Fenta Mx 25

Leaflet accompanying the packaging: patient information

Fenta MX 25, 25 micrograms/hour, transdermal patch

Fenta MX 50, 50 micrograms/hour, transdermal patch

Fenta MX 75, 75 micrograms/hour, transdermal patch

Fenta MX 100, 100 micrograms/hour, transdermal 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 further questions, you should ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What Fenta MX is and what it is used for
• 2. Important information before using Fenta MX
• 3. How to use Fenta MX
• 4. Possible side effects
• 5. How to store Fenta MX
• 6. Contents of the packaging and other information

1. What Fenta MX is and what it is used for

The medicine is called Fenta MX.
The Fenta MX patches help to alleviate very severe, chronic pain:

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

The Fenta MX patches contain an active substance called fentanyl. Fentanyl belongs to a group of strong painkillers, known as opioids.

2. Important information before using Fenta MX

When not to use Fenta MX

if the patient is allergic to fentanyl, hydrogenated castor oil, soy, peanuts, or any of the other ingredients of this medicine (listed in section 6);
if the patient experiences short-term pain (e.g., sudden pain or post-operative pain);
if the patient has breathing disorders (slowed or shallow breathing);
Do not use this medicine if any of the above situations apply to the patient. In case of doubt before using Fenta MX, consult a doctor or pharmacist.

Warnings and precautions

Fenta MX may cause life-threatening side effects in people who do not regularly use prescribed opioid medications.
Fenta MX is a medicine that can be life-threatening to children. This also applies to used patches.
It should be remembered that the appearance of the patch (new or used) may attract children's attention,
and if attached to the skin or put in the mouth, it can pose a life-threatening risk to them in some cases. This medicine should be stored in a safe place, inaccessible to others - more information on this can be found in section 5.

Accidental attachment of the patch to another person

Patches should only be used on the skin of the person they have been prescribed for. There have been reports of accidental attachment of a transdermal fentanyl system to a family member's skin during close physical contact or sharing the same bed. Transferring the transdermal fentanyl system to another person's skin (especially a child) can cause fentanyl to penetrate the patch through the other person's skin and cause severe side effects, such as breathing difficulties (with slowed or shallow breathing), which can be fatal. If a patch is accidentally attached to another person's skin, it should be removed immediately and medical help should be sought.

Special caution is required when using Fenta MX

Before using this medicine, you should talk to your doctor or pharmacistif the patient has any of the following conditions, as close monitoring of the patient's condition may be necessary:

• the patient has had lung or breathing problems,
• the patient has had heart, liver, kidney, or low blood pressure problems,
• the patient has had a brain tumor,
• the patient has had persistent headaches or head injuries,
• the patient is elderly - may be more sensitive to the effects of this medicine,
• the patient has myasthenia gravis (a disease that causes fatigue and muscle weakness),
• the patient or someone in their family has ever abused or been dependent on alcohol, medications, or drugs (addiction),
• the patient is a smoker, the patient has had muscle tone disorders (such as cyclobenzaprine or diazepam), or the patient has had mood disorders (depression, anxiety, or personality disorder) or has been treated by a psychiatrist for other mental illnesses.

If any of the above situations apply to the patient (or the patient is unsure), they should consult a doctor or pharmacist before using Fenta MX.

During the use of patches, you should inform your doctor if the patient experiences

breathing problems during sleep. Opioids, such as Fenta MX, can cause sleep breathing disorders, such as sleep apnea (pauses in breathing during sleep) and nocturnal hypoxemia (low oxygen levels in the blood). You should inform your doctor if the patient, their partner, or caregiver notices any of the following symptoms:

• pauses in breathing during sleep
• nighttime awakenings due to shortness of breath
• difficulty maintaining sleep
• excessive daytime sleepiness. The doctor may decide to change the dose of the medicine.

During the use of patches, you should inform your doctor if the patient notices a change in

pain perception. If the patient feels that:

• the pain no longer subsides after applying the patch
• the pain worsens
• there is a change in the way the pain is perceived (e.g., the patient feels pain in a different part of the body)
• touching the body causes pain that should not be there. Do not change the dose yourself. The doctor may decide to change the dose or treatment.

Side effects and Fenta MX

• Fenta MX may cause unusual drowsiness and slowed or shallow breathing. These breathing disorders can be life-threatening or even fatal, especially in people who have not previously used strong opioid painkillers (such as Fenta MX or morphine). If the patient or someone around them 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.
• If the patient develops a fever while using Fenta MX, they should tell their doctor - an increase in body temperature may increase the absorption of the medicine through the skin.
• Fenta MX may cause constipation; the patient should ask their doctor or pharmacist how to prevent or alleviate constipation. Repeated, long-term use of Fenta MX may lead to reduced efficacy of the medicine (tolerance to the medicine) or dependence. Increasing the dose of the patches may provide temporary relief from pain, but it can also be harmful. If the patient notices that their medicine is becoming less effective, they should consult their doctor. The doctor will decide whether to increase the dose or gradually reduce the use of Fenta MX. Additionally, if the patient is concerned about becoming dependent, they can consult their doctor about this. In section 4 of the leaflet, there is a complete list of possible side effects.

Avoid exposing the patch attachment site to direct heat from external sources, such as heating pads, electric blankets, hot water bottles (thermoses), heated waterbeds, heat lamps, or tanning beds. You should also avoid sunbathing and using prolonged hot baths, saunas, or hot springs. In these situations, there is a risk of increased release of fentanyl from the patch.

Withdrawal symptoms after stopping the use of Fenta MX

Do not stop using this medicine suddenly. Stopping the use of this medicine may cause withdrawal symptoms, such as anxiety, difficulty sleeping, irritability, restlessness, anxiety, palpitations, increased blood pressure, nausea, 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, this is done by gradually reducing the dose, so that any unpleasant withdrawal symptoms are minimized. See also section 2 "Withdrawal symptoms after stopping the use of Fenta MX".

Fenta MX and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This includes medicines available without a prescription or herbal medicines. Also, when buying other medicines at the pharmacy, tell the pharmacist about the use of Fenta MX.
The attending doctor will know which medicines can be safely used with Fenta MX.
The patient will require close monitoring if they are using certain medicines listed below or if they are stopping certain medicines listed below, as this may affect the strength of the necessary effect of Fenta MX.
In particular, tell your doctor or pharmacist if the patient is taking:

• other painkillers, such as opioids (e.g., buprenorphine, nalbuphine, or pentazocine) and certain painkillers used for neuropathic pain (gabapentin and pregabalin);
• sleeping pills (such as temazepam, zaleplon, or zolpidem);
• tranquilizers (such as alprazolam, clonazepam, diazepam, hydroxyzine, or lorazepam) and antipsychotic medications (such as aripiprazole, haloperidol, olanzapine, risperidone, or phenothiazines);
• muscle relaxants (such as cyclobenzaprine or diazepam);
• certain antidepressants called SSRIs or SNRIs (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine) - more information is below;
• certain medications used to treat depression or Parkinson's disease, called MAOIs (such as isocarboxazid, phenelzine, selegiline, or tranylcypromine). Do not use Fenta MX for 14 days after stopping these medications - 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 medications (such as itraconazole, ketoconazole, fluconazole, or voriconazole);
• medications used to treat HIV (such as ritonavir);
• antiarrhythmic medications (such as amiodarone, diltiazem, or verapamil);
• antituberculosis medications (such as rifampicin);
• certain antiepileptic medications (such as carbamazepine, phenobarbital, or phenytoin);
• certain medications used to treat nausea and motion sickness (such as phenothiazines);
• certain medications used to treat heartburn or stomach ulcers (such as cimetidine);
• certain medications used to treat angina or high blood pressure (such as nicardipine);
• certain medications used to treat blood cancers (such as idelalisib).

Using Fenta MX with antidepressants

The risk of side effects increases when used with certain antidepressants. Fenta MX may interact with these medications, and the patient may experience changes in mental state, such as agitation, hallucinations, and other effects, such as changes in blood pressure, rapid heartbeat, high temperature, excessive reflexes, lack of coordination, muscle stiffness, nausea, vomiting, and diarrhea.

Using Fenta MX with substances that inhibit the activity of the central nervous system (CNS), including benzodiazepines, alcohol, and certain narcotic drugs

Tell your doctor if the patient is taking any other medications that slow down CNS activity. These include sleeping pills, anxiolytics, or medications that reduce awareness (see also above "Fenta MX and other medicines"), as well as alcohol and certain narcotic drugs.
Taking such medications with Fenta MX can cause significant drowsiness, decreased consciousness, breathing difficulties with slowed or shallow breathing, coma, and death.
Therefore, concurrent use can only be considered if other treatment options are not possible.
If the doctor prescribes Fenta MX to be used with sedatives, they will recommend a limited dose and treatment duration. The patient should strictly follow their recommendations regarding dosing. It may be helpful to inform friends or family members about the possibility of the above symptoms. If the patient experiences such symptoms, they should contact their doctor.
Do not drink alcohol while using Fenta MX without consulting the attending doctor.

