Fenpatch

Patient Information Leaflet: Information for the User

Read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you (or your child) only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What FenPatch is and what it is used for
2. What you need to know before using FenPatch
3. How to use FenPatch
4. Possible side effects
5. How to store FenPatch
6. Contents of the pack and other information

1. What FenPatch is and what it is used for

The name of this medicine is FenPatch.
The patches help relieve severe and long-lasting pain:

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

FenPatch contains a medicine called fentanyl, which belongs to a group of strong painkillers called opioids.

2. What you need to know before using FenPatch

Do not use FenPatch if:

• you are allergic to fentanyl or to any of the other ingredients of this medicine (listed in section 6).
• your pain is short-term, such as sudden pain or postoperative pain.
• you suffer from severe respiratory depression, with slow or shallow breathing.

Do not use this medicine if any of the points above apply to you or your child. If you have any doubts, consult your doctor, pharmacist, or nurse before using FenPatch.

Warnings and precautions

• FenPatch may cause life-threatening side effects in people who are not already regularly using prescribed opioid medicines.
• FenPatch is a medicine that could be life-threatening to children, even if the patches have already been used. Please be aware that an adhesive patch (new or used) may be attractive to a child, and if it sticks to a child’s skin or if the child puts it in their mouth, the result could be fatal.

Transfer of the patch to another person
The patch must only be used on the skin of the person for whom it was prescribed. Cases have been reported of accidental adhesion of the patch to a family member during close physical contact or while sharing the same bed with the person using the patch. A patch that accidentally sticks to another person (especially a child) may allow the medicine to pass through that person’s skin, causing serious adverse effects such as difficulty breathing, slow and weak breathing, which may be fatal. If the patch adheres to another person’s skin, remove it immediately and contact a doctor.

Special precautions with FenPatch
Talk to your doctor or pharmacist before using this medicine if any of the conditions listed below apply to you, as your doctor may need to monitor you more closely.

• If you have ever had lung or breathing problems.
• If you have ever had heart, liver, or kidney problems, or if you have or have had low blood pressure.
• If you have ever had a brain tumour.
• If you have ever had persistent headaches or a head injury.
• If you are elderly, as you may be more sensitive to the effects of this medicine.
• If you have a condition called “myasthenia gravis”, in which muscles become weak and tire easily.
• If you have ever abused or been dependent on alcohol, prescription medicines, or illegal substances.

If any of the conditions listed above apply to you (or if you are unsure), consult your doctor, pharmacist, or nurse before using FenPatch.

Side effects and FenPatch

• FenPatch may make you feel unusually drowsy and may slow and weaken your breathing. Very rarely, these breathing problems may be life-threatening or even fatal, especially in people who have never previously used strong opioid painkillers (such as FenPatch or morphine). If you or someone else notices that the person using the patch is unusually drowsy, with slow or weak breathing:
  • remove the patch immediately
  • contact a doctor immediately or go to the nearest hospital
  • encourage the person to move and speak as much as possible
• If you develop a fever while using FenPatch, inform your doctor, as fever may increase the amount of medicine passing through the skin.
• FenPatch may cause constipation; consult your doctor or pharmacist for advice on how to prevent or relieve constipation.
• Long-term repeated use of the patches may make the medicine less effective (i.e. you become ‘tolerant’ to it), or you may become dependent on it. See section 4 for a complete list of possible side effects. While wearing the patch, avoid exposure to direct heat sources such as heating pads, electric blankets, hot water bottles, heated water beds, or heat or tanning lamps. Avoid prolonged sun exposure, long hot baths, saunas, or hot thermal baths. Doing so may increase the amount of medicine released from the patch.

Patches must not be cut into smaller pieces, as the quality, efficacy, and safety of patches divided in this way have not been established.
For athletes: using the medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
Using fentanyl patches as a doping agent may be hazardous to health.

