Prospecto: information for the user

Fentanilo Matrix ratiopharm 50 micrograms/hour transdermal patch EFG

Read this prospect carefully before starting to use this medication because it contains important information for you.

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

1. What isFentanilo Matrix ratiopharmand for what it is used

2. What you need to know before starting to useFentanilo Matrix ratiopharm

3. How to useFentanilo Matrix ratiopharm

4. Possible adverse effects

5. Storage ofFentanilo Matrix ratiopharm

6. Contents of the package and additional information

This medicine is called Fentanilo Matrix ratiopharm.

The patches help to relieve very strong and lasting pain:

• In adults who need continuous pain treatment
• In children over 2 years of age who are already using opioid medication and need continuous pain treatment.

Fentanilo Matrix ratiopharm contains a medicine called fentanilo. It belongs to a group of strong pain-relieving medicines called opioids.

Do not use Fentanilo Matrix ratiopharm

• 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 circumstances. If you are unsure, consult your doctor or pharmacist before using Fentanilo Matrix ratiopharm.

Warnings and precautions

If the patch sticks to another person

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

Be especially careful with Fentanilo Matrix ratiopharm

Consult your doctor or pharmacist beforeusing this medicine if you are in any of the following circumstances. Your doctor will have to monitor you more closely if:

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

If you meet any of the above conditions (or if you are unsure), consult your doctor or pharmacist before using Fentanilo Matrix ratiopharm.

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

• pauses in breathing while sleeping
• waking up at night due to lack of air
• difficulty staying asleep
• excessive daytime sleepiness.

Your doctor may decide to modify the dose.

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

• that the patch no longer relieves the pain
• an increase in pain
• a change in the way you feel the pain (for example, you feel pain in another part of your body)
• pain when you come into contact with your body that should not cause pain.

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

Side effects and Fentanilo Matrix ratiopharm

• Fentanilo Matrix ratiopharm may make you feel exceptionally sleepy and cause your breathing to be slower or weaker. In rare cases, these breathing problems can be life-threatening or even fatal, especially in people who have not used strong prescription opioids before. If you, or your partner or caregiver, observe that the person wearing the patch is unusually sleepy, breathing slowly or weakly.
• Remove the patch
• Call a doctor or go to the nearest hospital immediately
• Have the person move and talk as much as possible

• If you have a fever while using Fentanilo Matrix ratiopharm, talk to your doctor. This may increase the amount of medicine that passes through your skin.
• Fentanilo Matrix ratiopharm may cause constipation; talk to your doctor or pharmacist for advice on how to prevent or relieve constipation.

See section 4 for the complete list of possible side effects.

When wearing the patch, do not expose it to direct heat, such as heating pads, electric blankets, hot water bottles, hot baths, or heat lamps or tanning beds. Do not take the sun or long hot baths and do not use saunas or hot tubs. If you do, you may increase the amount of medicine released from the patch.

The patches should not be cut into smaller pieces as the quality, efficacy, and safety of such divided patches have not been demonstrated.

Doping

The use of fentanyl patches may result in a positive test for doping. The use of fentanyl patches as a doping agent can be hazardous to your health.

Long-term use and tolerance

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

Dependence and addiction

The repeated use of Fentanilo Matrix ratiopharm may also cause dependence, abuse, and addiction, which could lead to a potentially fatal overdose. The risk of these side effects may be higher with a higher dose and longer use. Dependence or addiction may cause you to feel a lack of control over the amount of medicine you should use or how often you should use it. You may feel the need to continue using the medicine even if it no longer helps to relieve pain.

The risk of dependence or addiction varies from person to person. The risk of becoming dependent or addicted to Fentanilo Matrix ratiopharm may be higher if:

• You or any member of your family have abused alcohol or experienced dependence on it, prescription medications, or illegal drugs ("addiction").
• You are a smoker.
• You have ever had mood problems (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental health conditions.

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

• You need to use the medicine for a longer period than indicated by your doctor.
• You need to use a higher dose than recommended.
• You are using the medicine for reasons other than those prescribed, such as "to stay calm" or "to help you sleep."
• You have made repeated and unsuccessful attempts to stop using the medicine or control your use.

