Package leaflet: Information for the patient

Fenta MX 25, 25 micrograms/hour, transdermal system, patch
Fenta MX 50, 50 micrograms/hour, transdermal system, patch
Fenta MX 75, 75 micrograms/hour, transdermal system, patch
Fenta MX 100, 100 micrograms/hour, transdermal system, patch
Fentanylum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

What Fenta MX is and what it is used for
Important information before using Fenta MX
How to use Fenta MX
Possible side effects
How to store Fenta MX
Contents of the pack and other information

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

The medicine is called Fenta MX.
Fenta MX patches help relieve severe, chronic pain:

in adults requiring continuous pain relief medication;
in children over 2 years of age who have already been receiving opioid medications and who require continuous pain relief treatment.

Fenta MX patches contain the 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 rosin, 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-surgical pain);
if the patient has respiratory disorders (slow or shallow breathing);
Do not use this medicine if any of the above situations apply to the patient. If in doubt, consult a doctor or pharmacist before using Fenta MX.

Warnings and precautions
Fenta MX may cause life-threatening adverse effects in individuals who are not already regularly taking prescribed opioid medicines.
Fenta MX is a medicine that may be life-threatening to children, including used patches.
Note that the appearance of the patch (new or used) may attract children's attention, and if attached to the skin or placed in the mouth, it may in some cases pose a risk to their life. This medicine must be stored in a safe place inaccessible to others – more information on this can be found in section 5.

Accidental adhesion of the patch to another person
Patches must be used only on the skin of the person for whom they have been prescribed. Cases have been reported of accidental adhesion of a fentanyl transdermal system to a family member's skin during close physical contact or sharing the same bed. Transfer of the fentanyl transdermal system to another person's skin (especially a child) may result in fentanyl passing through the skin of that person, causing severe adverse effects such as breathing difficulties (with slowed or shallow breathing), which may lead to death. If a patch adheres to another person's skin, remove it immediately and seek medical help.

Special caution when using Fenta MX
Before using this medicine, consult a doctor or pharmacist if the patient has any of the following conditions, as close monitoring may be required:

the patient has ever had lung diseases or breathing difficulties,
the patient has ever had heart, liver, or kidney function disorders or low blood pressure,
the patient has ever had a brain tumor,
the patient has ever had persistent headaches or head injury,
the patient is elderly – may be more sensitive to the effects of this medicine,
the patient has myasthenia gravis, a disease causing muscle fatigue and weakness,
the patient or anyone in the family has ever abused or been dependent on alcohol, medicines, or drugs ("addiction"),
the patient is a smoker, has ever 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), consult a doctor or pharmacist before using Fenta MX.

While using the patches, inform the doctor if the patient experiences breathing problems during sleep.
Opioids such as Fenta MX may cause breathing disorders during sleep, such as sleep apnea (pauses in breathing during sleep) and nocturnal hypoxia (low blood oxygen levels). Inform the doctor if the patient, their partner, or caregiver notices any of the following symptoms:

pauses in breathing during sleep
nighttime awakenings due to breathlessness
difficulty maintaining sleep
excessive daytime sleepiness. The doctor may decide to adjust the dose.

While using the patches, inform the doctor if the patient notices a change in pain perception.
If the patient experiences any of the following:

pain no longer subsides after applying the patch
pain intensifies
a change in the way pain is felt (e.g., pain felt in another part of the body)
touch causes pain that should not be present.
Do not change the dose independently. The doctor may decide to adjust the dose or treatment.

Adverse effects and Fenta MX

Fenta MX may cause unusual drowsiness and slowed or shallow breathing. Very rarely, these respiratory disorders may be life-threatening or even fatal, especially in individuals who have not previously used strong opioid painkillers (such as Fenta MX or morphine). If the patient or someone nearby 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 immediately to the nearest hospital
encourage the patient to move and speak.
If fever occurs during treatment with Fenta MX, inform the doctor – increased body temperature may enhance drug absorption through the skin.
Fenta MX may cause constipation; consult a doctor or pharmacist on how to prevent or relieve constipation. Repeated, long-term use of Fenta MX may lead to reduced effectiveness of the medicine (tolerance) or dependence. Increasing the patch dose may temporarily reduce pain but may also be harmful. If the patient notices that the medicine becomes less effective, they should consult the doctor. The doctor will decide whether it is better to increase the dose or gradually reduce the use of Fenta MX. If the patient is concerned about possible dependence, they may also consult the doctor. A complete list of possible adverse effects is provided in section 4 of the leaflet.