Other medicines and FenPatch
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This includes medicines you buy without a prescription and herbal preparations. In addition, you must inform the pharmacist that you are using FenPatch when purchasing any medicine at the pharmacy.
Your doctor will know which medicines are safe to take together with FenPatch. If you start or stop taking any of the medicines listed below, careful monitoring may be needed, as this may affect the dose of FenPatch required for you.

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

• other pain medicines, such as other opioid painkillers (e.g. buprenorphine, nalbuphine, or pentazocine)
• medicines that help you sleep (e.g. temazepam, zaleplon, or zolpidem)
• medicines for anxiety (tranquillisers such as alprazolam, clonazepam, diazepam, hydroxyzine, or lorazepam) and medicines for mental conditions (antipsychotics such as aripiprazole, haloperidol, olanzapine, risperidone, or phenothiazines)
• medicines to relax muscles (e.g. cyclobenzaprine or diazepam)
• certain medicines used to treat depression called SSRIs or SNRIs (e.g. citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine) – see below for more information
• certain medicines used to treat depression or Parkinson’s disease called MAOIs (e.g. isocarboxazid, phenelzine, selegiline, or tranylcypromine). You must not use FenPatch within 14 days of stopping these medicines – see below for more information
• certain antihistamines, especially those causing drowsiness (e.g. chlorpheniramine, clemastine, cyproheptadine, diphenhydramine, or hydroxyzine)
• certain antibiotics used to treat infections (e.g. erythromycin or clarithromycin)
• medicines used to treat fungal infections (e.g. itraconazole, ketoconazole, fluconazole, or voriconazole)
• medicines used to treat HIV infection (e.g. ritonavir)
• medicines used to treat arrhythmia (irregular heartbeat) (e.g. amiodarone, diltiazem, or verapamil)
• medicines used to treat tuberculosis (e.g. rifampicin)
• certain medicines used to treat epilepsy (e.g. carbamazepine, phenobarbital, or phenytoin)
• certain medicines used to treat nausea or motion sickness (e.g. phenothiazines)
• certain medicines used to treat heartburn or ulcers (e.g. cimetidine)
• certain medicines used to treat angina (chest pain) or high blood pressure (e.g. nicardipine)
• certain medicines used to treat blood cancer (e.g. idelalisib).

FenPatch with sedative medicines such as benzodiazepines or related medicines
Concomitant use of FenPatch and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), and coma, and may be life-threatening. Therefore, concomitant use should only be considered if no other treatment options are available.
However, if your doctor prescribes FenPatch together with sedative medicines, the dose and duration of concomitant therapy must be determined by your doctor.
Inform your doctor about all sedative medicines you are taking and follow your doctor’s dosage recommendations carefully. It may be helpful to inform friends or family members to watch for the signs and symptoms listed above. Contact your doctor if these symptoms occur.

FenPatch with antidepressants
The risk of side effects increases if you are taking medicines such as certain antidepressants. FenPatch may interact with these medicines, leading to changes in mental state, such as feeling agitated, seeing things or hearing or smelling things that are not real (hallucinations), and other effects such as changes in blood pressure, rapid heartbeat, high body temperature, hyperreflexia (excessive reflexes), lack of coordination, muscle stiffness, nausea, vomiting, and diarrhoea.

Surgery
If you think you may need an anaesthetic, inform your doctor or dentist that you are using FenPatch.

FenPatch and alcohol
Do not drink alcohol while using FenPatch unless you have discussed it with your doctor. FenPatch may cause drowsiness or slowed breathing. Drinking alcohol may worsen these effects.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
FenPatch must not be used during pregnancy unless you have discussed it with your doctor.
FenPatch must not be used during childbirth, as the medicine may affect the newborn’s breathing.
Do not use FenPatch if you are breastfeeding. You must not breastfeed for 3 days after removing the FenPatch patch, as the medicine may pass into breast milk.

