DUROGESIC MATRIX 50 micrograms/hour TRANSDERMAL PATCHES

Introduction

Package Leaflet: Information for the User

Durogesic Matrix 50 micrograms/hour transdermal patches

fentanyl

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

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Durogesic Matrix is and what it is used for
2. What you need to know before you use Durogesic Matrix
3. How to use Durogesic Matrix
4. Possible side effects
5. Storing Durogesic Matrix
6. Contents of the pack and other information

1. What Durogesic Matrix is and what it is used for

This medicine is called Durogesic Matrix

The patches help to relieve very strong and long-lasting pain:

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

Durogesic Matrix contains a medicine called fentanyl. It belongs to a group of strong pain-relieving medicines called opioids.

2. What you need to know before you use Durogesic Matrix

Do not use Durogesic Matrix

• If you are allergic to fentanyl or any of the other ingredients of this medicine (listed in section 6)
• If you have pain that is only short-lasting, such as pain after an operation
• If you have breathing difficulties, with slow and shallow breathing

Do not use this medicine if you or your child are in any of these situations. If you are not sure, consult your doctor or pharmacist before using Durogesic Matrix.

Warnings and precautions

• Durogesic Matrix can have serious side effects that can be life-threatening in people who are not using opioids regularly.
• Durogesic Matrix is a medicine that can be life-threatening to children, even if the patches have already been used. Be aware that a sticky patch (used or unused) can be tempting to a child, and if it sticks to the child's skin or if the child puts it in their mouth, it can be fatal.
• Keep this medicine in a safe place where other people cannot get to it, see section 5 for more information.

If the patch sticks to another person

The patch should only be used on the skin of the person it has been prescribed for. There have been cases where the patch has stuck to another family member through close physical contact or sharing the same bed with the person wearing the patch. If the patch sticks accidentally to another person (especially a child), the medicine in the patch can pass through their skin and can cause serious side effects, such as breathing difficulties, with slow and shallow breathing, which can be life-threatening. If the patch sticks to another person's skin, it should be removed immediately and a doctor should be seen.

Be careful with Durogesic Matrix

Consult your doctor or pharmacist beforeusing this medicine if you are in any of the following situations. Your doctor will need to keep a closer check on you:

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

If you have any of these conditions (or if you are not sure), consult your doctor or pharmacist before using Durogesic Matrix.

Tell your doctor while you are using the patch if you have breathing difficulties while you are sleeping.Opioids like Durogesic Matrix can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses while sleeping) and sleep-related hypoxemia (low oxygen levels in the blood). Talk to your doctor if you, your partner, or carer notice any of the following symptoms:

• breathing pauses while sleeping
• waking up during the night feeling short of breath
• difficulty staying asleep
• excessive sleepiness during the day.

Your doctor may decide to change the dose.

Tell your doctor while you are using the patch if you notice any change in your pain.If you:

• feel that the patch is no longer relieving your pain
• have an increase in your pain
• have a change in the type of pain you are experiencing (for example, you feel pain in a different part of your body)
• feel pain even when you are not normally aware of pain (for example, when you touch something that should not hurt).

Do not change the dose yourself. Your doctor may decide to change the dose or switch to a different treatment.

Side effects and Durogesic Matrix

• Durogesic Matrix can make you feel extremely drowsy and can slow down your breathing. Occasionally, these breathing problems can be life-threatening or even fatal, especially in people who have not used strong opioid painkillers like Durogesic Matrix or morphine before. If you, or your partner or carer, notice that you are unusually drowsy, with slow and shallow breathing:

• remove the patch;
• call a doctor or go to the hospital immediately;
• try to keep the person awake and talking as much as possible.

• If you get a high temperature while using Durogesic Matrix, talk to your doctor. This can increase the amount of medicine that passes through your skin.
• Durogesic Matrix can cause constipation; talk to your doctor or pharmacist for advice on how to prevent or relieve constipation.

You can find a full list of possible side effects in section 4.

