Fentanyl Matrix Viatris 50 mcg/h transdermal patches EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Fentanil Matrix Viatris 50 micrograms/hour transdermal patches EFG

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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Fentanilo Matrix Viatris is and what it is used for

The name of your medicine is Fentanilo Matrix Viatris.

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 medicines and who require continuous pain treatment.

Fentanilo Matrix Viatris contains a medicine called fentanil. It belongs to a group of strong painkillers called opioids.

2. What you need to know before using Fentanilo Matrix Viatris

Do not use Fentanilo Matrix Viatris if:

• You are allergic to fentanyl or to any of the other ingredients of this medicine (listed in section 6).
• You have pain that only lasts for a short period of time, such as sudden pain or pain after surgery.
• You have difficulty breathing, slow breathing, or shallow breathing.

Do not use this medicine if you or your child have any of the conditions listed above. If in doubt, consult your doctor or pharmacist before starting to use Fentanilo Matrix Viatris.

Warnings and precautions

• Fentanilo Matrix Viatris may cause potentially life-threatening side effects in people who are not already regularly using prescribed opioid medicines.
• Fentanilo Matrix Viatris is potentially fatal to children, even if the patches have already been used. Note that a transdermal patch (used or unused) may be attractive to a child, and if it adheres to a child's skin or is placed in the mouth, the result can be fatal.
• Store this medicine in a secure and protected place, out of reach of others. For further information, see section 5.

Application of the patch to another person

The patch should only be applied to the skin of the person for whom it has been prescribed. Cases have been reported in which patches have accidentally adhered to a family member due to physical contact or sharing the same bed as the person wearing the patch. If a patch accidentally adheres to another person (especially a child), the medicine may pass through their skin and cause serious adverse effects, such as difficulty breathing, slow or shallow breathing, which may be fatal. If the patch adheres to another person’s skin, remove it immediately and seek medical attention.

Take special care with Fentanilo Matrix Viatris

Consult your doctor or pharmacist before starting to use this medicine if any of the following apply to you; your doctor may need to monitor you more closely if:

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

If any of the above conditions apply to you (or if you are unsure), consult your doctor or pharmacist before starting to use fentanyl.

While using the patch, inform your doctor if you experience breathing problems during sleep.
Opioids such as fentanyl can cause sleep-related breathing disorders such as sleep apnoea (pauses in breathing during sleep) 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 during sleep
• Waking up at night due to shortness of breath
• Difficulty staying asleep
• Excessive daytime sleepiness

Your doctor may decide to adjust the dose.

While using the patch, inform your doctor if you notice a 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 touch to your body 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 Fentanilo Matrix Viatris

• Fentanyl may make you unusually drowsy and may cause you to breathe more slowly or shallowly. In rare cases, these breathing problems may be potentially life-threatening, especially in people who have not previously used strong opioid painkillers (such as Fentanilo Matrix Viatris) or morphine. If you, your partner, or caregiver notice that the person wearing the patch is unusually drowsy, with slow or shallow breathing:

• Remove the patch.

• Call a doctor or go to the nearest hospital immediately.

• Keep the person moving and talking as much as possible.

• If you develop a fever while using fentanyl, inform your doctor: this may increase the amount of medicine passing through the skin.

• Fentanyl may cause constipation. Consult your doctor or pharmacist for advice on how to prevent or relieve constipation.

See section 4 for a complete list of possible adverse effects.

Long-term use and tolerance

This medicine contains fentanyl, an opioid. Repeated use of opioid analgesics may cause the drug to become less effective (the body becomes accustomed to it, known as pharmacological tolerance). You may also become more sensitive to pain while using fentanyl. 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 is losing effectiveness, consult your doctor. Your doctor will decide whether it is better to increase the dose or gradually reduce the use of fentanyl.

