Patient Information Leaflet

Fentanilo Matrix Sandoz 12 micrograms/hour Transdermal Patches EFG

Fentanilo Matrix Sandoz 25 micrograms/hour Transdermal Patches EFG

Fentanilo Matrix Sandoz 50 micrograms/hour Transdermal Patches EFG

Fentanilo Matrix Sandoz 75 micrograms/hour Transdermal Patches EFG

Fentanilo Matrix Sandoz 100 micrograms/hour Transdermal Patches EFG

Read this 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 and should not be given to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before starting to use Fentanilo Matrix Sandoz..

3.How to use Fentanilo Matrix Sandoz..

4.Possible side effects.

5Storage of Fentanilo Matrix Sandoz.

6.Contents of the pack and additional information.

The name of this medication is Fentanilo Matrix Sandoz.

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 medications and need continuous pain treatment.

Fentanilo Matrix Sandoz contains a medication called fentanilo. It belongs to a group of strong pain-relieving medications called opioids.

You should not use Fentanilo Matrix Sandoz if:

• you are allergic to fentanyl, colophony resin (hydrogenated), soy, peanuts, or any of the other ingredients of this medicine (listed in section 6),
• you have short-term pain, such as sudden pain or pain after an operation,
• you have difficulty breathing, slow or weak breathing.

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

Warnings and precautions

If the patch sticks to another person

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

Be especially careful with Fentanilo Matrix Sandoz

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

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

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

While using the patch, report to your doctor if you experience breathing problems while sleeping.Fentanyl and other opioids can cause sleep-related breathing disorders such as sleep apnea (pauses in breathing while sleeping) and sleep-related hypoxemia (low oxygen levels in the blood). Talk to your doctor if you, your partner, or caregiver notice any of the following symptoms:

• pauses in breathing while sleeping,
• waking up at night due to lack of air,
• difficulty staying asleep,
• excessive daytime sleepiness. Your doctor may decide to adjust your dose.

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

• the patch no longer relieves 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 you come into contact with your body that should not cause pain.

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

Side effects and Fentanilo Matrix Sandoz

• Fentanyl can make you feel unusually sleepy and slow or weak breathing.

In rare cases, these breathing problems can be life-threatening or even fatal, especially in people who have not used strong prescription painkillers (such as fentanyl or morphine) before. If you, or your partner or caregiver, notice that the person wearing the patch is unusually sleepy, slow or weak 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 have a fever while using fentanyl, report it to your doctor. This can increase the amount of medicine that passes through your skin,
• Fentanyl can cause constipation, talk to your doctor or pharmacist for advice on how to prevent or relieve constipation,

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

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

Long-term use and tolerance

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

Dependence and addiction

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

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

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

If you notice any of the following symptoms while using Fentanilo Matrix Sandoz, 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, such as "to stay calm" or "to help you sleep".
• You have made repeated and unsuccessful attempts to stop using the medicine or control your use.
• You feel unwell when you stop using the medicine, and you feel better once you take it again ("withdrawal symptoms").

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

Withdrawal symptoms when stopping useFentanilo Matrix Sandoz

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

Other medicines and Fentanilo Matrix Sandoz

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

Your doctor will know which medicines can be taken safely with Fentanilo Matrix Sandoz. They may need to monitor you closely if you are taking any of the following medicines or if you stop taking any of the following medicines, as this may affect the amount of fentanyl you need.

Particularly, inform your doctor or pharmacist if you are taking:

• Other pain medicines, such as other strong opioid painkillers (such as buprenorphine, nalbuphine, or pentazocine) and some painkillers for neuropathic pain (gabapentin and pregabalin).
• Sleeping aids (such as temazepam, zaleplon, or zolpidem).
• Anxiety-reducing medicines (tranquilizers, such as alprazolam, clonazepam, diazepam, hydroxyzine, or lorazepam) and medicines for mental health conditions (antipsychotics, such as aripiprazole, haloperidol, olanzapine, risperidone, or phenothiazines).
• Muscle relaxants (such as cyclobenzaprine or diazepam).
• Some antidepressants called SSRIs or SNRIs (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine). - See below for more information.
• Some medicines used to treat depression or Parkinson's disease called MAOIs (such as isocarboxazid, phenelzine, selegiline, or tranylcypromine). Do not use fentanyl in the 14 days following the interruption of these medicines. - See below for more information.
• Some antihistamines, especially those that cause drowsiness (such as chlorphenamine, clemastine, ciproheptadine, 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 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 heartburn 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 Sandoz with antidepressants

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

Fentanilo Matrix Sandoz with central nervous system depressants, including benzodiazepines, alcohol, and some narcotics

Consult your doctor if you are taking any other medicine that slows down your central nervous system (CNS depressants). CNS depressants include medicines that make you sleep, reduce anxiety, or decrease consciousness (see also "Other medicines and Fentanilo Matrix Sandoz"); but alcohol and some narcotics are also CNS depressants. The use of this type of medicine with fentanyl can cause severe drowsiness, decreased consciousness, difficulty breathing with slow or shallow breathing, coma, and death. Due to this, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes fentanyl along with sedatives, your doctor should limit the dose and duration of concomitant treatment. Follow your doctor's recommendations closely. It may be helpful to inform friends or family members who are aware of the signs and symptoms mentioned above. Contact your doctor when you experience these symptoms.