Avoid exposing the patch application site to direct external heat sources such as heating pads, electric blankets, hot water bottles (heat packs), heated water beds, heating or tanning lamps. Do not sunbathe or use prolonged hot baths, saunas, or hot thermal springs. In these situations, there is a risk of increased fentanyl release from the patch.

Withdrawal symptoms after stopping Fenta MX
Do not abruptly discontinue this medicine. Withdrawal symptoms may occur, such as restlessness, difficulty falling asleep, irritability, agitation, anxiety, palpitations, increased blood pressure, nausea or vomiting, diarrhea, loss of appetite, tremor, chills, or sweating. If the patient wishes to stop using this medicine, they should first consult a doctor. The doctor will advise how to do so; usually, this involves gradually reducing the dose to minimize any unpleasant withdrawal symptoms.

Fenta MX and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to use. This includes over-the-counter medicines or herbal remedies. Also, when purchasing other medicines at the pharmacy, inform the pharmacist about the use of Fenta MX.
The treating doctor will know which medicines can be safely used with Fenta MX. Close monitoring may be required when using or discontinuing certain medicines listed below, as they may affect the required strength of Fenta MX.

In particular, inform the 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 medicines (such as temazepam, zaleplon, or zolpidem);
sedatives (tranquilizers, such as alprazolam, clonazepam, diazepam, hydroxyzine, or lorazepam) and antipsychotics (such as aripiprazole, haloperidol, olanzapine, risperidone, or phenothiazines);
medicines that reduce muscle tension (such as cyclobenzaprine or diazepam);
certain antidepressants called SSRIs or SNRIs (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine) – further information below;
certain medicines used to treat depression or Parkinson's disease, known as MAOIs (such as isocarboxazid, phenelzine, selegiline, or tranylcypromine). Do not use Fenta MX within 14 days after stopping these medicines – see below;
certain antihistamines, especially those causing 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 in HIV infection (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 peptic ulcer disease (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).

Use of Fenta MX with antidepressant medicines
The risk of adverse effects increases when used concurrently with certain antidepressants. Fenta MX may interact with these medicines, leading to changes in mental status, such as agitation, hallucinations (seeing, feeling, or hearing things that are not real), and other effects such as blood pressure fluctuations, rapid heartbeat, high temperature, excessive reflexes, lack of coordination, muscle stiffness, nausea, vomiting, and diarrhea.

Use of Fenta MX with substances that depress the central nervous system (CNS), including benzodiazepines, alcohol, and certain narcotic medicines
Inform the doctor if the patient is taking any other medicines that slow down CNS function. These include medicines such as sleeping pills, anxiety relievers, or consciousness-reducing agents (see also above "Fenta MX and other medicines"), as well as alcohol and certain narcotic medicines. Taking such medicines with Fenta MX may cause significant drowsiness, reduced consciousness, breathing difficulties with slowed or shallow breathing, coma, and death. Therefore, concurrent use should only be considered when other treatment options are not possible.
If the doctor prescribes Fenta MX to be used together with sedatives, they will recommend a limited dose and duration of combined treatment. It is essential to strictly follow their dosing instructions. It may be helpful to inform friends or family about the possibility of these symptoms occurring. If such symptoms occur, contact the doctor.
Do not drink alcohol while using Fenta MX without first discussing it with the treating doctor.

Surgery
If the patient is undergoing anesthesia, inform the doctor or dentist about the use of Fenta MX.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Fenta MX should not be used during pregnancy unless discussed with the doctor.
Fenta MX is not recommended during labor, as it may cause respiratory disorders in the newborn.
Long-term use of Fenta MX during pregnancy may cause withdrawal symptoms in the newborn (such as loud crying, tremor, seizures, poor feeding, and diarrhea), which may be life-threatening if not recognized and treated. If withdrawal symptoms in the child are suspected, contact the 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, use tools, or operate machinery. Do not drive until the patient knows how their body reacts to the medicine.
Consult a doctor or pharmacist if the patient is unsure whether it is safe to drive while using this medicine.

Fenta MX contains soy oil
Patients allergic to peanuts or soy should not use this medicine.

3. How to use Fenta MX

This medicine should always be used exactly as directed by the doctor. In case of doubts, consult
the doctor or pharmacist.
The doctor will determine the most appropriate dose of Fenta MX for the patient, taking into account
the intensity of pain, the patient's general condition, and previous pain treatment methods.
Application and changing of patches

Each patch contains enough medicine for 3 days (72 hours).
The patch should be changed every third day, unless otherwise directed by the doctor.
The old patch must always be removed before applying a new one.
The patch should always be changed at the same time of day every 3 days (72 hours).
If the patient uses more than one patch, all patches should be changed simultaneously.
It is recommended to record the day, date, and time of patch application to remember when to change the patch.
The following table shows when to change the patch:

Plaster applied on:	Change plaster on:
Monday	Thursday
Tuesday	Friday
Wednesday	Saturday
Thursday	Sunday
Friday	Monday
Saturday	Tuesday
Sunday	Wednesday

Where to apply the patch
Adults

Patches should be applied to a flat surface on the upper part of the body or on the arm (avoiding joint areas).

Children

The patch should always be applied to the upper back to minimize the possibility of the child removing it.
The patch should be checked frequently to ensure it is properly adhered to the skin.
It is essential that the child does not remove the patch and put it into their mouth, as this may be life-threatening and even result in death.
The child should be carefully observed for 48 hours after:
application of the first patch
application of a patch with a higher strength.
It may take some time for the patch to reach its full effect. Therefore, it may be necessary to give the child additional pain-relieving medication before the full effect of the medicine becomes apparent. Your doctor will advise you accordingly.

Adults and children
Do not apply the patch:

to the same site consecutively,
to areas with movement (around joints), irritated or damaged skin,
to heavily hairy skin. If the skin at the application site is hairy, do not shave it (shaving may irritate the skin), but trim the hair as close to the skin as possible before applying the patch.

Applying the patch
Step 1: preparing the skin

Before applying the patch, ensure the skin is completely dry, clean, and cool.
If the skin needs cleaning, use cool water only.
Do not use soap or other cleaning agents, 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 individually packaged in a sealed pouch.
Tear the pouch at the notch.
Gently peel back one edge of the pouch completely.
Hold both sides of the opened pouch and pull apart.
Remove the patch and apply it immediately.
Keep the empty pouch to dispose of the used patch later.
Each patch may be used only once.
Do not remove the patch from the pouch until ready to apply.
Check whether the patch is damaged.
Do not use patches that are cut, torn, or otherwise damaged.
Never cut or divide the patches.

Step 3: removing the protective liner and applying the patch to the skin

Ensure clothing over the patch site will be loose; avoid tight or elastic clothing that might press on the patch.
Carefully peel back half of the transparent protective liner from the center of the patch. Avoid touching the adhesive surface of the patch.
Apply the adhesive side of the patch to the skin.
Remove the remaining part of the protective liner and press the entire patch firmly onto the skin with the palm of your hand.
Hold in place for at least 30 seconds. Ensure the patch adheres completely, especially at the edges.

Step 4: removing the patch

Immediately after removing the patch, fold it in half so the adhesive sides stick together.
Place it in the original pouch and dispose of it according to local guidelines.
Used patches should be stored out of sight and out of reach of children. Even used patches still contain medicine that may be harmful and potentially life-threatening to children.

Step 5: washing hands

After applying or removing the patch, always wash hands with clean water only.

