Patient Information Leaflet

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
Fentanylum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

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

Leaflet Contents

What Fentanyl Actavis is and what it is used for
What you need to know before using Fentanyl Actavis
How to use Fentanyl Actavis
Possible side effects
How to store Fentanyl Actavis
Contents of the pack and other information

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

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

in adults requiring continuous opioid analgesic therapy,
in children over 2 years of age who have already been treated with opioid analgesics and require continuous pain relief.

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

2. 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 postoperative pain
if the patient has severe respiratory depression (markedly slowed and shallow breathing).

Do not use this medicine if any of the above situations apply to the patient. In case of
doubt, consult a doctor or
pharmacist before using Fentanyl Actavis.
Warnings and precautions

Fentanyl Actavis may cause life-threatening adverse effects in people who do not regularly use opioid-containing medicines.
Fentanyl Actavis is a medicine that may be life-threatening to a child. This also applies to used patches. Consider that the appearance of the patch (both before and after use) may encourage a child to apply it to the body, put it in the mouth, etc., which may lead to death.
This medicine must be stored in a safe place inaccessible to others – see section 5 for further information.

In case the Fentanyl Actavis patch is accidentally applied to another person's skin
The patch should only be applied to the skin of the person for whom it has been prescribed by a doctor.
Cases have been reported where the patch was accidentally transferred to the skin of a family member
during close physical contact or while sharing the same bed with a person using
patches. A patch accidentally applied to the skin of another person (especially a child) may
lead to drug absorption through the skin and cause serious adverse effects such as
respiratory disturbances with slow and shallow breathing, which may be life-threatening. In case of
accidental application of the patch to another person's skin, remove it immediately and contact a
doctor.
Special caution is required when using Fentanyl Actavis
Before using this medicine, talk to your doctor or pharmacist if any of the following situations apply:

the patient has ever had lung diseases or breathing difficulties,
the patient has ever had heart, liver, kidney function disorders or low blood pressure,
the patient has ever had a brain tumour,
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 condition characterized by muscle weakness and fatigue,

If any of the above situations apply to the patient (or the patient is unsure), talk
to a doctor or pharmacist before using Fentanyl Actavis.
While using the patch, inform your doctor if you experience breathing problems during sleep. Opioids such as Fentanyl Actavis may cause sleep-related breathing disorders, such as sleep apnoea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels). Inform your doctor if
the patient, their partner or caregiver notices any of the following
symptoms:

pauses in breathing during sleep
waking up at night due to breathlessness
difficulty maintaining continuous sleep
excessive daytime sleepiness The doctor may decide to adjust the dose.

While using the patch, inform your doctor of any changes in pain perception. If the patient notices:

the patch no longer relieves pain
increased pain intensity
change in the way pain is felt (e.g. pain felt in another part of the body)
pain triggered by contact with the body that should not cause pain.

Do not change the dose of the medicine on your own. The doctor may decide to change the dose or treatment.
Adverse effects of Fentanyl Actavis

Fentanyl Actavis may cause unusual fatigue and slowed, shallow breathing. Very rarely, these breathing disorders may be life-threatening, especially in people who have not previously used opioid pain medicines (such as Fentanyl Actavis or morphine). If the patient or someone nearby notices that the person using the patches is excessively drowsy and has slow or shallow breathing, they should:
remove the patch,
contact a doctor, or go immediately to the nearest hospital,
encourage the patient to move and speak.
If fever occurs during treatment with Fentanyl Actavis, talk to a doctor – increased body temperature may significantly increase drug absorption through the skin.
Fentanyl Actavis may cause constipation; talk to a doctor or pharmacist about how to prevent or relieve constipation.