Durogesic Matrix, like other opioids, can affect the normal production of hormones in the body, such as cortisol, prolactin, or sex hormones, especially if you have used Durogesic Matrix for a long time. The effects of these hormonal changes can include feeling unwell or uneasy (including nausea), loss of appetite, tiredness, weakness, dizziness, low blood pressure, infertility, or decreased sex drive. Additionally, female patients may experience changes in their menstrual cycle, while male patients may experience impotence or enlarged breasts. If you notice any of these signs, talk to your doctor.

When you are wearing the patch, do not expose it to direct heat, such as heating pads, electric blankets, hot water bottles, heat lamps, or tanning lamps. Do not take a hot bath or shower, or use a sauna or hot tub. If you do, you may increase the amount of medicine that is released from the patch.

Long-term use and tolerance

This medicine contains fentanyl, an opioid. Repeated use of opioid painkillers can make the medicine less effective (your body gets used to it, which is known as tolerance). You may also become more sensitive to pain when using Durogesic Matrix. This is known as hyperalgesia. Increasing the dose of the patches may continue to relieve pain for a while, but it can also be harmful. If you find that the medicine is not working as well as it did, talk to your doctor. Your doctor will decide whether it is better for you to increase the dose or to gradually reduce your use of Durogesic Matrix.

Dependence and addiction

Repeated use of Durogesic Matrix can also lead to dependence, abuse, and addiction, which can result in a potentially life-threatening overdose. The risk of these side effects may be greater with higher doses and longer use. Dependence or addiction can lead to a feeling of losing control over how much medicine you use or how often you use it. You may feel that you need to keep using the medicine even if it is no longer relieving your pain.

The risk of dependence or addiction varies from person to person. The risk of becoming dependent on or addicted to Durogesic Matrix may be greater if:

• You or a member of your family have abused alcohol, prescription medicines, or illegal drugs (‘addiction’).
• You smoke.
• You have ever had mental problems (depression, anxiety, or personality disorders) or have received treatment for mental health problems.

If you notice any of the following symptoms while using Durogesic Matrix, it could be a sign of dependence or addiction.

• You need to use the medicine for longer than your doctor has prescribed.

• You need to use a higher dose than your doctor has prescribed.

• You are using the medicine for reasons other than those prescribed by your doctor, for example, ‘to feel relaxed’ or ‘to help you sleep’.
• You have tried to stop using the medicine but cannot.
• You feel unwell when you stop using the medicine, and you feel better once you start using it again (‘withdrawal symptoms’).

If you notice any of these signs, talk to your doctor to determine the best course of treatment for you, when it is appropriate to stop the medicine, and how to do it safely.

Withdrawal symptoms when stopping Durogesic Matrix

Do not stop using this medicine suddenly. You may experience withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, awareness of your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, loss of appetite, shaking, chills, or sweating. If you want to stop using this medicine, talk to your doctor first. Your doctor will tell you how to do it, usually by gradually reducing the dose.

Other medicines and Durogesic Matrix

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. You should also tell your pharmacist if you are using Durogesic Matrix when you buy any medicines from the pharmacy.

Your doctor will know which medicines can be taken safely with Durogesic Matrix. You may need to be closely monitored if you are taking any of the types of medicines listed below, or if you stop taking any of the types of medicines listed below, as this can affect the dose of Durogesic Matrix that you need.

In particular, tell your doctor or pharmacist if you are taking:

• Other pain-relieving medicines, such as other opioid painkillers (e.g. buprenorphine, nalbuphine, or pentazocine) and some pain-relieving medicines for nerve pain (gabapentin and pregabalin).
• Medicines to help you sleep (such as temazepam, zaleplon, or zolpidem).
• Medicines to help you relax (tranquillisers, such as alprazolam, clonazepam, diazepam, hydroxyzine, or lorazepam) and medicines for mental health problems (antipsychotics, such as aripiprazole, haloperidol, olanzapine, risperidone, or phenothiazines).
• Medicines to relax your muscles (such as cyclobenzaprine or diazepam).
• Certain medicines used to treat depression called SSRIs or SNRIs (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine) – see below for more information.
• Certain medicines used to treat depression or Parkinson’s disease called MAOIs (such as isocarboxazid, phenelzine, selegiline, or tranylcypromine). You should not use Durogesic Matrix in the 14 days after stopping these medicines – see below for more information.
• Certain antihistamines, especially those that cause drowsiness (such as chlorphenamine, clemastine, ciproheptadine, diphenhydramine, or hydroxyzine).
• Certain antibiotics used to treat infections (such as erythromycin or clarithromycin).
• Medicines used to treat fungal infections (such as itraconazole, ketoconazole, fluconazole, or voriconazole).
• Medicines used to treat HIV infection (such as ritonavir).
• Medicines used to treat irregular heartbeats (such as amiodarone, diltiazem, or verapamil).
• Medicines used to treat tuberculosis (such as rifampicin).
• Certain medicines used to treat epilepsy (such as carbamazepine, phenobarbital, or phenytoin).
• Certain medicines used to treat nausea or vomiting (such as phenothiazines).
• Certain medicines used to treat heartburn or stomach ulcers (such as cimetidine).
• Certain medicines used to treat angina (chest pain) or high blood pressure (such as nicardipine).
• Certain medicines used to treat blood cancer (such as idelalisib).

Using Durogesic Matrix with antidepressants

The risk of side effects increases if you are taking medicines such as certain antidepressants. Durogesic Matrix can interact with these medicines and you may experience changes in your mental state such as agitation, seeing, feeling, hearing, or smelling things that are not there (hallucinations), and other effects such as changes in blood pressure, rapid heartbeat, high body temperature, overactive reflexes, lack of coordination, muscle stiffness, nausea, vomiting, and diarrhoea (these could be signs of serotonin syndrome). If they are used together, your doctor may want to monitor you closely to detect these side effects, especially when starting treatment or when changing the dose of the medicine.

Using Durogesic Matrix with central nervous system depressants, including alcohol and some narcotics

Using Durogesic Matrix with sedative medicines such as benzodiazepines or related medicines 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 other treatment options are not possible.

However, if your doctor prescribes Durogesic Matrix with sedative medicines, your doctor will limit the dose and duration of concomitant treatment.

Tell your doctor about all sedative medicines you are taking, and follow your doctor's dosage recommendations carefully. It may be helpful to inform friends or family members so they can recognize the signs and symptoms mentioned above. Contact your doctor if you experience these symptoms.

Do not drink alcohol while using Durogesic Matrix, unless you have talked to your doctor first.

Use in athletes

Athletes are informed that this medicine contains a component that may result in a positive doping test.

Operations

If you think you are going to have an anaesthetic, tell your doctor or dentist that you are using Durogesic Matrix.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Durogesic Matrix should not be used during pregnancy, unless you have discussed it with your doctor.

Durogesic Matrix should not be used during labour, as the medicine can affect the breathing of the newborn baby.

Long-term use of Durogesic Matrix during pregnancy may cause withdrawal symptoms in your newborn baby, such as high-pitched crying, irritability, and poor feeding, which can be life-threatening if not recognized and treated. Talk to your doctor immediately if you think your baby may have withdrawal symptoms.

Do not use Durogesic Matrix if you are breastfeeding. You should not breastfeed for 3 days after removing the Durogesic Matrix patch. This is because the medicine can pass into breast milk.

Driving and using machines

Durogesic Matrix can affect your ability to drive or use machines or tools, as it may make you feel drowsy or dizzy. If this happens, do not drive or use machines or tools. Do not drive while using this medicine until you know how it affects you.

Talk to your doctor or pharmacist if you are unsure whether it is safe for you to drive while using this medicine.

3. How to use Durogesic Matrix

Follow the administration instructions for this medication exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your doctor will decide which concentration of Durogesic Matrix is most suitable for you, taking into account the intensity of your pain, your general condition, and the type of pain treatment you have received so far.

Before starting treatment and regularly during treatment, your doctor will also explain what you can expect from using Durogesic Matrix, when and for how long you should use it, when you should contact your doctor, and when you should stop using it (see also section 2, “Withdrawal syndrome when stopping treatment with Durogesic Matrix”).

How to apply and change patches

• Each patch contains a sufficient amount of medication for 3days (72hours).
• You should change the patch every three days, unless your doctor has indicated otherwise.
• Always remove the used patch beforeapplying a new one.
• Always change the patch at the same timeof day every 3 days (72 hours).
• If you are using more than one patch, change them all at the same time.
• Make a note of the day of the week, date, and time each time you apply a patch to remember when you need to change it.
• The following table shows when you should change the patch:

Where to apply the patch

Adults

• Apply the patch to a flat area of the torso or arm (never over a joint).

Children

• Always apply the patch to the upper back so that your child has difficulty reaching or removing it.
• Check occasionally to ensure the patch is still adhered to the skin.
• It is essential that the child does not remove the patch and put it in their mouth, as this could be life-threatening or fatal.
• Keep your child under close observation for 48 hours after:

• Applying the first patch
• Applying a patch with a higher dose

• The patch may take some time to reach its maximum effect. Therefore, your child may need other pain relievers until the patch is effective. Your doctor will explain this to you.

Adults and children:

Do not apply the patch to

• The same site twice in a row.
• Areas that move a lot (joints), irritated skin, or skin with wounds.
• Areas of skin with a lot of hair. If there is hair, do not shave it (the skin becomes irritated with shaving). Instead, cut it as close to the skin as possible.

How to apply the patch

Step 1: Prepare the skin

• Before applying the patch, check that the skin is completely dry, clean, and fresh
• If you need to wash the skin, use only cold water
• Do not use soap or other cleaners, creams, moisturizers, oils, or talc before applying the patch
• Do not apply the patch immediately after a hot bath or shower

Step 2: Open the pouch

• Each patch is sealed in its own pouch
• Open the pouch by tearing or cutting it at the notch, marked with an arrow
• Gently tear or cut completely along the edge of the pouch (if using scissors, cut along the sealed edge to avoid damaging the patch)

• Hold the two parts of the open pouch and pull to separate them
• Remove the patch and use it immediately
• Save the empty pouch to dispose of the used patch later
• Use each patch only once
• Do not remove the patch from its pouch until you are ready to use it
• Check that the patch is not damaged
• Do not use the patch if it is divided, cut, or damaged in any way
• Never divide or cut the patch

Step 3: Peel and press

• Make sure the patch will be covered by loose clothing and not stuck under tight or elastic fabric
• Carefully peel off one half of the shiny plastic protective layer, starting from the center of the patch. Try not to touch the adhesive part of the patch
• Press this adhesive part of the patch onto the skin
• Remove the other part of the protective layer and press the entire patch onto the skin with the palm of your hand
• Hold it pressed for at least 30 seconds. Make sure the patch is well adhered, especially around the edges

Step 4: Dispose of the patch

• As soon as you remove the patch, fold it in half, so that the adhesive side sticks to itself
• Put it back in the original pouch and throw it away following the instructions of your pharmacist
• Keep used patches out of sight and reach of children; although they are used, the patches contain medication that can harm children and even be fatal

Step 5: Wash your hands

• Always wash your hands with water only after handling the patches

More information on using Durogesic Matrix

Daily activities during patch use

• The patches are water-resistant
• You can shower or bathe with the patch on, but do not rub it
• If your doctor agrees, you can exercise or play sports with the patch on
• You can also swim with the patch on, but:

• Do not use hot tubs or whirlpools
• Do not cover the patch with tight or elastic clothing
• When wearing the patch, do not expose it to direct heat, such as heating pads, electric blankets, hot water bottles, waterbeds, or heat or tanning lamps. Do not sunbathe or take prolonged hot baths, and do not use saunas. If you do, you may increase the amount of medication released from the patch.

How long do the patches take to work?

• The first patch may take some time to reach its maximum effect.
• Your doctor may give you additional pain relievers during the first few days.
• Afterwards, the patch should help relieve pain continuously, so you may be able to stop taking other pain relievers. However, your doctor may prescribe additional pain relievers from time to time.

How long will you need to use the patches?

• Durogesic Matrix patches are indicated for prolonged pain. Your doctor will tell you how long you can expect to use the patches.

If your pain worsens

• If your pain worsens suddenly after applying the last patch, check the patch. If it is no longer adhering well or has come off, you should replace the patch (see also the section If the patch comes off).
• If your pain worsens over time while using the patches, your doctor may try patches with a higher dose or prescribe additional pain relievers (or both).
• If increasing the patch dose does not help, your doctor may decide to stop using the 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 them and contact your doctor immediately or call the Toxicology Information Service. Tel.: (91) 562 04 20, indicating the medication and the amount applied, or go to the hospital.

Signs of overdose include breathing problems or weak breathing, tiredness, extreme drowsiness, inability to think clearly or walk or talk normally, and dizziness, drowsiness, or confusion. An overdose can also cause a brain disorder known as toxic leukoencephalopathy.

If you forget to change the patch

• If you forget to change the patch, change it as soon as you remember and make a note of the day and time. Change the patch again after 3days (72hours), as usual.
• If you are significantly late, you should talk to your doctor, as you may need additional pain relievers, but do notapply extra patches.

If the patch comes off

• If the patch falls off before it is due to be changed, apply a new one immediately and make a note of the day and time. Choose a new skin area:
• On the torso or arm
• On the upper back of your child
• Inform your doctor about this and leave the patch on for another 3days (72hours)or for the time indicated by your doctor, before changing the patch in the usual way
• If the patches tend to fall off, consult your doctor, pharmacist, or nurse

If you want to stop using the patches

• Do not stop using this medication abruptly. If you want to stop using this medication, talk to your doctor first. Your doctor will tell you how to do it, usually by gradually reducing the dose so that the unpleasant withdrawal effects are minimal. See also section 2, “Withdrawal symptoms when stopping Durogesic Matrix”.
• If you stop using the patches, do not start using them again without consulting your doctor first. You may need a different dose when you resume treatment.

If you have any other questions about using this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

If you, your partner, or caregiver notice any of the following signs in the person wearing the patch, remove the patch and call a doctor or go to the nearest hospital immediately. You may need urgent medical treatment.

• Unusual drowsiness, slower or weaker breathing than expected.

Follow the above recommendations and make the person wearing the patch move and talk as much as possible. In very rare cases, these breathing difficulties can be life-threatening or even fatal, especially in people who have not used strong opioid pain relievers (such as Durogesic Matrix or morphine) before. (Uncommon, may affect up to 1 in 100 people)

• Sudden swelling of the face or throat, severe irritation, redness, or blisters on the skin.

These can be signs of a severe allergic reaction. (Frequency cannot be estimated from the available data)

• Seizures (convulsions). (Uncommon, may affect up to 1 in 100 people)

• Decreased 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 10people)

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

Common (may affect up to 1 in 10people)

• Allergic reaction
• Lack of appetite
• Difficulty sleeping
• Depression
• Feeling anxious or confused
• Seeing, feeling, hearing, or smelling things that are not there (hallucinations)
• Tremors or muscle spasms
• Abnormal sensation in the skin, such as tingling or prickling (paresthesia)
• Feeling that everything is spinning (vertigo)
• Fast or irregular heartbeat (palpitations, tachycardia)
• Increased blood pressure
• Shortness of breath (dyspnea)
• Diarrhea
• Dry mouth
• Stomach pain or indigestion
• Excessive sweating
• Itching, rash, or redness of the skin
• Difficulty urinating or emptying the bladder completely
• Extreme tiredness, weakness, or general malaise
• Feeling cold
• Swelling of the hands, ankles, or feet (peripheral edema)

