Fentanil Actavis

Leaflet attached to the packaging: information for the user

Fentanyl Actavis, 25 micrograms per hour, transdermal system, patch

Fentanyl Actavis, 50 micrograms per hour, transdermal system, patch

Fentanyl Actavis, 75 micrograms per hour, transdermal system, patch

Fentanyl Actavis, 100 micrograms per hour, transdermal system, patch

Fentanyl

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

• You should keep this leaflet, so 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 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 Fentanyl Actavis and what is it used for
• 2. Important information before using Fentanyl Actavis
• 3. How to use Fentanyl Actavis
• 4. Possible side effects
• 5. How to store Fentanyl Actavis
• 6. Contents of the pack and other information

1. What is Fentanyl Actavis and what is it used for

Fentanyl Actavis is a medicine in the form of patches that are stuck to the skin.
Fentanyl Actavis is indicated for the treatment of severe chronic pain:

• in adults who require continuous treatment with painkillers
• in children over 2 years of age who have already used opioid medicines and require continuous treatment with painkillers.

Fentanyl Actavis contains the active substance fentanyl, which belongs to a group of strong painkillers called opioids.

2. Important information before using Fentanyl Actavis

When not to use Fentanyl Actavis

• if the patient is allergic to fentanyl or any of the other ingredients of this medicine (listed in section 6)
• if the patient has pain that only lasts for a short time, i.e. acute 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. If in doubt, consult a doctor or pharmacist before using Fentanyl Actavis.

Warnings and precautions

• Fentanyl Actavis may cause life-threatening side effects in people who do not regularly use opioid painkillers.
• Fentanyl Actavis is a medicine that can be a danger to a child's life. This also applies to used patches. It should be taken into account that the appearance of the patch (both before and after use) may encourage a child to stick it to their body, put it in their mouth, etc., which can lead to death.
• This medicine should be stored in a safe place, out of reach of other people - see section 5 for further information.

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

The patch should only be applied to the skin of the person it has been prescribed for by a doctor.
There have been reports of patches being accidentally transferred to the skin of a family member,
during close physical contact or while sharing the same bed with the person using the patches. A patch accidentally stuck to another person's skin (especially a child) can cause the medicine to be absorbed through the skin and cause serious side effects such as breathing difficulties with slow and shallow breathing, which can be life-threatening. If a patch is accidentally stuck to another person's skin, it should be removed immediately and a doctor should be consulted.

Particular caution should be exercised when using Fentanyl Actavis

Before using this medicine, the patient should discuss with their doctor or pharmacist if any of the following situations apply:

• the patient has ever had lung disease or breathing difficulties,
• the patient has ever had heart, liver, kidney problems, or low blood pressure,
• the patient has ever had a brain tumor,
• the patient has ever had persistent headaches or a head injury,
• 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 discuss with their doctor or pharmacist before using Fentanyl Actavis.

During treatment with the patch, the patient should inform their doctor if they experience

breathing problems during sleep.Opioids such as Fentanyl Actavis can cause sleep-related breathing disorders, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (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 maintaining sleep continuity
• excessive daytime sleepiness

During treatment with the patch, the patient should inform their doctor about any changes in pain perception

pain.If the patient notices:

• that the patch no longer relieves pain
• increased pain
• a change in the way pain is perceived (e.g. feeling pain in a different part of the body)
• pain in situations where the body should not hurt.

Do not change the dose of the medicine yourself. The doctor may decide to change the dose or treatment.

Side effects of Fentanyl Actavis

• Fentanyl Actavis may cause unnatural fatigue, as well as slowed and shallow breathing. Very rarely, these breathing disorders can be life-threatening, especially in people who have not previously used opioid painkillers (such as Fentanyl Actavis 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 fever occurs while using Fentanyl Actavis, the patient should discuss with their doctor - an increase in body temperature can significantly increase the absorption of the medicine through the skin.
• Fentanyl Actavis may cause constipation; the patient should discuss with their doctor or pharmacist how to prevent or alleviate constipation.

