Fenvel: detailed information

Patient Information Leaflet: Information for the user

Fenvel 25 micrograms/h transdermal patches, 50 micrograms/h transdermal patches, 75 micrograms/h transdermal patches, 100 micrograms/h transdermal patches

fentanyl
Generic medicine
Please read this leaflet carefully before using this medicine because 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 only for you (or for your child). Do not give it to other people, even if their symptoms are the same as yours, because it could be dangerous.
If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.
Contents of this leaflet:

What Fenvel is and what it is used for
What you need to know before using Fenvel
How to use Fenvel
Possible side effects
How to store Fenvel
Contents of the pack and other information

1. What Fenvel is and what it is used for

The name of this medicine is Fenvel.
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.

Fenvel contains a drug called fentanyl, which belongs to a group of strong painkillers known as opioids.

2. What you need to know before using Fenvel

Do not use Fenvel if

you are allergic to fentanyl or 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 have difficulty breathing, with slow or shallow breathing.

Do not use this medicine if any of the points listed above apply to you or your child. If you have any doubts,
consult your doctor or pharmacist before using Fenvel.
Warnings and precautions

Fenvel may cause life-threatening side effects in people who are not already regularly using prescribed opioid medicines.
Fenvel is a medicine that could be life-threatening to children, even if the patches have already been used. Please note that a sticky patch (new or used) may attract a child's attention and could stick to their skin, or the child might put it in their mouth, which could result in a fatal outcome.
Keep this medicine in a safe and secure place, out of reach of others – see section 5 for more information.

Transfer of the patch to another person
The patch must be used only 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. An accidental attachment of the patch to another person (especially a child)
can result in the medicine passing through the other person’s skin, causing serious side effects such as difficulty
breathing, slow and shallow breathing, which may be fatal. If the patch adheres to another person’s skin, remove
the patch immediately and contact a doctor.

Special precautions with Fenvel
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 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 conditions listed above apply to you (or if you have any doubts), consult your doctor,
pharmacist, or nurse before using Fenvel.
While using the patch, inform your doctor if you have breathing problems during sleep.
Opioids such as Fenvel can cause sleep-related breathing disorders such as sleep apnoea (pauses in breathing
during sleep) and sleep-related hypoxaemia (low blood oxygen levels). 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 the pain you feel.
If you experience:

pain 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 yourself. Your doctor may decide to adjust the dose or change your treatment.

Side effects and Fenvel

Fenvel may make you feel unusually drowsy and can slow and weaken your breathing. Very rarely, these breathing problems can be life-threatening or even fatal,

especially in people who have never previously used strong opioid painkillers (such as Fenvel or
morphine). If you or someone else notices that the person using the patch is unusually sleepy, with slow or
shallow breathing:
remove the patch;
call your doctor immediately or go to the nearest hospital;
keep the person moving and talking as much as possible.

If you develop a fever while using Fenvel, inform your doctor, as fever can increase the amount of medicine passing through the skin.
Fenvel 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.

Fenvel, like other opioids, may affect the normal production of hormones in the body, such as cortisol, prolactin,
or sex hormones, especially if you have been taking Fenvel for a long time. Effects of these hormonal changes may
include nausea or vomiting, loss of appetite, fatigue, weakness, dizziness, low blood pressure, infertility, or
decreased sex drive.
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 with your doctor.
While wearing the patch, do not expose yourself to direct heat sources such as heating pads, electric blankets,
hot water bottles, heated water beds, or heat lamps or sunbeds. Avoid sunbathing, long hot baths, saunas, or
hot whirlpool 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 Fenvel. This is known as hyperalgesia.
Increasing the dose of patches 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 Fenvel.
Dependence and addiction
This medicine contains fentanyl, an opioid. It may cause dependence and/or addiction.
Repeated use of Fenvel may also lead to dependence, abuse, and addiction, which could result in a potentially
fatal overdose. The risk of these side effects may increase with higher doses and prolonged duration of use.
Dependence or addiction may make you feel you have lost control over the amount of medicine needed or how
often you need to 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 on or addicted to Fenvel if:

you or a family member have previously had problems with alcohol, prescription medicines, or illegal substances (“substance abuse”);
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 Fenvel 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 those 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.
You feel unwell when stopping the medicine, and feel better when you resume using it (“withdrawal symptoms”).

