Matrifen 12 mikrogramuv/godzinem sistem trandermalni

PATIENT INFORMATION LEAFLET

Information leaflet included in the packaging: patient information

Matrifen, 12 micrograms/hour, transdermal system, patch

Matrifen, 25 micrograms/hour, transdermal system, patch

Matrifen, 50 micrograms/hour, transdermal system, patch

Matrifen, 75 micrograms/hour, transdermal system, patch

Matrifen, 100 micrograms/hour, transdermal system, patch

fentanyl

You should carefully read the contents of this leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Matrifen and what is it used for
• 2. Important information before using Matrifen
• 3. How to use Matrifen
• 4. Possible side effects
• 5. How to store Matrifen
• 6. Package contents and other information

1. What is Matrifen and what is it used for

The name of this medicine is Matrifen.
Matrifen is indicated for the treatment of chronic pain:

• in adults who require continuous administration of painkillers
• in children over 2 years of age who have already used opioid medications and require continuous administration of painkillers.

Matrifen contains the active substance fentanyl, which is a strong painkiller belonging to the opioid group.

2. Important information before using Matrifen

When not to use Matrifen

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6),
• in case of acute, sudden, or post-operative pain,
• if the patient has severe respiratory depression (significant slowing and shallowing of breathing).

Do not use this medicine if any of the above situations apply to the patient. In case of doubts, consult your doctor or pharmacist before using Matrifen.

Warnings and precautions

• Matrifen may cause life-threatening side effects in people who do not regularly use opioid painkillers.
• Matrifen is a medicine that can be life-threatening for children. This also applies to used patches. It should be considered that the appearance of the patch (used or unused) may encourage a child to touch it, stick it to their body, put it in their mouth, etc., which can lead to death.
• The medicine should be stored in a safe and protected place, inaccessible to other people - see section 5 for more information.

In case of accidental attachment of the Matrifen patch to another person's skin

Patches should only be applied to the skin of the person they have been prescribed for.
Several cases of accidental attachment of a patch to another person's skin have been reported during close physical contact or while sleeping in the same bed with the person using the patches.
Accidental attachment of a patch to another person's skin (especially a child) can cause the medicine to be absorbed through the skin and lead to severe side effects such as respiratory disorders with slow and shallow breathing, which can be life-threatening.
If such a situation occurs, the patch should be removed immediately and a doctor should be consulted.

Special caution is required when using Matrifen

Beforeusing this medicine, you should talk to your doctor or pharmacistif any of the following situations apply:

• the patient has had lung disease or breathing difficulties,
• the patient has had heart, liver, kidney, or low blood pressure problems,
• the patient has had a brain tumor,
• the patient has had headaches or head injuries,
• the patient is elderly - may be more sensitive to the effects of this medicine,
• the patient has myasthenia gravis, a condition characterized by muscle weakness and fatigue

If any of the above situations apply to the patient (or the patient is unsure), they should talk to their doctor or pharmacist before using Matrifen.

During patch use, the patient should inform their doctor if they experience breathing problems during sleep.

Opioids, such as Matrifen, can cause breathing disorders during sleep, such as sleep apnea (pauses in breathing during sleep) and sleep hypoxia (low oxygen levels in the blood). The patient should inform their doctor if they, their 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. The doctor may decide to change the dose of the medicine.

During patch use, the patient should inform their doctor if they notice a change in their pain perception. If the patient feels that:

• the pain is no longer relieved after applying the patch
• the pain is worsening
• there is a change in the way the pain is perceived (e.g., the patient feels pain in a different part of the body)
• pain occurs when touched, which should not be the case. The patient should not change the dose on their own. The doctor may decide to change the dose or treatment.

Side effects of Matrifen

• Matrifen may cause unnatural fatigue, as well as slowed and shallow breathing. Very rarely, these breathing disorders can be life-threatening or lead to death, especially in people who have not previously used opioid painkillers (such as Matrifen or morphine). If the patient, partner, or caregiver notices that the person using the patches is excessively sleepy and has slow or shallow breathing, they should:
• remove the patch
• call a doctor or go to the nearest hospital immediately
• encourage the patient to move and talk as much as possible.
• If the patient develops a fever while using Matrifen, they should talk to their doctor - an increase in body temperature can significantly increase the absorption of the medicine through the skin.
• Matrifen may cause constipation; the patient should talk to their doctor or pharmacist about how to prevent or alleviate constipation.