For a full list of adverse effects, see section 4.
Fentanyl Actavis, like other opioids, may affect normal hormone production in the body, such as cortisol, prolactin or sex hormones, especially with long-term use of Fentanyl Actavis. The effects of these hormonal changes may include malaise (including vomiting), loss of appetite, fatigue, weakness, dizziness, low blood pressure, infertility or reduced libido. In addition, women may experience changes in menstrual cycle, and men may experience impotence or breast enlargement. If the patient notices any of these symptoms, contact a doctor.
While using the patch, avoid excessive exposure of the patch application site to direct heat sources, such as heating pads, electric blankets, hot water bottles (hot water bottles), heated waterbeds, heating or tanning lamps. Do not sunbathe, take prolonged hot baths, use saunas or bathe in a hot whirlpool bath. In these situations, increased release of fentanyl from the patch due to elevated temperature may occur.
The transdermal system containing fentanyl contains metal. The patch must be removed before undergoing magnetic resonance imaging (MRI), as it may heat up during the MRI examination 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 pain medicines may lead to reduced effectiveness of the medicine (the patient becomes accustomed to it, known as tolerance). During treatment with Fentanyl Actavis, the patient's sensitivity to pain may also increase. This phenomenon is known as hyperalgesia.
Increasing the dose of patches may temporarily further reduce pain intensity, but it may also be harmful. If the patient notices reduced effectiveness of the medicine, they should consult a doctor. The doctor will decide whether increasing the dose or gradually reducing the use of Fentanyl Actavis is a better solution for the patient.
Dependence and addictive use
This medicine contains fentanyl, which is an opioid. It may cause dependence and/or addiction.
Repeated use of Fentanyl Actavis may also lead to dependence, abuse and addictive use, which may result in life-threatening overdose. The risk of these adverse effects may increase with increasing dose and duration of use. Dependence or addictive use may cause the patient to lose control over how much medicine to use or how often to use it. The patient may feel the need to continue using the medicine, even if it does not help relieve their pain symptoms.
The risk of dependence or addictive use varies between individuals. The risk of dependence on or addictive use of Fentanyl Actavis may be higher if:

the patient or anyone in their family has ever abused or been dependent on alcohol, prescription medicines or illegal substances ("addiction");
the patient smokes tobacco;
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 any of the following symptoms occur in the patient during treatment with Fentanyl Actavis, this may indicate dependence or addictive use.

The patient must take this medicine for longer than recommended by the doctor.
The patient must take a higher dose than recommended.
The patient uses this medicine for reasons other than those for which the doctor prescribed it, e.g. "to calm down" or "to be able to sleep".
The patient has made several unsuccessful attempts to stop or control the use of this medicine.
After stopping the use of this medicine, the patient feels unwell, but feels better when using the medicine again ("withdrawal effect").

If the patient notices any of these symptoms, they should discuss with their doctor the best treatment strategy for them, including when it is appropriate to stop treatment and how to safely discontinue treatment.
Withdrawal symptoms when stopping Fentanyl Actavis
Do not suddenly stop using this medicine. Withdrawal symptoms may occur, such as
anxiety, difficulty falling asleep, irritability, agitation, anxiety, palpitations (rapid heartbeat),
elevated blood pressure, malaise or illness, diarrhoea, 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 advise how to do this – usually by gradually
reducing the dose to minimize any adverse withdrawal effects.
Fentanyl Actavis and other medicines
Tell your doctor or pharmacist about all medicines currently or recently taken/used by the patient, as well as any medicines the patient plans to take/use.
This also includes medicines available without a prescription and herbal medicines. When buying other medicines at the pharmacy, tell the pharmacist that you are using Fentanyl Actavis.
The treating doctor knows which medicines can be safely taken/used with Fentanyl Actavis. The patient will require close monitoring if taking/using certain medicines listed below or if stopping certain medicines listed below, as this may affect the required strength of Fentanyl Actavis.
In particular, tell your doctor or pharmacist if the patient is taking/using:

Other pain medicines, including opioid pain medicines (such as buprenorphine, nalbuphine or pentazocine) and certain pain medicines used for neuropathic pain (gabapentin and pregabalin).
Sleeping medicines (such as temazepam, zaleplon or zolpidem).
Sedatives (tranquillisers such as alprazolam, clonazepam, diazepam, hydroxyzine or lorazepam) and antipsychotic medicines (such as aripiprazole, haloperidol, olanzapine, risperidone or phenothiazines).
Medicines that reduce muscle tension (such as cyclobenzaprine or diazepam).
Certain antidepressants known as SSRIs or SNRIs (such as citalopram, duloxetine,

escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline or venlafaxine) – see
below.