If you notice any of these signs, consult your doctor to discuss the best treatment approach for you, including
when it may be appropriate to stop treatment and how to do so safely.
Withdrawal symptoms when stopping Fenvel
Do not stop taking this medicine abruptly. 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,
talk to your doctor first. Your doctor will advise you on how to do so, usually by gradually reducing the dose to
minimise unpleasant withdrawal effects.
Other medicines and Fenvel
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. You should also inform the
pharmacist that you are using Fenvel when purchasing any medicine at the pharmacy.
Your doctor will know which medicines are safe to take with Fenlev. If you start or stop taking any of the
medicines listed below, careful monitoring may be needed, as this may affect the dose of Fenvel required for
you.
In particular, inform your doctor or pharmacist if you are taking:

other pain medicines, such as other opioid painkillers (like buprenorphine, nalbuphine, or pentazocine) and some nerve pain medicines (gabapentin and pregabalin);
medicines that help you sleep (such as 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 (such as cyclobenzaprine or diazepam);
certain antidepressants called SSRIs or SNRIs (such as 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 (such as isocarboxazid, phenelzine, selegiline, or tranylcypromine). You must not use Fenvel within 14 days of stopping these medicines – for more information, see below;
certain antihistamines, especially those causing drowsiness (such as chlorpheniramine, clemastine, cyproheptadine, diphenhydramine, or hydroxyzine);
certain antibiotics used to treat infections (such as erythromycin or clarithromycin);
medicines used to treat fungal infections (such as itraconazole, ketoconazole, fluconazole, or voriconazole);
medicines used to treat HIV infection (such as ritonavir);
medicines used to treat arrhythmia (irregular heartbeat) (such as amiodarone, diltiazem, or verapamil);
medicines used to treat tuberculosis (such as rifampicin);
certain medicines used to treat epilepsy (such as carbamazepine, phenobarbital, or phenytoin);
certain medicines used to treat nausea or motion sickness (such as phenothiazines);
certain medicines used to treat heartburn or ulcers (such as cimetidine);
certain medicines used to treat angina (chest pain) or high blood pressure (such as nicardipine);
certain medicines used to treat blood cancer (such as idelalisib).

Fenvel with antidepressants
The risk of side effects increases if you are taking medicines such as certain antidepressants.
Fenvel may interact with these medicines, leading to changes in mental state, such as feeling agitated, seeing
things or hearing sounds or smelling odours 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 (these could be signs of Serotonin Syndrome).
If taken together, your doctor may want to monitor you closely for these side effects, especially when starting
treatment or changing the dose.
Use with central nervous system depressants, including alcohol and certain narcotic medicines
Concomitant use of Fenvel 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 available.
However, if your doctor prescribes Fenvel together with sedative medicines, the dose and duration of
concomitant treatment must be limited by your doctor.
Inform your doctor about all sedative medicines you are taking and follow your doctor’s dose recommendations
closely. It may be helpful to inform friends or family members to watch for the signs and symptoms listed above.
Contact your doctor if you experience such symptoms.
Do not drink alcohol while using Fenvel unless you have discussed it with your doctor.
Surgery
If you are scheduled for anaesthesia, inform your doctor or dentist that you are using Fenvel.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
consult your doctor or pharmacist before using this medicine.
Fenvel must not be used during pregnancy unless you have discussed it with your doctor.
Fenvel must not be used during childbirth, as the medicine may affect the newborn’s breathing.
Prolonged use of Fenvel 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 Fenvel if you are breastfeeding. You must not breastfeed for 3 days after removing the Fenvel patch,
as the medicine may pass into breast milk.
Driving and using machines
Fenvel 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.
For those engaged in sports
Using this medicine without a medical need constitutes doping and may lead to a positive anti-doping test.

