Fentanyl Matrix CINFA 100 micrograms/h transdermal patches EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

fentanilo matrix cinfa 100 micrograms/hour transdermal patches EFG

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

What fentanilo matrix cinfa is and what it is used for
What you need to know before using fentanilo matrix cinfa
How to use fentanilo matrix cinfa
Possible adverse effects
How to store fentanilo matrix cinfa
Contents of the pack and other information

1. What fentanilo matrix cinfa is and what it is used for

This medicine is called fentanilo matrix cinfa.

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 cinfa contains a medicine called fentanilo. It belongs to a group of strong painkillers known as opioids.

2. What you need to know before starting to use fentanilo matrix cinfa

Do not use fentanilo matrix cinfa

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 fentanilo matrix cinfa.

Warnings and precautions

Consult your doctor or pharmacist before starting to use fentanilo matrix cinfa.

Fentanyl may have life-threatening adverse effects in people who are not regularly using prescribed opioids.
Fentanyl 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.
Store this medicine in a safe and secure place, out of reach of others (see section 5 for more information).

If the patch sticks 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 some reported cases in which the patch has accidentally adhered to another family member through close physical contact or by sharing the same bed with the person wearing the patch. If the patch accidentally sticks to another person (particularly a child), the medication from the patch may pass through that person's skin and may cause serious adverse effects, such as difficulty breathing, 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 fentanilo matrix cinfa

Consult your doctor or pharmacist before using this medicine if you are in any of the following situations. Your doctor may need to monitor you more closely:

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

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

While using the patch, inform your doctor if you experience breathing problems during sleep. Opioids such as fentanyl can cause sleep-related breathing disorders, such as sleep apnea (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 your 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 triggered by touch that should not cause pain

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

Adverse effects and fentanilo matrix cinfa

Fentanyl may cause unusual drowsiness 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 fentanyl 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 immediately.
Call a doctor or go to the nearest hospital right away.
Keep the person moving and talking as much as possible.
If you develop a fever while using fentanyl, speak with your doctor. Fever may increase the amount of medication passing through your skin.
Fentanyl may cause constipation; speak with your doctor or pharmacist for advice on how to prevent or relieve constipation.

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

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. Avoid prolonged sun exposure, hot baths, saunas, or hot tubs. Doing so may increase the amount of medication released from the patch.

Long-term use and tolerance

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

Dependence and addiction

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

Repeated use of fentanilo matrix cinfa 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 cause a feeling of losing control over the amount of medication you need to take or how often you need to take it. You may feel a need to continue using the medication even if it no longer helps relieve your pain.

The risk of dependence or addiction varies from person to person. The risk of becoming dependent on or addicted to fentanilo matrix cinfa may be greater if:

You or any member of your family have abused alcohol or experienced dependence on alcohol, prescription medications, or illegal drugs ("addiction").
You smoke.
You have ever had mood disorders (such as 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 fentanilo matrix cinfa, this could be a sign of dependence or addiction:

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

Withdrawal symptoms when stopping fentanilo matrix cinfa

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

Children

Fentanilo is used in children over 2 years of age who are opioid-tolerant, already receiving opioid medication, and who require continuous pain treatment.

Other medicines and fentanilo matrix cinfa

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

This includes over-the-counter medicines and herbal products. You should also inform your pharmacist that you are using fentanilo if you purchase any medicine from the pharmacy.

Your doctor will know which medicines can be safely used with fentanilo. They may need to monitor you closely if you are using any of the types of medicines listed below or if you stop using any of them, as this may affect the dose of fentanilo you require.

In particular, inform your doctor or pharmacist if you are 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 calm down (tranquilizers, 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 antidepressants known as 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 fentanilo 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 indigestion 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 fentanilo matrix cinfa with antidepressants

The risk of adverse effects increases if you are taking medicines such as certain antidepressants. Fentanilo 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 diarrhea (which 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 certain narcotic medicines

Concomitant use of fentanyl and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, breathing difficulties (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 fentanyl together with sedative medicines, your doctor should limit the dose and duration of concomitant treatment.

