25 micrograms / hour, 50 micrograms / hour, 75 micrograms / hour, 100 micrograms / hour transdermal 
patch fentanyl

What Fentanyl Actavis is and what it is used for

The name of your medicine is Fentanyl Actavis.

The patches relieve very severely and long-lasting pain:

  • in adults who need continuous pain treatment
  • in children over 2 years of age who are already using opioid medicines and need continuous pain treatment.

Fentanyl Actavis contains a medicine called fentanyl . It belongs to a group of strong painkillers called opioids.

Fentanyl contained in Fentanyl Actavis may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before using Fentanyl Actavis

Do not use Fentanyl Actavis

  • you are allergic to fentanyl or any of the other ingredients of this medicine (listed in section 6).
  • you suffer from pain that lasts only a short period of time, such as sudden pain or pain after a surgical procedure.
  • you have difficulty breathing with slow or shallow breathing.

Do not use this medicine if any of the above apply to you or your child. If you have any further questions, ask your doctor or pharmacist before taking Fentanyl Actavis.

Warnings and cautions

Fentanyl Actavis can cause life-threatening side effects in people who are not already taking regular prescription opioid medicines. Fentanyl Actavis is a medicine that can be life-threatening for children, even if the patches are already in use. Keep in mind that a self-adhesive patch (unused or used) can be attractive to a child and if the patch sticks to the child’s skin or if the child puts it in his mouth, it can be fatal.

Depot patches that stick to another person

The patch should only be used on the skin of the person for whom it has been prescribed. There are reported cases where patches are accidentally stuck to another family member, during close physical contact, or by sharing the same bed as the wearer of the patch. A transdermal patch that accidentally gets stuck on another person (especially children) can cause drugs to pass through the other person’s skin and cause serious side effects such as slow and shallow breathing difficulties, which can be fatal. If the patch sticks to another person’s skin, remove the patch immediately and consult a physician.

Take special care with Fentanyl Actavis

Talk to your doctor or pharmacist before using this medicine if any of the following apply to you – your doctor may need to examine you more carefully about:

  • you have ever had problems with your lungs or breathing
  • you have ever had problems with your heart, liver, kidneys or have had low blood pressure
  • you have ever had a brain tumor
  • you have ever had a prolonged headache or a head injury
  • you are older – you may be more sensitive to the effects of this medicine
  • you have a disease called myasthenia gravis when the muscles become weak and tired quickly
  • you have ever abused or been addicted to alcohol, prescription drugs, or illegal drugs.

If any of the above apply to you (or you feel unsure), talk to your doctor or pharmacist before using Fentanyl Actavis.

Side effects and Fentanyl Actavis

  • Fentanyl Actavis can make you unusually sleepy and cause you to breathe more slowly and shallowly. In very rare cases, these breathing problems can be life-threatening or even fatal, especially in people who have never used strong painkillers with opioids (such as Fentanyl Actavis or morphine). If you or your partner or caregiver notice that the person wearing the patch is unusually sleepy and is breathing slowly or shallowly:
  • Remove the patch
  • Call a doctor or go to the nearest hospital immediately
  • Make sure the person is moving and talking as much as possible
  • If you get a fever while using Fentanyl Actavis, tell your doctor – it may cause an increased amount of medicine to pass through your skin.
  • Fentanyl Actavis can cause constipation. Consult a doctor or pharmacist for help in preventing or treating constipation.
  • Repeated, long-term treatment with the patches may make the medicine less effective (you will become “tolerant” of it) or make you addicted to it.

See section 4 for a complete list of possible side effects.

When wearing the patch, do not expose it to direct heat, such as heating pads, electric blankets, hot water bottles, heated water beds, or heat or sun lamps. You should not sunbathe, take long hot baths, bathe or take hot whirlpool baths. If you do this, you may get an increased amount of medication from the patch.

Other medicines and Fentanyl Actavis

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This also applies to over-the-counter medicines and herbal medicines. You should also tell the pharmacy staff that you are using Fentanyl Actavis if you buy any medicines at the pharmacy.

