throat, severe irritation, redness or blistering of the skin. These may be signs of a serious allergic reaction. (Frequency cannot be estimated from available clinical data)
• Seizures (fits). (Uncommon, may affect up to 1 in 100 people)
• Reduced level of consciousness or loss of consciousness (Uncommon, may affect up to 1 in 100 people)

The following side effects have also been reported.
Very common (may affect more than 1 in 10 people)

• Nausea, vomiting, constipation
• Feeling sleepy (drowsiness)
• Feeling dizzy
• Headache

Common (may affect up to 1 in 10 people)

• Allergic reaction
• Loss of appetite
• Difficulty sleeping
• Depression
• Anxiety or confusion
• Seeing things, hearing sounds or smelling odours that do not exist (hallucinations)
• Tremors or muscle spasms
• Unusual skin sensations, such as tingling or touching sensations (paraesthesiae)
• Sensation of spinning (dizziness)
• Rapid or irregular heartbeat (palpitations, tachycardia)
• High blood pressure
• Shortness of breath (dyspnoea)
• Diarrhoea
• Dry mouth
• Stomach ache or indigestion
• Excessive sweating
• Itching, rash or redness of the skin
• Inability to urinate or to completely empty the bladder
• Feeling of tiredness, weakness or general malaise
• Feeling cold
• Swelling of the hands, ankles or feet (peripheral oedema)

Uncommon (may affect up to 1 in 100 people)

• Feeling restless or disoriented
• Feeling extremely happy (euphoria)
• Decreased sensitivity, especially of the skin (hypoesthesia)
• Memory loss
• Blurred vision
• Slow heartbeat (bradycardia) or low blood pressure
• Bluish discolouration of the skin due to low oxygen levels in the blood (cyanosis)
• Loss of intestinal contractions (ileus)
• Itchy skin rash (eczema), allergic reaction or other skin disorders at the site of the patch
• Flu-like illness
• Sensation of change in body temperature
• Fever
• Muscle spasm
• Difficulty achieving or maintaining an erection (impotence) or problems during sexual intercourse
• Difficulty swallowing

Rare side effects (may affect up to 1 in 1,000 people)

• Constriction of the pupils (miosis)
• Periodic stopping of breathing (apnoea)

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

• Lack of male sex hormones (androgen deficiency)
• Delirium (symptoms may include a combination of agitation, restlessness, disorientation, confusion, fear, seeing or hearing things that do not exist, sleep disturbances, nightmares)
• You may become dependent on DUROGESIC (see section 2).

You may notice a rash, redness or mild itching of the skin at the site of the patch. These
reactions are usually mild in intensity and disappear after you remove the patch. If they do not
resolve, or if the patch causes significant skin irritation, inform your doctor.
Repeated use of the patches may cause the medicine to become less effective (you may become accustomed to it or more sensitive to pain) or you may become dependent on it.
If you switch to DUROGESIC from another analgesic or if you stop using DUROGESIC suddenly, you may experience withdrawal symptoms such as vomiting, nausea, diarrhoea, anxiety or chills. Inform your doctor if any of these symptoms occur.
Withdrawal symptoms have also been reported in newborns whose mothers used DUROGESIC for a prolonged period during pregnancy.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store DUROGESIC

Where to store the patches
Store all patches (used and unused) out of sight and reach of children.
Keep in the original container to protect from light. This medicine does not require
any special storage temperature conditions.
Store this medicine in a safe and secure place, inaccessible to other people. Accidental or intentional
use of this medicine by someone to whom it has not been prescribed
can cause serious harm and may be fatal.

How long to store DUROGESIC
Do not use DUROGESIC after the expiry date stated on the carton and on the sachet. The expiry date refers to the last day of that month. Expired patches must be returned to a pharmacy.

How to dispose of used patches or patches no longer used
A used or unused patch that accidentally adheres to another person, especially a child, can be fatal.
Used patches should be folded firmly in half so that the adhesive side sticks to itself. They should then be stored safely in their original sachet and kept out of sight and reach of others, especially children, until safely disposed of. Ask your pharmacist how to dispose of medicines you no longer use.
Do not dispose of any medicine via wastewater or household waste. These measures will help protect the environment.

6. Package contents and other information

What DUROGESIC contains
DUROGESIC 12 μg/hour
The active substance in DUROGESIC is fentanyl. Each patch contains 2.1 mg of fentanyl, which releases
a dose of 12 micrograms/hour.
DUROGESIC 25 μg/hour
The active substance in DUROGESIC is fentanyl. Each patch contains 4.2 mg of fentanyl, which releases
a dose of 25 micrograms/hour.
DUROGESIC 50 μg/hour
The active substance in DUROGESIC is fentanyl. Each patch contains 8.4 mg of fentanyl, which releases
a dose of 50 micrograms/hour.
DUROGESIC 75 μg/hour
The active substance in DUROGESIC is fentanyl. Each patch contains 12.6 mg of fentanyl, which releases
a dose of 75 micrograms/hour.
DUROGESIC 100 μg/hour
The active substance in DUROGESIC is fentanyl. Each patch contains 16.8 mg of fentanyl, which releases
a dose of 100 micrograms/hour.

Other components of the patch are:
Backing layer: film, polyvinyl acetate copolymer / ethylene terephthalate,
Protective liner: silicone-coated polyester film,
Drug layer: polyacrylate adhesive.
Inks (on backing)
DUROGESIC 12 µg/hour also contains printable ink, orange.
DUROGESIC 25 µg/hour also contains printable ink, red.
DUROGESIC 50 µg/hour also contains printable ink, green.
DUROGESIC 75 µg/hour also contains printable ink, blue.
DUROGESIC 100 µg/hour also contains printable ink, grey.

Description of the appearance of DUROGESIC and contents of the pack
DUROGESIC 12 μg/hour
DUROGESIC is a translucent rectangular patch with rounded corners. Each patch measures 5.25 cm² and
is marked with a border and "DUROGESIC 12 μg fentanyl/h" in orange ink.
DUROGESIC 25 μg/hour
DUROGESIC is a translucent rectangular patch with rounded corners. Each patch measures 10.5 cm² and
is marked with a border and "DUROGESIC 25 μg fentanyl/h" in red ink.
DUROGESIC 50 μg/hour
DUROGESIC is a translucent rectangular patch with rounded corners. Each patch measures 21.0 cm² and
is marked with a border and "DUROGESIC 50 μg fentanyl/h" in green ink.
DUROGESIC 75 μg/hour
DUROGESIC is a translucent rectangular patch with rounded corners. Each patch measures 31.5 cm² and
is marked with a border and "DUROGESIC 75 μg fentanyl/h" in blue ink.
DUROGESIC 100 μg/hour
DUROGESIC is a translucent rectangular patch with rounded corners. Each patch measures 42.0 cm² and
is marked with a border and "DUROGESIC 100 μg fentanyl/h" in grey ink.

The patches are individually packed in heat-sealed pouches (acrylonitrile film or cyclic olefin copolymer) and supplied in cartons containing 3, 4, 5, 8, 10, 16, 20 or 30 patches.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Janssen-Cilag S.p.A.
Viale Fulvio Testi, 280/6
20126 Milano MI
Manufacturer
Janssen Pharmaceutica NV - Turnhoutseweg 30, 2340 Beerse – Belgium

This medicinal product is authorised in the European Economic Area (EEA) Member States and in the United Kingdom (Northern Ireland) under the following names: