Durogesic Matrix 100 microgram/h transdermal patches: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Durogesic Matrix 100 micrograms/hour transdermal patches

fentanyl

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for you (or your child) only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these effects are not listed in this leaflet. See section 4.

Contents of the leaflet

What Durogesic Matrix is and what it is used for
What you need to know before using Durogesic Matrix
How to use Durogesic Matrix
Possible adverse effects
How to store Durogesic Matrix
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 relieve severe and long-lasting pain:

in adults who require continuous pain treatment
in children over 2 years of age who are already using opioid medication and who require continuous pain treatment.

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

2. What you need to know before using 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 short-term pain, such as sudden pain or pain after surgery
If you have difficulty breathing with slow or weak breathing

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

Warnings and precautions

Durogesic Matrix may cause life-threatening adverse effects in people who are not regularly using prescribed opioids.
Durogesic Matrix is a medicine that could be life-threatening to children, even if the patches have already been used. Please note that an adhesive patch (used or unused) may be attractive to a child, and if it sticks to the child's skin or if the child puts it in their mouth, the result may be fatal.
Keep this medicine in a secure and safe place, out of reach of others; see section 5 for more information.

If the patch sticks to another person

The patch must only be used on the skin of the person for whom the doctor has prescribed it. There have been cases where the patch has accidentally stuck to another family member through close physical contact or sharing the same bed with the person wearing the patch. If the patch accidentally sticks to another person (especially a child), the medicine from the patch may pass through the other person's skin and may cause serious adverse effects, such as difficulty breathing, with slow or weak breathing that can be fatal. If the patch sticks to another person’s skin, remove it immediately and seek medical help.

Take special care with Durogesic Matrix

Consult your doctor or pharmacist before using this medicine if you are in any of the following situations. Your doctor will 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 low blood pressure.
If you have ever had a brain tumour.
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 disorder called "myasthenia gravis", in which muscles become weak and tire easily.

If you have any of the above conditions (or are unsure), consult your doctor or pharmacist before using Durogesic Matrix.

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

Pauses in breathing while sleeping
Waking up at night due to breathlessness
Difficulty staying asleep
Excessive daytime sleepiness

Your doctor may decide to adjust the dose.

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

The patch no longer relieves your pain
An increase in pain
A change in the way you feel pain (e.g., pain in another part of your body)
Pain from body contact that should not cause pain

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

Adverse effects and Durogesic Matrix

Durogesic Matrix may cause unusual drowsiness and slow or weak breathing. In very rare cases, these breathing problems may be life-threatening or even fatal, especially in people who have not previously used strong opioid painkillers (such as Durogesic Matrix or morphine). If you, your partner, or caregiver notice that the person wearing the patch is unusually drowsy, with slow or weak breathing:
Remove the patch;
Call a doctor or go immediately to the nearest hospital;
Encourage the person to move and speak as much as possible.
If you develop a fever while using Durogesic Matrix, speak to your doctor. This may increase the amount of medicine passing through your skin.
Durogesic Matrix may cause constipation; speak to your doctor or pharmacist for advice on how to prevent or relieve constipation.

The full list of possible adverse effects can be found in section 4.

Like other opioids, Durogesic Matrix may affect the normal production of hormones in the body such as cortisol, prolactin, or sex hormones, especially if you have used Durogesic Matrix for long periods. The effects of these hormonal changes may include feeling unwell (including nausea and vomiting), loss of appetite, fatigue, weakness, dizziness, low blood pressure, infertility, or reduced sex drive. In addition, female patients may experience changes in their menstrual cycle, while male patients may experience impotence or breast enlargement. If you notice any of these signs, consult your doctor.

While wearing the patch, do not expose it to direct heat sources such as heating pads, electric blankets, hot water bottles, heated water beds, or heat or tanning lamps. Avoid prolonged sun exposure, hot baths, saunas, or hot tubs. Doing so may increase the amount of medicine released from the patch.

Long-term use and tolerance

This medicine contains fentanyl, an opioid. Repeated use of opioid painkillers may make the medicine less effective (the body gets used to it, known as pharmacological tolerance). You may also become more sensitive to pain while using Durogesic Matrix. This is known as hyperalgesia. Increasing the patch dose may continue to reduce pain for a time, but it may also be harmful. If you notice the medicine losing effectiveness, consult your doctor. Your doctor will decide whether it is better to increase the dose or gradually reduce the use of Durogesic Matrix.

Dependence and addiction

This medicine contains fentanyl, which is an opioid. It may cause dependence and/or addiction.

Repeated use of Durogesic Matrix may also lead to dependence, abuse, and addiction, which could result in a potentially fatal overdose. The risk of these adverse effects may be higher with higher doses and prolonged use. Dependence or addiction may lead to a feeling of loss of control over the amount of medicine you need to take or how often you need to take it. You may feel the need to continue using the medicine even if it no longer helps relieve 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 higher if:

You or any member of your family have abused alcohol or been dependent on it, or have had dependence on prescription medicines or illegal drugs ("addiction").
You smoke.
You have ever had mood disorders (depression, anxiety, or a personality disorder) or have received psychiatric treatment for other mental illnesses.

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 prescribed by your doctor.
You need to use a higher dose than recommended.
You are using the medicine for reasons other than prescribed, for example, "to stay calm" or "to help you sleep".
You have made repeated unsuccessful attempts to stop using the medicine or control its use.
You feel unwell when you stop using the medicine, and feel better once you take it again ("withdrawal effects").

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

Withdrawal symptoms when stopping Durogesic Matrix

Do not stop using this medicine abruptly. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, awareness of your heartbeat (palpitations), increased blood pressure, feeling sick or being sick, diarrhoea, loss of appetite, tremors, chills, or sweating may occur. If you wish to stop using this medicine, speak to your doctor first. Your doctor will advise you on how to do so, usually by gradually reducing the dose to minimise unpleasant withdrawal effects.

Other medicines and Durogesic Matrix

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

Your doctor will know which medicines can be safely taken with Durogesic Matrix. Close monitoring may be required if you are taking or stop taking any of the following types of medicines, as this may affect the dose of Durogesic Matrix you need.

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

Other pain medicines, such as other opioid analgesics (e.g., buprenorphine, nalbuphine, or pentazocine) and some medicines for neuropathic 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 disorders (antipsychotics, such as aripiprazole, haloperidol, olanzapine, risperidone, or phenothiazines).
Medicines to relax muscles (such as cyclobenzaprine or diazepam).
Some antidepressants known as SSRIs or SNRIs (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine) – more information below.
Some medicines used to treat depression or Parkinson’s disease called MAOIs (such as isocarboxazid, phenelzine, selegiline, or tranylcypromine). You must not use Durogesic Matrix within 14 days of stopping these medicines – more information below.
Some antihistamines, especially those causing drowsiness (such as chlorpheniramine, clemastine, cyproheptadine, diphenhydramine, or hydroxyzine).
Some 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).
Some medicines used to treat epilepsy (such as carbamazepine, phenobarbital, or phenytoin).
Some medicines used to treat nausea or dizziness (such as phenothiazines).
Some medicines used to treat indigestion or ulcers (such as cimetidine).
Some medicines used to treat angina (chest pain) or high blood pressure (such as nicardipine).
Some medicines used to treat blood cancer (such as idelalisib).

Use of Durogesic Matrix with antidepressants

The risk of adverse effects increases if you are taking medicines such as certain antidepressants. Durogesic Matrix may interact with these medicines, and you may experience changes in mental state such as agitation, seeing, feeling, hearing, or smelling things that are not present (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 used together, your doctor may want to monitor you closely for these side effects, especially when starting treatment or when the dose of the medicine is changed.

Use with central nervous system depressants, including alcohol and some narcotic medicines

Concomitant use of Durogesic Matrix and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may 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 Matrix together with sedative medicines, your doctor should limit the dose and duration of concomitant treatment.

Inform your doctor of all sedative medicines you are taking and strictly follow your doctor’s dosing recommendations. It may be helpful to inform friends or family about 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 discussed it with your doctor first.

Use in athletes

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

Surgery

If you are due to receive anaesthesia, inform 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 plan to become pregnant, consult your doctor or pharmacist 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 childbirth, as the medicine may affect the newborn's breathing.

Prolonged use of Durogesic Matrix during pregnancy may cause withdrawal symptoms (such as high-pitched crying, restlessness, seizures, poor feeding, and diarrhoea) in your newborn baby, which may be potentially fatal if not recognised and treated. Speak to your doctor immediately if you think your baby may have withdrawal symptoms.

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

Driving and using machines

Durogesic Matrix may affect your ability to drive and use machines or tools, as it may cause drowsiness or dizziness. If so, do not drive or operate tools or machinery. Do not drive while using this medicine until you know how it affects you.

Talk to your doctor or pharmacist if you have any doubts about whether it is safe for you to drive while using this medicine.

3. How to use Durogesic Matrix

Follow exactly the instructions for using this medicine given by your doctor. If in 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 to you 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 the patches

Each patch contains enough medicine for 3 days (72 hours).
You should change the patch every three days, unless your doctor has instructed you otherwise.
Always remove the used 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 of the week, date, and time each time you apply a patch, so you remember when to change it.
The table below shows when you should change the patch:

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 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 from time to time that the patch remains stuck to the skin.
It is important that the child does not remove the patch and put it in their mouth, as this could endanger their life or be 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 full effect. Therefore, your child may need additional painkillers until the patch becomes effective. Your doctor will explain this to you.

Adults and children:

Do not apply the patch to

The same site twice in succession.
Areas that move a lot (joints), irritated skin, or skin with wounds.
areas of skin with excessive hair. If there is hair, do not shave it (shaving may irritate the skin). Instead, cut the hair 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 cool.
If you need to wash the skin, use only cold water.
Do not use soap or other cleansers, creams, moisturizers, oils, 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 sealed in its own pouch.
Open the pouch by tearing or cutting along the notch indicated by an arrow.
Gently tear or completely cut along the edge of the pouch (if using scissors, make the cut next to the sealed edge to avoid damaging the patch).

Two illustrations show hands opening a plastic pouch, first by pressing down and then by pulling the opposite sides to open it

Hold the two parts of the opened pouch and pull them apart.
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 its pouch until you are ready to use it.
Check that the patch is not damaged.
Do not use the patch if it is split, cut, or otherwise damaged.
Never divide or cut the patch.

Step 3: Peel and press

Make sure the patch will be covered by loose clothing and do not adhere it under tight or elastic fabric.
Carefully peel off half of the shiny plastic protective layer, starting from the center of the patch. Avoid touching the adhesive side of the patch.
Press this adhesive part of the patch onto the skin.
Remove the other half of the protective layer and press the entire patch onto the skin with the palm of your hand.
Hold pressure for at least 30 seconds. Ensure the patch adheres well, especially around the edges.

Step 4: Disposing of the patch

Immediately after removing the patch, fold it in half with the adhesive side sticking to itself.
Place it back into the original pouch and dispose of it according to your pharmacist's instructions.
Keep used patches out of sight and reach of children; even when used, patches contain medicine that could harm children and may even be fatal.

Step 5: Washing hands

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

More information on the use of Durogesic Matrix

Daily activities while using the patches

The patches are water-resistant.
You may shower or bathe while wearing the patch, but do not rub it.
If your doctor agrees, you may exercise or engage in sports while wearing the patch.
You may also swim while wearing the patch, but:
Do not use hot hydrotherapy baths.
Do not cover the patch with elastic or tight fabrics.
While wearing the patch, do not expose it to direct heat sources such as heating pads, electric blankets, hot water bottles, heated water beds, or heat or tanning lamps. Do not sunbathe, take prolonged hot baths, or use saunas. Doing so may increase the amount of medicine released from the patch.

How long do the patches take to work?

The first patch may take some time to reach its full effect.
Your doctor may provide you with additional painkillers during the first few days.
Afterwards, the patch should help relieve pain continuously, allowing you to stop taking other painkillers. However, your doctor may occasionally prescribe additional painkillers.

How long will you need to use the patches?

Durogesic Matrix patches are indicated for long-term pain. Your doctor will advise you on how long you can expect to use the patches.

If pain worsens

If your pain suddenly worsens after applying the last patch, check the patch. If it is no longer adhering properly or has come off, replace the patch (see also 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 painkillers (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 immediately and contact your doctor right away or call the Toxicology Information Service at (91) 562 04 20, stating the medication and amount applied, or go to the hospital.

Signs of overdose include difficulty breathing or weak breathing, fatigue, extreme drowsiness, inability to think clearly or to walk or speak normally, and dizziness, lightheadedness, or confusion. An overdose may also cause a brain disorder known as toxic leukoencephalopathy.

If you forget to change the patch

If you forget to change the patch, do so as soon as you remember, and note the date and time. Then resume changing the patch every 3 days (72 hours) as usual.
If you are significantly delayed, you should speak with your doctor, as you may need additional painkillers, but do not apply extra patches.

If the patch comes off

If the patch falls off before it should be changed, apply a new one immediately and note the date and time. Choose a new skin site:
On the trunk or arm
On the upper back of your child
Inform your doctor about this and keep the new patch on for another 3 days (72 hours) or for the duration your doctor advises, before changing the patch in the usual way.
If patches tend to come off frequently, consult 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, speak with your doctor first. Your doctor will guide you on how to do this, usually by gradually reducing the dose to minimize unpleasant withdrawal symptoms. See also section 2, "Withdrawal symptoms when stopping Durogesic Matrix".
If you stop using the patches, do not restart them without first consulting your doctor. You may require a different dose when resuming treatment.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

If you, or your partner or caregiver, notice any of the following signs in the person wearing the patch, remove the patch immediately and contact a doctor or go straight to the nearest hospital. Urgent medical treatment may be needed.

Unusual drowsiness, breathing slower or weaker than expected.

Follow the instructions above and encourage the person wearing the patch to move and speak as much as possible. In very rare cases, these breathing difficulties may be life-threatening or even fatal, especially in people who have not previously used strong opioid painkillers (such as Durogesic Matrix or morphine). (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 may be signs of a serious allergic reaction. (Frequency cannot be estimated from available data)
Seizures (convulsions). (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 adverse effects have also been reported

Very common (may affect more than 1 in 10 people)

Nausea, vomiting, constipation
Feeling sleepy (somnolence)
Feeling dizzy
Headache

Common (may affect up to 1 in 10 people)

Allergic reaction
Loss of appetite
Difficulty sleeping
Depression
Feeling anxious or confused
Seeing, feeling, hearing or smelling things that are not present (hallucinations)
Tremors or muscle spasms
Strange skin sensations such as tingling or prickling (paraesthesia)
Sensation of spinning (vertigo)
Fast or irregular heartbeat (palpitations, tachycardia)
Increased blood pressure
Feeling short of breath (dyspnoea)
Diarrhoea
Dry mouth
Stomach pain or indigestion
Excessive sweating
Itching, rash or redness of the skin
Inability to urinate or empty the bladder completely
Severe 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)
Reduced sensation or sensitivity, especially in the skin (hypoesthesia)
Memory loss
Blurred vision
Slow heartbeat (bradycardia) or low blood pressure
Bluish discoloration of the skin due to reduced oxygen in the blood (cyanosis)
Loss of intestinal contractions (ileus)
Itchy skin rash (eczema), allergic reaction or other skin disorders at the application site
Flu-like illness
Sensation of changes in body temperature
Fever
Muscle cramps
Difficulty achieving or maintaining an erection (impotence) or problems with sexual performance
Difficulty swallowing

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

Constriction of the pupils (miosis)
Occasional interruption of breathing (apnoea)

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

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

You may notice skin rash, redness or mild itching at the site where the patch is applied. This is usually mild and disappears after removing the patch. If it does not, or if the patch causes significant skin irritation, inform your doctor.

Repeated use of the patches may cause the medicine to lose effectiveness (you may become tolerant to it or may become more sensitive to pain), or may lead to dependence.

If you switch from another painkiller to Durogesic Matrix, or if you stop using Durogesic Matrix suddenly, you may experience withdrawal symptoms such as dizziness, feeling unwell, diarrhoea, anxiety or tremors. Inform your doctor if you experience any of these effects.

Cases have also been reported of newborn infants experiencing withdrawal symptoms after their mothers used Durogesic Matrix for a prolonged period during pregnancy.

Reporting of adverse effects

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

5. Storage of Durogesic Matrix

Where to store the patches

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

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

Store this medicine in a secure and safe place, where others cannot access it. It may be very harmful and cause death in people who may accidentally or intentionally use this medicine when it has not been prescribed for them.

How long can Durogesic Matrix be stored

Do not use this medicine after the expiry date stated on the carton and on the pouch. The expiry date refers to the last day of the month indicated. If the patches have expired, return them to the pharmacy.

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

How to dispose of used or unused patches

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

Used patches should be folded firmly in half so that the adhesive side sticks to itself. They should then be safely discarded by placing them back into the original pouch and keeping them out of sight and reach of others, especially children, until they can be safely disposed of. Ask your pharmacist how to dispose of packaging and medicines you no longer need.

Medicines must not be disposed of via wastewater or household waste. Take packaging and unused medicines to the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Durogesic Matrix

The active substance of Durogesic Matrix is fentanyl. Each transdermal patch contains 16.8 mg of fentanyl, which releases a dose of 100 micrograms/hour.

Other components of the patch:

Backing layer: Polyester film/ethylene-vinyl acetate copolymer,
Protective liner: Silicone-coated polyester film,
Drug layer: Polycrylate adhesive.

Printing inks (on the back):
The Durogesic Matrix 100 micrograms/hour patch also contains grey printing ink.

Description of the product and contents of the pack

Durogesic is a translucent, rectangular patch with rounded edges. Each patch measures 42.0 cm² and is marked with a border and the text “Durogesic Matrix 100 µg fentanyl/h” printed in grey ink.

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

Only certain pack 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 European Economic Area member states under the following names:

Austria, Belgium, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Greece, Hungary, Iceland, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovenia, Sweden	Durogesic
Germany	Durogesic SMAT
Ireland	Durogesic DTrans
Spain	Durogesic Matrix

Date of the most recent review of this leaflet: August 2025.

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/.