A full list of side effects can be found in section 4.
Do not heat the patch application site with external heat sources, such as heated pads, electric blankets, hot water bottles, heated beds, heat lamps, or tanning lamps. Do not sunbathe or use prolonged warming baths, saunas, or whirlpool baths. In these situations, there is a risk of increased release of the medicine from the patch.

Long-term use and tolerance

This medicine contains fentanyl, which is an opioid painkiller. Repeated use of opioid painkillers can lead to reduced effectiveness of the medicine (the patient becomes accustomed to it, which is known as tolerance to the medicine). During Matrifen use, the patient's sensitivity to pain may also increase. This phenomenon is known as hyperalgesia. Increasing the patch dose may temporarily reduce the severity of the pain, but it can also be harmful. If the patient notices a decrease in the effectiveness of the medicine, they should talk to their doctor. The doctor will decide whether it is better for the patient to increase the dose or gradually reduce the use of Matrifen.

Dependence and addictive use

This medicine contains fentanyl, which is an opioid. It can cause dependence and (or) addiction.
Repeated use of Matrifen can also lead to dependence, abuse, and addictive use, which can result in life-threatening overdose. The risk of these side effects may increase with increasing dose and duration of use. Dependence or addictive use can cause the patient to feel a loss of control over the amount of medicine they use or how often they take it. The patient may feel the need to continue using the medicine, even if it no longer helps alleviate their pain.

• The patient or someone in their family has previously abused or been dependent on alcohol, prescription drugs, or illegal substances (addiction);
• The patient smokes tobacco;
• The patient has previously experienced mood disorders (depression, anxiety disorders, or personality disorders) or has been treated by a psychiatrist for other mental health conditions.

If the patient experiences any of the following symptoms while using Matrifen, it may indicate dependence or addictive use:

• The patient needs to take the medicine for a longer period than prescribed by the doctor.
• The patient needs to take a higher dose than prescribed.
• The patient uses the medicine for reasons other than those for which the doctor prescribed it, such as "to calm down" or "to fall asleep".
• The patient has repeatedly tried to stop or control the use of the medicine but has been unsuccessful.
• After stopping the use of the medicine, the patient feels unwell and experiences improvement in their condition when they start using the medicine again (withdrawal effect).

If the patient experiences any of these symptoms, they should discuss the best treatment strategy with their doctor, including determining when it is appropriate to stop treatment and how to safely end treatment.

Withdrawal symptoms after stopping Matrifen use

The patient should not suddenly stop using this medicine. Withdrawal symptoms may occur, such as anxiety, difficulty sleeping, irritability, restlessness, anxiety, rapid heartbeat (palpitations), increased blood pressure, nausea or vomiting, diarrhea, loss of appetite, tremors, chills, or sweating. If the patient wants to stop using this medicine, they should first talk to their doctor. The doctor will inform them how to do it; usually, it is done by gradually reducing the dose, so that any unpleasant withdrawal symptoms are minimized. See also section 2 "Withdrawal symptoms after stopping Matrifen use".

Matrifen and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
This includes all over-the-counter medicines or herbal medicines. When buying other medicines at the pharmacy, the patient should tell the pharmacist that they are using Matrifen.
The attending doctor knows which medicines can be safely used with Matrifen. The patient will require close monitoring if they are taking any of the medicines listed below or if they stop taking any of the medicines listed below, as this may affect the required potency of Matrifen.
In particular, the patient should tell their doctor or pharmacist if they are taking:

• Other opioid painkillers (such as buprenorphine, nalbuphine, or pentazocine) and some painkillers for nerve pain (gabapentin and pregabalin).
• Sleeping pills (such as temazepam, zaleplon, or zolpidem).
• Tranquilizers (such as alprazolam, clonazepam, diazepam, hydroxyzine, or lorazepam) and antipsychotic medicines (such as aripiprazole, haloperidol, olanzapine, risperidone, or phenothiazines).
• Muscle relaxants (such as cyclobenzaprine or diazepam).
• Certain antidepressants called SSRI or SNRI (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine) - see below.
• Certain antidepressants or medicines used to treat Parkinson's disease called IMAO (such as isocarboxazid, phenelzine, selegiline, or tranylcypromine). Matrifen should not be used for 14 days after stopping these medicines - see below.
• Certain antihistamines, especially those that cause drowsiness (such as chlorpheniramine, clemastine, cyproheptadine, diphenhydramine, or hydroxyzine).
• Certain antibiotics (such as erythromycin or clarithromycin).
• Antifungal medicines (such as itraconazole, ketoconazole, fluconazole, or voriconazole).
• Medicines used to treat HIV infection (such as ritonavir).
• Anti-arrhythmic medicines (such as amiodarone, diltiazem, or verapamil).
• Antituberculosis medicines (such as rifampicin).
• Certain antiepileptic medicines (such as carbamazepine, phenobarbital, or phenytoin).
• Certain medicines used to treat nausea and motion sickness (such as phenothiazines).
• Certain medicines used to treat heartburn and stomach ulcers (such as cimetidine).
• Certain medicines used to treat coronary artery disease (angina pectoris) or high blood pressure (such as nicardipine).
• Certain medicines used to treat blood cancers (such as idelalisib).

Using Matrifen with antidepressants

The risk of side effects increases when used with certain antidepressants. There may be an interaction between Matrifen and these medicines, and the patient may experience changes in their mental state, such as agitation, hallucinations (seeing, feeling, hearing, or smelling things that do not exist), and other effects such as changes in blood pressure, rapid heartbeat, high temperature, excessive reflexes, coordination disorders, muscle stiffness, nausea, vomiting, and diarrhea (these may be symptoms of serotonin syndrome). In the case of concurrent use, the doctor may want to closely monitor the patient for such side effects, especially when starting treatment or when changing the dose of the medicine.

Using Matrifen with medicines that act on the central nervous system, including alcohol and certain narcotics

Concomitant use of Matrifen with sedatives such as benzodiazepines or other medicines with similar effects increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, concomitant use should only be considered when no other treatment options are available.
If the doctor prescribes Matrifen together with sedatives, the dose and duration of concomitant treatment should be determined by the doctor.
The patient should tell their doctor about all sedatives they are taking and strictly follow the dose of the medicine recommended by the doctor. It may be helpful to inform friends or relatives to be aware of the above symptoms. If such symptoms occur, the patient should contact their doctor.

Surgical procedures

If the patient suspects they may undergo anesthesia, they should tell their doctor or dentist that they are using Matrifen.

Using Matrifen with alcohol

The patient should not drink alcohol before talking to their doctor.
Matrifen may cause drowsiness and slowed breathing. Alcohol can enhance these effects.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Matrifen should not be used during pregnancy, unless discussed with the doctor.
Matrifen should not be used during the perinatal period, as it may cause respiratory disorders in the newborn.
Long-term use of Matrifen during pregnancy may cause withdrawal symptoms in the newborn (such as loud crying, tremors, seizures, poor feeding, and diarrhea), which can be life-threatening if not recognized and treated. If withdrawal symptoms are suspected in the child, the patient should immediately contact their doctor.
Matrifen should not be used during breastfeeding. The patient should not breastfeed for 3 days after removing the Matrifen patch. The medicine may pass into breast milk.

Driving and using machines

Matrifen may affect the patient's ability to drive and use machines or tools because it can cause drowsiness and dizziness. If such symptoms occur, the patient should not drive vehicles or operate any machines or tools. The patient should not drive until they know how they react to the medicine.
The patient should talk to their doctor or pharmacist if they are unsure whether they can safely drive while using this medicine.

3. How to use Matrifen

This medicine should always be used as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.
The doctor will decide which strength of Matrifen is suitable for the patient, based on the severity of the pain, the patient's overall condition, and the pain treatment used so far.
Before starting and regularly during treatment, the doctor will also discuss with the patient what to expect from using Matrifen, when and for how long to take it, when to consult a doctor, and when to stop using the medicine (see also section 2 "Withdrawal symptoms after stopping Matrifen use").