Surgery

If the patient is to undergo anesthesia, they should tell their doctor or dentist about the use of Fenta MX.

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.
Fenta MX should not be used during pregnancy, unless the patient has discussed it with their doctor.
Fenta MX is not recommended during labor, as it may cause breathing difficulties in the newborn.
Long-term use of Fenta MX during pregnancy may cause withdrawal symptoms in the newborn (such as loud crying, trembling, seizures, insufficient feeding, and diarrhea), which can be life-threatening if not recognized and treated. If it is suspected that the child may experience withdrawal symptoms, the patient should contact their doctor immediately.
Do not use Fenta MX while breastfeeding. Do not breastfeed for 3 days after removing the Fenta MX patch. The medicine passes into breast milk.

Driving and operating machinery

Fenta MX affects the ability to drive and operate machinery or tools, as it may cause drowsiness or dizziness. In such cases, do not drive vehicles, use tools, or operate machinery. Do not drive vehicles until you know how the medicine affects you.
Talk to your doctor or pharmacist if the patient is unsure whether they can safely drive while using this medicine.

Fenta MX contains soybean oil

Patients allergic to peanuts or soy should not use this medicine.

3. How to use Fenta MX

This medicine should always be used as directed by the doctor. If you are unsure, consult your doctor or pharmacist.
The doctor will determine the most suitable dose of Fenta MX for the patient, taking into account the severity of the pain, the patient's overall condition, and their previous pain treatment.

Using and changing patches

• Each patch contains enough medicine for 3 days (72 hours).
• The patch should be changed every third day, unless the doctor recommends otherwise.
• Always remove the old patch 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 one patch, all patches should be changed at the same time.
• The patient should write down the day, date, and time of patch application to remember when to change the patch.
• The following table shows when to change the patch:

Where to apply the patch

Adults

• Patches should be applied to a flat surface of the upper body or arm (avoiding areas around joints).

Children

• The patch should always be applied to the upper back to minimize the possibility of the child removing the patch.
• It is essential to frequently check if the patch is properly attached to the skin.
• The child should not remove the patch and put it in their mouth, as this can be life-threatening and even fatal.
• The child should be closely monitored for 48 hours after:
• applying the first patch
• applying a patch with a higher strength.
• It may take some time for the patch to reach its maximum effect. Therefore, it may be necessary to administer additional painkillers to the child until the full effect of the medicine is apparent. The attending doctor will inform the patient about this.

Adults and children

Do not apply the patch:

• to the same place twice in a row,
• to areas with movement (around joints), irritated, or damaged skin,
• to very hairy skin. If the skin at the patch attachment site is hairy, do not shave the hair (shaving irritates the skin), but before applying the patch, cut the hair as close to the skin as possible.

Applying the patch

Step 1: preparing the skin

• Before applying the patch, make sure the skin is completely dry, clean, and cool.
• If the skin needs to be cleaned, use cold water.
• Do not use soap or other cleaning products, creams, lotions, or talcum powder before applying the patch.
• Do not apply the patch immediately after a hot bath or shower.

Step 2: opening the pouch

• Each patch is placed in an individual pouch.
• Tear the pouch at the notch.
• Gently peel off one edge of the pouch completely.
• Grasp both edges of the open pouch and stretch.
• Remove the patch and apply it immediately.
• Keep the empty pouch to use later to remove the used patch.
• Each patch can only be used once.
• Do not remove the patch from the pouch until you are ready to apply it.
• Check if the patch is damaged.
• Do not use patches that are cut, broken, or damaged in any way.
• Never divide or cut patches.

Step 3: unfolding the patch and applying it to the skin

• Make sure the clothing at the patch site is loose; do not wear tight or elastic clothing that may press on the patch.
• Carefully peel off the middle part of the transparent protective layer. Avoid touching the adhesive layer of the patch.
• Apply the adhesive layer of the patch to the skin.
• Remove the second part of the protective layer and press the entire patch to the skin with your hand.
• Hold for at least 30 seconds. Make sure the patch adheres completely, especially at the edges.