Uncommon (may affect up to 1 in 100people)

• Feeling agitated or disoriented
• Feeling extremely happy (euphoria)
• Decreased sensation or sensitivity, especially in the skin (hypoesthesia)
• Memory loss
• Blurred vision
• Slow heartbeat (bradycardia) or low blood pressure
• Bluish color of the skin due to decreased oxygen in the blood (cyanosis)
• Loss of intestinal contractions (ileus)
• Skin rash with itching (eczema), allergic reaction, or other skin disorders where the patch is applied
• Flu-like illness
• Feeling of changed body temperature
• Fever
• Muscle contraction
• Difficulty getting or maintaining an erection (impotence) or problems having sex
• Difficulty swallowing

Rare side effects (may affect up to 1 in 1000people)

• Pupil constriction (miosis)
• Occasional interruption of breathing (apnea)

The following side effects have also been reported, but their exact frequency isunknown:

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

You may notice rashes, redness, or a slight itching of the skin at the patch application site. This is usually mild and disappears after removing the patch. If it does not, or if the patch irritates your skin a lot, inform your doctor.

Repeated use of the patches can make the medication less effective (you get used to it or become more sensitive to pain) or can cause dependence.

If you switch from another pain reliever to Durogesic Matrix or if you stop using Durogesic Matrix abruptly, you may experience withdrawal symptoms, such as dizziness, feeling sick, diarrhea, anxiety, or tremors. Inform your doctor if you notice any of these effects.

There have also been reports of newborn babies experiencing withdrawal symptoms after their mothers used Durogesic Matrix for a prolonged period during pregnancy.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Durogesic Matrix

Where to store the patches

Keep all patches (used and unused) out of sight and reach of children.

Store in the original pouch to protect from light. This medication does not require any special storage temperature.

Store this medication in a safe and secure place where others cannot access it. It can be very harmful and cause death if people who have not been prescribed it use it accidentally or intentionally.

How long can you store Durogesic Matrix

Do not use this medication after the expiration date, which appears on the box and pouch. The expiration date is the last day of the month indicated. If the patches are expired, take them to the pharmacy.

Do not use this medication if you notice that the patches are damaged.

How to dispose of used or unused patches

Accidental exposure of another person to used and unused patches, especially children, can result in a fatal outcome.

Used patches should be folded firmly in half, so that the adhesive side of the patch sticks to itself. Then, they should be thrown away safely by putting them in the original pouch and keeping them out of sight and reach of others, especially children, until they are disposed of safely. Ask your pharmacist how to dispose of the packaging and medications you no longer need.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Container Contents and Additional Information

Composition ofDurogesic Matrix

The active ingredient of Durogesic Matrix is fentanyl. Each transdermal patch contains 8.4 mg of fentanyl, which releases a dose of 50 micrograms/hour.

The other components of the patch are:

Support layer: Polyester/ethylene-vinyl acetate copolymer film,

Protective layer: Siliconized polyester film,

Medicinal layer: Acrylic adhesive.

Printing inks (on the back):

The Durogesic Matrix 50 micrograms/hour patch also contains green printing ink.

Appearance of the Product and Container Contents

Durogesic is a translucent, rectangular patch with rounded edges. Each patch measures 21.0 cm2, and is marked with an edge and with “Durogesic Matrix 50 µg fentanyl/h” in green printing ink.

The patches come in individual heat-sealed pouches (acrylonitrile or cyclic olefin copolymer layer), and are supplied in cardboard boxes containing 3, 4, 5, 8, 10, 16, 20 or 30 pouches.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Janssen-Cilag, S.A.

Paseo del Club Deportivo 1, Edificio 16

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Janssen Pharmaceutica N.V.

Turnhoutseweg 30

2340 Beerse

Belgium

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

Date of the last revision of this leaflet:October 2024.

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.