Driving and using machines
FenPatch may impair your ability to drive or use machines or tools, as it may cause drowsiness or dizziness. If this occurs, do not drive and do not use any tools or machinery. Do not drive while using this medicine until you know how it affects you.
Consult your doctor or pharmacist if you have any doubts about whether it is safe to drive while using this medicine.

3. How to use FenPatch

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Your doctor will decide the most appropriate dose of FenPatch for you, based on the intensity of
your pain, your general health condition, and the type of pain treatment you have previously received.

Application and replacement of the patch

• Each patch contains enough medicine for 3 days (72 hours).
• You must change the patch every third day, unless otherwise instructed by your doctor.
• 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, change all patches at the same time.
• Record the day, date, and time when you apply a patch, so you can remember when to replace it.
• The following table shows when to change the patch:

Where to apply the patch
Adults

• Apply the patch to a flat area of the trunk or upper arm (not over a joint).

Children

• Always apply the patch to the upper back to make it difficult for the child to touch or remove it.
• Nevertheless, check frequently to ensure the patch remains properly adhered to the skin.
• It is important that the child does not remove the patch or put it in their mouth, as this could be life-threatening or even fatal.
• Closely observe the child for 48 hours after:
  • the first patch has been applied
  • a patch with a higher dose has been applied
• The patch may take some time to reach its full effect. Therefore, the child may need to use other painkillers until the patch becomes effective. Your doctor will discuss this with you.

Adults and children:
Do not apply the patch

• In the same area two times in a row.
• On areas that move a lot (joints), on irritated skin, or on wounded skin.
• On areas with dense hair. Do not shave the hair (shaving may irritate the skin), but trim it as close to the skin as possible with scissors.

How to apply the patch
Step 1: Prepare the skin

• Ensure the skin is completely dry, clean, and cool before applying the patch.
• If cleaning is necessary, use only cold water.
• Do not use soap or any other cleanser, nor creams, moisturizers, oils, or talcum powder before applying the patch.
• Do not apply a patch immediately after a hot bath or shower.

Step 2: Open the pouch

• Each patch is sealed in an individual pouch.
• Tear or cut the pouch at the notch indicated by the arrow.
• Carefully tear or cut completely along the edge of the pouch (if using scissors, cut close to the sealed edge to avoid damaging the patch).

• • Hold both sides of the opened pouch and separate them.
  • Remove the patch and use it immediately.
  • Keep the empty pouch to dispose of the used patch later.
  • Use each patch only once.
  • Do not remove the patch from the pouch until you are ready to use it.
  • Inspect the patch to check if it is damaged.
  • Do not use the patch if it has been cut, divided, or appears damaged.
  • Never cut or divide the patch.

Step 3: Peel and press

• Make sure the patch will be covered by loose-fitting clothing and will not be compressed under tight or elastic bandages.
• Carefully peel off half of the shiny plastic liner starting from the center of the patch. Try not to touch the adhesive side of the patch.
• Press this adhesive part of the patch onto the skin.
• Remove the other half of the plastic liner and press the entire patch onto the skin with the palm of your hand.
• Apply firm pressure for at least 30 seconds, ensuring the patch adheres well, especially along the edges.

Step 4: Disposing of the patch

• Immediately after removing a patch, fold it in half firmly so that the adhesive side sticks to itself.
• Place it back into the original pouch and dispose of the pouch according to your pharmacist’s instructions.
• Keep used patches out of sight and reach of children, as even used patches contain some medicine that could be dangerous or even fatal to children.

Step 5: Washing

• After touching the patch, always wash your hands using only running water.

Additional information for using FenPatch

Daily activities while using the patch

• The patch is waterproof.
• You may take a shower or bath while wearing the patch, but do not rub it.
• If approved by your doctor, you may exercise or engage in sports while wearing the patch.
• You may also swim while wearing the patch, but:
  • do not use hot hydrotherapy baths
  • do not place tight or elastic bandages over the patch
• While wearing the patch, do not expose it to direct heat sources such as heating pads, electric blankets, hot water bottles, heated water beds, heat lamps, or sunbeds. Avoid prolonged sun exposure, hot baths, or saunas, as this may increase the amount of medicine released from the patch.