For a full list of side effects, see section 4.
During treatment with the patch, the patient should avoid excessive exposure of the patch application site to direct heat sources, such as heating pads, electric blankets, hot water bottles (hot compresses), heated water beds, heat lamps, or tanning beds. The patient should not sunbathe, take long hot baths, saunas, or hot tubs with whirlpools. In these situations, there is a possibility of increased release of fentanyl from the patch due to increased temperature.
The transdermal system with fentanyl contains metal. The patch should be removed before undergoing magnetic resonance imaging (MRI), as it may heat up during the MRI and cause burns at the application site.
Long-term use and tolerance

This medicine contains fentanyl, which is an opioid medicine. Repeated use of opioid painkillers can lead to decreased effectiveness of the medicine (the patient gets used to it, which is known as tolerance to the medicine). During treatment with Fentanyl Actavis, the patient's sensitivity to pain may also increase. This phenomenon is known as hyperalgesia.
Increasing the dose of the patches 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 consult their doctor. The doctor will decide whether it is better for the patient to increase the dose or gradually reduce the use of Fentanyl Actavis.
Dependence and addictive use

This medicine contains fentanyl, which is an opioid. It can cause dependence and/or addiction.
Repeated use of Fentanyl Actavis 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 how much medicine to use or how often to take it. The patient may feel the need to continue using the medicine, even if it no longer helps to relieve their pain.

The risk of dependence or addictive use varies from person to person. The risk of dependence on Fentanyl Actavis or its addictive use may be higher if:

• the patient or someone in their family has ever abused or been dependent on alcohol,

prescription or non-prescription medicines or illegal substances (addiction);

• the patient smokes;
• the patient has ever had mood disorders (depression, anxiety disorders, or personality disorders) or has been treated by a psychiatrist for other mental illnesses.

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

• The patient must take the medicine for a longer period than prescribed by the doctor.
• The patient must take a higher dose than prescribed.
• The patient uses the medicine for reasons other than those for which the doctor prescribed it, for example, "to calm down" or "to fall asleep".
• The patient has repeatedly tried to stop or control the use of the medicine but failed.
• 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 notices any of these symptoms, they should discuss with their doctor the best treatment strategy, including determining when it is appropriate to stop treatment and how to safely stop using the medicine.

Withdrawal symptoms when stopping Fentanyl Actavis

The patient should not suddenly stop using this medicine. Withdrawal symptoms may occur, such as anxiety, difficulty sleeping, irritability, restlessness, anxiety, palpitations (rapid heartbeat), increased blood pressure, malaise, or illness, diarrhea, loss of appetite, tremors, chills, or sweating. If the patient wants to stop using this medicine, they should first discuss it with their doctor. The doctor will inform them how to do it - usually by gradually reducing the dose to minimize any unwanted withdrawal effects. See also section 2 "Withdrawal symptoms when stopping Fentanyl Actavis".

Fentanyl Actavis 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 medicines that can be bought without a prescription and herbal medicines. When buying other medicines at the pharmacy, the patient should also tell the pharmacist that they are using Fentanyl Actavis.
The attending doctor knows which medicines can be safely used with Fentanyl Actavis. The patient will require close monitoring if they are using or have recently used any of the medicines listed below, or if they have stopped using any of the medicines listed below, as this may affect the strength of the necessary effect of Fentanyl Actavis.
In particular, the patient should tell their doctor or pharmacist if they are taking or using:

• Other painkillers, including opioid painkillers (such as buprenorphine, nalbuphine, or pentazocine) and some painkillers used for neuropathic pain (gabapentin and pregabalin).
• Sleeping pills (such as temazepam, zaleplon, or zolpidem).
• Sedatives (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 antiparkinsonian medicines called MAOIs (such as isocarboxazid, phenelzine, selegiline, or tranylcypromine). Fentanyl Actavis should not be used for 14 days after stopping these medicines - see below.
• Certain antihistamines, especially those with a sedative effect (such as chlorpheniramine, clemastine, cyproheptadine, diphenhydramine, or hydroxyzine).
• Certain antibiotics (such as erythromycin or clarithromycin).
• Antifungal medicines (such as itraconazole, ketoconazole, fluconazole, or voriconazole).
• HIV medicines (such as ritonavir).
• Anti-arrhythmic medicines (such as amiodarone, diltiazem, or verapamil).
• Anti-tuberculosis 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 Fentanyl Actavis with antidepressants

The risk of side effects increases when Fentanyl Actavis is used with certain antidepressants. There may be an interaction between Fentanyl Actavis 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). When using these medicines together, the doctor may recommend close monitoring of the patient for such side effects, especially when starting treatment or changing the dose of the medicine.

