PACKAGE LEAFLET: INFORMATION FOR THE USER

Fenticer 25 mcg/hour transdermal patches, 50 mcg/hour transdermal patches, 75 mcg/hour transdermal patches, 100 mcg/hour transdermal patches

Fentanyl
Generic medicine
Please 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 their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

What Fenticer is and what it is used for
What you need to know before using Fenticer
How to use Fenticer
Possible side effects
How to store Fenticer
Package contents and other information

1. What Fenticer is and what it is used for

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

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

Fenticer contains an active substance called fentanyl, which belongs to a group of strong painkillers
called opioids.

2. What you need to know before using Fenticer

Do not use Fenticer if

You are allergic to fentanyl, hydrogenated rosin, soy, peanuts, or any of the other ingredients of this medicine (listed in section 6).
If your pain is short-term, such as sudden pain or postoperative pain.
If you have difficulty breathing, with slow or shallow breathing. Do not use this medicine if any of the above points apply to you or your child. If you have any doubts, consult your doctor or pharmacist before using Fenticer.

Warnings and precautions

Fenticer may cause life-threatening side effects in people who are not already regularly using prescribed opioid medicines. FI FENTICER
Fenticer is a medicine that can be life-threatening to children, even if the patches have already been used. Please note that an adhesive patch (new or used) may be attractive to a child, and if it sticks to the child's skin or if the child puts it in their mouth, the result may be fatal.
Store this medicine in a safe and secure place, out of reach of other people – see section 5 for more information.

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 while in close physical contact or sharing the same bed with the person using the patch. A patch that accidentally adheres to another person (especially if a child) may result in the medicine passing through the other person’s skin, causing severe adverse effects such as difficulty breathing, with slow and shallow breathing, which may be fatal. If the patch sticks to another person’s skin, remove it immediately and contact a doctor.

Special precautions with Fenticer
Consult 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 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 any of the above conditions apply to you (or if you have any doubts), consult your doctor or pharmacist before using Fenticer.
While using the patch, inform your doctor if you have breathing problems during sleep. Opioids such as Fenticer can cause sleep-related breathing disorders such as sleep apnoea (pauses in breathing during sleep) and sleep-related hypoxaemia (low oxygen levels in the blood). Inform your doctor if you, your partner, or your caregiver notice any of the following:

Pauses in breathing during sleep
Waking up at night due to shortness of breath
Difficulty staying asleep
Excessive daytime sleepiness. Your doctor may decide to adjust the dose.

While using the patch, inform your doctor if you notice a change in your pain. If you experience:

Pain that is no longer relieved by the patch
An increase in pain
A change in the way you feel pain (e.g., pain in another part of the body)
Pain when touched in a way that should not hurt. Do not change the dose on your own. Your doctor may decide to adjust the dose or change your treatment.

Side effects and Fenticer

Fenticer may make you unusually drowsy and may slow and shallow your breathing. Very rarely, these breathing problems may be life-threatening or even fatal, especially in people who have never used strong opioid painkillers before (such as Fenticer or morphine). If you, your partner, or a close person notices that the person using the patch is unusually drowsy, with slow or shallow breathing:
- Remove the FI FENTICER patch
Call your 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 Fenticer, inform your doctor, as fever may increase the amount of medicine passing through the skin.
- Fenticer may cause constipation; consult your doctor or pharmacist for advice on how to prevent or relieve constipation. See section 4 for a complete list of possible side effects.

Fenticer, like other opioids, may affect the normal production of hormones in the body, such as cortisol, prolactin, or sex hormones, especially if you have taken Fenticer for a long time. The effects of these hormonal changes may include nausea or vomiting, loss of appetite, fatigue, weakness, dizziness, low blood pressure, infertility, or reduced sexual desire. In addition, female patients may experience changes in their menstrual cycle, while male patients may experience impotence or breast tissue enlargement. If you notice any of these signs, speak to your doctor.
While wearing the patch, do not expose yourself to direct sources of heat, such as heating pads, electric blankets, hot water bottles, heated water beds, or heat or tanning lamps. Avoid sunbathing, long hot baths, saunas, or hot hydrotherapy baths. Doing so may increase the amount of medicine absorbed from the patch.
Long-term use and tolerance
This medicine contains fentanyl, an opioid medicine. Repeated use of opioid painkillers may make the medicine less effective (you become accustomed to it, a phenomenon known as drug tolerance). You may also become more sensitive to pain while using Fenticer. This is known as hyperalgesia. Increasing the patch dose may help reduce pain for a while, but it may also be harmful. If you notice the medicine becoming less effective, consult your doctor. Your doctor will decide whether it is better to increase the dose or gradually reduce the use of Fenticer.
Dependence and addiction
This medicine contains fentanyl, an opioid. It may cause dependence and/or addiction.
Repeated use of Fenticer may also lead to dependence, abuse, and addiction, which may result in a potentially fatal overdose. The risk of these adverse effects may increase with higher doses and prolonged duration of use. Dependence or addiction may make you feel that you no longer have control over the amount of medicine needed or how often you must use it. You may feel the need to continue using the medicine, even if it no longer helps relieve pain.
The risk of developing dependence or addiction varies from person to person. You may have a higher risk of becoming dependent or addicted to Fenticer if:

