FENTANIL MATRIX RATIOPHARM 12 micrograms/hour transdermal patches

Introduction

Package Leaflet: Information for the User

Fentanilo Matrix ratiopharm 12 micrograms/hour transdermal patch EFG

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Fentanilo Matrix ratiopharm is and what it is used for
2. What you need to know before you use Fentanilo Matrix ratiopharm
3. How to use Fentanilo Matrix ratiopharm
4. Possible side effects
5. Storing Fentanilo 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 to relieve very strong and long-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 fentanyl. It belongs to a group of strong pain-relieving medicines called opioids.

2. What you need to know before you use Fentanilo Matrix ratiopharm

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 an operation.
• if you have breathing difficulties, 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 not sure, talk to your doctor or pharmacist before using Fentanilo Matrix ratiopharm.

Warnings and precautions

• Fentanilo Matrix ratiopharm can have life-threatening side effects in people who are not regularly using prescribed opioids.
• Fentanilo Matrix ratiopharm is a medicine that can be life-threatening to children, even if the patches have already been used. Note that an adhesive patch (used or unused) can be tempting to a child, and if it sticks to the child's skin or if the child puts it in their mouth, the result can be fatal.

• Keep this medicine in a safe and protected place, where others cannot access it, see section 5 for more information.

If the patch sticks to another person

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

Be careful with Fentanilo Matrix ratiopharm

Talk to your doctor or pharmacist beforeusing 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 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 the muscles become weak and tired easily.

If you have any of the above conditions (or if you are not sure), talk to your doctor or pharmacist before using Fentanilo Matrix ratiopharm.

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

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

Your doctor may decide to change the dose.

Tell your doctor if you notice a change in your pain.If you feel:

• that the patch no longer relieves your pain
• an increase in pain
• a change in the way you feel pain (for example, you feel pain in another part of your body)
• pain when there should be no pain.

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

Side effects and Fentanilo Matrix ratiopharm

• Fentanilo Matrix ratiopharm can make you feel extremely sleepy and can slow down your breathing. In rare cases, these breathing problems can be life-threatening or even fatal, especially in people who have not used strong opioid painkillers before (such as Fentanilo Matrix ratiopharm or morphine). If you, your partner, or caregiver notice that the person wearing the patch is unusually sleepy, with slow or weak breathing.
• • Remove the patch
  • Call a doctor or go to the nearest hospital immediately
  • Get the person to move and talk as much as possible

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

In section 4, you can find the complete list of possible side effects.

When wearing the patch, do not expose it to direct heat, such as heat pads, electric blankets, hot water bottles, water beds, heat lamps, or tanning lamps. Do not take sunbaths 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 can result in a positive doping test. The use of fentanyl patches as a doping agent can be hazardous to health.

Long-term use and tolerance

This medicine contains fentanyl, an opioid. Repeated use of opioid painkillers can make the medicine less effective (the body gets used to it, which is 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 can also be harmful. If you notice that the medicine is becoming less effective, talk to your doctor. Your doctor will decide whether it is better to increase the dose or gradually reduce the use of Fentanilo Matrix ratiopharm.

Dependence and addiction

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

Repeated use of Fentanilo Matrix ratiopharm can also lead to dependence, abuse, and addiction, which can result in a potentially fatal overdose. The risk of these side effects may be greater with higher doses and longer use. Dependence or addiction can lead to a feeling of loss 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 to relieve pain.

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

• You or any member of your family have abused alcohol or have been dependent on it, or have taken prescription medicines or illegal drugs ("addiction").
• You are a smoker.
• You have ever had mood problems (depression, anxiety, or personality disorder) or have received treatment from a psychiatrist for other mental health problems.

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 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, for example, "to stay calm" or "to help you sleep".
• You have made repeated unsuccessful attempts to stop using the medicine or control its use.

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

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

Withdrawal symptoms when stopping Fentanilo Matrix ratiopharm

Do not stop using this medicine suddenly. 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 tell you how to do it, usually by gradually reducing the dose so that the unpleasant withdrawal effects are minimized.

Other medicines and Fentanilo Matrix ratiopharm

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

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

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

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

Using Fentanilo Matrix ratiopharm with antidepressants

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

Using Fentanilo Matrix ratiopharm with central nervous system depressants, including alcohol and some narcotic medicines

Using Fentanilo Matrix ratiopharm and sedative medicines, such as benzodiazepines or related medicines, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. For this reason, concomitant use should only be considered when other treatment options are not possible.

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

Tell your doctor about all sedative medicines you are taking or using, and follow the dose recommended by your doctor strictly. It may be useful to inform friends or family to alert them to the signs and symptoms described above. Contact your doctor if you experience these symptoms.

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

Operations

If you are going to have an operation, tell your doctor or dentist that you are using Fentanilo Matrix ratiopharm.

Pregnancy and breastfeeding

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

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

Fentanilo Matrix ratiopharm should not be used during labor, as the medicine can affect the breathing of the newborn.

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

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

Driving and using machines

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

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

3. How to use Fentanilo Matrix ratiopharm

Follow your doctor's administration instructions for this medication exactly. If you have any doubts, 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 what you can expect from using 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 from stopping Fentanilo Matrix ratiopharm").