Your doctor will know which medicines are safe to take with Fentanyl Actavis. If you are taking any of the types of medicines listed below or if you stop taking any of these, you may need to be closely monitored as it may affect the dose of FentanylActavis you need.

In particular, tell your doctor or pharmacist if you are taking:

  • Other painkillers, such as opioid painkillers (such as buprenorphine, nalbuphine, or pentazocine).
  • Medicines to help you sleep (such as temazepam, zaleplon, or zolpidem).
  • Medicines that make you feel calmer (sedatives such as alprazolam, clonazepam, diazepam, hydroxyzine, or lorazepam) and medicines for mental problems (antipsychotics such as aripiprazole, haloperidol, olanzapine, risperidone, or phenothiazines).
  • Muscle relaxants (such as cyclobenzaprine or diazepam ).
  • Some medicines are used to treat depression, called SSRIs or SNRIs (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine ) – see below for more information.
  • Some medicines for depression or Parkinson’s disease called MAO inhibitors(such as isocarboxazid, phenelzine, selegiline, or tranylcypromine). You should not take Fentanyl Actavis within 14 days of stopping these medicines – see below for more information.
  • Some antihistamines, especially those that make you sleepy (such as chlorphenamine, clemastine, cyproheptadine, diphenhydramine, or hydroxyzine ).
  • Some antibiotics are used for infection (such as erythromycin or clarithromycin).
  • Medicines for fungal infections (such as itraconazole, ketoconazole , fluconazoleor voriconazole).
  • Drugs for HIV – infections (such as ritonavir).
  • Medicines for irregular heartbeat (such as amiodarone, diltiazem, or verapamil).
  • Medicines for tuberculosis (such as rifampicin).
  • Some medicines for epilepsy (such as carbamazepine, phenobarbital, or phenytoin).
  • Some medicines for nausea or motion sickness (such as phenothiazines).
  • Some medicines for heartburn or stomach ulcers (such as cimetidine).
  • Some medicines for angina (chest pain) or high blood pressure (such as nicardipine).
  • Some medicines are used to treat blood cancer (such as idelalisib).

Concomitant use of Fentanyl Actavis and sedatives such as benzodiazepines or related drugs increases the risk of drowsiness, difficulty breathing ( respiratory depression ), coma and may be life-threatening. Due to this, concomitant treatment should only be considered when no other treatment options are possible.

If your doctor nevertheless prescribes Fentanyl Actavis together with sedative medicines, your doctor should limit the dose and the time you take the medicines together.

Tell your doctor about all sedatives you are taking and follow your doctor’s dosing recommendations carefully. It may be helpful to tell friends and relatives about the signs and symptoms described above. Contact a doctor if you experience such symptoms.

Fentanyl Actavis with antidepressants

The risk of side effects is increased if you take medicines such as certain medicines for depression. Fentanyl Actavis may interact with these medicines and you may find that your mental state changes so that you, for example, feel anxious or see, feel, hear or smell something that does not exist (hallucinations) and experience other effects such as altered blood pressure, rapid heartbeat, high body temperature, overactive reflexes, lack of coordination, muscle stiffness, nausea, vomiting, and diarrhea.

Operations

If you think you are getting anesthesia, tell your doctor or dentist that you are taking Fentanyl Actavis.

Fentanyl Actavis and alcohol

Do not drink alcohol while taking Fentanyl Actavis unless you have first talked to your doctor.

Fentanyl Actavis can make you sleepy and you can breathe more slowly. If you drink alcohol, these effects will be aggravated.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Fentanyl Actavis should not be used during pregnancy unless you have first discussed this with your doctor.

Fentanyl Actavis should not be used during childbirth, as it may affect the breathing of the newborn baby.

Do not use Fentanyl Actavis if you are breast-feeding. You should not breast-feed for 3 days after removing your Fentanyl Actavis patch. The reason for this is that the drug can pass into breast milk.

Driving and using machines

Fentanyl Actavis may affect your ability to drive and use machines or tools as it may make you drowsy or dizzy. If this happens, do not drive or use any tools or machines. Do not drive while using this medicine until you know how it affects you.