You or a family member have previously suffered from alcohol, prescription medicine, or illegal substance abuse or addiction ("substance addiction");
You are a smoker;
You have previously had mood disorders (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

The appearance of any of the following signs during the use of Fenticer may indicate dependence or addiction.

You feel the need to use the medicine for longer than prescribed by your doctor
You feel the need to use a higher dose than recommended
You use the medicine for reasons other than prescribed, e.g., "to stay calm" or "to help sleep"
You have repeatedly tried to stop or control the use of this medicine without success

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When you stop taking the medicine, you feel unwell, and when you start again, you feel better ("withdrawal effects").

If you notice any of these signs, consult your doctor to discuss the best treatment path for you, including when it may be appropriate to stop treatment and how to do so safely.
Withdrawal symptoms when stopping Fenticer
Do not stop taking this medicine suddenly. Withdrawal symptoms may occur, such as restlessness, difficulty sleeping, irritability, agitation, anxiety, awareness of your heartbeat (palpitations), increased blood pressure, feeling unwell, diarrhoea, loss of appetite, tremor, chills, or sweating. If you wish to stop taking this medicine, speak to your doctor first. Your doctor will advise you on how to do so, usually by gradually reducing the dose to minimize unpleasant withdrawal effects.
Other medicines and Fenticer
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines purchased without a prescription and herbal preparations. You should also inform the pharmacist that you are using Fenticer when purchasing any medicine at the pharmacy.
Your doctor will know which medicines are safe to take with Fenticer. If you start or stop taking any of the medicines listed below, careful monitoring may be needed, as this may affect the dose of Fenticer 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) and certain nerve pain medicines (gabapentin and pregabalin).
Medicines to 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 antidepressants known as SSRIs or SNRIs (e.g., citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine) – for more information, see below
Certain medicines used to treat depression or Parkinson’s disease called MAOIs (e.g., isocarboxazid, phenelzine, selegiline, or tranylcypromine). You must not use Fenticer within 14 days of stopping these medicines – for more information, see below
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 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).

Fenticer with antidepressants
The risk of side effects increases if you are taking medicines such as certain antidepressants.
FI FENTICER
Fenticer may interact with these medicines, leading to changes in mental state, such as feeling agitated, seeing, perceiving things, or hearing sounds or smelling odours that do not exist (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 (these may be symptoms of Serotonin Syndrome). If used together, your doctor may wish to monitor you closely for such side effects, especially when starting treatment or changing the dose.
Use with central nervous system depressants, including benzodiazepines, alcohol, and certain narcotic medicines
Concomitant use of Fenticer and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are possible.
However, if your doctor prescribes Fenticer together with other sedative medicines, the dose and duration of concomitant treatment must be limited by your doctor.
Inform your doctor of all sedative medicines you are taking and carefully follow your doctor’s recommendations regarding dosage. It may be helpful to inform friends or family members about the signs and symptoms listed above. Contact your doctor if you experience these symptoms.
Do not drink alcohol while using Fenticer, unless you have first discussed it with your doctor.
Surgery
If you think you will need anaesthesia, inform your doctor or dentist that you are using Fenticer.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Fenticer must not be used during pregnancy unless you have discussed it with your doctor.
Fenticer must not be used during childbirth, as the medicine may affect the newborn’s breathing.
Prolonged use of Fenticer during pregnancy may cause withdrawal symptoms in the newborn (such as high-pitched crying, restlessness, seizures, poor feeding, and diarrhoea), which may be potentially fatal if not recognised and treated. Inform your doctor immediately if you think your baby may have withdrawal symptoms.
Do not use Fenticer if you are breastfeeding. You must not breastfeed for 3 days after removing the Fenticer patch. This is because the medicine may pass into breast milk.
Driving and using machines
Fenticer may impair your ability to drive or use machines or tools because it may cause drowsiness or dizziness. If this occurs, do not drive or operate 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.
Fenticer contains soy oil
If you are allergic to peanuts or soy, do not use this medicine.