• You feel unwell when you stop using the medicine, and you feel better once you take it again ("withdrawal symptoms").

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

Withdrawal symptoms when stopping Fentanilo Matrix ratiopharm

Do not stop using this medicine abruptly. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhea, loss of appetite, tremors, chills, or sweating may occur. If you want to stop using this medicine, talk to your doctor first. Your doctor will advise you on how to do it, usually the dose will be gradually reduced to minimize unpleasant withdrawal symptoms.

Other medicines and Fentanilo Matrix ratiopharm

Inform your doctor or pharmacist if you are taking/using, have taken/recently used, or may need to take/use any other medicine. This includes over-the-counter medicines and herbal remedies. You should also inform your pharmacist that you are using Fentanilo Matrix ratiopharm if you buy any medicine at the pharmacy.

Your doctor will know which medicines can be taken/safely used with Fentanilo Matrix ratiopharm. It may be necessary to closely monitor you if you are taking/using any of the types of medicines listed below or if you stop taking/using some of the types of medicines listed, as this may affect the dose of Fentanilo Matrix ratiopharm you need.

Especially, inform your doctor or pharmacist if you are taking/using:

• Other pain medicines, such as other strong prescription opioids (e.g., buprenorphine, nalbuphine, or pentazocine) and some pain medicines for neuropathic pain (gabapentin and pregabalin)
• Medicines to help you sleep (e.g., temazepam, zaleplon, or zolpidem)
• Medicines to help you calm down (tranquilizers, e.g., alprazolam, clonazepam, diazepam, hydroxyzine, or lorazepam) and medicines for mental health conditions (antipsychotics, e.g., 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) – see below for more information
• Some medicines used to treat depression or Parkinson's disease called MAOIs (e.g., isocarboxazid, phenelzine, selegiline, or tranylcypromine). Do not use Fentanilo Matrix ratiopharm in the 14 days following the interruption of these medicines – see below for more information.
• Some antihistamines, especially those that cause drowsiness (e.g., chlorpheniramine, clemastine, ciproheptadine, 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 irregular heartbeats (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 dizziness (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)

Using Fentanilo Matrix ratiopharm with antidepressants

The risk of side effects increases if you are taking or using medicines such as certain antidepressants. Fentanilo Matrix ratiopharm may 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, hyperactive reflexes, lack of coordination, muscle stiffness, nausea, vomiting, and diarrhea (which may be signs of a serotonin syndrome). If you are using them together, your doctor may want to closely monitor you to detect these side effects, especially when starting treatment or when changing the dose of the medicine.

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

The use of Fentanilo Matrix ratiopharm with sedatives, such as benzodiazepines or related medicines, increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be life-threatening. For this reason, concurrent use should only be considered when other treatment options are not possible.

However, if your doctor prescribes Fentanilo Matrix ratiopharm with sedatives, the dose and duration of concurrent treatment should be limited by your doctor.

Inform your doctor about all sedatives you are taking or using and strictly follow the recommended dose by your doctor. It may be helpful to inform friends or family members to alert them to the signs and symptoms described above. Contact your doctor if you experience these symptoms.

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

Surgery

If you think you will be receiving anesthesia, inform your doctor or dentist that you are using Fentanilo Matrix ratiopharm.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Fentanilo Matrix ratiopharm should not be used during pregnancy, unless you have talked to your doctor.

Fentanilo Matrix ratiopharm should not be usedduring labor, as the medicine may affect the newborn's breathing.

Prolonged use of Fentanilo Matrix ratiopharm during pregnancy may cause withdrawal symptoms (such as loud crying, feeling restless, convulsions, poor feeding, and diarrhea) in your newborn, which can be potentially fatal if not recognized and treated. Talk to your doctor immediately if you think your baby may have withdrawal symptoms.

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

Driving and operating machinery

FentaniloMatrix ratiopharm may affect your ability to drive and operate machines or tools, as it may cause drowsiness or dizziness. If this is the case, do not drive or operate tools or machines. 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.

