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Fentanyl Orion

Document: Fentanyl Orion transdermal patch ENG PL change


Package leaflet: Information for the user


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


Read all of this leaflet carefully before you start using this medicine because it contains important information for you.


What is in this leaflet

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

2. What you need to know before you use Fentanyl Orion

3. How to use Fentanyl Orion

4. Possible side effects

5. How to store Fentanyl Orion

6. Contents of the pack and other information


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


Fentanyl is one of a group of strong painkillers called opioids.

The painkiller, fentanyl, slowly passes from the patch, through the skin and into the body.


Adults:

Fentanyl Orion is used for treatment of severe and long-lasting pain that can only adequately be managed with strong pain relievers.


Children:

Fentanyl Orion is used for the long term treatment of severe and long-lasting pain in children aged 2 years or older who have previously been treated with other strong pain relievers.



2. What you need to know before you use Fentanyl Orion


Do notuse Fentanyl Orion

- if you are allergic to fentanyl, peanut, soyaor any of the other ingredients of this medicine (listed in section 6).

- if you suffer from pain which lasts only for a short period, e.g. after a surgical procedure.

- if your central nervous system is severely impaired, for instance by brain injury.

if you have severe breathing difficulties.


Warnings and precautions


Talk to your doctor or pharmacist before usingFentanyl Orion.


WARNING:

Fentanyl Orion is a medicinal product that could be life‑threatening to children. This is also the case with used transdermal patches. Bear in mind that the design of this medicinal product could be tempting to a child which in some cases may lead to a fatal outcome. Fentanyl Orion can have life‑threatening side‑effects in persons that are not using prescribed opioid medicines on a regular basis.


Keep this product out of the sight and reach of children before and after use.


Your doctor will use the treatment with Fentanyl Orionas a part of an integrated treatment of pain and will regularly monitor you for your individual response to Fentanyl Orion.


Before starting to use Fentanyl Orion you should inform your doctor if you suffer from any of the below conditions, because the risk of side effects is higher and/or your doctor may need to prescribe a lower dose of fentanyl.


Constipation

Fentanyl Orion can cause constipation. Talk to your doctor or pharmacist for advice on how to prevent constipation.


Serotonin syndrome

Tell your doctor if you are using or have recently used certain medicines to treat depression called selective serotonin reuptake inhibitors (SSRIs), serotonin–norepinephrine reuptake inhibitors (SNRIs) or medicines known as monoamine oxidase (MAO) inhibitors (e.g. moclobemide against depression or selegiline against Parkinson’s disease). Concomitant use with Fentanyl Orion and these medicines may increase the risk of so called serotonin syndrome, a potentially life-threatening condition. Signs and symptoms of serotonin syndrome may include a combination of the following: agitation, hallucinations, coma, rapid heart rate, fast changes in blood pressure, increased body temperature, overactive reflexes, loss of coordination, rigidity, diarrhoea, nausea and vomiting. Get medical care right away if you think serotonin syndrome is happening to you.


Fever and external heat

Inform your doctor if you develop fever during the treatment, as increased body temperature may cause too much medicine to pass through the skin and result in overdose or even death.

For the same reason you should avoid exposing the patch on the skin to direct heat, such as heating pads, electric blankets, hot‑water bottles, heat or tanning lamps, heated water beds, and prolonged saunas, hot baths and hot whirlpool spa baths. Avoid also intensive sunbathing. It is allowed to stay outside in the sun, but you must protect the patch with some piece of clothing during hot summer days.


Drug dependence

Like with many other strong painkillers, tolerance, physical or psychological dependence may develop if you use Fentanyl Orion for a longer period. However, this is rarely seen during treatment of pain due to cancer. Tell your doctor if you have a history of drug dependence or alcohol abuse, because your risk of dependence might be increased and the doctor may want to monitor your drug use more closely. Abuse or intentional misuse of this medicine may result in overdose or death.


Older people and emaciated patients

If you are an elderly patient or if you are in a very bad physical condition (cachectic), your doctor will monitor you more carefully, because it may be necessary to prescribe a lower dose.

Patch sticking to another person

The patch should be used only on the skin of the person for whom it was ordered by the doctor. Cases have been reported where a patch was accidentally stuck to a family member while in close physical contact or sharing the same bed as the patch wearer. A patch sticking to another person (particularly a child) may result in an overdose. In case the patch sticks to the skin of another person, take the patch off immediately and seek medical attention.


