Fentanyl Matrix ratiopharm 50 micrograms/hour transdermal patches EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Fentanil Matrix ratiopharm 50 micrograms/hour transdermal patch 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, ask 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 they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

This medicine is called Fentanilo Matrix ratiopharm.

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.

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

2. What you need to know before using Fentanil Matrix ratiopharm

Do not use Fentanil Matrix ratiopharm

• if you are allergic to fentanyl or to 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 Fentanil Matrix ratiopharm.

Warnings and precautions

• Fentanil Matrix ratiopharm can cause life-threatening adverse effects in people who are not regularly using prescribed opioids.

• Fentanil Matrix ratiopharm is a medicine that could be life-threatening to children, even if the patches have already been used. Please note that a transdermal patch (used or unused) may be attractive to a child, and if it adheres to the child's skin or if the child puts it in their mouth, the result could be fatal.

• Keep this medicine in a secure and protected place, out of reach of others; see section 5 for more information.

If the patch adheres 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 adhered to another family member through close physical contact or sharing the same bed with the person wearing the patch. If the patch accidentally adheres to another person (particularly a child), the medicine from the patch can pass through the other person’s skin and may cause serious adverse effects, such as difficulty breathing, with slow or weak breathing, which could be fatal. If the patch adheres to another person’s skin, remove it immediately and seek medical help.

Take special care with Fentanil Matrix ratiopharm

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.
• 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 a head injury.
• You are elderly, as you may be more sensitive to the effects of this medicine.
• 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 Fentanil Matrix ratiopharm.

While using the patch, inform your doctor if you have breathing problems while sleeping. Opioids such as Fentanil Matrix ratiopharm 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 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 Fentanil Matrix ratiopharm

• Fentanil Matrix ratiopharm may cause you to feel unusually drowsy and may slow down or weaken your 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 Fentanil Matrix ratiopharm 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 Fentanil Matrix ratiopharm, speak to your doctor. This may increase the amount of medicine passing through your skin.

• Fentanil Matrix ratiopharm may cause constipation; speak to your doctor or pharmacist for advice on how to prevent or relieve constipation.

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

Fentanil Matrix ratiopharm, like other opioids, may affect the normal production of hormones in the body such as cortisol, prolactin, or sex hormones, especially if you have used Fentanil Matrix ratiopharm for long periods. The effects of these hormonal changes may include feeling unwell or malaise (including 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. Do not sunbathe, take prolonged hot baths, or use saunas or hot tubs. Doing so could increase the amount of medicine released from the patch.

Patches must not be cut into smaller pieces, as the quality, efficacy, and safety of such divided patches have not been established.

Doping

The use of fentanyl patches may result in a positive doping test. The use of fentanyl patches as a doping agent may be dangerous to health.

Long-term use and tolerance

This medicine contains fentanyl, an opioid. Repeated use of opioid painkillers may make the medicine less effective (the body becomes accustomed to it, known as pharmacological tolerance). You may also become more sensitive to pain when using Fentanil Matrix ratiopharm. 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 Fentanil Matrix ratiopharm.

Dependence and addiction

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

Repeated use of Fentanil Matrix ratiopharm 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 lack of control over the amount of medicine you need to use or how often you need to use 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 or addicted to Fentanil Matrix ratiopharm may be higher if:

• You or any member of your family have abused alcohol or experienced dependence on alcohol, prescription medicines, or illegal drugs (“addiction”).
• You are a smoker.
• 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 Fentanil Matrix ratiopharm, 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 those prescribed, e.g., “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 start taking 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 Fentanil Matrix ratiopharm

Do not stop using this medicine abruptly. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling or having a rapid 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 this, usually by gradually reducing the dose to minimise unpleasant withdrawal effects.

Other medicines and Fentanil Matrix ratiopharm

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

Your doctor will know which medicines can be safely used with Fentanil Matrix ratiopharm. You may need to be monitored closely if you are taking or stop taking any of the following types of medicines, as this may affect the dose of Fentanil Matrix ratiopharm you need.