Dependence and addiction

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

Repeated use of fentanyl may also lead to dependence, abuse, and addiction, which could result in potentially fatal overdose. The risk of these adverse effects may be higher with higher doses and prolonged use. Dependence or addiction may cause a feeling of lack of control over the amount of medication you need to use or how often you need to use it. You may feel a need to continue using the medication even though it does not help relieve your pain.

The risk of dependence or addiction varies from person to person. The risk of becoming dependent on or addicted to fentanyl may be higher if:

• You or any member of your family have abused alcohol or experienced dependence on alcohol, prescription medications, or illegal drugs (“addiction”).
• You smoke.
• You have ever had mood disorders (depression, anxiety, or a personality disorder) or have received treatment from a psychiatrist for other mental illnesses.

If you notice any of the following symptoms while using fentanyl, it could be a sign of dependence or addiction:

• You need to use the medication for longer than prescribed by your doctor.
• You need to use a higher dose than recommended.
• You are using the medication for reasons other than those prescribed, for example, “to stay calm” or “to help you sleep.”
• You have made repeated unsuccessful attempts to stop using the medication or control its use.
• You feel unwell when you stop using the medication, and you feel better once you resume taking it (“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 discontinue the medication, and how to do so safely.

If you are wearing the patch, do not expose it to direct heat sources such as electric heating pads, electric blankets, hot water bottles, heated water beds, or heat or tanning lamps. Do not sunbathe or take prolonged hot baths. Do not go to saunas, hot tubs, or spas. If you do, you may increase the amount of medication you receive from the patch.

Other medicines and Fentanilo Matrix Viatris

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines. This includes medicines you buy without a prescription or herbal remedies. If you purchase medicines at the pharmacy, you should also tell the pharmacist that you are using fentanyl.

Your doctor will know which medicines you can safely take with fentanyl. You may need to be closely monitored if you are starting or stopping any of the following types of medicines, as this may affect the strength of fentanyl you require.

Specifically, tell your doctor or pharmacist if you are taking:

• Other pain medicines, such as other opioid analgesics (e.g., buprenorphine, nalbuphine, or pentazocine) and some analgesics for neuropathic pain (gabapentin and pregabalin).

• Medicines to help you sleep (such as temazepam, zaleplon, or zolpidem).

• Medicines to help you relax (tranquilizers, such as alprazolam, clonazepam, diazepam, hydroxyzine, or lorazepam) and medicines for mental conditions (antipsychotics, such as aripiprazole, haloperidol, olanzapine, risperidone, or phenothiazines).

• Medicines to relax muscles (such as cyclobenzaprine or diazepam).

• Some medicines used to treat depression called SSRIs or SNRIs (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine). See information below.

• Some medicines used to treat depression or Parkinson’s disease called MAOIs (such as isocarboxazid, phenelzine, selegiline, or tranylcypromine). You must not take fentanyl within 14 days after stopping these medicines: see information below.

• Some antihistamines, especially those that make you drowsy (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 arrhythmias (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 sunburn 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).

Fentanilo Matrix Viatris with antidepressants

The risk of adverse effects increases if you are taking medicines such as certain antidepressants. Fentanyl may interact with these medicines, and you may experience changes in mental status, such as excitement, seeing, feeling, hearing, or smelling things that are not there (hallucinations), and other effects such as changes in blood pressure, rapid heart rate, high body temperature, hyperactive reflexes, lack of coordination, muscle stiffness, nausea, vomiting, and diarrhea.

Use with central nervous system depressants, including alcohol and certain narcotics

Inform your doctor if you are taking any other medicine that slows down your central nervous system (CNS depressants). For example, CNS depressants include medicines that make you drowsy, reduce anxiety, or decrease consciousness (see also “Other medicines and Fentanilo Matrix Viatris”); alcohol and certain narcotics are also CNS depressants. Taking these types of medicines with Fentanilo Matrix Viatris may cause severe drowsiness, decreased consciousness, breathing difficulties with slow or shallow breathing, coma, or death.

Do not drink alcohol while using Fentanilo Matrix Viatris unless you have first discussed it with your doctor.