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

Your doctor will decide what concentration of Fentanilo Matrix ratiopharm 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 it, your doctor will also explain what you can expect from the use of Fentanilo Matrix ratiopharm, 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, “Symptoms of withdrawal when stopping the use of Fentanilo Matrix ratiopharm”.

How to apply and change the patches

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

Where to apply the patch

Adults

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

Children

• Apply the patch always to the upper back so that your child has difficulty reaching or removing it.
• Check occasionally that 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 put their life in danger 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 maximum effect. Therefore, your child may need other painkillers until the patch is effective. Your doctor will explain this.

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 wounds.
• Areas of skin with a lot of hair. If there is hair, do not shave it (the skin irritates 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 package

• Each patch is sealed in its own package.
• Open the package by tearing or cutting along the perforation.
• Gently tear or cut the package edge completely.

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

Step 3: Peel and press

• Make sure the patch will be covered by a loose garment and do not adhere it under elastic or tight clothing.
• Peel off the transparent plastic protective layer from the center of the patch, taking care not to touch the adhesive part of the patch.
• Press the adhesive part of the patch onto the skin.
• Remove the other protective layer and press the entire patch onto the skin with the palm of your hand.
• Hold for 30 seconds or more. 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, with the adhesive side sticking to itself.
• Put it back in the original package and dispose of it according to your pharmacist's instructions.
• Keep used patches out of sight and reach of children; although used, the patches contain medication that can harm children and even be fatal.

Step 5: Wash your hands

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

More information about the use of Fentanilo Matrix ratiopharm

Activities during the use of patches

• The patches are water-resistant.
• You can take a shower or bath with the patch on, but do not rub it.
• If your doctor agrees, you can exercise or engage in sports with the patch on.
• You can also swim with the patch on, but:
• • Do not use hot tubs.
  • Do not cover the patch with elastic or tight clothing.

• When wearing the patch, do not expose it to direct heat, such as heating pads, electric blankets, hot water bottles, hot tubs, or heat lamps or tanning beds. Do not take the sun or long 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 act?

• The first patch may take some time to reach its maximum effect.
• Your doctor may give you additional painkillers during the first few days.
• After that, the patch should help relieve pain continuously, allowing you to stop taking or using other painkillers. However, your doctor may prescribe additional painkillers occasionally.

For how long will you have to use the patches?

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

If the pain worsens

• If your pain worsens suddenly after applying the last patch, check the patch. If it no longer adheres well or has fallen off, replace the patch (see also the section “If the patch falls 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 and contact your doctor immediately.

The signs of overdose include difficulty breathing or shallow breathing, fatigue, extreme drowsiness, inability to think clearly or walk or speak normally, and feeling of fainting, dizziness, or confusion. An overdose can also cause a brain disorder known as toxic leukoencephalopathy.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to change the patch

• If you forget to change the patch, change it as soon as you remember and note the day and time. Then, change the patch after 3 days (72 hours), as usual.
• If you are late, you should talk to your doctor, as you may need additional painkillers, but do not apply additional patches.

If the patch falls off

• If the patch falls off before it should be changed, apply a new one immediately and note the day and time. Choose a new skin area:
• • On the trunk or arm
  • On the upper back of your child

• Inform your doctor about this and leave the patch on for another 3 days (72 hours) or for the time your doctor tells you, 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 the dose will be gradually reduced to minimize unpleasant withdrawal symptoms. See also section 2, “Symptoms of withdrawal when stopping the use of Fentanilo Matrix ratiopharm”.
• If you stop using the patches, do not use them again without asking your doctor first. You may need a different dose to resume treatment.

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

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

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

• Unusual drowsiness, slower or weaker breathing than expected.

Follow the previous recommendations and have the person wearing the patch move and talk as much as possible. In very rare cases, these breathing difficulties can compromise life or even be fatal, especially in people who have not used strong opioid analgesics (such as Fentanilo Matrix ratiopharm or morphine) before. (Rare, may affect up to 1 in 100 people).

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

They may all be signs of a severe allergic reaction. (The frequency cannot be estimated from the available data).