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

Surgery

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be 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 can affect the newborn's breathing.

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

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

Driving and operating machinery

Fentanilo Matrix Sandoz 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 operate tools or machines. Do not drive while using this medicine until you know how it affects you.

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

Fentanilo Matrix Sandoz contains soy oil

Do not use this medicine if you are allergic to peanuts or soy.

Always follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your doctor will decide what concentration of fentanyl is most suitable for you, taking into account the intensity of the pain, your general condition, and the type of pain treatment you have received so far.

Before starting treatment and regularly during it, your doctor will also explain to you what you can expect from the use of Fentanilo Matrix Sandoz, when and for how long you should use it, when you should contact your doctor, and when you should discontinue use (see also section 2, Withdrawal symptoms when stopping the use of Fentanilo Matrix Sandoz).

Use and change of patches

• Each patch contains enough medication to last3 days (72 hours).
• You must change the patch every 3 days, unless your doctor has told you otherwise.
• Always remove the used patchbeforeapplying a new one.
• Change the patch alwaysat the same timeof the day every 3 days (72 hours).
• If you are using more than one patch, change them all at the same time.
• Record the day, date, and time each time you apply a patch, to remember when to change it.

• The following table shows when to change the patch:

Where to apply the patch

Adults

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

Children

• Apply the patch always to the upper back so that your child has difficulty reaching or removing it.
• Check occasionally that the patch is still stuck to the skin.
• It is essential that the child does not remove the patch and put it in their mouth, as this could put their life in danger or be fatal.
• Keep your child under close observation for 48 hours after:

• Applying the first patch.
• Applying a patch with a higher dose.

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

Adults and children:

Do not apply the patch to

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

Applying a patch

Step 1: Prepare the skin

• Before applying the patch, make sure your skin is completely dry, clean, and fresh.
• If you need to wash the skin, use only cold water.
• -Do not use soap or other cleaners, creams, moisturizers, oils, or talc before applying the patch.
• Do not apply the patch after a hot bath or shower.

Step 2: Open the package

• Each patch is sealed in its own package.
• Rip the package along the perforation.
• Rip the package edge gently.
• Hold both sides of the open package and pull them apart.
• Remove the patch and use it immediately.
• Save the empty package to dispose of the used patch later.
• Use each patch only once.
• Do not remove the patch from its package until you are ready to use it.
• Inspect the patch to make sure it is not damaged.
• Do not use the patch if it is torn, cut, or appears damaged.
• Never cut or divide the patch.

Step 3: Remove and press

• Make sure the patch will be covered by a loose garment and not adhere under a tight or elastic fabric.
• Carefully remove the first part of the shiny plastic protective layer starting from the center of the patch. Be careful not to touch the adhesive side of the patch.
• Press this adhesive side 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 it pressed for at least 30 seconds. Make sure it sticks well, especially the edges.

Step 4: Remove the patch

• As soon as you remove the patch, fold it firmly in half so that the adhesive side sticks to itself.
• Put it back in its original package and dispose of it according to your pharmacist's instructions.
• Keep used patches out of the sight and reach of children; even used patches contain medication that can harm children and be fatal.

Step 5: Wash your hands

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

More about using Fentanilo Matrix Sandoz

Daily activities while using the patches

• The patches are impermeable.
• You can take a shower or bath while using a patch, but do not rub it.
• If your doctor agrees, you can exercise or engage in sports while using the patch.
• You can also swim with the patch on, but:

- Do not use hot tubs.

- Do not place a tight or elastic fabric over the patch.

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

How quickly do the patches work?

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

For how long will you have to use the patches?

• The fentanyl patches are indicated for the treatment of chronic pain. Your doctor will tell you how long you can expect to use the patches.

If the pain worsens

• If your pain suddenly worsens after applying the last patch, check the patch. If it no longer sticks well or has fallen off, replace the patch (see also the section If the patch falls off).
• If your pain worsens over time while using these 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 the patches and contact your doctor immediately, go to the hospital, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount applied.

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

If you forget to change your patch

• If you forget to change the patch, change it as soon as you remember and note the day and time.
• Change the patch again after3 days (72 hours)as usual.
• If you are delayed, you should talk to your doctor, as you may need some additional painkillers, butdo notapply an extra patch.

If a patch falls off

• If a patch falls off before you need to change it, apply a new one immediately and note the day and time. Use a new area of the skin:

• On the trunk or arm.
• On the upper back of your child.

• Inform your doctor of what happened and leave the new patch for another3 days (72 hours)or according to your doctor's instructions, before changing the new patch as usual.
• If your patches continue to fall off, consult your doctor, pharmacist, or nurse.