Additional information on the use of Fenta MX
Daily activities while using patches

Patches are water-resistant.
You may take a shower or bath, but do not rub the patch.
With your doctor's approval, you may perform physical exercise or engage in sports while using the patch.
You may also swim while wearing the patch, but:
avoid prolonged hot baths or sauna use,
avoid tight or elastic clothing that might press on the patch.
While using the patch, avoid excessive exposure of the application site to external heat sources such as heating pads, electric blankets, hot water bottles (heat packs), heated beds, heat lamps, or sunbeds. Sunbathing, prolonged hot baths, and sauna use should also be avoided. Increased temperature may lead to increased release of fentanyl from the patch.

How quickly will the patch work?

After applying the first dose, the effect of the patch may be delayed.
Your doctor may recommend additional pain-relieving medication on the first day.
After this, the patch should provide continuous pain control, allowing you to stop taking other pain medications. However, your doctor may occasionally recommend additional pain-relieving medications.

How long will the patient use patches?

Fenta MX patches are used in the treatment of chronic pain. Your doctor will inform you about the expected duration of therapy.

In case of worsening pain

If pain suddenly worsens after applying the last patch, check the patch. If it is no longer adhering properly or has fallen off, replace it (see also section "If the patch comes off").
If pain worsens over time during patch use, your doctor may recommend a patch with higher strength and/or additional pain-relieving medication.
If increasing the patch strength does not improve pain control, your doctor may decide to discontinue patch treatment.

In case of overdose of Fenta MX (using more patches than recommended or using a patch with a higher dose than prescribed by the doctor)
If too many patches are used or a patch containing a higher dose than prescribed is applied, remove the patch (or patches) immediately and contact your doctor as soon as possible.
Symptoms of overdose include breathing difficulties or shallow breathing, fatigue, excessive drowsiness, inability to think clearly, walk, or speak normally, and feelings of faintness, dizziness, or confusion.

If the patient forgets to change the patch

Change the patch as soon as you remember and note the date and time. Change the next patch according to the regular schedule after 3 days (72 hours).
If a longer time has passed since the last patch change, talk to your doctor, as additional pain-relieving medication may be needed, but do not apply an extra patch.

If the patch comes off

If the Fenta MX patch comes off before the required time for replacement, apply a new patch immediately and note the date and time. Apply the new patch to a different site:
on the upper part of the body or arm,
on the upper back – for children.
Inform your doctor and leave the new patch in place for 3 days (72 hours) or as directed by your doctor, until the next scheduled patch change.
If repeated early detachment of the patch occurs, contact your doctor, pharmacist, or nurse.

Stopping the use of patches

Do not stop using this medicine abruptly. If the patient wishes to discontinue treatment, they should first consult their doctor. The doctor will advise how to do this; usually, this involves gradually reducing the dose to minimize withdrawal symptoms. See also section 2 "Withdrawal symptoms after stopping Fenta MX".
If the patient has used patches for a prolonged period, the body may have become accustomed to the medicine. Stopping the patches suddenly may cause unpleasant symptoms.
If patch treatment is discontinued, do not restart therapy without consulting your doctor. In such cases, a different dose may be required.

If you have any further questions about the use of this medicine, please consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the following symptoms occur in a person using the patches,
remove the patch immediately and contact a doctor or go immediately to the
nearest hospital. Intensive medical care may be necessary.

Feeling of excessive drowsiness, slowed or shallow breathing. Follow the advice above and encourage the patient to move and speak. Very rarely, these breathing problems 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 fewer 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 determined from available data.)
Seizures. (Uncommon: may occur in fewer than 1 in 100 people)
Disturbance of consciousness or loss of consciousness. (Uncommon: may occur in fewer than 1 in 100 people)