Applying and changing patches

• Each patch contains enough medicine for 3 days (72 hours).
• The patch should be changed every third day, unless the doctor advises otherwise.
• The old patch should always be removed beforeapplying a new one.
• The patch should always be changed at the same timeevery 3 days (72 hours).
• If the patient is using more than 1 patch, all patches should be changed at the same time.
• The patient should write down the day and time they applied the patch to remember when to change it.
• The following table shows when to change the patch:

Patch applied on: Patch change on:

Monday
Thursday
Tuesday
Friday
Wednesday
Saturday
Thursday
Sunday
Friday
Monday
Saturday
Tuesday
Sunday
Wednesday

Where to apply the patch

Adults

• The patches should be applied to a flat surface of the upper body or arm (avoiding joint areas).

Children

• To minimize the risk of the child touching or removing the patch, it should be applied to the upper back.
• The patch should be frequently checked to ensure it is properly attached to the skin.
• It is essential to ensure the child does not remove the patch and put it in their mouth, as this can be life-threatening or lead to death.
• The child should be closely monitored for 48 hours after:
• Applying the first patch
• Applying a patch with a higher dose.
• The action of the patch may be delayed after the first application. Therefore, before the full effect of the medicine is apparent, the child may need to receive additional painkillers. The doctor will inform the patient about this.

Adults and children

The patch should not be applied:

• to the same place twice in a row
• to areas with movement (near joints), irritated, or damaged skin.
• to very hairy skin. If there is hair, it should not be shaved (shaving irritates the skin). Instead, the hair should be cut as close to the skin as possible.

Applying the patch

Step 1: Preparing the skin

• The patient should ensure the skin is completely dry, clean, and cool before applying the patch.
• If the skin needs to be cleaned, it should be done with cold water.
• Soap or other cleansing products, oils, creams, lotions, or talcum powder should not be used before applying the patch.
• The patch should not be applied immediately after a hot bath or shower.

Step 2: Opening the pouch

• Each patch is placed in an individual pouch.
• The pouch should be cut open with scissors along the dotted line.
• The edge of the pouch should be carefully and completely cut off without damaging the patch inside.

• The patient should grasp the open pouch by both edges and pull it apart.
• The patch should be removed and immediately applied.
• The empty pouch should be kept to use later for disposing of the used patch.
• Each patch can only be used once.
• The patch should not be removed from the pouch until it is applied.
• The patient should check if the patch is damaged.
• Patches that are cut, broken, or damaged in any way should not be used.
• Patches should never be divided or cut.

Step 3: Removing the protective layer and applying the patch to the skin

• The patient should ensure the clothing in the patch application area is loose; tight, elastic bands or bandages should not be worn.
• The patient should carefully remove one half of the protective layer from the center of the patch. The adhesive layer of the patch should be avoided.
• The adhesive layer of the patch should be applied to the skin.
• The second part of the protective layer should be removed and the entire patch pressed onto the skin with the palm of the hand.
• The patch should be held in place for at least 30 seconds. The patient should ensure the patch is fully attached, especially at the edges.

Step 4: Removing the patch

• Immediately after removing the patch, it should be folded in half to make the adhesive layers stick together.
• The patch should be placed in the original pouch and disposed of according to the pharmacist's instructions.
• Used patches should be stored in a place that is out of sight and inaccessible to children - even used patches still contain medicine that can be harmful to children and pose a risk to their life.

Step 5: Washing hands

• The patient should always wash their hands with clean water after applying or removing a patch.

Additional information about using Matrifen

Daily activities while using patches

• The patches are waterproof.
• The patient can take a shower or bath, but should not rub the patch.
• With the doctor's permission, the patient can exercise or engage in sports while using the patches.
• The patient can also swim while wearing a patch, but:
• The patient should not use prolonged warming baths or saunas.
• The patient should not wear tight, elastic bands or bandages in the patch application area.
• While using the patches, the patient should not heat the patch application site with external heat sources, such as heated pads, electric blankets, hot water bottles, heated beds, heat lamps, or tanning lamps. The patient should not sunbathe or use prolonged warming baths, saunas, or whirlpool baths. In these situations, there is a risk of increased release of the medicine from the patch. How quickly will the patch work?-
• The maximum effect of the first patch may be delayed.
• During the initial treatment period, the doctor may recommend additional painkillers.
• After the initial treatment period, the patch should provide constant pain relief, so the patient can stop taking other painkillers. However, the doctor may occasionally recommend using additional painkillers.

