Fentanyl Orion 12 micrograms / hour transdermal patch 
Fentanyl Orion 25 micrograms / hour transdermal patch 
Fentanyl Orion 50 micrograms / hour transdermal patch 
Fentanyl Orion 75 micrograms / hour transdermal patch 
Fentanyl Orion 100 micrograms / hour transdermal patch

fentanyl

What Fentanyl Orion is and what it is used for

The name of your medicine is Fentanyl Orion.

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

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

What you need to know before using Fentanyl Orion

Do not use Fentanyl Orion:

  • if you are allergic to fentanyl, peanuts, soy, or any of the other ingredients of this medicine (listed in section 6)
  • if you suffer from pain that lasts only a short period of time, such as sudden pain or pain after a surgical procedure
  • if 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 Orion.

Warnings and cautions



Fentanyl Orion may cause life-threatening side effects in people who are not already regularly taking prescription opioid medicines. Fentanyl Orion is a drug that can be life-threatening for children. This also applies to used patches. 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.

Custodian locks attached to another person

The patch should only be used on the skin of the person prescribed by the doctor. There are reported cases where a patch was accidentally stuck to a family member during close physical contact or when a bed was shared with the wearer of the patch. A patch that has adhered to another person (especially a child) can cause drugs to pass through the other person’s skin and cause serious side effects such as difficulty breathing with slow and shallow breathing, which can be fatal. If the patch has adhered to another person’s skin, remove the patch immediately and consult a physician.

Take special care with Fentanyl Orion

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

  • you have ever had problems with your lungs or breathing
  • you have ever had problems with your heart, liver, kidneys or 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 Orion.

Side effects and Fentanyl Orion

  • Fentanyl Orion may 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 Orion 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 Orion, tell your doctor – it may cause an increased amount of medicine to pass through your skin.
  • Fentanyl Orion may 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 Orion

Tell your doctor or nurse 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 your pharmacist that you are taking Fentanyl Orion if you buy any medicines at the pharmacy.

Your doctor will know which medicines are safe to take with Fentanyl Orion. 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 FentanylOrion you need.

Above all, tell your doctor or pharmacist if you are taking:

  • other pain-relieving drugs, such as smärtillande drugs with opioid’s (such as buprenorphine, nalbuphine, or pentazocine)
  • medicines that 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 Orion within 14 days of stopping these medicines – see below for more information.
  • some antihistamines, especially those that make you sleepy (such as chlorpheniramine, clemastine, cyproheptadine, diphenhydramine, or hydroxyzine)
  • certain antibiotics used for infection (such as erythromycin or clarithromycin)
  • antifungal drugs (such as itraconazole, ketoconazole , fluconazole or voriconazole)
  • drugs against HIV – infection’s (such as ritonavir)
  • medicines for irregular heartbeat (such as amiodarone, diltiazem, or verapamil)
  • drugs for tuberculosis (such as rifampicin)
  • certain medicines for epilepsy (such as carbamazepine, phenobarbital, or phenytoin)
  • certain medicines for nausea or motion sickness (such as phenothiazines)
  • certain medicines for heartburn or stomach ulcers (such as cimetidine)
  • certain medicines for angina (chest pain) or high blood pressure (such as nicardipine)
  • certain medicines used to treat blood cancer (such as idelalisib).

Concomitant use of Fentanyl Orion and sedatives, such as benzodiazepines or similar drugs, increases the risk of drowsiness, difficulty breathing ( respiratory depression ), and coma, which can be life-threatening. Due to this, concomitant use should only be considered when other treatment options are not possible.

If your doctor prescribes Fentanyl Orion at the same time as sedatives, the dose and treatment time should be limited.

Tell your doctor if you are taking any sedatives and carefully follow your doctor’s dose recommendations. It may be helpful to inform friends or relatives about paying attention to the signs and symptoms described above. Contact a doctor if you experience any of these symptoms.

Fentanyl Orion with antidepressants The 
risk of side effects is increased if you take medicines such as certain antidepressants. Fentanyl Orion may interact with these medicines and you may find that your mental status 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, fast 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 using Fentanyl Orion.

Fentanyl Orion with food, drink, and alcohol

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

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

Pregnancy, breastfeeding, and fertility

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 Orion should not be used during pregnancy unless you have first discussed it with your doctor.

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

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

Driving and using machines

Fentanyl Orion 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 increased 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.

Important information about some of the ingredients of Fentanyl Orion

Fentanyl Orion contains soybean oil. If you are allergic to peanuts or soy, do not use this medicine.