Handling of patches

The patches should not be cut into smaller parts, because the quality, efficacy and safety of such divided patches have not been demonstrated.


Children

Fentanyl Orion may only be used in children aged 2 years or older who have previously been treated with other opioids (e.g. morphine). Fentanyl Orion should not be used in infants and toddlers under 2 years of age.

To guard against accidental ingestion by children, caution should be used when choosing the application site for Fentanyl transdermal patch (see section 3. How to use Fentanyl Orion) and the adhesion of the patch should be monitored closely.


Other medicines and Fentanyl Orion


Please tell your doctor if you use barbiturates (used for treating sleep disorders), buprenorphine, nalbuphine or pentazocine (other strong painkillers). It is not recommended to use those together with Fentanyl Orion because they may reduce or increase the effects of fentanyl, and induce withdrawal symptoms in opioid‑dependent patients.


Do not take concomitantly with Fentanyl Orion other medicines that depress function of the central nervous system, as this might result in breathing difficulties, low blood pressure, profound sedation, coma or death. This applies, for example, to:

- medicines used for treating anxiety (anxiolytics and tranquillisers)

- medicines used for treating depression (antidepressants), e.g. nefazodone

- medicines used for treating psychological disorders (neuroleptics)

- general anaesthetics, if you think you are going to have general anaesthesia, tell the doctor or dentist that you are using Fentanyl Orion

some medicines for back pain or other painful musculoskeletal conditions (muscle relaxants)

- medicines used for treatingsleep disorders (hypnotics, sedatives)

- medicines used for treating allergies or travelsickness (antihistamines/antiemetics)

- other strong painkillers of the opioid group

- alcohol


You should not take the medicines listed below at the same time as you are using Fentanyl Orion, unless you are closely monitored by your doctor. These medicines may increase the effects and side effects of Fentanyl Orion and even cause serious respiratory depression. This applies, for example, to:

- ritonavir, saquinavir, nelfinavir (used to treat AIDS)

- ketoconazole, itraconazole, voriconazole (used to treat fungal diseases)

- diltiazem, verapamil, amiodarone (used to treat heart diseases)

- cimetidine (used to treat gastrointestinal diseases)

- macrolide antibiotics (used to treat infections), e.g. clarithromycin, erythromycin, telithromycin, troleandomycin


Tell your doctor if you are taking or have recently been taking medicines called CYP3A4 inducers, for example:

These medicines may reduce the effect of Fentanyl Orion and a dose adjustment may be necessary.


Serotonin syndrome

Tell your doctor or pharmacist if you are using certain medicines to treat depression called selective serotonin reuptake inhibitors (SSRIs), serotonin–norepinephrine reuptake inhibitors (SNRIs) or medicines known as monoamine oxidase (MAO) inhibitors (e.g. moclobemide against depression or selegiline against Parkinson’s disease). Your doctor should be aware if you are using these medicines, or have been using them within the last 14 days,because concomitant use with Fentanyl Orion may increase the risk of serotonin syndrome, a potentially life-threatening condition. For more information see section “Warnings and precautions”.


Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.

Fentanyl Orion with food, drink and alcohol

Simultaneous use of Fentanyl Orion and alcoholic beverages increases the risk of severe adverse reactions, and may cause breathing difficulties, a fall of blood pressure, profound sedation and coma.


Pregnancy and breast‑feeding


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.


Pregnancy

Fentanyl Orion should not be used during pregnancy unless clearly necessary, because the safety of fentanyl in pregnancy remains unknown. If you get pregnant during treatment with Fentanyl Orion , consult your doctor.


The use of Fentanyl Orion during labour and delivery is not recommended, because fentanyl is not appropriate for management of short‑term pain and because it may cause breathing problems in the newborn infant.


Breast‑feeding

You should not breastfeed during treatment with Fentanyl Orion. Fentanyl passes into breast-milk and may cause side effects in the breast-fed infant as sedation and respiratory depression. Any breast milk produced during treatment or within 72 hours after the removal of the last patch should be discarded.


Driving and using machines


Fentanyl Orion has major influence on the ability to drive and use machines. This has to be expected especially at the beginning of treatment, at any change of dosage as well as in connection with alcohol or tranquilizers. If you have been using the same dose of Fentanyl Orion for a longer period of time, your doctor may decide that you are permitted to drive and use dangerous machines. Do not drive or operate dangerous machines while using Fentanyl Orion, unless your doctor has told you that such is permitted.