Using Fentanyl Actavis with medicines that act on the central nervous system, including alcohol and certain narcotic medicines.

Using Fentanyl Actavis with sedative medicines, such as benzodiazepines or similar medicines, increases the risk of drowsiness, breathing problems (respiratory depression), coma, and life-threatening situations. Therefore, concurrent use should only be considered when other treatment options are not possible.
If the doctor prescribes Fentanyl Actavis to be used with sedative medicines, the dose and duration of treatment should be limited by the doctor.
The patient should tell their doctor about all sedative medicines they are taking or using and follow the doctor's instructions for dosing. It is helpful to inform friends or relatives about the possibility of experiencing the above symptoms. The patient should contact their doctor if such symptoms occur.
The patient should not drink alcohol while using Fentanyl Actavis without first discussing it with their doctor.

Surgical procedures

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

Fentanyl Actavis and alcohol

The patient should not drink alcohol without first discussing it with their doctor.
Fentanyl Actavis can cause drowsiness and slowed breathing. Alcohol can increase 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.
Fentanyl Actavis should not be used during pregnancy, unless discussed with a doctor.
Fentanyl Actavis should not be used during childbirth, as it may cause breathing difficulties in the newborn.
Long-term use of Fentanyl Actavis during pregnancy may cause withdrawal symptoms in the newborn (such as loud crying, restlessness, seizures, poor feeding, and diarrhea), which can be life-threatening if not recognized and treated. The patient should immediately discuss with their doctor if they think their child may be experiencing withdrawal symptoms.

Driving and using machines

Fentanyl Actavis can affect the ability to drive and use machines, as it can cause drowsiness and dizziness. If the patient experiences such symptoms, they should not drive or operate any machines or tools.
The patient should not drive until they know how the medicine affects them.
The patient should discuss with their doctor or pharmacist if they are unsure whether they can drive while using this medicine.

3. How to use Fentanyl Actavis

This medicine should always be used exactly as prescribed by the doctor. If the patient is unsure, they should ask their doctor or pharmacist.
The doctor will decide what dose of Fentanyl Actavis is suitable for the patient, based on the severity of the pain, the patient's overall condition, and the type of pain treatment used previously.
Before starting and regularly during treatment, the doctor will also discuss with the patient what to expect from using Fentanyl Actavis, 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 when stopping Fentanyl Actavis").

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 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 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:

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 the area around the joints).

Children

• To minimize the possibility of the child removing the patch, it should be applied to the

upper back.

• The patient should always check frequently if the patch is properly stuck to the skin.
• It is essential to ensure that the child does not remove the patch and put it in their mouth, as this can be life-threatening.
• The patient should observe the child closely for 48 hours after:
• Applying the first patch
• Applying a patch with a higher strength.
• The action of the patch may be delayed after the first dose is applied. In this case, the child may need to take additional painkillers before the full effect of the medicine is apparent. The attending 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 (around joints), irritated, or damaged skin.
• To very hairy skin. If there is hair at the patch application site, it should be carefully cut (not shaved - shaving irritates the skin) before applying the patch.