3. How to use Fenticer

FI FENTICER
Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Your doctor will decide the most appropriate Fenticer dosage for you, based on the intensity of your pain, your general health condition, and the type of pain treatment you have received so far.
Before starting treatment and regularly during treatment, your doctor will also discuss with you what you can expect from using Fenticer, when and for how long it is necessary to use it, when to contact your doctor, and when to stop treatment (see also section 2, Withdrawal symptoms when stopping Fenticer).

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.
Make a note of 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:

If you apply the patch on Change the patch on
Monday ➔ Thursday
Tuesday ➔ Friday
Wednesday ➔ Saturday
Thursday ➔ Sunday
Friday ➔ Monday
Saturday ➔ Tuesday
Sunday ➔ Wednesday

Where to apply the patch
Adults

Apply the patch to a flat area of the 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 firmly attached 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.
Observe the child carefully 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 maximum 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

To the same spot two times in a row.
On areas that move a lot (joints), irritated skin, or skin with wounds.
On areas with thick hair. Hair present should not be shaved (shaving may irritate the skin), but should be cut as close to the skin as possible with scissors.

How to apply the patch
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Step 1: Prepare the skin

Ensure the skin is completely dry, clean, and undamaged before applying the patch.
If cleaning the skin is necessary, use only cool water.
Do not use soap or any other detergent, nor 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 pouch

Each patch is sealed in its individual pouch.
Open the pouch at the notch.
Carefully cut completely along the edge of the pouch (if using scissors, cut close to the sealed edge to avoid damaging the patch).
Gently pull apart both sides of the opened pouch.
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.
Patches may occasionally show crystallization (white structures on the edges and/or on the surface of the matrix). This does not affect the application or efficacy of the patches.
Inspect the patch to see 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

Ensure the patch will be covered by loose 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.
Maintain pressure for at least 30 seconds, ensuring the patch adheres well, especially along the edges.

Step 4: Disposal 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 the 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: Wash hands

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

Additional information for using Fenticer
Daily activities while using patches

The patches are waterproof.
You may take a shower or bath while wearing the patch, but do not rub it.
If your doctor allows, you may exercise or engage in sports while wearing the patch.
You may also swim while wearing the patch, but:
- do not use hot thermal baths or hot tubs
- do not apply 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.

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How quickly does the patch work?

The first patch may take some time to reach its maximum effect.
Your doctor will provide you with other painkillers for the first day or as long as needed.
After this period, the patch should help relieve pain continuously, allowing you to stop using other analgesics. However, your doctor may still prescribe additional painkillers from time to time.

How long should you use the patches?

Fenticer patches are indicated for long-term pain. Your doctor will be able to tell you how long they expect you to use the patches.

If pain worsens

If your pain suddenly worsens after applying your last patch, check the patch. If it is not sticking properly or has detached, replace the patch (See also section "If the patch detaches").
If pain worsens over time while using these patches, your doctor may try a stronger-dose patch or prescribe additional painkillers (or both).
If increasing the patch dosage does not help, your doctor may decide to stop using the patches.

If you use too many patches or a patch with the wrong dosage
If you have applied too many patches or a patch with the wrong dosage, remove the patch immediately and contact your doctor without delay.
Signs of overdose include difficulty breathing or shallow breathing, fatigue, extreme drowsiness, inability to think clearly, walk, or speak normally, and feelings of faintness, dizziness, or confusion. Overdose may also cause a brain disorder known as toxic leukoencephalopathy.

If you forget to change the patch

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

If the patch detaches

If a patch detaches before it needs to be changed, apply a new one immediately and note the day and time. Use a new skin area on:
- the trunk or upper arm
- the upper back of the child
Inform your doctor what happened and leave the new patch in place for another 3 days (72 hours) or as directed by your doctor, before changing the patch as usual.
If patches continue to fall off, speak with your doctor, pharmacist, or nurse.