If you are not sure if it is safe for you to drive a vehicle while you are taking this medicine, talk to your doctor or pharmacist.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

3. How to use Fentanyl Actavis

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Your doctor will decide which strength of Fentanyl Actavis is most suitable for you, taking into account how severe your pain is, your general condition, and the type of pain treatment you have received so far.

Use and change patches

  • There is enough medicine in each patch to last for 3 days (72 hours).
  • You should change your patch every three days unless your doctor has told you otherwise.
  • Always remove the old patch before applying the new one.
  • Always change patches at the same time of day every three days (72 hours).
  • If you use more than one patch, change all patches at once.
  • Write down the day, date, and time you put on the patch, so you know when you need to change your patch.

The following table shows you when it is time to change patches:

Put on your patch at Change your patch on
Monday Thursday
Tuesday Friday
Wednesday Saturday
Thursday Sunday
Friday Monday
Saturday Tuesday
Sunday Wednesday

Here you put on the patch

Adults

  • Apply the patch on a flat part of your upper body or arm (not over a joint).

Children

  • Always put the patch on the upper back so that the child does not have access to or remove the patch.
  • Check from time to time if the patch remains on the skin.
  • Your child mustn’t take the patch and put it in his mouth as it can be life-threatening and even fatal.
  • Observe your child very closely for 48 hours after:
  • the first patch has been applied.
  • a higher dose patch has been applied.
  • It may take some time for the patch to take full effect. Therefore, your child may also need to take other painkillers before the patches take effect. Your doctor will talk to you about this.

Adults and children:

Do not attach the patch

  • The same place twice in a row.
  • Skin surfaces that move a lot (joints), skin that is irritated or has sores.
  • Skin with a lot of hair. If there is hair, do not shave it off (shaving irritates the skin). Instead, cut the hair as close to the skin as possible.

Put on a patch

Step 1: Prepare the skin

  • Make sure the skin is completely dry, clean, and cool before applying the patch.
  • If you need to clean your skin, use only cold water.
  • Do not use soap or other detergents, creams, moisturizing lotions, oils, or talcum powder before applying the patch.
  • Do not apply a patch immediately after a hot bath or shower.

Step 2: Open the envelope

  • Each patch is enclosed in a separate envelope.
  • The Fentanyl Actavis patch should be removed from the protective bag by first folding in the notch (located near the corner of the bag label) and then gently tearing the material of the bag. If scissors are used to open the bag, this should be done near the sealed edge so as not to damage the patch inside.
  • Take out the patch and apply it immediately.
  • Save the empty envelope so that you can put your used patch in the latter when the patch is to be thrown away.
  • Each patch should only be used once.
  • Do not remove the patch from the envelope until you are ready to use it.
  • Check that the patch is not damaged.
  • Do not use the patch if it has been split, cut, or looks damaged.
  • Never divide or cut the patch.

Step 3: Pull off and press firmly

  • Make sure that the patch will be covered by loose clothing and that it will not sit under a tight or elastic band.
  • Carefully pull one-half of the glossy protective film away from the center of the patch. Avoid touching the adhesive side of the patch.
  • Press the adhesive side of the patch onto the skin.
  • Remove the second protective film and press the entire patch onto the skin using the palm of your hand.
  • Press for at least 30 seconds. Make sure it fits well, especially at the edges.

Step 4: Discard the patch

  • As soon as you remove the patch, fold it carefully in the middle so that the adhesive side sticks together.
  • Put it back in its original envelope and discard the envelope according to the pharmacist’s instructions.
  • Keep used patches out of the reach and sight of children – even used patches contain some medicines that can harm children and can even be fatal.

Step 5: Wash

  • Always wash your hands with clean water only after handling the patch.

More about using Fentanyl Actavis

Everyday activities when the patch is used

  • The patches are water-resistant.
  • You can shower or bathe while wearing the patch, but do not rub on the patch itself.
  • If your doctor agrees, you can exercise and participate in sports activities while wearing the patch.
  • You can also swim while wearing the patch, but:
  • Do not bathe in hot tubs.
  • Do not apply tight or elastic bands over the patch.
  • When wearing the patch do not expose it to direct heat, such as heating pads, electric blankets, hot water bottles, heated water beds, or heat or sun lamps. You should not sunbathe, take long hot baths or take a sauna. If you do this, you may get an increased amount of medication from the patch.