Applying the patch

Step 1: Preparing the skin

• The patient should make sure 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, oil, 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 Fentanyl Actavis patch should be removed from the protective pouch by tearing it open at the notched cut (located near the arrow on the label), and then carefully tearing the packaging material. If scissors are used to open the packaging, they should be cut close to the outer edge, so as not to damage the transdermal system inside.
• The patch should be removed and applied immediately.
• The empty pouch should be kept to use later to dispose of the used patch.
• Each patch can only be used once.
• The patch should not be removed from the pouch until ready to apply it.
• 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 make sure the clothing at the patch site is loose; tight or elastic clothing that could press on the patch should not be worn.
• The patient should carefully peel off one half of the transparent protective layer from the center of the patch. The patient should avoid touching the adhesive layer of the patch.
• The adhesive layer of the patch should be applied to the skin.
• The second part of the protective layer should be removed and the 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 make sure the patch is stuck completely, especially at the edges.

Step 4: Removing the patch

• Immediately after removing the patch, it should be folded in half, so the adhesive layers stick together.
• It should be placed in the original pouch and disposed of according to the instructions.
• Used patches should be kept out of sight and reach of children - even used patches still contain medicine that can be harmful to children and threaten their lives.

Step 5: Washing hands

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

Additional information about using Fentanyl Actavis

Daily activities while using the 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 hot baths or saunas.
• should not wear tight or elastic clothing that could 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, electrically heated blankets, hot water bottles (hot compresses), heated water beds, heat lamps, or tanning beds. The patient should also not sunbathe or use prolonged hot baths or saunas. There is a possibility of increased release of fentanyl from the patch due to increased temperature.

How quickly will the patch work?

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

How long will the patient use the patches?

• Fentanyl Actavis 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 increases after applying the last patch, the patient should check the patch. If it is no longer stuck well or has fallen off, it should be replaced (see also the section "In case of patch detachment").
• If the pain increases over time while using the patches, the attending doctor may prescribe a patch with a higher strength, and/or additional painkillers.
• If increasing the patch strength does not improve the pain, the doctor may decide to stop using the patches.

Using a higher dose of Fentanyl Actavis than prescribed (too many patches or a patch with a higher dose than prescribed by the doctor)

If the patient uses too many patches or a patch with a higher dose of Fentanyl Actavis than prescribed by the doctor, they 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 sleepiness, inability to think clearly, difficulty walking or talking normally, and feeling faint, dizzy, or confused. 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 discuss with their doctor, as additional painkillers may be necessary, but notan additional patch.

should be applied.

In case of patch detachment

• If the Fentanyl Actavis patch comes off before it is time to change it, the patient should apply a new one 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 standard patch change.
• If the situation of the patch coming off repeatedly occurs, the patient should contact their doctor, pharmacist, or nurse.

Stopping the use of patches

• The patient should not suddenly stop using this medicine. If the patient wants to stop using this medicine, they should first discuss it with their doctor. The doctor will inform them how to do it - usually by gradually reducing the dose to minimize any unwanted withdrawal effects. See also section 2 "Withdrawal symptoms when stopping Fentanyl Actavis".
• When stopping the use of patches, 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 questions about using the medicine, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, Fentanyl Actavis can cause side effects, although not everybody gets them.

If the patient or their 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.

• Feeling excessively tired, slowed, or shallow breathing. The patient should follow the above advice and encourage the patient to move and talk. Very rarely, these breathing disorders can be life-threatening, especially in people who have not previously used opioid painkillers (such as Fentanyl Actavis or morphine). (Uncommon, may affect up to 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 affect up to 1 in 100 people).
• Decreased consciousness or loss of consciousness. (Uncommon, may affect up to 1 in 100 people).

The following side effects have also been reported

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

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

Common side effects (may affect up to 1 in 10 people):

• allergic reaction
• loss of appetite
• insomnia
• depression
• feeling anxious or confused
• hallucinations (seeing, feeling, or hearing things that do not exist)
• tremors or muscle spasms
• paresthesia (abnormal sensations, tingling, burning of the skin)
• 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
• difficulty urinating or completely emptying the bladder
• feeling tired, weak, or unwell
• feeling cold
• peripheral edema on the limbs.

Uncommon side effects (may affect up to 1 in 100 people):

• agitation or disorientation
• euphoria (an unnatural state of happiness and increased activity)
• numbness
• memory loss
• blurred vision
• slow heartbeat or low blood pressure
• cyanosis (lack of oxygen)
• intestinal obstruction (ileus)
• rash, allergic contact dermatitis, contact dermatitis at the 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 affect up to 1 in 1,000 people):

• pupil constriction
• apnea.