Inform your doctor of all sedative medicines you are taking and strictly follow your doctor's dosing recommendations. It may be helpful to inform friends or family members so they are aware of the signs and symptoms mentioned above. Contact your doctor if you experience these symptoms.

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

Use in athletes

Athletes are advised that this medicine contains a component that may result in a positive analytical finding in doping controls.

Surgery

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

Pregnancy and breastfeeding

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

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

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

Prolonged use of fentanyl during pregnancy may cause withdrawal symptoms (such as high-pitched crying, restlessness, seizures, poor feeding, and diarrhea) in the newborn baby, which can be potentially fatal if not recognized and treated. Speak to your doctor immediately if you think your baby may be experiencing withdrawal symptoms.

Do not use fentanyl while breastfeeding. You must not breastfeed for 3 days after removing the fentanyl patch, as the medicine can pass into breast milk.

Driving and using machines

Ask your doctor whether you are allowed to drive or operate machinery while being treated with fentanyl. It is important to observe how this medicine affects you before driving or operating machinery. Do not drive or operate machinery if you feel drowsy, dizzy, have blurred or double vision, or have difficulty concentrating. Exercise particular caution at the start of treatment, after a dose increase, when switching formulations, and/or when taking other medicines concomitantly.

3. How to use fentanilo matrix cinfa

Before starting treatment and regularly during treatment, your doctor will also explain to you what to expect from using fentanilo matrix cinfa, 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 cinfa").

Always follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

How to apply and change the patches

Each patch contains a sufficient amount of medication for 3 days (72 hours).
You should change the patch every 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 following table 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 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 regularly that the patch remains attached to the skin.
It is important that the child does not remove the patch and put it in their mouth, as this could endanger their life 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 full effect. Therefore, your child may need additional painkillers until the patch becomes 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.
hairy skin areas. If there is hair, do not shave it (shaving irritates 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 you need to wash the skin, use only cold 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 along the notch indicated by an arrow.
Gently tear or completely cut along the edge of the pouch (if using scissors, cut close to the sealed edge to avoid damaging the patch).

Two illustrations show hands pressing and then shaking a small plastic wrapper to open a medical container against a pink background

Hold the two parts of the opened pouch and pull them apart.
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 otherwise damaged.
Never divide or cut the patch.

Step 3: Peel and press

Make sure the patch will be covered by loose clothing and do not apply it under tight or elastic fabric.
Carefully peel off half of the shiny plastic protective layer, starting from the center of the patch. Avoid touching the adhesive side of the patch.
Press this adhesive part of the patch onto the skin.
Remove the other half of the protective layer and press the entire patch onto the skin with the palm of your hand.
Hold pressure for at least 30 seconds. Ensure the patch is well adhered, 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 according to your pharmacist's instructions.
Keep used patches out of sight and reach of children; even when used, patches contain medication that could harm children and even be fatal.

Step 5: Washing hands

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

More information on the use of fentanilo matrix cinfa

Daily activities while using the patches

The patches are water-resistant.
You may shower or bathe while wearing the patch, but do not rub it.
If your doctor agrees, you may exercise or engage in sports while wearing the patch.
You may also swim while wearing the patch, but:
Do not use hot tubs or whirlpool 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 or tanning lamps. Do not sunbathe, take prolonged hot baths, or use saunas. Doing so 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 full effect.
Your doctor may provide additional painkillers during the first few days.
Afterwards, the patch should help relieve pain continuously, allowing you to stop taking other painkillers. However, your doctor may occasionally prescribe additional painkillers.

How long will you need to use the patches?

Fentanyl 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 last patch, check the patch. If it is no longer adhering properly or has detached, replace the patch (see also section If the patch detaches).
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 more fentanilo matrix cinfa than you should

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

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

If you forget to use fentanilo matrix cinfa

If you forget to change the patch, change it as soon as you remember and note the date and time. Then resume changing the patch every 3 days (72 hours) as usual.
If you are significantly delayed, you should speak to your doctor, as you may need additional painkillers, but do not apply extra patches.