How quickly do the patches take effect?

  • It may take some time for your first patch to take full effect.
  • Your doctor may also give you other painkillers for the first day.
  • After that, the patch should relieve the pain continuously so that you can stop taking other painkillers, but your doctor may prescribe other painkillers from time to time.

How long will you use the patches?

  • Fentanyl Actavis patches are intended for long-term pain. Your doctor can tell you how long you can expect to use the patches.

If your pain worsens

  • If your pain worsens while you use the patches, your doctor may try to give you patches with higher strength or additional painkillers (or both).
  • If it does not help to increase the strength of the patches, your doctor may stop using the patches.

If you use too many patches or patches with the wrong strength

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you have applied too many patches or patches with the wrong strength, remove the patches and contact a doctor immediately.

Signs of overdose include difficulty breathing or shallow breathing, fatigue, extreme drowsiness, inability to think clearly, walk or speak normally, lethargy, dizziness, and confusion.

If you forget to change your patch

  • If you forget to change your patch, do it as soon as you can and write down the day and time. Change the patch again after 3 days (72 hours) as usual.
  • If you are very late in changing your patch, talk to your doctor, as you may need more painkillers, but do not put on an extra patch.

If a patch comes off

  • If a patch comes off before it is time to change, immediately apply a new one and write down the day and time. Apply a new skin surface on:
  • Your upper body or arm
  • The upper part of your baby’s back.
  • Let your doctor know that this has happened and leave the patch on for another 3 days (72 hours), or the time specified by your doctor, before changing to a new patch as usual.

If your patches constantly come off, talk to a doctor, pharmacist, or nurse.

If you want to stop using the patches

Talk to your doctor before stopping using these patches.

  • If you have been using them for a long time, your body may have become accustomed to them. If you suddenly quit, you may start to feel unwell.
  • If you stop using the patches, do not start again without first asking your doctor. You may need a different strength of the patches when you start again.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

If you or your partner or caregiver notice any of the following in the person using the patch, remove the patch and call a physician or go to the nearest hospital immediately. The person may need immediate medical attention.

  • Unusual drowsiness, slower or shallower breathing than expected.
  • Follow the advice above and make sure the person who used the patch moves and talks as much as possible. In very rare cases, these breathing difficulties can be life-threatening or even fatal, especially in people who have never used strong painkillers with opioids (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 blistering of your skin. This may be a sign of an allergic reaction  (Has been reported, occurs in an unknown number of users)
  • Seizures. (Uncommon, may affect up to 1 in 100 people.)
  • Decreased level of consciousness or loss of consciousness. (Uncommon, may affect up to 1 in 100 people).

The following side effects have also been reported

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

  • Nausea, vomiting, constipation
  • Sleepiness ( somnolence )
  • Dizziness
  • Headache

Common (may affect up to 1 in 10 people)

  • Allergic reaction
  • Loss of appetite
  • Difficulty sleeping
  • Depression
  • The feeling of anxiety and confusion
  • To see, feel, hear or smell something that does not exist (hallucinations)
  • Shaking or muscle twitching
  • Abnormal sensation in the skin, such as tingling or crawling sensation ( paresthesias )
  • Dizziness (fraud)
  • Rapid or irregular heartbeat ( palpitation, tachycardia )
  • High blood pressure
  • Shortness of breath ( dyspnoea )
  • Diarrhea
  • Dry mouth
  • Abdominal pain or indigestion
  • Significantly increased sweating
  • Itching, rash, or redness of the skin
  • Inability to urinate or empty bladder properly
  • Severe fatigue, weakness, or general malaise
  • To feel frozen
  • Swollen hands, ankles, or feet (peripheral edema )

Uncommon (may affect up to 1 in 100 people)