How quickly does the patch work?

• The first patch may take some time to reach its full effect.
• Your doctor will provide additional painkillers for the first day or as long as needed.
• After this period, the patch should provide continuous pain relief, allowing you to discontinue other analgesics. However, your doctor may still prescribe additional painkillers from time to time.

How long should you use the patches?

• FenPatch patches are indicated for long-term pain. Your doctor will be able to advise you on how long treatment is expected to last.

If pain worsens

• If your pain worsens while using these patches, your doctor may try a higher-dose patch or prescribe additional painkillers (or both).
• If increasing the patch dose does not help, your doctor may decide to discontinue the use of patches.

If you use too many patches or a patch with the wrong dose
If you have applied too many patches or a patch with the wrong dose, remove the patch and contact your
doctor immediately.
Signs of overdose include: difficulty breathing or weak breathing, fatigue, extreme drowsiness, inability to think clearly, walk or speak normally, and feelings of fainting, dizziness, or confusion.

If you forget to change the patch

• If you forget, change the patch as soon as you remember, and note the day and time. Then change the next patch after 3 days (72 hours), as usual.
• If you are significantly late in changing the patch, contact your doctor, as you may need additional painkillers, but do not apply an extra patch.

If the patch comes off

• If a patch comes off before it needs to be changed, apply a new one immediately and note the day and time. Use a new skin site on:
• the trunk or arm
• the upper back (in a child).
• Inform your doctor about what happened and leave the new patch in place for 3 days (72 hours) or as directed by your doctor before resuming your regular patch change schedule.
• If patches continue to fall off, discuss this with your doctor, pharmacist, or nurse.

If you wish to stop using the patches

• Consult your doctor before stopping the use of these patches.
• If you have been using the patch for some time, your body may have become accustomed to it. Stopping abruptly may make you feel unwell.
• If you stop using the patches, do not restart without first consulting your doctor, as you may need a patch with a different dose.

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

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, FenPatch can cause adverse effects, although not everyone experiences them.
If you, or anyone else, notice that the person using the patch shows any of the following symptoms, remove the patch immediately and contact a doctor straight away or go to the nearest hospital, as they may require urgent medical treatment.

• Unusual drowsiness, with breathing slower or shallower than normal.

Follow the recommendations above, keep the person who used the patch as active as possible, and encourage them to talk. Very rarely, these breathing difficulties can be life-threatening or even fatal, especially in people who have never previously used strong opioid analgesics (such as FenPatch or morphine). (Uncommon, may affect up to 1 in 100 people)

• Sudden swelling of the face or throat, severe irritation, redness, or blistering of the skin. These may be signs of a severe allergic reaction. (Frequency cannot be estimated from available clinical data)
• Seizures (convulsions). (Uncommon, may affect up to 1 in 100 people.)
• Reduced level of consciousness or loss of consciousness (Uncommon, may affect up to 1 in 100 people.)

The following adverse effects have also been reported.
Very common (may affect more than 1 in 10 people)

• Nausea, vomiting, constipation
• Feeling sleepy (drowsiness)
• Feeling dizzy
• Headache

Common (may affect up to 1 in 10 people)

• Allergic reaction
• Loss of appetite
• Difficulty sleeping
• Depression
• Anxiety or confusion
• Seeing things, hearing sounds, or smelling odours that do not exist (hallucinations)
• Tremors or muscle spasms
• Unusual skin sensations, such as tingling or crawling sensations (paraesthesia)
• Sensation of spinning (dizziness)
• Rapid or irregular heartbeat (palpitations, tachycardia)
• High blood pressure
• Shortness of breath (dyspnoea)
• Diarrhoea
• Dry mouth
• Stomach ache or indigestion
• Excessive sweating
• Itching, rash, or redness of the skin
• Inability to urinate or to completely empty the bladder
• Feeling of fatigue, weakness, or general malaise
• Feeling cold
• Swelling of the hands, ankles, or feet (peripheral oedema)