If the patch detaches

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 patch in place for another 3 days (72 hours) or for the time your doctor specifies, before changing the patch as usual.
If patches tend to fall off, consult your doctor or pharmacist.

If you interrupt treatment with fentanilo matrix cinfa

Do not stop using this medicine abruptly. If you wish to stop using this medicine, speak to your doctor first. Your doctor will advise you on how to do so, usually by gradually reducing the dose to minimize unpleasant withdrawal symptoms. See also section 2, “Withdrawal symptoms when stopping fentanilo matrix cinfa”.
If you stop using the patches, do not restart them without first consulting your doctor. You may need a different dose when resuming treatment.

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

4. Possible adverse effects

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

If you, or the patient’s partner or caregiver, notice any of the following signs in the person wearing the patch, remove the patch immediately and contact a doctor or go straight to the nearest hospital. Urgent medical treatment may be required.

Unusual drowsiness, slower or weaker breathing than expected.

Follow the instructions above and encourage the person wearing the patch to move and speak as much as possible. In very rare cases, these breathing difficulties can be life-threatening or even fatal, especially in individuals who have not previously used strong opioid painkillers (such as fentanyl or morphine). (Uncommon: may affect up to 1 in 100 patients).

Sudden swelling of the face or throat, severe irritation, redness, or blisters on the skin. These may all be signs of a severe allergic reaction. (Frequency not known: cannot be estimated from available data).
Seizures (convulsions). (Uncommon: may affect up to 1 in 100 patients).
Reduced level of consciousness or loss of consciousness. (Uncommon: may affect up to 1 in 100 patients).

The following adverse effects have also been reported

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

Nausea, vomiting, constipation.
Feeling sleepy (somnolence).
Dizziness.
Headache.

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

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.
Abnormal skin sensations such as tingling or prickling (paresthesia).
Sensation of spinning (vertigo).
Rapid 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.
Inability to urinate or to completely empty the bladder.
Severe fatigue, weakness, or general malaise.
Feeling cold.
Swelling of the hands, ankles, or feet (peripheral edema).

Uncommon (may affect up to 1 in 100 patients):

Feeling restless or disoriented.
Feeling extremely happy (euphoria).
Decreased 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 application site.
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 (may affect up to 1 in 1,000 patients):

Constriction of the pupils (miosis).
Occasional interruption of breathing (apnea).

Frequency not known (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 cinfa (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 become "tolerant" to it), or may lead to dependence.

If you switch from another painkiller to fentanyl, or if you stop using fentanyl abruptly, you may experience withdrawal symptoms such as dizziness, feeling unwell, diarrhea, 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 fentanyl for a prolonged period during pregnancy.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, 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. Fentanyl Matrix cinfa Storage

Keep this medicine out of the sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiry date stated on the carton and on the sachet after EXP. The expiry date refers to the last day of the month indicated.

Do not use this medicine if you notice that the patches are damaged.

Store this medicine in a secure and protected place, inaccessible to other individuals. This medicine may cause serious harm or even be fatal to people, especially children, who use it accidentally or intentionally when it has not been prescribed for them.

Used patches should be folded firmly in half so that the adhesive side sticks to itself. Then they should be safely disposed of by placing them back into the original sachet and keeping them secure until they can be safely discarded.

Medicines should not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of fentanilo matrix cinfa

The active substance is fentanyl. Each patch contains 19.2 mg of fentanyl (amount released: 100 micrograms/hour).
The other components are acrylic polymer, lauryl alcohol, laminated film of polyester/ethylene vinyl acetate, silicone-coated polyester film, ink.

Appearance of the product and contents of the pack

It is presented in paper/polyethylene terephthalate film/polyethylene/aluminum/co-extruded polyamide pouches containing 1 transdermal patch. Each pack contains 5 rectangular transdermal patches.

fentanilo matrix cinfa are patches composed of: a transparent rectangular layer, a transparent, colorless and opaque adhesive matrix containing the active substance, and a transparent, easily removable film.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Date of the most recent revision of this leaflet: March 2025

Detailed 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/

You can access detailed and up-to-date information on this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/71854/P_71854.html

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