Surgery

If you think you are going to receive anesthesia, inform your doctor or dentist that you are using fentanyl.

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.

Fentanyl should not be used during pregnancy unless you have discussed it with your doctor.

Fentanyl should not be used during labor, as the medicine may affect the newborn’s breathing.

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

Driving and using machines

Fentanyl may affect your ability to drive and use machines or tools, as it may cause drowsiness or dizziness. If this happens, do not drive or use 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 are unsure whether it is safe to drive while taking this medicine.

3. How to use Fentanilo Matrix Viatris

Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, you should consult your doctor or pharmacist again.

Your doctor will decide which dose of Fentanilo Matrix Viatris is most suitable, taking into account the severity 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 fentanyl, 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 fentanyl treatment").

Application and changing of patches

• Each patch contains enough medication to last 3 days (72 hours).
• You must change the patch every three days, unless your doctor has instructed otherwise.
• Always remove the old patch before applying a new one.
• Always change the patch at the same time of day every 3 days (72 hours).
• If you use more than one patch, change all patches at the same time.
• Record the day, date, and time of patch application so you remember when to change it.
• The following table shows when to 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 smooth area of the upper body or arm (not over a joint).

Use in Children

• Always apply the patch to the upper back, so the child cannot reach it and remove it.
• Check frequently that the patch remains adhered to the skin.
• It is important that the child does not remove the patch and put it in their mouth, as this could pose a life-threatening or even fatal risk.
• Monitor your child closely during the 48 hours following:
  • Application of the first patch.
  • Application of a patch with a higher dose.
• It may take some time for the patch to reach its maximum effect. Therefore, your child may need additional pain relief until the patches become fully effective. Your doctor will advise you if necessary.

Adults and Children:

Do not apply the patch to

• The same site two times in a row.
• Areas that move a lot (joints), irritated skin, or skin with cuts.
• Hairy skin. If there is hair, do not shave it (shaving may irritate the skin). Instead, cut the hair as close to the skin as possible using scissors.

Applying a Patch

Step 1: Skin Preparation

• Ensure the skin is completely dry, clean, and undamaged before applying the patch.
• If you need to wash the skin, use water only.
• Do not use soap, oil, lotions, alcohol, or other cleansers that may irritate the skin.
• Do not apply the patch immediately after a hot bath or shower.

Step 2: Open the Pouch

• Each patch is stored in a sealed pouch.
• To open the pouch, make a small cut near the sealed edge of the pouch using the tip of scissors (Figure 1).

Figure 1:

• Gently tear the pouch open completely with your hands (Figure 2).

Figure 2:

• Hold both sides of the opened pouch, pull them apart so the pouch opens on three sides, and remove the patch (Figure 3).

Figure 3:

• Remove the patch and use it immediately (Figure 4).

Figure 4:

• Keep the empty pouch to dispose of the used patch later.
• Each patch should be used only once.
• Do not remove the patch from its pouch until you are ready to use it.
• Check the patch for any damage.
• Do not use the patch if it is split, cut, or appears damaged.
• Never divide or cut the patch.

Step 3: Peel and Press

• Ensure the patch is covered by loose clothing and not trapped under a strap or elastic band.
• The patch should be applied immediately after opening the package. After removing the protective liner, carefully peel back half of the transparent protective layer away from the center of the patch. Try not to touch the adhesive side of the patch (Figure 5).

Figure 5:

• Press this adhesive part of the patch onto the skin (Figure 6).

Figure 6:

• Remove the other half of the transparent protective layer (Figure 7).

Figure 7:

• Press the entire patch onto the skin with the palm of your hand.
• Maintain pressure for at least 30 seconds. Make sure the patch adheres well to the skin, especially around the edges (Figure 8).

Figure 8:

Step 4: How to Dispose of the Patch

• As soon as the patch is removed, fold it firmly in half so the adhesive sides stick together.
• Return it to its original pouch and dispose of the pouch according to the instructions provided by your pharmacist.
• Keep used patches out of sight and reach of children; even when used, patches contain medication that could harm children and could even be fatal.