Uncommon (may affect up to 1 in 100 people)

• Feeling restless or disoriented
• Feeling extremely happy (euphoria)
• Decreased sensitivity, especially of the skin (hypoesthesia)
• Memory loss
• Blurred vision
• Slow heartbeat (bradycardia) or low blood pressure
• Bluish discoloration of the skin due to low oxygen in the blood (cyanosis)
• Loss of intestinal contractions (ileus)
• Itchy skin rash (eczema), allergic reaction, or other skin disorders at the site of the patch
• Flu-like illness
• Sensation of change in body temperature
• Fever
• Muscle spasm
• Difficulty achieving or maintaining an erection (impotence) or problems during sexual intercourse

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

• Constriction of the pupils (miosis)
• Periodic cessation of breathing (apnoea)

Not known (frequency cannot be estimated from available data):

• Lack of male sex hormones (androgen deficiency)
• Delirium (symptoms may include a combination of agitation, restlessness, disorientation, confusion, fear, seeing or hearing things that do not exist, sleep disturbances, nightmares)

You may notice a skin rash, redness, or mild itching in the area where the patch is applied. These reactions are usually mild in intensity and disappear after the patch is removed. If they do not resolve, or if the patch causes significant skin irritation, inform your doctor. Repeated use of the patches may reduce the effectiveness of the medicine (you become "tolerant" to it), or you may become dependent on it.

If you switch to FenPatch from a different analgesic, or if you stop using FenPatch abruptly, you may experience withdrawal symptoms such as vomiting, nausea, diarrhoea, anxiety, or shivering. Inform your doctor if any of these symptoms occur.
Withdrawal symptoms have also been reported in newborns whose mothers used FenPatch for a prolonged period during pregnancy.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report adverse effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. How to store FenPatch

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

How long to store FenPatch
Do not use this medicine after the expiry date stated on the carton and sachet. The expiry date refers to the last day of that month. Expired patches must be returned to a pharmacy.

This medicine does not require any special storage conditions.

How to dispose of used or unused patches
A used or unused patch that accidentally adheres to another person, especially a child, could be fatal.

Used patches must be firmly folded in half so that the adhesive side sticks to itself. They should then be safely stored in their original sachet and kept out of sight and reach of others, especially children, until safely disposed of. Ask your pharmacist how to dispose of medicines you no longer use.

Do not dispose of any medicine via wastewater or household waste. This will help protect the environment.

6. Package contents and other information

What FenPatch contains
The active substance is fentanyl.
FenPatch 12 micrograms/h transdermal patch
Each patch releases 12.5 micrograms of fentanyl per hour. Each 3.75 cm patch contains 2.063 mg of fentanyl.
FenPatch 25 micrograms/h transdermal patch
Each patch releases 25 micrograms of fentanyl per hour. Each 7.5 cm patch contains 4.125 mg of fentanyl.
FenPatch 50 micrograms/h transdermal patch
Each patch releases 50 micrograms of fentanyl per hour. Each 15 cm patch contains 8.25 mg of fentanyl.
FenPatch 75 micrograms/h transdermal patch
Each patch releases 75 micrograms of fentanyl per hour. Each 22.5 cm patch contains 12.375 mg of fentanyl.
FenPatch 100 micrograms/h transdermal patch
Each patch releases 100 micrograms of fentanyl per hour. Each 30 cm patch contains 16.5 mg of fentanyl.