The following adverse 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 fewer 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)
tremor or muscle spasms
unusual skin sensations, such as tingling (paraesthesia)
sensation of spinning
sensation of rapid or irregular heartbeat (palpitations, tachycardia)
high blood pressure
shortness of breath (dyspnoea)
diarrhoea
dry mouth
abdominal pain, indigestion
excessive sweating
itching, rash or redness of the skin
difficulty passing urine or completely emptying the bladder
general feeling of marked fatigue, weakness or malaise
feeling cold
swelling of hands, ankles or feet (peripheral oedema)
Uncommon (may occur in fewer than 1 in 100 people)
feeling of restlessness or disorientation
feeling of excessive well-being (euphoria)
reduced sensation, especially in the skin (hypoesthesia)
memory loss
blurred vision
slow heart rate (bradycardia) or low blood pressure
bluish discoloration of the skin due to lack of oxygen in the blood (cyanosis)
lack of intestinal contractions (ileus)
itchy rash (urticaria), allergic reaction or other skin disorders at the site of patch application
flu-like symptoms
sensation of changes in body temperature
fever
muscle twitching
difficulty achieving or maintaining erection (impotence) or disturbances in sexual function
Rare (may occur in fewer than 1 in 1000 people)
constricted pupils
temporary cessation of breathing (apnoea)
Frequency not known (cannot be determined from available data)
lack of male sex hormones (androgen deficiency)
delirium (symptoms may include a combination of restlessness, anxiety, disorientation, confusion, fear, seeing or hearing things that are not there, sleep disturbances, nightmares)

A rash, redness or mild itching may occur at the site where the patch is applied to the skin.
These reactions are usually mild and resolve after removing the patch. If they do not resolve or if the patch causes significant skin irritation, inform your doctor.

Repeated use of the patches may lead to reduced effectiveness of the medicine (tolerance may develop) or the patient may become dependent on it.

When switching from previously used painkillers to Fenta MX, or after abrupt discontinuation of Fenta MX, withdrawal symptoms (such as nausea, vomiting, diarrhoea, anxiety or chills) may occur in some patients. If such symptoms occur, inform your doctor immediately.

Withdrawal symptoms have been observed in newborns of mothers who used Fenta MX for a prolonged period during pregnancy.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Fenta MX

All patches (new and used) must be stored out of sight and out of reach of
children.
This medicine must be stored in a secure place where others cannot access it. It may cause serious harm and can be fatal to individuals who accidentally or intentionally take this medicine when it has not been prescribed for them.
Do not use this medicine after the expiry date stated on the cardboard box and sachet after EXP. The expiry date refers to the last day of the stated month.
Store in the original packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. Doing so will help protect the environment.
Accidental exposure to a used or unused patch, especially in a child, may be fatal.
A used patch must be folded in half with the adhesive sides together, placed back into the original pouch, and stored safely until it can be disposed of properly in a location out of sight and out of reach of others, especially children.

6. Contents of the pack and other information

What Fenta MX contains
The active substance is fentanyl.
Each transdermal system, patch with a release surface area of 10.5 cm² contains 5.78 mg of fentanyl
(corresponding to a release rate of 25 micrograms of fentanyl per hour).
Each transdermal system, patch with a release surface area of 21 cm² contains 11.56 mg of fentanyl
(corresponding to a release rate of 50 micrograms of fentanyl per hour).
Each transdermal system, patch with a release surface area of 31.5 cm² contains 17.34 mg of fentanyl
(corresponding to a release rate of 75 micrograms of fentanyl per hour).
Each transdermal system, patch with a release surface area of 42 cm² contains 23.12 mg of fentanyl
(corresponding to a release rate of 100 micrograms of fentanyl per hour).
The other ingredients are: purified soybean oil, rosin, hydrogenated resin.
Adhesive layer: poly(2-ethylhexyl acrylate, vinyl acetate) 1:1
Outer protective layer: polyethylene terephthalate
Protective liner (to be removed): 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 by a protective film (which must be removed before use), designed to be applied to the skin.
Packs contain 5, 10, 16, or 20 transdermal systems (patches).

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria

Manufacturer
HEXAL AG
Industriestrasse 25
83607 Holzkirchen, Germany

For further information about the medicinal product 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

Fenta mx 50