How long will the patient use the patches?

• Matrifen patches are used to treat chronic pain. The attending doctor will inform the patient about the expected duration of treatment.

In case of increased pain

• If the pain suddenly worsens after applying the last patch, the patient should check the patch. If it is no longer attached well or has fallen off, it should be replaced (see also the section "In case of patch detachment").
• If the pain worsens over time while using the patches, the doctor may recommend a patch with a higher dose and (or) administer additional painkillers.
• If increasing the patch dose does not improve the pain, the doctor may decide to stop using the patches.

In case of using more patches than recommended or a patch with an incorrect dose

In case of using too many patches or a patch with an incorrect dose, the patient should immediately remove the patches and contact their doctor as soon as possible.
Overdose symptoms include breathing disorders or shallow breathing, fatigue, excessive drowsiness, inability to think clearly, difficulty walking or talking normally, and feelings of fainting, dizziness, or confusion. Overdose can also cause brain disorders called toxic leukoencephalopathy.

If the patient forgets to change the patch

• The patient should change the patch as soon as they remember and make a note of the day and time. The next patch should be changed after the standard 3 days (72 hours).
• If more time has passed since the patch was changed, the patient should talk to their doctor, as additional painkillers may be necessary, but they should notapply an additional patch.

In case of patch detachment

• If the patch detaches before the required change time, the patient should apply a new patch in its place and make a note of the day and time. The patch should be applied to a different area:
• on the upper body or arm.
• on the upper back - in the case of children.
• The patient should inform their doctor and leave the patch on for 3 days (72 hours)or as advised by the doctor, until the next scheduled patch change.
• If the patch detachment situation recurs, the patient should contact their doctor, pharmacist, or nurse.

Stopping patch use

• The patient should not suddenly stop using this medicine. If they want to stop using it, they should first talk to their doctor. The doctor will inform them how to do it; usually, it is done by gradually reducing the dose, so that any unpleasant withdrawal symptoms are minimized. See also section 2 "Withdrawal symptoms after stopping Matrifen use".
• When stopping patch use, the patient should not restart treatment without consulting their doctor. In such a situation, a different dose than before may be required.

If the patient has any further doubts about using the medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If the patient, partner, or caregiver notices any of the following symptoms in the person using the patches, they should immediately remove the patch and contact their doctor or go to the nearest hospital. Intensive medical care may be necessary.

Medical care.

• Feeling excessively tired, slowed down, or having shallow breathing. The patient should follow the above advice and be encouraged to move and talk as much as possible. Very rarely, these breathing disorders can be life-threatening or lead to death, especially in people who have not previously used strong opioid painkillers (such as Matrifen or morphine). (Uncommon, may occur in 1 in 100 people).
• Sudden swelling of the face or throat, severe irritation, redness, or blisters on the skin. These may be symptoms of a severe allergic reaction. (Frequency cannot be estimated from the available data.)
• Seizures. (Uncommon, may occur in 1 in 100 people).
• Decreased consciousness or loss of consciousness. (Uncommon, may occur in 1 in 100 people).
• 100).

The following side effects have also been reported

Very common side effects (may occur in more than 1 in 10 people):

• nausea, vomiting, constipation,
• drowsiness,
• feeling dizzy,
• headache.

Common side effects (may occur in less than 1 in 10 people):

• allergic reaction,
• loss of appetite,
• insomnia,
• depression,
• feeling anxious or confused,
• seeing, feeling, hearing, or smelling things that do not exist (hallucinations),
• tremors or muscle spasms,
• disorders of sensation, tingling, burning skin (paresthesia),
• dizziness,
• rapid heartbeat or palpitations,
• high blood pressure,
• shortness of breath,
• diarrhea,
• dry mouth,
• abdominal pain or indigestion,
• excessive sweating,
• itching, rash, redness of the skin,
• inability to urinate or fully empty the bladder,
• feeling tired, weak, or unwell,
• feeling cold,
• peripheral edema on the limbs.