How to applyand change the patches

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

Where to apply the patch

Adults

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

Children

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

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

Adults and children:

Do not apply the patch to

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

How to apply the patch

Step 1: Prepare the skin

• Before applying the patch, check that the skin is completely dry, clean, and fresh
• If you need to wash the skin, use only cold water
• Do not use soap or other cleaners, creams, moisturizers, oils, or 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 it along the notch
• Gently tear or completely cut the edge of the pouch

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

Step 3: Peel and press

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

Step 4: Dispose of the patch

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

Step 5: Wash your hands

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

More information on using Fentanilo Matrix ratiopharm

Daily activities during patch use

• The patches are water-resistant
• You can shower or bathe with the patch on, but do not rub it
• If your doctor agrees, you can exercise or play sports with the patch on
• You can also swim with the patch on, but:
• • Do not use hot tubs or whirlpools
  • Do not cover the patch with tight or elastic fabrics

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

How long do the patches take to work?

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

How long will you need to use the patches

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

If your pain worsens

• If your pain worsens suddenly after applying the last patch, check the patch. If it is no longer well adhered or has come off, you should replace the patch (see also the section "If the patch comes off").
• If your pain worsens over time while using the patches, your doctor may try patches with a higher dose or prescribe additional pain relievers (or both).
• If increasing the patch dose does not help, your doctor may decide to stop using the patches.

If you use too many patches or a patch with the wrong dose

If you have applied too many patches or a patch with the wrong dose, remove them and contact your doctor immediately.

Signs of overdose include difficulty breathing or shallow breathing, fatigue, extreme drowsiness, inability to think clearly or walk or talk normally, and feeling faint, dizzy, or confused. 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 make a note of the day and time. Then, change the patch again after 3 days (72 hours), as usual.
• If you are significantly late, you should talk to your doctor, as you may need additional pain relievers, but do notapply additional patches.

If the patch comes off

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

• Tell your doctor about this and leave the patch on for another 3 days (72 hours)or for the time your doctor indicates, before changing the patch in the usual way
• If the patches tend to fall off, consult your doctor, pharmacist, or nurse.

If you want to stop using the patches

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

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

4. Possible side effects

Like all medications, this medication can have side effects, although not everyone will experience them.

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

• Unusual drowsiness, slower or weaker breathing than expected.

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

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

All of these can 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 side effects have also been reported

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

• Nausea, vomiting, constipation
• Feeling drowsy (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, hearing, or smelling things that are not there (hallucinations)
• Tremors or muscle spasms
• Strange sensation in the skin, such as tingling or numbness (paresthesia)
• Feeling that everything is spinning (vertigo)
• Fast or irregular heartbeat (palpitations, tachycardia)
• Increased blood pressure
• Shortness of breath (dyspnea)
• Diarrhea
• Dry mouth
• Stomach pain or indigestion
• Excessive sweating
• Itching, rash, or redness of the skin
• Difficulty urinating or emptying the bladder completely
• Extreme fatigue, weakness, or general malaise
• Feeling cold
• Swelling of the hands, ankles, or feet (peripheral edema)

Uncommon (may affect up to 1 in 100 people)

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

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

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

Unknown frequency (cannot be estimated from 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 really there, sleep disturbances, nightmares)
• You may become dependent on Fentanilo Matrix ratiopharm (see section 2).

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

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

If you switch from another pain reliever to 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. Tell 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 a prolonged period during pregnancy

Reporting side effects

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

5. Storage of Fentanilo Matrix ratiopharm

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, where others cannot access it. This medication can cause serious harm and even be fatal if used or taken accidentally or intentionally by someone who has not been prescribed it.

How long can you store Fentanilo Matrix ratiopharm

Do not use this medication after the expiration date shown on the box and on the pouch 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 above 30°C.

How to dispose of used or unused patches

Accidental exposure of another person to used and unused patches, especially children, can be fatal.

Used patches should be folded firmly in half, so that the adhesive side of the patch sticks to itself. Then, they should be thrown away safely by putting them back in the original pouch and keeping them out of sight and reach of others, especially children, until they are disposed of safely.

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

6. Container Content and Additional Information

Composition of Fentanilo Matrix ratiopharm 12 micrograms/hour transdermal patch

• The active ingredient is fentanyl.

Each patch releases 12.5 micrograms of fentanyl per hour. Each 3.75 cm2 transdermal patch contains 2.063 mg of fentanyl.

• The other components are:

Adhesive layer: acrylic adhesive layer

Supporting film: polypropylene laminate, blue printing ink

Removable coating: siliconized ethylene tetraphthalate laminate

Product Appearance and Container Content

Fentanilo Matrix ratiopharm is a transparent transdermal patch with an adhesive backing so that it can be stuck onto the skin. The transdermal patches are equipped with blue printing with the concentration.

Fentanilo Matrix ratiopharm 12 micrograms/h is available in packs of 2, 3, 4, 5, 8, 10, 16 or 20 transdermal patches.

Only some 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 12 µg/h Matrixpflaster

Spain: Fentanilo Matrix ratiopharm 12 micrograms/hour transdermal patch EFG

France: Fentanyl Teva Santé 12 microgrammes/heure, dispositif transdermique

Date of the last revision of this leaflet:March 2025

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