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

• 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 (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 medicines used to treat depression called 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 Fentanil Matrix ratiopharm within 14 days of stopping these medicines – more information below
• Some antihistamines, especially those that cause 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 stomach burning 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 Fentanil Matrix ratiopharm with antidepressants

The risk of adverse effects increases if you are taking or using medicines such as certain antidepressants. Fentanil Matrix ratiopharm 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, hyperactive reflexes, lack of coordination, muscle rigidity, 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 Fentanil Matrix ratiopharm 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 Fentanil Matrix ratiopharm with sedative medicines, the dose and duration of concomitant treatment should be limited by your doctor.

Inform your doctor about all sedative medicines you are taking or using and strictly follow the dose recommended 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 such symptoms.

Do not drink alcohol while using Fentanil Matrix ratiopharm, unless you have first discussed it with your doctor.

Surgery

If you are due to receive anaesthesia, inform your doctor or dentist that you are using Fentanil Matrix ratiopharm.

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.

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

Fentanil Matrix ratiopharm should not be used during childbirth, as the medicine may affect the newborn’s breathing.

Prolonged use of Fentanil Matrix ratiopharm during pregnancy may cause withdrawal symptoms (such as high-pitched crying, restlessness, seizures, poor feeding, and diarrhoea) in your newborn baby, which could 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 Fentanil Matrix ratiopharm if you are breastfeeding. You must not breastfeed for 3 days after removing the Fentanil Matrix ratiopharm patch. This is because the medicine may pass into breast milk.

Driving and using machines

Fentanil Matrix ratiopharm 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 Fentanilo Matrix ratiopharm

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

Your doctor will decide which 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 treatment, your doctor will also explain to you what to 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, “Withdrawal symptoms when stopping Fentanilo Matrix ratiopharm”).

How to apply and change the patches

• Each patch contains enough medicine for 3 days (72 hours).
• You must change the patch every three days, unless your doctor has instructed 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 of them 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 upper 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 periodically to ensure 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 be life-threatening or fatal.

• Closely monitor your child 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 pain relief until the patch becomes effective. Your doctor will advise you accordingly.

Adults and children:

Do not apply the patch to

• The same site two times in a row.
• Areas with frequent movement (joints), or to irritated or wounded skin.
• Hairy skin areas. 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, ensure the skin is completely dry, clean, and cool
• If washing is necessary, use only cool 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 at the notch
• Gently tear or completely cut along the edge of the pouch

• Hold both parts of the opened pouch and pull to separate them
• 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 shows any damage
• Never divide or cut the patch

Step 3: Peel and press

• Make sure the patch will be covered by loose clothing; do not apply it under tight or elastic fabric
• Carefully peel off half of the transparent protective plastic layer, starting from the center of the patch. Avoid touching the adhesive side of the patch
• Press the adhesive side of the patch onto the skin
• Remove the remaining part of the protective layer and press the entire patch onto the skin with the palm of your hand
• Press firmly 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 so that the adhesive side sticks to itself
• Place it back into the original pouch and dispose of it as instructed by your pharmacist
• Keep used patches out of sight and reach of children; even when used, patches still contain medication that could harm children and may even be fatal

Step 5: Wash hands

• Always wash your hands with water only after handling patches

More information on the use of Fentanilo Matrix ratiopharm

Daily activities while using patches

• The patches are water-resistant

• You may shower or bathe with the patch in place, but do not rub it

• If your doctor agrees, you may exercise or play sports while wearing the patch

• You may also swim while wearing the patch, but:

  • Do not use hot tubs or 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, heat lamps, or sunbeds. Avoid prolonged sunbathing or hot baths and do not use saunas. Doing so may increase the amount of medication released from the patch.

How long does it take for the patches to work?

• The first patch may take some time to reach its full effect.
• Your doctor may prescribe additional painkillers during the first few days.
• Afterwards, the patch should provide continuous pain relief, allowing you to stop or reduce other painkillers. However, your doctor may occasionally prescribe additional painkillers as needed.