Step 4: removing the patch

• Immediately after removing the patch, fold it in half so that the adhesive layers stick together.
• Put it in the original pouch and dispose of it according to the instructions.
• Used patches should be stored in a place that is not visible and inaccessible to children. Even used patches still contain medicine that can be harmful to children and pose a life-threatening risk.

Step 5: washing hands

• After applying and removing the patch, always wash your hands with clean water only.

Additional information about using Fenta MX

Daily activities while using patches

• Patches are waterproof.
• You can take a shower or bath, but do not rub the patch.
• With the doctor's permission, you can exercise or engage in sports while using the patch.
• You can also swim while wearing the patch, but:
• do not use prolonged hot baths or saunas,
• do not wear tight or elastic clothing that may press on the patch.
• While using the patch, avoid excessive exposure of the patch attachment site to external heat sources, such as heating pads, electric blankets, hot water bottles (thermoses), heated waterbeds, heat lamps, or tanning beds. Do not sunbathe or use prolonged hot baths, saunas, or hot springs. There is a risk of increased release of fentanyl from the patch due to elevated temperature.

How quickly will the patch work?

• The effect of the patch may be delayed after the first dose is applied.
• The doctor may recommend additional painkillers on the first day.
• After that, the patch should provide continuous pain control, so the patient can stop taking other painkillers. However, the attending doctor may occasionally recommend additional painkillers.

How long will the patient use the patches?

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

In case of increased pain

• If the pain suddenly worsens after applying the last patch, check the patch. If it is no longer attached well or has fallen off, replace it (see also "If the patch falls off").
• If the pain worsens over time while using the patches, the attending doctor may prescribe a patch with a higher strength and (or) administer additional painkillers.
• If increasing the patch strength does not improve the pain, the doctor may decide to stop using the patches.

In case of using a higher dose of Fenta MX than recommended (too many patches or a patch with a higher dose than prescribed by the doctor)

In case of using too many patches or a patch with a higher dose of Fenta MX than prescribed by the doctor, remove the patch (or patches) immediately and contact a doctor as soon as possible.
Symptoms of overdose include breathing difficulties or shallow breathing, fatigue, excessive drowsiness, inability to think clearly, difficulty walking or talking normally, and feelings of fainting, dizziness, or confusion.

If the patient forgets to change the patch

• Change the patch as soon as you remember and note the day and time. The next patch should be changed after 3 days (72 hours).
• If more time has passed since the patch was changed, talk to your doctor, as additional painkillers may be necessary, but do notapply an extra patch.

In case the patch falls off

• If the Fenta MX patch falls off before the required change time, apply a new one in its place and note the day and time. Apply the patch to a different location:
• on the upper body or arm,
• on the upper back - in children.
• Tell your doctor and leave the patch on for 3 days (72 hours)or as directed by your doctor, until the next standard patch change.
• If the patch falls off repeatedly, contact your doctor, pharmacist, or nurse.

Stopping the use of patches

• Do not stop using this medicine suddenly. 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, this is done by gradually reducing the dose, so that any unpleasant withdrawal symptoms are minimized. See also section 2 "Withdrawal symptoms after stopping the use of Fenta MX".
• If the patient has been using the patches for a long time, their body may have become accustomed to the medicine. If the patient stops using the patches suddenly, they may feel unwell.
• If the patient stops using the patches, they should not start using them again without consulting their doctor. In this situation, a different dose than before may be required.

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

4. Possible side effects

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

If you notice any of the following symptoms in the person using the patches, remove the patch and contact a doctor or go to the nearest hospital immediately. Intensive medical care may be necessary.

• Feeling overly drowsy, slowed down, or having shallow breathing. Follow the above advice and encourage the patient to move and talk. These breathing disorders can be life-threatening, especially in people who have not previously used strong opioid painkillers (such as Fenta MX or morphine). (Uncommon: may occur in less than 1 in 100 people)
• Sudden swelling of the face or throat, severe irritation, redness, or blistering of the skin. These may be symptoms of a severe allergic reaction. (Frequency cannot be estimated from the available data.)
• Seizures. (Uncommon: may occur in less than 1 in 100 people)
• Changes in consciousness or loss of consciousness. (Uncommon: may occur in less than 1 in 100 people)