If you want to stop using the patches

Do not stop using this medicine abruptly. If you wish to stop using this medicine, speak with your doctor first. Your doctor will advise you on how to do this, usually by gradually reducing the dose to minimize any unpleasant withdrawal effects. See also section 2, "Withdrawal symptoms when stopping Fenticer".
If you stop using the patches, do not restart without first consulting your doctor, as you may need a patch with a different dosage.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
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4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you, your partner, or someone close to you notices 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 given above and keep the person who was using the patch as awake and active as possible, and talk to them. Very rarely, these breathing difficulties can be life-threatening or even fatal, particularly in people who have never previously used strong opioid analgesics (such as FENTICER or morphine). (Uncommon, may affect up to 1 in 100 people)
Sudden redness 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 the available clinical data.)
Seizures (fits). (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 side 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 100 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 touch sensations (paraesthesiae)
Sensation of spinning (vertigo)
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 tiredness, weakness or general malaise
Feeling cold
Swelling of the hands, ankles or feet (peripheral oedema)

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Uncommon (may affect up to 1 in 100 people)

Feeling restless or disoriented
Feeling extremely happy (euphoria)
Reduced sensation, 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 levels in the blood (cyanosis)
Loss of intestinal contractions (ileus)
Itchy skin rash (eczema), allergic reaction or other skin disorder at the site of the patch
Flu-like illness
Sensation of body temperature changes
Fever
Muscle spasm
Difficulty achieving or maintaining an erection (impotence) or problems during sexual intercourse
Difficulty swallowing

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

Constriction of the pupils (miosis)
Periodic interruption of breathing (apnoea)

Frequency not known (frequency cannot be estimated from the 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 are not there, sleep disturbances, nightmares)
You may become dependent on FENTICER (see section 2).

You may notice a rash, redness, or mild itching at the site where the patch was applied. These symptoms are
usually mild and disappear after you remove the patch. If they do not resolve, or if the patch causes significant
skin irritation, inform your doctor.
Repeated use of the patches may cause the medicine to become less effective (you may become tolerant or more
sensitive to pain), or you may become dependent on it.
If you switch to FENTICER from another analgesic or if you stop using FENTICER suddenly, you may experience
withdrawal effects such as feeling unwell, malaise, diarrhoea, anxiety, or chills. Inform your doctor if any of
these effects occur.
Withdrawal symptoms have also been reported in newborns whose mothers used FENTICER for a prolonged period
during pregnancy.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fenticer

Where to store the patches
Keep all patches (used and unused) out of the sight and reach of children.
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Store this medicinal product in a safe and secure place, inaccessible to other people. Accidental or intentional
intake of this medicinal product by other people to whom it has not been prescribed may cause serious harm
and be fatal.
How long to store Fenticer
Do not use this medicinal product after the expiry date stated on the box and sachet after "EXP.". The
expiry date refers to the last day of that month.
Store in the original packaging.
How to dispose of used or unused patches
A used or unused patch that accidentally adheres to another person, especially a child, may be fatal.
Used patches must be firmly folded in half so that the adhesive side sticks to itself. They must 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. Ask your pharmacist how to dispose of
medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Fenticer contains

The active substance is fentanyl.

Each transdermal patch (surface absorption area equal to 10.5 cm²) contains:
5.78 mg of fentanyl, corresponding to a release rate of 25 micrograms/hour of fentanyl.
Each transdermal patch (surface absorption area equal to 21 cm²) contains:
11.56 mg of fentanyl (corresponding to a release rate of 50 micrograms/hour of fentanyl).
Each transdermal patch (surface absorption area equal to 31.5 cm²) contains:
17.34 mg of fentanyl (corresponding to a release rate of 75 micrograms/hour of fentanyl).
Each transdermal patch (surface absorption area equal to 42 cm²) contains:
23.12 mg of fentanyl (corresponding to a release rate of 100 micrograms/hour of fentanyl).

The other components are:
Protective liner (to be removed before applying the patch to the skin):
Poly(ethylene terephthalate) sheet, siliconized
Self-adhesive matrix:
Hydrogenated rosin resin
Copolymer of 2-ethylhexyl acrylate and vinyl acetate
Refined soybean seed oil

Waterproof backing film:
Poly(ethylene terephthalate) sheet
Printing ink

Description of the appearance of Fenticer and contents of the pack
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Fenticer is a transparent, elongated and rounded transdermal patch consisting of an adhesive membrane that ensures adherence to the skin, covered by a protective liner (to be removed before application).
Fenticer is available in packs containing 3, 5, 7, 10, 14, 16 and 20 transdermal patches.
Hospital packs: 5 transdermal patches
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz GmbH
Biochemiestrasse 10
Kundl 6250
Austria
Legal Representative in Italy: Sandoz S.p.A., Viale Luigi Sturzo, 43 – 20154 Milan, Italy

Responsible manufacturer for batch release
Hexal AG
Industriestrasse, 25
83607 Holzkirchen
Germany

This medicinal product has been authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
AT: Fentanyl "Hexal" 12 µg/h - transdermales Matrixpflaster
Fentanyl "Hexal" 25 µg/h - transdermales Matrixpflaster
Fentanyl "Hexal" 50 µg/h - transdermales Matrixpflaster
Fentanyl "Hexal" 75 µg/h - transdermales Matrixpflaster
Fentanyl "Hexal" 100 µg/h - transdermales Matrixpflaster