3. How to use Fenvel

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 dose of Fenvel 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 Fenvel, when and for how long it should be used, when to contact your doctor, and when treatment should be stopped (see also section 2, Withdrawal symptoms when stopping Fenvel).

Application and replacement of patches

Each patch contains enough medicine for 3 days (72 hours).
You should 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 every 3 days (72 hours).
If you are using more than one patch, change all patches at the same time.
Note down 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 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.
However, check regularly 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 site two times in a row.
To areas that move a lot (joints), irritated skin, or skin with wounds.
To areas with excessive hair. Hair should not be shaved (shaving may irritate the skin), but cut as close to the skin as possible with scissors.

How to apply the patch
Step 1: Prepare the skin

Make sure 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 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.

Applies only to pouches with pre-cut notches:
Step 2: Open the pouch

Each patch is sealed in its own pouch.
Locate the pre-cut notches at the ends of the sealed edge.
Carefully tear the pouch material from one pre-cut notch to the other.
Further open the pouch along the adjacent side and fold it back to fully open.
Remove the patch and apply it immediately.
Keep the empty pouch to dispose of the used patch.
Each patch must be used only once.
Do not remove the patch from the pouch until you are ready to use it.
Check that the patch is not damaged.
Do not use patches that are split, cut, or otherwise damaged.
Do not divide or cut the patch.

Applies only to child-resistant pouches without pre-cut notches:
Step 2: Open the pouch

Each patch is sealed in its own pouch.
Cut along the two areas of the sealed edge of the pouch indicated by the arrows.
Carefully and completely tear both edges of the pouch starting from the cuts.
Further open the pouch along the adjacent sides and fold it back to fully open.
Remove the patch and apply it immediately.
Keep the empty pouch to dispose of the used patch.
Each patch must be used only once.
Do not remove the patch from the pouch until you are ready to use it.
Check that the patch is not damaged.
Do not use patches that are split, cut, or otherwise damaged.
Do not divide or cut the patch.

Step 3: Peel and press

Make sure the patch will be covered by comfortable clothing and not constricted 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: Dispose of the patch

Immediately after removing a patch, fold it firmly in half 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

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

Additional information for using Fenvel
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 your doctor allows, you may exercise or participate in sports while wearing the patch.
Do not use hot hydrotherapy baths.
Do not apply tight or elastic bandages over the patch.
While wearing the patch, do not expose it to direct sources of heat 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 maximum effect.
Your doctor will provide additional painkillers for the first day or as needed.
After this period, the patch should help relieve pain continuously, allowing you to stop other analgesics. However, your doctor may still prescribe additional painkillers from time to time.

How long should you use the patches?

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

If your pain worsens

If your pain suddenly worsens after applying the latest patch, check the patch. If it is not sticking properly or has come off, replace it (see also section 'If the patch comes off').
If your 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 dose does not help, your doctor may decide to stop using the 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 immediately and contact your doctor right away.
Signs of overdose include difficulty breathing or shallow breathing, fatigue, extreme drowsiness, inability to think clearly, walk or speak normally, and feelings of fainting, 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 comes off

If a patch comes off before it needs to be changed, apply a new one immediately and note the day and time. Apply it to a new skin site on:
- your trunk or arm;
- your child’s upper back.
Inform your doctor about what happened and leave the patch in place for 3 days (72 hours) or as directed by your doctor before changing it as usual.
If patches continue to fall off, discuss this 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 to 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 Fenvel'.
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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you, your partner, or the person caring for you notices that the person using the patch
shows any of the following symptoms, remove the patch immediately and contact a doctor
or go to the nearest hospital, as urgent medical treatment may be required.