  • Feeling anxious or confused strong feeling of happiness ( euphoria )
  • Decreased sensation or sensitivity, especially in the skin ( hypoesthesia )
  • Memory loss
  • Dimsyn
  • Slow heartbeat ( bradycardia ) or low blood pressure
  • Blue skin caused by low oxygen content in the blood (cyanosis)
  • Intestinal cramps ( ileus )
  • Itchy skin rash ( eczema ), an allergic reaction, or other skin conditions where the patch is located
  • Flu-like illness
  • The feeling of change in body temperature
  • Fever
  • Muscle twitching
  • Difficulty getting and maintaining an erection ( impotence ) or problems having sex

Rare side effects (may affect up to 1 in 1,000 people)

  • Condensed pupils are ( mios )
  • Temporary respiratory arrest ( apnea )

No known frequency

  • Lack of male sex hormone (androgen deficiency)
  • Delirium (symptoms may include a combination of anxiety, restlessness, disorientation, confusion, fear, seeing and hearing things that do not exist, sleep disturbance, nightmares)

You may notice a rash, redness, or slight itching in the skin where the patch is located. This is usually mild and disappears once you have removed the patch. If it does not disappear or if the patch irritates the skin very much, tell your doctor.

Repeated, long-term treatment with the patches may make the medicine less effective (you will become “tolerant” of it) or make you addicted to it.

If you switch from another painkiller to Fentanyl Actavis or if you suddenly stop using Fentanyl Actavis, you may experience withdrawal symptoms such as nausea, diarrhea, anxiety, or shaking. Tell your doctor if you get any of these symptoms.

There are also reports of newborns experiencing withdrawal symptoms after their mothers have been using Fentanyl Actavis for a long time during pregnancy.

5. How to store Fentanyl Actavis

Storage space

Keep all patches (used and unused) out of the reach and sight of children.

Storage time

Do not use this medicine after the expiry date which is stated on the carton and envelope after EXP. or EXP. The expiration date is the last day of the specified month. If the patches have passed their expiry date, take them to your pharmacist.

Storage instructions

Do not store above 30 ° C.

How to dispose of used patches or patches you no longer need

If a used or unused patch is accidentally stuck on another person, especially a child, it can be fatal.

Used patches should be folded so that the adhesive side of the patch is glued together. It should then be put back in the original envelope and kept out of sight and reach of other persons, especially children until it is disposed of safely. Ask your pharmacist how to dispose of medicines no longer required.

Medicines should not be disposed of via wastewater or household waste. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

Fentanyl Actavis 25 micrograms / hour transdermal patch

  • The active substance is fentanyl .

Each patch releases 25 micrograms of fentanyl per hour. Each patch with a surface area of ​​7.5 cm 2 contains 4.125 mg of fentanyl.

Fentanyl Actavis 50 micrograms / hour transdermal patch

  • The active substance is fentanyl .

Each patch releases 50 micrograms of fentanyl per hour. Each 15 cm patch contains 8.25 mg of fentanyl.

Fentanyl Actavis 75 micrograms / hour transdermal patch

  • The active substance is fentanyl .

Each patch releases 75 micrograms of fentanyl per hour. Each patch with a surface area of ​​22.5 cm 2 contains 12.375 mg of fentanyl.

Fentanyl Actavis 100 micrograms / hour transdermal patch

  • The active substance is fentanyl .

Each patch releases 100 micrograms of fentanyl per hour. Each patch with a surface area of ​​30 cm 2 contains 16.5 mg of fentanyl.

  • Other ingredients are:

Adhesive surface: polyacrylate adhesive

Protective film: polypropylene film, blue ink

Release control membrane: polyethylene terephthalate film (siliconized)

What the medicine looks like and the contents of the pack

Fentanyl Actavis is a clear transdermal patch with a sticky back so that it can adhere to the skin. The transdermal patches are provided with a blue marking with strength.

Fentanyl Actavis is supplied in packs of 3, 4, 5, 8, 10, 16, or 20 transdermal patches.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

IS-220 Hafnarfjörður

Iceland

Manufacturer

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

IS-220 Hafnarfjörður

Iceland

Luye Pharma AG

Am Windfeld 35

83714 Miesbach

Germany

Merckle GmbH,

Ludwig-Merckle-Strasse 3

Blaubeuren,

Baden-Wuerttemberg, 89143

Germany

Muhammad Nadeem

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