Certain antidepressants or antiparkinsonian medicines known as MAOIs (such as isocarboxazid, phenelzine, selegiline or tranylcypromine). Do not use Fentanyl Actavis for 14 days after stopping these medicines – see below.
Certain antihistamines, especially those with sedative effects (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 for HIV infection (such as ritonavir).
Antiarrhythmic medicines (such as amiodarone, diltiazem or verapamil).
Medicines for tuberculosis (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 heart disease (angina pectoris) or high blood pressure (such as nicardipine).
Certain medicines used to treat blood cancers (such as idelalisib).

Using Fentanyl Actavis with antidepressant medicines
The risk of adverse effects increases when used simultaneously with certain antidepressants. An interaction between Fentanyl Actavis and these medicines may occur, leading to changes in mental state, e.g. agitation, hallucinations (seeing, feeling, hearing or smelling things that do not exist) and other effects such as blood pressure fluctuations, rapid heartbeat, high temperature, excessive reflexes, coordination disorders, muscle stiffness, nausea, vomiting and diarrhoea (these may be symptoms of serotonin syndrome). When using these medicines together, the doctor may recommend close monitoring for such adverse effects, especially when starting treatment or changing the dose of the medicine.
Use with medicines that depress the central nervous system, including alcohol and certain narcotic medicines.
Concomitant use of Fentanyl Actavis with sedative medicines, such as benzodiazepines or similar medicines, increases the risk of drowsiness, breathing problems (respiratory depression), coma and potentially life-threatening events. Therefore, concomitant use should only be considered when other treatment options are not possible.
If the doctor prescribes Fentanyl Actavis to be used together with sedative medicines, the dose and duration of treatment should be limited by the doctor.
Tell your doctor about all sedative medicines you are taking or using and strictly follow the doctor's dosing instructions. It may be helpful to inform friends or relatives about the possibility of the symptoms described above. Contact your doctor if such symptoms occur.
Do not drink alcohol while using Fentanyl Actavis until you have discussed it with your treating doctor.
Surgical procedures
If the patient suspects they may undergo anaesthesia, tell the doctor or dentist that they are using Fentanyl Actavis.
Fentanyl Actavis and alcohol
Do not drink alcohol until you have discussed it with your treating doctor.
Fentanyl Actavis may cause fatigue and slowed breathing. Alcohol may worsen these effects.
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.
Fentanyl Actavis should not be used during pregnancy unless discussed with a doctor.
Do not use Fentanyl Actavis during labour, as it may cause respiratory disturbances in the newborn.
Long-term use of Fentanyl Actavis during pregnancy may cause withdrawal symptoms (such as loud crying, restlessness, seizures, poor feeding and diarrhoea) in the newborn, which may be life-threatening if not recognised and treated. Contact a doctor immediately if you suspect your child may be experiencing withdrawal symptoms.
Do not use Fentanyl Actavis during breastfeeding. Do not breastfeed for 3 days after removing the Fentanyl Actavis patch. The medicine passes into human milk.
Driving and operating machinery
Fentanyl Actavis may affect the ability to drive and operate machines or tools, as it may cause drowsiness and dizziness. If such symptoms occur, do not drive or operate any machinery or use any tools.
Do not drive until you know how the medicine affects you.
Talk to your doctor or pharmacist if you are unsure whether you can safely drive while using this medicine.

