Fenta Mx 50

Leaflet accompanying the packaging: patient information

Fenta MX 25, 25 micrograms/hour, transdermal patch system

Fenta MX 50, 50 micrograms/hour, transdermal patch system

Fenta MX 75, 75 micrograms/hour, transdermal patch system

Fenta MX 100, 100 micrograms/hour, transdermal patch system

Fentanyl

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of further doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for one person. Do not pass it on to others. The medicine may harm another person, even if their illness symptoms are the same.
• 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 Fenta MX and what is it 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 is Fenta MX and what is it 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 rosins, 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 respiratory disorders (slowed or shallow breathing);
Do not use this medicine if any of the above situations apply to the patient. In case of doubts 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 when stuck 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 other people - more information on this can be found in section 5.

Accidental sticking 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 sticking 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 the patch sticks 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, consult a 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 difficulties,
• the patient has had heart, liver, kidney, or low blood pressure disorders,
• 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 abused or been addicted to alcohol, medications, or drugs (addiction),
• the patient is a smoker, 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, the patient should inform the doctor if they experience

breathing problems during sleep. Opioids, such as Fenta MX, can cause sleep apnea (pauses in breathing during sleep) and hypoxia during sleep (low oxygen levels in the blood). The patient should inform the 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 the use of patches, the patient should inform the doctor if they notice 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 consult a doctor or pharmacist on 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 addiction. Increasing the dose of the patches may provide temporary pain relief, but it can also be harmful. If the patient notices that their medicine is becoming less effective, they should consult a doctor. The doctor will decide whether to increase the dose or gradually reduce the use of Fenta MX. If the patient has concerns about addiction, they can also consult a doctor about this. A full list of possible side effects can be found in section 4 of the leaflet.

It is recommended to avoid exposing the patch application site to direct heat from external sources, such as: heated pads, electric blankets, hot water bottles (hot compresses), heated water beds, heat lamps, or tanning beds. It is also not recommended to sunbathe or use prolonged warming baths, saunas, or hot springs. In these situations, there is a risk of increased fentanyl release from the patch.

Withdrawal symptoms after stopping the use of Fenta MX

Do not stop using this medicine abruptly. Stopping the use of this medicine may cause withdrawal symptoms, 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 consult a 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 the use of Fenta MX".

Fenta MX and other medicines

Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take. This includes over-the-counter medicines and herbal medicines. When buying other medicines at the pharmacy, the patient should also inform 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 taking certain medicines listed below or if they stop taking certain medicines listed below, as this may affect the strength of the necessary effect of Fenta MX.
In particular, the patient should tell the doctor or pharmacist if they are 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 medicines (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 medicines used to treat depression or Parkinson's disease, called MAOIs (such as isocarboxazid, phenelzine, selegiline, or tranylcypromine). Fenta MX 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 (such as ritonavir);
• antiarrhythmic 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 or stomach ulcers (such as cimetidine);
• certain medicines used to treat angina or high blood pressure (such as nicardipine);
• certain medicines 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 medicines, 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 the doctor if the patient is taking any other medicines that slow down CNS activity. These include sleeping pills, anxiolytics, or sedatives (see also "Fenta MX and other medicines" above), as well as alcohol and certain narcotic drugs.
Taking such medicines with Fenta MX can cause significant drowsiness, decreased consciousness, breathing difficulties with slowed or shallow breathing, coma, and death.
Concomitant 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 a 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 childbirth, 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, convulsions, 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 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 using machines

Fenta MX may affect the ability to drive and use machines or tools, as it may cause drowsiness or dizziness. In such cases, do not drive, use tools, or operate machines. Do not drive until you know how the medicine affects you.
Consult a doctor or pharmacist if the patient is unsure whether they can drive safely 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. In case of doubts, consult a 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 uses more than 1 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 joint areas).

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 give the child additional painkillers 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 moving areas (near joints), irritated, or damaged skin,
• to very hairy skin. If the skin is hairy at the patch application site, do not shave the hair (shaving irritates the skin), but cut it as close to the skin as possible before applying the patch.

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 opened pouch.
• Grasp both edges of the opened pouch and stretch it.
• Remove the patch and apply it immediately.
• Keep the empty pouch to use later to dispose of the used patch.
• Each patch can only be used once.
• Do not remove the patch from the pouch until 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 onto 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

• 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 patch.
• The patient can also swim while wearing the patch, but:
• should not use prolonged warming baths or saunas,
• should not wear tight or elastic clothing that may press on the patch.
• While using the patch, the patient should avoid excessive exposure of the patch application site to external heat sources, such as: heated pads, electric blankets, hot water bottles (hot compresses), heated water beds, heat lamps, or tanning beds. The patient should not sunbathe or use prolonged warming baths, saunas, or hot springs. There is a risk of increased fentanyl release 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 treatment.

In case of increased pain

• If the pain suddenly worsens after applying the last patch, the patient should check the patch. If it no longer adheres well or has fallen off, they should replace it (see also "In case 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 than recommended dose of Fenta MX (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, the patient should immediately remove the patch (or patches) and contact their doctor as soon as possible.
Symptoms of overdose include breathing difficulties or shallow breathing, fatigue, excessive drowsiness, difficulty thinking, walking, or talking normally, and feelings of fainting, dizziness, or confusion.

If the patient forgets to change the patch

• The patient should change the patch as soon as they remember and note the day and time. The next

patch should be changed after 3 days (72 hours)as usual.

• If more time has passed since the patch was changed, the patient should talk to their doctor, as they may need to use additional painkillers, but should notapply an extra patch.

In case the patch falls off

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

Stopping the use of patches

• Do not stop using this medicine abruptly. If the patient wants to stop using this medicine, they should first consult a 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 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 abruptly, they may feel unwell.
• If the patient stops using the patches, they should not restart treatment without consulting a doctor. In this situation, a different dose than before may be required.

In case of any further doubts about using this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Fenta MX can cause side effects, although not everybody gets them.

If the patient experiences any of the following symptoms, they should remove the patch and contact their doctor or go to the nearest hospital immediately. Intensive medical care may be necessary.

• Feeling overly drowsy, slowed, or 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
headache
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)
reduced sensation, especially on the skin (hypoesthesia)
memory loss
blurred vision
slow heartbeat (bradycardia) or low blood pressure
blue discoloration of the skin due to low oxygen levels 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 1000 people)
pupil constriction
temporary cessation of breathing (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, 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 resolve after removing the patch. If they do not resolve or the patch causes significant skin irritation, the patient should tell their doctor.
Repeated use of patches may lead to reduced efficacy of the medicine (tolerance to the medicine) or addiction.
After switching from other painkillers to Fenta MX or after abrupt cessation of Fenta MX, some patients may experience withdrawal symptoms (such as nausea, vomiting, diarrhea, anxiety, or shivering). The patient should immediately inform their doctor about such symptoms.
In newborns of mothers who used Fenta MX for a long time during pregnancy, withdrawal symptoms have been observed.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 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.
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 other people do not have access to 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. The patient should ask their 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, in a place that is not visible and inaccessible to others, especially children.

6. Contents of the packaging and other information

What Fenta MX contains

The active substance is fentanyl.
Each transdermal patch system, 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 system, 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 system, 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 system, 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, rosin, and hydrogenated rosin.
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 pack

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 stuck to the skin.
The packaging contains 5, 10, 16, and 20 transdermal patch systems, 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 EU countries, please contact:

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