BE: FENTANYL MATRIX SANDOZ 12.5 µG/H, PLEISTERS VOOR TRANSDERMAAL GEBRUIK
FENTANYL MATRIX SANDOZ 25 µG/H, PLEISTERS VOOR TRANSDERMAAL GEBRUIK
FENTANYL MATRIX SANDOZ 50 µG/H, PLEISTERS VOOR TRANSDERMAAL GEBRUIK
FENTANYL MATRIX SANDOZ 75 µG/H, PLEISTERS VOOR TRANSDERMAAL GEBRUIK
FENTANYL MATRIX SANDOZ 100 µG/H, PLEISTERS VOOR TRANSDERMAAL GEBRUIK

CZ: FENTALIS 12.5 µG/H TRANSDERMÁLNÍ NÁPLAST
FENTALIS 25 µG/H TRANSDERMÁLNÍ NÁPLAST
FENTALIS 50 µG/H TRANSDERMÁLNÍ NÁPLAST
FENTALIS 75 µG/H TRANSDERMÁLNÍ NÁPLAST
FENTALIS 100 µG/H TRANSDERMÁLNÍ NÁPLAST

DE: Fentamedica Matrix 12.5 µg/h transdermales Pflaster
Fentamedica Matrix 25 µg/h transdermales Pflaster
Fentamedica Matrix 50 µg/h transdermales Pflaster
Fentamedica Matrix 75 µg/h transdermales Pflaster
Fentamedica Matrix 100 µg/h transdermales Pflaster

IT: FENTICER

LU: Fentanyl Matrix Sandoz 12.5 µG/H
Fentanyl Matrix Sandoz 25 µG/H
Fentanyl Matrix Sandoz 50 µG/H
Fentanyl Matrix Sandoz 75 µG/H
Fentanyl Matrix Sandoz 100 µG/H

NL: Fentanyl 1A Pharma matrixpleister 12 µg/uur, pleister voor transdermaal gebruik
Fentanyl 1A Pharma matrixpleister 25 µg/uur, pleister voor transdermaal gebruik
Fentanyl 1A Pharma matrixpleister 50 µg/uur, pleister voor transdermaal gebruik
Fentanyl 1A Pharma matrixpleister 75 µg/uur, pleister voor transdermaal gebruik
Fentanyl 1A Pharma matrixpleister 100 µg/uur, pleister voor transdermaal gebruik

FI FENTICER

PL: FENTA MX 25, 25 µG/h, system transdermalny, plaster
FENTA MX 50, 50 µG/h, system transdermalny, plaster
FENTA MX 75, 75 µG/h, system transdermalny, plaster

PT: FENTANILO SANDOZ

SI: Fentanil Lek 12.5 mikrogramov/uro transdermalni obliži
Fentanil Lek 25 mikrogramov/uro transdermalni obliži
Fentanil Lek 50 mikrogramov/uro transdermalni obliži
Fentanil Lek 100 mikrogramov/uro transdermalni obliži

SK: FENTANYL SANDOZ 25 µG/H MATRIX TRANSDERMÁLNA NÁPLAST
FENTANYL SANDOZ 50 µG/H MATRIX TRANSDERMÁLNA NÁPLAST
FENTANYL SANDOZ 75 µG/H MATRIX TRANSDERMÁLNA NÁPLAST
FENTANYL SANDOZ 100 µG/H MATRIX TRANSDERMÁLNA NÁPLAST

ES: FENTANILO MATRIX SANDOZ 12.5 µG/H PARCHES TRANSDÉRMICOS EFG
FENTANILO MATRIX SANDOZ 25 µG/H PARCHES TRANSDÉRMICOS EFG
FENTANILO MATRIX SANDOZ 50 µG/H PARCHES TRANSDÉRMICOS EFG
FENTANILO MATRIX SANDOZ 75 µG/H PARCHES TRANSDÉRMICOS EFG
FENTANILO MATRIX SANDOZ 100 µG/H PARCHES TRANSDÉRMICOS EFG

UK: YEMEX 12 MICROGRAM/HOUR TRANSDERMAL PATCH
YEMEX 25 MICROGRAM/HOUR TRANSDERMAL PATCH
YEMEX 50 MICROGRAM/HOUR TRANSDERMAL PATCH
YEMEX 75 MICROGRAM/HOUR TRANSDERMAL PATCH
YEMEX 100 MICROGRAM/HOUR TRANSDERMAL PATCH

FI FENTICER