Unusual drowsiness, with breathing slower or shallower than normal. Follow the recommendations given above and 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, particularly in people who have never previously used strong opioid analgesics (such as Fenvel 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 determined from available 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 side effects have also been reported
Very common (may affect more than 1 in 10 people)

Nausea, vomiting, constipation.
Feeling sleepy (drowsiness).
Dizziness.
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 prickling (paraesthesia).
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 empty the bladder completely.
Feeling of tiredness, 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 levels 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 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).

Not known (frequency cannot be determined 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 become dependent on Fenvel (see section 2).

You may experience a rash, redness, or mild itching at the site of the patch. These symptoms are usually mild and disappear after removing the patch. If they do not resolve, or if the patch causes significant skin irritation, inform your doctor.
Repeated use of the patches may make the medicine less effective (you may become accustomed to it or may become more sensitive to pain), or you may become dependent on it.
If you switch to Fenvel from another analgesic or if you suddenly stop using Fenvel, you may experience withdrawal symptoms such as vomiting, nausea, diarrhoea, anxiety, or chills. Inform your doctor if any of these symptoms occur.
Withdrawal symptoms have also been reported in newborns whose mothers used Fenvel 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 https://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 Fenvel

Where to store the patches
Store all patches (used and unused) out of sight and reach of children.
Keep this medicine in a safe and secure place, inaccessible to other people. Accidental or intentional ingestion of this medicine by individuals for whom it has not been prescribed may cause serious harm and can be fatal.

How long to store Fenvel
Do not use this medicine after the expiry date stated on the packaging. 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, if accidentally attached to another person—especially a child—can be fatal.
Used patches must be folded firmly in half so that the adhesive side sticks to itself. They should then be safely stored in their original pouch 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 flush any medicine down the drain or dispose of it in household waste. This will help protect the environment.

6. Package contents and other information

What Fenvel contains
The active substance is fentanyl.
Fenvel 25 micrograms/h transdermal patches
1 transdermal patch with an active surface area of 7.5 cm contains 4.125 mg of fentanyl, releasing 25
micrograms of fentanyl per hour.
Fenvel 50 micrograms/h transdermal patches
1 transdermal patch with an active surface area of 15 cm contains 8.25 mg of fentanyl, releasing 50
micrograms of fentanyl per hour.
Fenvel 75 micrograms/h transdermal patches
1 transdermal patch with an active surface area of 22.5 cm contains 12.375 mg of fentanyl, releasing
75 micrograms of fentanyl per hour.
Fenvel 100 micrograms/h transdermal patches
1 transdermal patch with an active surface area of 30 cm contains 16.5 mg of fentanyl, releasing 100
micrograms of fentanyl per hour.
The other components are:
Adhesive surface: polyacrylate adhesive film.
Backing layer: polypropylene sheet; blue printing ink.
Removable protective layer: siliconized polyethylene terephthalate sheet.

Description of the appearance of Fenvel and contents of the pack
Fenvel is a colourless transparent transdermal patch with an adhesive backing allowing it to adhere to the skin. The patches have the concentration printed in blue on the surface.
Fenvel is available in packs containing 1, 3, 4, 5, 8, 10, 16 or 20 transdermal patches.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
EG S.p.A., Via Pavia, 6 – 20136 Milan, Italy

Manufacturer
STADA Arzneimittel AG, Stadastr. 2-18, 61118 Bad Vilbel (Germany)
STADA Arzneimittel GmbH, Muthgasse 36 – 1190 Vienna (Austria)
Centrafarm Services B.V., Van de Reijtstraat 31-E, 4814 NE Breda (The Netherlands)

This medicinal product is authorised in the European Economic Area (EEA) Member States under the
following names:
AT Fentanyl STADA
BE Fentanyl Matrix EG
CZ ADOLOR
DE Fentanyl STADA 12, (25, 50, 75, 100) Microgramm/h Matrixpflaster
ES FENTANILO MATRIX STADA
FI Fentanyl STADA
FR FENTANYL EG
IT Fenvel
LU Fentanyl Matrix EG
NL Fentanyl CF