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

• -male sex hormone deficiency (androgen deficiency)
• delirium (symptoms may include agitation, restlessness, disorientation, confusion, anxiety, seeing or hearing things that do not exist, sleep disturbances, nightmares).
• The patient may become dependent on Fentanyl Actavis (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 disappear after the patch is removed. If they do not disappear or the patch causes significant skin irritation, the patient should tell their doctor.
Repeated use of patches may lead to decreased effectiveness of the medicine (tolerance to the medicine may develop) or the patient may become dependent on it.
It is also possible that some patients may experience withdrawal symptoms (such as nausea, vomiting, diarrhea, restlessness, and chills) when switching from previously used opioids to Fentanyl Actavis or when treatment is suddenly stopped. The patient should inform their doctor immediately if they experience such symptoms.
Withdrawal symptoms have been observed in newborns of mothers who chronically used Fentanyl Actavis during pregnancy.

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 Monitoring, 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, https://smz.ezdrowie.gov.pl/.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Fentanyl Actavis

Where to store the patches

Fentanyl Actavis patches (both unused and used) should be stored in a place that is out of sight and reach of children.
This medicine should be stored in a safe place, out of reach of other people. It can cause serious harm or even death if used or taken accidentally or intentionally by someone who has not been prescribed it.

How long can Fentanyl Actavis be stored

Do not use this medicine after the expiry date stated on the packaging after "Expiry date" or "EXP". The expiry date refers to the last day of the month stated.
If the expiry date has passed, the patient should return any unused patches to the pharmacy.

Storage conditions

Do not store above 30°C.

How to dispose of used and unused patches

Accidental attachment of an unused or used patch can be fatal, especially in children.
After removing the patch from the skin, the used patch should be folded in half, with the adhesive layers stuck together, placed in the original pouch, and disposed of in a safe way, out of reach of children. 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. Contents of the pack and other information

What Fentanyl Actavis contains

• The active substance of the medicine is fentanyl. Each Fentanyl Actavis 25 µg/hpatch releases 25 micrograms of fentanyl per hour. One patch with an active surface area of 7.5 cm contains 4.125 mg of fentanyl.

Each Fentanyl Actavis 50 µg/hpatch releases 50 micrograms of fentanyl per hour. One patch with an active surface area of 15 cm contains 8.25 mg of fentanyl.
Each Fentanyl Actavis 75 µg/hpatch releases 75 micrograms of fentanyl per hour. One patch with an active surface area of 22.5 cm contains 12.375 mg of fentanyl.
Each Fentanyl Actavis 100 µg/hpatch releases 100 micrograms of fentanyl per hour.
One patch with an active surface area of 30 cm contains 16.5 mg of fentanyl.

• The other ingredients are: Polyacrylate: copolymer of 2-ethylhexyl acrylate, 2-hydroxyethyl acrylate, methyl acrylate (35.5:1:12). Outer foil PP 40 μm (NNA 40 μm), marked with blue ink. Protective layer: silicone-coated polyethylene terephthalate PET 100 μm.

What Fentanyl Actavis looks like and contents of the pack

Fentanyl Actavis is a transparent patch with a sticky surface, so it can be stuck to the skin. The transdermal system has a blue print indicating the strength.
Fentanyl Actavis is available in packs containing 5 or 10 transdermal systems.

Marketing authorization holder

Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjörður
Iceland

Manufacturer

Actavis Group PTC ehf.
Dalshraun 1
IS-220 Hafnarfjörður
Iceland
Luye Pharma AG
Am Windfeld 35
83714 Miesbach
Germany
Merckle GmbH
Ludwig-Merckle-Strasse 3
Blaubeuren
89143 Baden-Wuerttemberg
Germany

To obtain more detailed information on the medicine and its names in the Member States of the European Economic Area, please contact the representative of the marketing authorization holder:

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00.

Date of last revision of the leaflet: March 2025