The excipients are:
Adhesive layer: Polycrylate adhesive layer
Protective liner: Polypropylene sheet, blue printing ink
Release membrane: Silicone-coated polyethylene terephthalate sheet

Description of the appearance of FenPatch and contents of the pack
FenPatch is a transparent transdermal patch with an adhesive side that adheres to the skin. The transdermal patches have blue printing indicating their dosage strength.

FenPatch 12 micrograms/h transdermal patch
FenPatch is available in packs containing 2, 3, 4, 5, 8, 10, 15, 16 or 20 transdermal patches.

FenPatch 25 micrograms/h transdermal patch
FenPatch 50 micrograms/h transdermal patch
FenPatch 75 micrograms/h transdermal patch
FenPatch 100 micrograms/h transdermal patch
FenPatch is available in packs containing 3, 4, 5, 10, 15, 16 or 20 transdermal patches.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
ratiopharm GmbH
Graf-Arco Strasse 3
89079 Ulm (Germany)

Manufacturer
Merckle GmbH
Ludwig-Merckle Strasse 3
89143 Blaubeuren (Germany)

This medicinal product is authorized in the European Economic Area countries under the following names:

Austria
Fentoron 12 µg/h - transdermales Matrixpflaster

Czech Republic
Fentanyl-ratiopharm 12 μg/h
Fentanyl-ratiopharm 25 µg/h
Fentanyl-ratiopharm 50 µg/h
Fentanyl-ratiopharm 75 µg/h
Fentanyl-ratiopharm 100 µg/h

Finland
Fentanyl ratiopharm 12 mikrog/tunti depotlaastari
Fentanyl ratiopharm 25 mikrog/tunti depotlaastari
Fentanyl ratiopharm 50 mikrog/tunti depotlaastari
Fentanyl ratiopharm 75 mikrog/tunti depotlaastari
Fentanyl ratiopharm 100 mikrog/tunti depotlaastari

Germany
Fentanyl-ratiopharm 12 Mikrogramm/h Matrixpflaster
Fentanyl-ratiopharm 25 Mikrogramm/h Matrixpflaster
Fentanyl-ratiopharm 50 Mikrogramm/h Matrixpflaster
Fentanyl-ratiopharm 75 Mikrogramm/h Matrixpflaster
Fentanyl-ratiopharm 100 Mikrogramm/h Matrixpflaster

Hungary
Fentanyl-ratiopharm 25 mikrogramm/h transzdermális tapasz
Fentanyl-ratiopharm 50 mikrogramm/h transzdermális tapasz
Fentanyl-ratiopharm 75 mikrogramm/h transzdermális tapasz
Fentanyl-ratiopharm 100 mikrogramm/h transzdermális tapasz

Italy
FenPatch 12 micrograms/h transdermal patch
FenPatch 25 micrograms/h transdermal patch
FenPatch 50 micrograms/h transdermal patch
FenPatch 75 micrograms/h transdermal patch
FenPatch 100 micrograms/h transdermal patch

Norway
Fentanyl ratiopharm 12 mikrogram/time depotplaster
Fentanyl ratiopharm 25 mikrogram/time depotplaster
Fentanyl ratiopharm 50 mikrogram/time depotplaster
Fentanyl ratiopharm 75 mikrogram/time depotplaster
Fentanyl ratiopharm 100 mikrogram/time depotplaster

Slovakia
Fentanyl-ratiopharm 12 µg/h
Fentanyl-ratiopharm 25 µg/h
Fentanyl-ratiopharm 50 µg/h
Fentanyl-ratiopharm 75 µg/h
Fentanyl-ratiopharm 100 µg/h

Sweden
Fentanyl ratiopharm 12 mikrogram/timme depotplåster
Fentanyl ratiopharm 25 mikrogram/timme depotplåster
Fentanyl ratiopharm 50 mikrogram/timme depotplåster
Fentanyl ratiopharm 75 mikrogram/timme depotplåster
Fentanyl ratiopharm 100 mikrogram/timme depotplåster