Step 5: Washing

• Always wash your hands with plain water after handling the patch.

More Information About Using Fentanilo Matrix Viatris

Daily Activities While Using Patches

• The patches are waterproof.

• 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 with the patch, but:

• Do not use in hot tubs or whirlpool baths.

• Do not place a strap or elastic band over the patch.

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

When Will the Patches Start Working?

• It may take some time for the first patch to reach its maximum effect.
• Your doctor may provide other pain relievers, including for the first day.
• Afterwards, the patch should help relieve your pain continuously, allowing you to stop taking other pain relievers. However, your doctor may prescribe additional pain relievers from time to time.

How Long Will You Use the Patches?

• Fentanyl patches are for long-term pain. Your doctor will tell you how long you can continue using 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 pain worsens over time while using the patches, your doctor may try a higher-dose patch or prescribe additional pain relief (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 the Wrong Dose Patch

If you have applied too many patches or the patch has an incorrect dose, remove them immediately and contact your doctor or pharmacist, call the Toxicology Information Service at 91 562 04 20 (specify the medication and amount applied), or go to the nearest hospital. Bring the packaging and any remaining patches with you.

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

If You Forget to Change the Patch

• If you forget, change the patch as soon as you remember and note the date and time. Then change the patch again after 3 days (72 hours), as usual.
• If you delay changing the patch significantly, speak to your doctor, as you may need additional pain relief, but do not apply another patch.

If a Patch Comes Off

• If a patch comes off before it should be changed, apply a new one immediately and note the date and time. Apply it to a new skin site on:

• The upper body or arm.

• Your child's shoulder.

• Inform your doctor about what happened and keep the patch in place for another 3 days (72 hours) or as directed by your doctor before changing the patch in the usual way.

• If patches continue to fall off, speak to your doctor, pharmacist, or nurse.

If You Want to Stop Using the Patches

• Talk to your doctor if you wish to stop using these patches.
• If you have been using them for some time, your body may have become accustomed to them. Stopping suddenly may make you feel unwell.
• If you stop using patches, do not start using them again without first consulting your doctor. You may need a patch with a different dose when restarting.

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

4. Possible adverse effects

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

If you, your partner, or the caregiver observes any of the following 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 required.

• If the person feels unusually drowsy, or if their breathing becomes slower or weaker than normal. Follow the advice given above and keep the person moving and talking as much as possible. In very rare cases, these breathing difficulties may be potentially life-threatening, especially in people who have not previously used strong opioid painkillers (such as fentanyl or morphine). (Uncommon, may affect up to 1 in 100 people).
• Sudden swelling of the face or throat, severe skin irritation, redness, or blisters. These may be signs of a severe allergic reaction (frequency cannot be estimated from available data).
• Seizures (convulsions). (Uncommon, may affect up to 1 in 100 people).
• Loss of consciousness or reduced level 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.
• Drowsiness.
• Dizziness.
• Headache.

Common (may affect up to 1 in 10 people)

• Allergic reaction.
• Loss of appetite.
• Difficulty sleeping.
• Depression.
• Anxiety or confusion.
• Seeing, feeling, hearing, or smelling things that are not there (hallucinations).
• Muscle tremors or spasms.
• Strange skin sensations such as tingling or prickling (paraesthesia).
• Sensation of movement (dizziness).
• Fast or irregular heartbeat (palpitations or tachycardia).
• High blood pressure.
• Shortness of breath (dyspnoea).
• Diarrhoea.
• Dry mouth.
• Stomach pain or indigestion.
• Excessive sweating.
• Itching, rash, or skin redness.
• Inability to urinate or empty the bladder completely.
• Feeling tired, weak, or generally unwell.
• Feeling cold.
• Swollen hands, feet, or ankles (peripheral oedema).