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

• Decreased level of consciousness or loss of consciousness. (Rare, 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
• Feeling anxious or confused
• Seeing, feeling, or hearing things that are not present (hallucinations)
• Tremors or muscle spasms
• Strange sensation in the skin, such as tingling or prickling (paresthesia)
• Sensation of spinning (vertigo)
• Fast or irregular heartbeats (palpitations, tachycardia)
• Increased blood pressure
• Sensation of lack of air (dyspnea)
• Diarrhea
• Dry mouth
• Stomach pain or indigestion
• Excessive sweating
• Itching, rash, or redness of the skin
• Difficulty urinating or emptying the bladder completely
• Intense fatigue, weakness, or general discomfort
• Sensation of cold
• Swelling of the hands, ankles, or feet (peripheral edema)

Rare (may affect up to 1 in 100 people)

• Feeling agitated or disoriented
• Sensation of being extremely happy (euphoria)
• Decreased sensation or sensitivity, especially in the skin (hypoesthesia)
• Memory loss
• Blurred vision
• Slow heart rate (bradycardia) or low blood pressure
• Blue skin color caused by 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
• Sensation of change in body temperature
• Fever
• Muscle contraction
• Difficulty obtaining or maintaining an erection (impotence) or problems with sexual relations
• Difficulty swallowing

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

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

Unknown (the frequency cannot be estimated from the available data)

• 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 present, sleep disturbances, nightmares)
• You may become dependent on Fentanilo Matrix ratiopharm (see section 2).

You may notice rashes, redness, or a mild itching sensation on the skin where the patch is applied. It is usually mild and disappears after removing the patch. If not, or if the patch irritates your skin a lot, inform your doctor.

Repeated use of the patches may make the medicine less effective (you become accustomed to it or become more sensitive to pain) or may cause dependence.

If you switch from another analgesic to Fentanilo Matrix ratiopharm or if you stop using Fentanilo Matrix ratiopharm 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 Fentanilo Matrix ratiopharm for an extended period during pregnancy.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possibleside effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Where to store the patches

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

Store this medication in a safe and protected place, to which no other people can access. This medication can cause serious harm and even be fatal to people who use it or take it accidentally or intentionally when not prescribed.

How long can you store Fentanilo Matrix ratiopharm

Do not use this medicationafter the expiration date that appears on the box and on the package after CAD or EXP. The expiration date is the last day of the month indicated. If the patches are expired, take them to the pharmacy.

Do not store at a temperature above 30º C.

How to dispose of used patches or patches no longer in use

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

Used patches should be folded firmly in half, so that the adhesive side of the patch adheres to itself. Then, they should be safely disposed of by placing them in the original package and storing them out of sight and reach of other people, especially children, until they are safely disposed of.

Medications should not be thrown away through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of Fentanilo Matrix ratiopharm 50 micrograms/hour transdermal patch

- The active ingredient is fentanilo.

Cada patch releases 50 micrograms of fentanilo per hour. Each transdermal patch of 15 cm2contains 8.25 mg of fentanilo.

- The other components are:

Adhesive layer: acrylic adhesive layer

Support film: polypropylene sheet, blue printing ink

Removable coating: ethylene terephthalate film (siliconized)

Appearance of the product and contents of the packaging

Fentanilo Matrix ratiopharmis a transparent transdermal patch with an adhesive backing that can be stuck to the skin. The transdermal patches are equipped with a blue print with the concentration.

Fentanilo Matrix ratiopharm50 micrograms/his available in packaging of 3, 5, 10 or 20 transdermal patches.

Only some packaging sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

Teva Pharma, S.L.U.

C/Anabel Segura, 11 Edificio Albatros B, 1st Floor

28108 Alcobendas, Madrid (Spain)

Responsible manufacturer

Merckle GmbH

Ludwig-Merckle-Strasse 3,

89143 Blaubeuren (Germany)

Or

Luye Pharma AG

Am Windfeld 35

83714 Miesbach

Germany

This medicine is authorized in the member states of the European Economic Area with the following names:

Germany:Fentanyl ratiopharm 50 µg/h Matrix patch

Spain:Fentanilo Matrix ratiopharm 50 micrograms/hour transdermal patch EFG

France:Fentanyl Teva Health50 micrograms/hour, transdermal device

Revision date of this leaflet:April 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.