If you want to stop using the patches

• Do not stop using this medication abruptly. If you want to stop using this medication, talk to your doctor first. Your doctor will tell you how to do it, usually the dose will be gradually reduced to minimize the unpleasant effects of withdrawal. See also section 2, “Withdrawal symptoms when stopping the use of Fentanilo Matrix Sandoz”.
• If you have been using the patches for some time, your body may have become accustomed to them. Stopping the patches abruptly may make you feel unwell
• If you stop using the patches, do not use them again without first asking your doctor. You may need a different dose to resume treatment.

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

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

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

• Unusual feeling of drowsiness, slower or weaker breathing than expected.

Follow the previous recommendations and keep the person wearing the patch moving and talking as much as possible. In very rare cases, these breathing difficulties can put a person's life at risk or even be fatal, especially in people who have not used strong opioid analgesics (such as Fentanilo Matrix Sandoz or morphine) before. (Rare, may affect up to 1 in 100 people).

• Sudden swelling of the face or throat, severe irritation, redness, or blisters on the skin. These may be signs of a severe allergic reaction. (Frequency cannot be estimated from available data).

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

• Reduced consciousness or loss of consciousness. (Rare, may affect up to 1 in 100 people).

The following side effects have also been reported

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

• Nausea, vomiting, constipation,
• Feeling sleepy (drowsiness),
• Feeling dizzy,
• Headache,

Common (may affect up to 1 in 10 people):

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

Rare (may affect up to 1 in 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 there, sleep disturbances, nightmares),
• You may become dependent on Fentanilo Matrix Sandoz transdermal patches (see section 2).

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

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

If you switch from another painkiller to Fentanilo Matrix Sandoz or if you suddenly stop using Fentanilo Matrix Sandoz, you may experience withdrawal symptoms such as dizziness, nausea, diarrhea, anxiety, or tremors. Inform your doctor if you notice any of these symptoms.

There have also been cases of newborn babies experiencing withdrawal symptoms after their mothers used Fentanilo Matrix Sandoz for an extended period during pregnancy.

Reporting of side effects

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

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

Store this medication in a protected and secure location, where other people cannot access it. It can be very harmful and cause death to people who may accidentally or intentionally use this medication when not prescribed.

Do not use this medication after the expiration date that appears on the box and on the pouch after “CAD/EXP”. The expiration date is the last day of the month indicated.

Store in the original packaging.

A used or unused patch accidentally stuck to another person, especially a child, can be fatal. Used patches should be folded firmly in half, so that the adhesive side of the patch adheres to itself. They should then be disposed of safely by placing them back in the original pouch and storing them out of sight and reach of other people, especially children, until they are disposed of safely.

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

Fentanilo Matrix Sandoz Composition

The active ingredient is fentanilo.

Fentanilo Matrix Sandoz 12 micrograms/hour transdermal patches

Each transdermal patch (5.25 cm² of absorption surface area) contains: 2.89 mg of fentanilo (which corresponds to a release rate of 12.5 micrograms/hour of fentanilo).

Fentanilo Matrix Sandoz 25 micrograms/hour transdermal patches

Each transdermal patch (10.5 cm² of absorption surface area) contains: 5.78 mg of fentanilo (which corresponds to a release rate of 25 micrograms/hour of fentanilo).

Fentanilo Matrix Sandoz 50 micrograms/hour transdermal patches

Each transdermal patch (21 cm² of absorption surface area) contains: 11.56 mg of fentanilo (which corresponds to a release rate of 50 micrograms/hour of fentanilo).

Fentanilo Matrix Sandoz 75 micrograms/hour transdermal patches

Each transdermal patch (31.5 cm² of absorption surface area) contains: 17.34 mg of fentanilo (which corresponds to a release rate of 75 micrograms/hour of fentanilo).

Fentanilo Matrix Sandoz 100 micrograms/hour transdermal patches

Each transdermal patch (42 cm² of absorption surface area) contains: 23.12 mg of fentanilo (which corresponds to a release rate of 100 micrograms/hour of fentanilo).

The other components are:

Protective film (remove before applying the patch to the skin):

Polycarbonate film, siliconized

Matrix adhesive layer:

Hydrogenated colophony resin

Poly(2-ethylhexyl acrylate-co-vinyl acetate)

Refined soybean oil

Waterproof coating film:

Polycarbonate film

Printing ink

Appearance of the product and contents of the package

Fentanilo Matrix Sandozis a transparent, rounded, and oblong transdermal patch with an adhesive membrane and covered with a protective film (which is removed before application) so it can be stuck to the skin.

Fentanilo Matrix Sandozis available in packages with 3, 5, 7, 10, 14, 16, and 20 transdermal patches.

Hospital packs with 5 transdermal patches.

Only some package sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible Manufacturer

Hexal AG

Industriestrasse 25

83607 Holzkirchen

Germany

Last review date of thisleaflet:April 2024

More detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/