Uncommon (may affect up to 1 in 100 people)

• Disorientation or excitement.
• Feeling of overwhelming happiness (euphoria).
• Reduced sensation, especially in the skin (hypoesthesia).
• Memory loss.
• Blurred vision.
• Slow heartbeat (bradycardia) or low blood pressure.
• Purple spots on the skin caused by low oxygen levels in the blood (cyanosis).
• Lack of intestinal contractions (ileus).
• Itchy skin rashes (eczema), allergic reactions, or other skin disorders at the site where the patch was applied.
• Flu-like illness.
• Sensation of changes in body temperature.
• Fever.
• Muscle jerks.
• Difficulty achieving or maintaining an erection (impotence) or problems with sexual function.
• Difficulty swallowing.

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

• Constriction of the pupils (miosis).
• Periodic cessation of breathing (apnoea).

Frequency not known (frequency cannot be estimated from available data)

• 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 fentanyl (see section 2).

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

Continuous use of the patches may cause the medicine to become less effective (you may become "tolerant" to it), or may lead to dependence.

If you switch from another painkiller to fentanyl, or if you suddenly stop using fentanyl, you may experience withdrawal symptoms such as general discomfort, dizziness, nausea, diarrhoea, anxiety, or tremors. Inform your doctor if you experience any of these effects.

Cases of newborns experiencing withdrawal symptoms have also been reported after their mothers used fentanyl 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 side effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you help provide more information on the safety of this medicine.

5. Storage of Fentanilo Matrix Viatris

Where to store the patches

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

Keep this medicine in a safe and secure place, inaccessible to other people. This medicine can cause serious harm or even death in individuals who use it accidentally or intentionally when it has not been prescribed to them.

How long can Fentanilo Matrix Viatris be stored

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

This medicine does not require special storage conditions.

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

A used or unused patch that accidentally adheres to another person, especially a child, can be fatal.

Used patches should be folded firmly in half so that the adhesive sides stick together. They must be safely discarded by placing them back into the original sealed pouch and kept out of sight and reach of others, especially children, until they are safely disposed of. Ask your pharmacist how to properly dispose of the packaging and any unused medicines.

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

6. Contents of the pack and other information

Composition of Fentanilo Matrix Viatris

The active substance is fentanyl. Each transdermal patch contains 8.4 mg of fentanyl on a surface area of 21.0 cm², which releases 50 micrograms of fentanyl per hour.

The other components are:

Polyacrylate adhesive, silicone-coated polyester film (protective liner), polyethylene terephthalate/ethylene vinyl acetate film (support layer), and white printing ink.

Appearance of the product and contents of the container

Fentanilo Matrix Viatris is a translucent rectangular patch printed with white ink and covered with a removable protective film.

The patches bear the following imprint: Fentanilo 50 µg/h

The patch is covered by a transparent protective film which is removed prior to application to expose the adhesive side, allowing it to be affixed to the skin.

The patches are individually packed in heat-sealed pouches and supplied in a carton.

Fentanilo Matrix Viatris is available in pack sizes of 3, 4, 5, 8, 10, 16 and 20 transdermal patches. However, not all pack sizes may be marketed.

Marketing Authorization Holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer

McDermott Laboratories Limited trading as Gerard Laboratories
35/36/75/76/77/80 Baldoyle Industrial Estate, Grange Road
Dublin 13
Ireland

Or

Mylan Hungary Ltd.
H-2900 Komarom
Mylan utca 1
Hungary

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany Fentanyl Mylan 50 Mikrogramm/Stunde, transdermales Pflaster
Denmark Fentanyl Mylan
Spain Fentanilo Matrix Viatris 50 microgramos/hora parches transdérmicos EFG
France Fentanyl Viatris 50 µg/h, dispositif transdermique
Norway Fentanyl Mylan
Netherlands Fentanyl matrixpleister Mylan 50 microgram/uur, pleister voor transdermaal gebruik
Portugal Fentanilo Mylan
Czech Republic Fentanyl Mylan 50 mikrogramu/hodinu, transdermální náplast

Date of the most recent review of this leaflet: May 2025

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