3. How to use Fentanyl Actavis

This medicine should always be used exactly as your doctor has told you. If you are unsure, please consult your doctor or pharmacist.
Your doctor will decide the most appropriate dose of Fentanyl Actavis for you, based on an assessment of the severity of your pain, your general condition, and the type of pain treatment you have previously been receiving.
Before starting and regularly during treatment, your doctor will also discuss with you what to expect from using Fentanyl Actavis, when and for how long you should use it, when you should contact your doctor, and when to stop using the medicine (see also section 2, "Withdrawal symptoms after stopping Fentanyl Actavis").

Applying and changing patches

Each patch contains enough medicine for 3 days (72 hours).
You should change the patch every third day unless your doctor tells you otherwise.
Always remove the old patch before applying a new one.
Always change the patch at the same time of day every 3 days (72 hours).
If you are using more than one patch, all patches should be changed at the same time.
You should write down the day, date, and time when you apply the patch so that you remember when to change it.
The table below shows when to change the patch:

Patch applied on: Change patch on:
Monday Thursday
Tuesday Friday
Wednesday Saturday
Thursday Sunday
Friday Monday
Saturday Tuesday
Sunday Wednesday

Where to apply the patch
Adults

Apply the patch to a flat area of the upper body or arm (avoiding joint areas).

Children

To minimize the risk of the child removing the patch, apply it to the upper back.
Always check frequently whether the patch is properly attached to the skin.
It is important that the child does not remove the patch and put it in their mouth, as this could be life-threatening.
The child should be observed particularly closely for 48 hours after:
Applying the first patch
Applying a patch with a higher strength
The effect of the patch after the first dose may be delayed. Therefore, the child may need additional pain-relief medicines until the full effect of the medicine becomes apparent. Your doctor will advise you about this.

Adults and children
Do not apply the patch:

In the same place two times in a row.
On moving areas (around joints), irritated, or damaged skin.
On heavily hairy skin. If there is hair at the site where the patch is to be applied, it should be carefully trimmed (not shaved—shaving may irritate the skin) before applying the patch.

Applying the patch
Step 1: Preparing the skin

Make sure the skin is completely dry, clean, and cool before applying the patch.
If the skin needs cleaning, use cool water only.
Do not use soap, oils, creams, balms, 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 contained in an individual pouch.
Remove the Fentanyl Actavis patch from its protective pouch by tearing along the serrated edge (located near the tip of the arrow on the packaging label), then carefully open the packaging material. If using scissors to open the package, cut close to the outer edge to avoid damaging the transdermal system inside.
Remove the patch and apply it immediately.
Keep the empty pouch to use later for disposal of the used patch.
Each patch must be used only once.
Do not remove the patch from the pouch until you are ready to apply it.
Check that the patch is not damaged.
Do not use patches that are cut, broken, or otherwise damaged in any way.
Never divide or cut patches.

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

Ensure clothing over the patch area will be loose; do not wear tight or elastic clothing that might press on the patch.
Carefully peel off one half of the transparent protective liner from the center of the patch. Avoid touching the adhesive layer of the patch.
Apply the adhesive side of the patch to the skin.
Remove the second part of the protective liner and press the entire patch firmly onto the skin with your hand.
Hold in place for at least 30 seconds. Make sure the patch adheres completely, especially around the edges.

Step 4: Removing the patch

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

Step 5: Washing hands

Always wash your hands with clean water only after applying or removing a patch.

Additional information about using Fentanyl Actavis
Daily activities while using patches

The 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 play sports while using the patch.
You may also swim while wearing the patch, but:
Do not use prolonged heat baths or saunas.
Do not wear tight or elastic clothing that might press on the patch.
While using the patch, you should avoid excessive exposure of the application site to external heat sources such as: heated pads, electrically heated blankets, hot water bottles (hot water bags), heated beds, heat lamps, or sunlamps. You should also avoid sunbathing and prolonged heat baths or saunas. Increased release of fentanyl from the patch may occur due to elevated temperature.