Uncommon side effects (may occur in less than 1 in 100 people):

• agitation or disorientation,
• unusual state of happiness and increased activity (euphoria),
• decreased sensation, especially skin (hypoesthesia),
• memory loss,
• blurred vision,
• slow heartbeat or low blood pressure,
• hypoxia (cyanosis),
• intestinal obstruction (ileus),
• itchy rash, allergic reaction, or other skin disorders at the patch application site,
• flu-like symptoms,
• feeling changes in body temperature,
• fever,
• muscle tremors,
• erectile dysfunction (impotence) or sexual function disorders
• difficulty swallowing.

Rare side effects (may occur in less than 1 in 1000 people):

• pupil constriction,
• periodic breathing pauses (apnea).

Frequency not known (cannot be estimated from the available data):

• male sex hormone deficiency (androgen deficiency),
• delirium (symptoms may include agitation, anxiety, disorientation, confusion, fear, seeing or hearing things that do not exist, sleep disorders, nightmares),
• dependence on Matrifen (see section 2).

A rash, redness, or mild itching may occur at the patch application site on the skin. These reactions are usually mild and resolve after the patch is removed. If they do not resolve or the patch causes significant skin irritation, the patient should tell their doctor.
Repeated use of patches may reduce the effectiveness of the medicine (the patient becomes accustomed to it or their sensitivity to pain increases) or may cause dependence on it.
After switching from other painkillers to Matrifen or suddenly stopping Matrifen use, the patient may experience withdrawal symptoms such as nausea, vomiting, diarrhea, anxiety, and chills. The patient should immediately inform their doctor if they experience such symptoms.
In newborns whose mothers have used Matrifen for a long time during pregnancy, cases of withdrawal symptoms have been observed.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Matrifen

Where to store the patches

Unused and used Matrifen patches should be stored in a place that is out of sight and inaccessible to children.
The medicine should be stored in a safe and protected place, inaccessible to other people. It can cause serious harm and lead to death if used accidentally or intentionally by someone it was not prescribed for.

How long can Matrifen be stored

The patient should not use this medicine after the expiration date stated on the outer packaging and protective pouch. The expiration date (after the abbreviation EXP) refers to the last day of the specified month.
In case of expiration, the patient should return unused patches to the pharmacy.
There are no special storage requirements.

How to dispose of used and unused patches

Accidental attachment of a used or unused patch to another person's skin, especially a child, can be fatal.
A used patch should be folded in half, with the adhesive layers stuck together, placed in the original pouch, and then placed in a location that is out of sight and inaccessible to third parties, especially children, until disposal. The patient should ask their pharmacist how to dispose of medicines that are no longer needed.
Medicines should not be disposed of in wastewater or household waste. This will help protect the environment.

6. Package contents and other information

What Matrifen contains

The active substance of the medicine is fentanyl.
The patches are available in 5 different strengths (see the table below).

The other ingredients are: dipropylene glycol, hydroxypropyl cellulose 10 mPas, dimethicone 350 cSt, silicone adhesive (amine resistant, medium tack), silicone adhesive (amine resistant, high tack), controlled-release membrane (ethylene-vinyl acetate copolymer EVA), outer foil (polyethylene terephthalate, PET), protective layer (polyethylene terephthalate, fluoropolymer), ink.

What Matrifen looks like and what the package contains

Matrifen transdermal system is a transparent, rectangular patch. Each patch is packaged in a heat-sealed, child-resistant pouch made of paper, aluminum, and polyethylene terephthalate (PET). The patches have a color print with the trade name, active substance, and dose:
Matrifen, 12 micrograms/hour: brown print.
Matrifen, 25 micrograms/hour: red print.
Matrifen, 50 micrograms/hour: green print.
Matrifen, 75 micrograms/hour: light blue print.
Matrifen, 100 micrograms/hour: gray print.
The patches are supplied in cartons containing 1, 2, 3, 4, 5, 8, 10, 16, and 20 systems.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Istituto Gentili S.r.l.
Via San Giuseppe Cottolengo 15
20143 Milan
Italy
e-mail: medinfo.pl@gentilipharma.com

Manufacturer

LTS Lohmann Therapie-Systeme AG
Lohmannstrasse 2

• D – 56626 Andernach Germany

Date of last revision of the leaflet:03.2025