How long will you need to use the patches?

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

If pain worsens

• If your pain suddenly worsens after applying the latest patch, check the patch. If it no longer adheres properly or has come off, replace it (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 and contact your doctor immediately.

Signs of overdose include difficulty breathing or shallow breathing, tiredness, extreme drowsiness, inability to think clearly or to walk or speak normally, and feeling faint, dizzy, or confused. An overdose may also cause a brain disorder known as toxic leukoencephalopathy.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at 91 562 04 20, stating the medication and the amount ingested.

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 the delay is significant, you should consult your doctor, who may prescribe 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 in place for another 3 days (72 hours) or for the duration specified by your doctor 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 discontinue this medicine, speak with your doctor first. Your doctor will advise you on how to do so, usually by gradually reducing the dose to minimize withdrawal symptoms. See also section 2, “Withdrawal symptoms when stopping Fentanilo Matrix ratiopharm”.
• If you stop using the patches, do not reuse them without first consulting your doctor. You may require a different dose when restarting 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 can have adverse 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 immediately and call a doctor or go straight to the nearest hospital. Urgent medical treatment may be needed.

• Unusual drowsiness, slower or weaker breathing than expected.

Follow the above recommendations 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 Fentanilo Matrix ratiopharm 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.

All of 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).

• Decreased 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)
• Rapid 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 to 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 heart rate (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 site of patch application
• Flu-like illness
• Sensation of body temperature changes
• 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)

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 Fentanilo Matrix ratiopharm (see section 2).

You may experience 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 this does not happen, 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 Fentanilo Matrix ratiopharm, or if you stop using Fentanilo Matrix ratiopharm suddenly, you may experience withdrawal symptoms such as dizziness, feeling sick, diarrhoea, anxiety, or tremors. Inform your doctor if you notice any of these effects.

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect 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 Fentanilo Matrix ratiopharm

Where to store the patches

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

Store this medicine in a safe and secure place, inaccessible to other people. This medicine may cause serious harm or even be fatal to individuals who accidentally or intentionally use or ingest it without having been prescribed.

How long can Fentanilo Matrix ratiopharm be stored

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

Do not store above 30°C.

How to dispose of used or unused patches

Accidental exposure of other persons, especially children, to used or unused patches 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 sachet and kept out of sight and reach of others, especially children, until they are safely disposed of.

Medicines must not be disposed of via wastewater or household waste. Take any unused medicines and their packaging to the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fentanilo Matrix ratiopharm 50 micrograms/h transdermal patch

• The active substance is fentanyl.

Each patch releases 50 micrograms of fentanyl per hour. Each 15 cm² transdermal patch contains 8.25 mg of fentanyl.

• The other components are:

Adhesive layer: polyacrylate adhesive layer

Backing film: polypropylene film, blue printing ink

Release liner: silicone-coated polyethylene terephthalate film

Appearance of the product and contents of the pack

Fentanilo Matrix ratiopharm is a transparent transdermal patch with an adhesive backing allowing it to be applied to the skin. The transdermal patches feature blue printing indicating the concentration.

Fentanilo Matrix ratiopharm 50 micrograms/h is available in packs containing 3, 5, 10 or 20 transdermal patches.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/Anabel Segura, 11 Edificio Albatros B, 1ª Planta

28108 Alcobendas, Madrid (Spain)

Manufacturer

Merckle GmbH

Ludwig-Merckle-Strasse 3,

89143 Blaubeuren (Germany)

Or

Luye Pharma AG

Am Windfeld 35

83714 Miesbach

Germany

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

Germany: Fentanyl ratiopharm 50 µg/h Matrixpflaster

Spain: Fentanilo Matrix ratiopharm 50 microgramos/hora parche transdérmico EFG

France: Fentanyl Teva Santé 50 microgrammes/heure, dispositif transdermique

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

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