How quickly will the patch work?

The effect of the patch may be delayed after the first dose.
Your doctor may prescribe additional pain-relief medicines for the first day.
After that, the patch should provide continuous pain control, allowing you to stop taking other pain-relief medicines. However, your doctor may occasionally recommend additional pain-relief medicines.

How long will the patient use patches?

Fentanyl Actavis patches are used to treat chronic pain. Your doctor will inform you about the expected duration of therapy.

If pain worsens

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 increases over time during patch treatment, your doctor may prescribe a patch with a higher strength and/or additional pain-relief medicines.
If increasing the patch strength does not improve pain control, your doctor may decide to discontinue patch treatment.

Using more than the recommended dose of Fentanyl Actavis (too many patches or a patch containing a higher dose than prescribed by the doctor)
If too many patches are used or a patch containing a higher dose of Fentanyl Actavis 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, walk, or speak clearly, and feelings of faintness, dizziness, or confusion. Overdose may also cause brain disorders known as toxic leukoencephalopathy.

If the patient forgets to change the patch

Change the patch as soon as you remember, and record the day and time. Change the next patch after 3 days (72 hours) as usual.
If a long time has passed since the last patch change, talk to your doctor, as additional pain-relief medicines may be needed. However, do not apply an additional patch.

If the patch comes off

If the Fentanyl Actavis patch comes off before the required change time, apply a new patch immediately and record the day and time. Apply the new patch in a different location:
On the upper body or arm.
On the upper back—in 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 suddenly. If you wish to stop using this medicine, speak to your doctor first. Your doctor will advise you how to do this—usually by gradually reducing the dose to minimize any withdrawal effects. See also section 2, "Withdrawal symptoms after stopping Fentanyl Actavis."
If you stop using the patches, do not restart treatment without consulting your doctor. In such a case, a different dose from the one previously used may be required.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient or caregiver notices any of the following symptoms in a person using the patches,
the patch should be removed immediately and the doctor contacted, or the person should go
without delay to the nearest hospital. Intensive medical care may be required.

Feeling of excessive fatigue, slowed or shallow breathing. Follow the advice above and encourage the patient to move and speak. Very rarely, these breathing problems may be life-threatening, particularly in people who have not previously used strong opioid painkillers (such as Fentanyl Actavis or morphine). (Uncommon, may occur in 1 in 100 people).
Sudden swelling of the face or throat, severe irritation, redness, or blisters on the skin. These may be symptoms of a severe allergic reaction. (Frequency cannot be determined from available data).
Seizures. (Uncommon, may occur in 1 in 100 people).
Reduced consciousness or loss of consciousness. (Uncommon, may occur in 1 in 100 people).

The following adverse reactions have also been reported
Very common adverse reactions (may occur in more than 1 in 10 people):

nausea, vomiting, constipation
drowsiness
dizziness
headache.

Common adverse reactions (may occur in up to 1 in 10 people):

allergic reaction
loss of appetite
insomnia
depression
feeling of anxiety or confusion
hallucinations (seeing, feeling, hearing things that do not exist)
tremor or muscle spasms
paraesthesia (sensory disturbances, tingling, burning skin)
dizziness
rapid heartbeat or palpitations
high blood pressure
shortness of breath
diarrhoea
dry mouth
abdominal pain or indigestion
excessive sweating
itching, rash, redness of the skin
difficulty passing urine or completely emptying the bladder
feeling of fatigue, weakness, malaise
feeling cold
peripheral swelling in the limbs.

Uncommon adverse reactions (may occur in up to 1 in 100 people):

restlessness or disorientation
euphoria (an unnatural state of cheerfulness and increased activity)
hypotension
memory loss
blurred vision
slow heartbeat or low blood pressure
cyanosis (lack of oxygen)
intestinal obstruction (ileus)
rash, allergic dermatitis, contact dermatitis at the application site
influenza-like symptoms
sensation of body temperature changes
fever
muscle twitching
erectile dysfunction (impotence) or sexual dysfunction
difficulty swallowing.