The following side effects have also been reported

Very common(may occur in more than 1 in 10 people)
nausea, vomiting, constipation
drowsiness
dizziness
headaches
Common(may occur in less than 1 in 10 people)
allergic reaction
loss of appetite
difficulty sleeping
depression
anxiety or confusion
seeing, feeling, hearing, or smelling things that are not there (hallucinations)
tremors or muscle spasms
abnormal skin sensations, such as tingling (paresthesia)
feeling of spinning
feeling of rapid or irregular heartbeat (palpitations, tachycardia)
high blood pressure
shortness of breath (dyspnea)
diarrhea
dry mouth
stomach pain, indigestion
excessive sweating
itching, rash, or redness of the skin
difficulty urinating or completely emptying the bladder
general feeling of severe fatigue, weakness, or malaise
feeling of cold
swelling of hands, ankles, or feet (peripheral edema)
Uncommon(may occur in less than 1 in 100 people)
feeling of agitation or disorientation
feeling of excessive carelessness (euphoria)
decreased sensation, especially on the skin (hypoesthesia)
memory loss
blurred vision
slow heartbeat (bradycardia) or low blood pressure
blue discoloration of the skin due to lack of oxygen in the blood (cyanosis)
lack of bowel movements (ileus)
itchy rash (urticaria), allergic reaction, or other skin disorders at the patch application site
flu-like symptoms
feeling of changes in body temperature
fever
muscle tremors
difficulty achieving or maintaining an erection (impotence) or sexual dysfunction
Rare(may occur in less than 1 in 1,000 people)
pupil constriction
temporary cessation of breathing (apnea)

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

lack of male sex hormones (androgen deficiency)
delirium (symptoms may include a combination of agitation, anxiety, disorientation, confusion, hallucinations, sleep disturbances, nightmares)
A rash, redness, or mild itching may occur at the patch application site on the skin. These reactions are usually mild and disappear after removing the patch. If they do not disappear or the patch causes significant skin irritation, tell your doctor.
Repeated use of patches may lead to reduced efficacy of the medicine (tolerance to the medicine) or dependence on it.
After changing from previously used painkillers to Fenta MX or after sudden withdrawal of Fenta MX, some patients may experience withdrawal symptoms (such as nausea, vomiting, diarrhea, anxiety, or shivering). Tell your doctor immediately if such symptoms occur.
In newborns of mothers who used Fenta MX for a long time during pregnancy, withdrawal symptoms have been observed.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your 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 181C, 02-222 Warsaw, tel.: +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.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Fenta MX

All patches (new and used) should be stored in a place that is not visible and inaccessible to children.
This medicine should be stored in a safe place, where others cannot access it. It can cause serious harm and be fatal if taken accidentally or intentionally by someone who has not been prescribed it.
Do not use this medicine after the expiration date stated on the carton and sachet after EXP. The expiration date refers to the last day of the specified month.
Store in the original packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
Accidental exposure to a used or unused patch, especially in children, can be fatal.
Used patches should be folded in half, with the adhesive layers stuck together, placed in the original pouch, and stored until disposal in a safe and secure manner, out of sight and reach of children.

6. Contents of the packaging and other information

What Fenta MX contains

The active substance is fentanyl.
Each transdermal patch with a release surface area of 10.5 cm contains 5.78 mg of fentanyl (which corresponds to a release rate of 25 micrograms of fentanyl per hour).
Each transdermal patch with a release surface area of 21 cm contains 11.56 mg of fentanyl (which corresponds to a release rate of 50 micrograms of fentanyl per hour).
Each transdermal patch with a release surface area of 31.5 cm contains 17.34 mg of fentanyl (which corresponds to a release rate of 75 micrograms of fentanyl per hour).
Each transdermal patch with a release surface area of 42 cm contains 23.12 mg of fentanyl (which corresponds to a release rate of 100 micrograms of fentanyl per hour).
The other ingredients are purified soybean oil, hydrogenated castor oil, and resin.
Adhesive layer:poly (2-ethylhexyl acrylate, vinyl acetate) 1:1
Outer protective layer:polyethylene terephthalate
Protective layer (removable):silicone-coated polyethylene terephthalate
Printing ink

What Fenta MX looks like and contents of the packaging

Fenta MX is a transparent, rounded, elongated patch with an adhesive layer, covered with a protective foil (which should be removed before use), which can be attached to the skin.
The packaging contains 5, 10, 16, and 20 transdermal patches.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria
Manufacturer
HEXAL AG
Industriestrasse 25
83607 Holzkirchen, Germany

To obtain more detailed information about the medicine and its names in other European Economic Area countries, please contact:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Date of last revision of the leaflet:09/2022
{Logo Sandoz}