3. How to use Fentanyl Orion


Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.


Your doctor will decide which strength of Fentanyl Orion is most suitable for you. Your doctor will base his judgement on: the severity of your pain, your general condition and the type of pain treatment that you have received so far.

According to your reaction the strength of the patch or the number of patches may need to be adjusted. The effect is reached within 24 hours after the first patch has been applied and its effects fall gradually after the patch is removed. Do not discontinue treatment without consulting your doctor.


Unless otherwise prescribed by your physician, the normal dosage is:

The patch strength should always be adapted to the severity of pain and the sensitivity of the individual patient.


Determining the treatment amount (dosage adjustment)

If you have not previously received strong painkillers (analgesics), treatment should be initiated with the lowest concentration of the active substance.

Since the concentration of fentanyl in the bloodstream rises slowly, the current analgesic treatment should be stopped no earlier than 12 hours after the patch has been applied. After this time, it is oriented to need. Fundamentally, the maximum analgesic effect can only be assessed after approx. 24 hours.

When switching from other strongly acting analgesics to Fentanyl Orion the 24‑hour requirement of the previously administered strong analgesic should first be calculated by your physician.


Dosage for maintaining the effect

If the analgesic effect is still insufficient after 72 hours, the dosage may be increased step by step by an additional 25 micrograms/hour until the desired analgesic effect is obtained. The possible need for other analgesics and the patient’s sensation of pain should be taken into account.


Use of several patches simultaneously

If the required dosage exceeds 100 micrograms fentanyl per hour, several patches of differing strength may be used simultaneously.


Additional or alternative methods of analgesic treatment should be considered if the required dosage exceeds 300 micrograms fentanyl per hour.


Change of treatment

If there is intent to switch from Fentanyl Orion to another strongly acting analgesic, the patch is removed, and the dosage of the new analgesic is adapted using the patient’s pain assessment.

After switching or dosage reduction, some patients may experience opioid withdrawal symptoms (such as nausea, vomiting, diarrhoea, fear conditions and muscle trembling). If stoppage of Fentanyl Orion is necessary, step‑by‑step reduction of the dosage, e.g. by using a weaker patch, is recommended.


Disturbed liver or kidney function

In patients with disturbed liver or kidney function, the active substance amount should be reduced, if applicable.


Use in children

Your doctor will choose the use of Fentanyl Orion 12 micrograms/hour only if your child received at least 30–44 mg morphine as daily oral dose or other opioid analgesic agents equivalent to morphine. In cases of oral dosages of 45–134 mg your doctor will prescribe the use of Fentanyl Orion 25 micrograms/hour. For children who receive more than 90 mg oral morphine a day, only limited information is currently available.

If the analgesic effect of Fentanyl Orion is insufficient, supplementary morphine or another short-duration opioid will be prescribed. Depending on the additional analgesic needs and the pain status of the child, the doctor may decide to increase the dose. The doctor will perform dose adjustments in steps of 12 micrograms fentanyl per hour.


Older people

Elderly patients should be carefully monitored for signs of overdose. A lower patch strength may have to be used.


Feverish patients

Dosage adaptation may be required in these patients during feverish periods.


How and when to use Fentanyl Orion

Apply Fentanyl Orion immediately after removal from the package and removal of the protective foil, onto a hairless smooth skin surface or an area from which the hair has been removed, in the region of the upper body (chest, back) or on the upper arm. Hair should not be shaved, but should be trimmed with scissors.

If required, the skin should be cautiously cleaned with water and dried thoroughly before applying the patch. Do not use soaps, oils, lotions, alcohol or other products which may irritate the skin or influence its characteristics. Ensure that the treatment location does not show skin irritations or small injuries (e.g. after irradiation or shaving).

Since the outside of the patch is protected by a waterproof cover foil, you can also wear it while showering.


Children: In young children, the upper back is the preferred location to apply the patch, to minimize the potential of the child removing the patch.


Only open the pouch immediately before use of the patch.

Advice for opening child resistant sachet:
1) You’ll find a mark which shows you how to cut the sachet (using scissors!)

2) Rip the sachet alongside using the resulting cuts

3) Open the sachet and take out the patch

Then remove the pull‑off foil from half of the patch. It is important to avoid touching the adhesive surface.