Rare adverse reactions (may occur in up to 1 in 1000 people):

pinpoint pupils (miosis)
apnoea.

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

deficiency of male sex hormones (androgen deficiency)
delirium (symptoms may include restlessness, anxiety, disorientation, confusion, fear, seeing or hearing things that are not there, sleep disturbances, nightmares).
The patient may become dependent on Fentanyl Actavis (see section 2).

At the site where the patch is applied to the skin, rash, redness or mild itching may occur.
These reactions are usually mild and disappear after removal of the patch. If they do not resolve, or if the patch causes significant skin irritation, inform the doctor.
With repeated use of patches, the effectiveness of the medicine may decrease (tolerance to the medicine may develop or sensitivity to pain may increase), or the patient may become dependent on it.
Withdrawal symptoms (such as nausea, vomiting, diarrhoea, restlessness and chills) may also occur in some patients after switching from previously used opioids to Fentanyl Actavis, or if treatment is suddenly stopped. Inform the doctor immediately if such symptoms occur.
Withdrawal symptoms have been observed in newborns of mothers who chronically used Fentanyl Actavis during pregnancy.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions to Medicinal Products 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, https://smz.ezdrowie.gov.pl/.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide 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) must be stored in a place that is out of sight and
out of reach of children.
This medicine must be kept in a secure place inaccessible to others. It may pose a serious risk, and even lead to death, in individuals who take or use it accidentally or intentionally, when it has not been prescribed to them.

How long can Fentanyl Actavis be stored
Do not use this medicine after the expiry date stated on the packaging following the wording: "Expiry date" or "EXP". The expiry date refers to the last day of the stated month. If the medicine has expired, return unused patches to a pharmacy.

Storage conditions
Do not store above 30°C.

How to dispose of used and unused patches
Accidental contact with an unused or used patch may result in death, especially in children.
After removal from the skin, the used patch should be folded in half with the adhesive sides together, placed back into the original pouch, and then disposed of safely, out of reach of children. Ask your pharmacist how to dispose of medicines no longer in use.
Medicines must not be disposed of via the sewage system or in household waste. Proper disposal helps protect the environment.

6. Contents of the pack and other information

What Fentanyl Actavis contains

The active substance is fentanyl. Each Fentanyl Actavis 25 µg/h patch releases 25 micrograms of fentanyl per hour. One patch with an active surface area of 7.5 cm² contains 4.125 mg of fentanyl.

Each Fentanyl Actavis 50 µg/h patch releases 50 micrograms of fentanyl per hour. One
patch with an active surface area of 15 cm² contains 8.25 mg of fentanyl.
Each Fentanyl Actavis 75 µg/h patch releases 75 micrograms of fentanyl per hour. One
patch with an active surface area of 22.5 cm² contains 12.375 mg of fentanyl.
Each Fentanyl Actavis 100 µg/h patch releases 100 micrograms of fentanyl per hour.
One patch with an active surface area of 30 cm² contains 16.5 mg of fentanyl.

Other ingredients are: Polyacrylate: copolymer of 2-ethylhexyl acrylate, 2-hydroxyethyl acrylate, methyl acrylate (35.5:1:12). Outer polypropylene (PP) film 40 μm (NNA 40 μm), printed with blue ink. Protective liner: silicone-coated polyethylene terephthalate (PET) 100 μm.

What Fentanyl Actavis looks like and contents of the pack
Fentanyl Actavis is a transparent patch with an adhesive surface allowing it to be applied to the skin. The transdermal system has a blue imprint indicating the strength.
Fentanyl Actavis is available in packs containing 5 or 10 transdermal systems.

Marketing Authorisation Holder
Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjörður
Iceland

Manufacturers
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

For further information about the medicinal product and its names in the Member States of the European Economic Area, please contact the representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00.

Fentanyl actavis