3. How to use Fentanyl Orion

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 Orion is most suitable for you. The doctor bases his assessment on 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 at the same time
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

step 2
  • Each patch is enclosed in a separate envelope.
  • Find the mark that shows where to cut the envelope (use scissors!)
  • Tear up the package along with the clip.
  • Open the envelope and take out the patch and use 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

step 3-1
step 3-2
step 3-3
  • 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 off one-half of the protective film. Avoid touching the adhesive side of the patch.
  • Press the adhesive side of the patch onto the skin.
  • Remove the other part of the 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 (see section 5).

Step 5: Wash

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

More about using Fentanyl Orion

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 Orion 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 much Fentanyl Orion or patch with the wrong strength

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 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 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 Fentanyl Orion

  • 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 Orion 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
  • drowsiness ( 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)
  • tremors or muscle twitching
  • abnormal sensation in the skin such as tingling or creeping sensation ( paresthesias )
  • dizziness (fraud)
  • rapid or irregular heartbeat ( palpitation, tachycardia )
  • high blood pressure
  • shortness of breath ( dyspnoea )
  • diarrhea
  • dry mouth
  • abdominal pain or indigestion
  • greatly increased sweating
  • itching, rash, or redness of the skin
  • inability to urinate or empty the 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):

  • anxiety or confusion
  • a strong feeling of happiness ( euphoria )
  • impaired 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 rash ( eczema ), an allergic reaction, or other skin conditions where the patch is located
  • flu-like illness
  • the feeling of changing body temperature
  • fever
  • muscle twitching
  • difficulty getting and maintaining an erection ( impotence ) or problems having sex.

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

  • contracted pupil er ( mios )
  • temporary respiratory arrest ( apnea )

Has been reported (occurs in an unknown number of users):

  • male sex hormone deficiency (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 Orion or if you suddenly stop using Fentanyl Orion, 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 Orion for a long time during pregnancy.

Reporting of side effects ar

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase the safety of medicines.

The Medical Products Agency

Box 26

751 03 Uppsala

www.lakemedelsverket.se

5. How to store Fentanyl Orion

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. The expiration date is the last day of the specified month. If the patches have passed their expiry date, take them to your pharmacist.

No special storage instructions.

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. Unused patches must be returned to the pharmacy. 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

  • The active substance is fentanyl. 
    Fentanyl Orion 12 micrograms / hour: A patch releases 12.5 micrograms of fentanyl per hour. A 4.25 cm patch contains 2.55 mg of fentanyl .
    Fentanyl Orion 25 micrograms / hour: A patch releases 25 micrograms offentanyl per hour. A8.5 cm 2 patch contains 5.1 mg of fentanyl .
    Fentanyl Orion 50 micrograms / hour: A patch releases 50 micrograms offentanyl per hour. A17 cm 2 patch contains 10.2 mg of fentanyl .
    Fentanyl Orion 75 micrograms / hour: A patch releases 75 micrograms offentanyl per hour. A25.5 cm 2 patch contains 15.3 mg of fentanyl .
    Fentanyl Orion 100 micrograms / hour: A patch releases 100 micrograms offentanyl per hour. A34 cm 2 patch contains 20.4 mg of fentanyl .
  • The other ingredients are: 
    Matrix components: Aloe vera leaf extract oil (based on tocopherol acetate from soybean oil), hydrogenated rosin pentaerythritol ester, poly (2-Ethylhexyl acrylate, vinyl acetate) (50:50)
    Release protective layer: Polyester foil
    Backing foil with print: Polyethylene terephthalate foil, printing ink

What the medicine looks like and the contents of the pack

Depot patches.

Fentanyl Orion transdermal patch is an opaque, colorless, rectangular patch with rounded corners and markings on the backing foil: “fentanyl 12 µg / h” / “fentanyl 25μg / h” / “fentanyl 50 /g / h” / “fentanyl 75 / µg / “fentanyl 100 ug / h” /

Fentanyl Orion is available in packs of 4, 5, 8, 10, 16, and 20 transdermal patches in individually packaged child-resistant sachets.

Marketing Authorisation Holder

Orion Corporation 
Orionintie 1 
FI_02200 Espoo

Finland

Manufacturer:

Orion Corporation Orion Pharma

Orionintie 1

FI- 02200 Espoo

Finland

For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Orion Pharma AB

medinfo@orionpharma.com

Muhammad Nadeem

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