Fentanyl Helm

Package leaflet: Information for the user

Fentanil Helm 25 micrograms/hour transdermal patch, 50 micrograms/hour transdermal patch, 75 micrograms/hour transdermal patch, 100 micrograms/hour transdermal patch

fentanyl
Generic medicine
Please read all of this leaflet carefully before you start 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 only. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Fentanil Helm is and what it is used for

The name of this medicine is Fentanil Helm.
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 who require continuous treatment for pain.

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

2. What you need to know before using Fentanil Helm

Do not use Fentanil Helm

• If you are allergic to fentanyl 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 in doubt, consult your doctor, pharmacist, or nurse before using Fentanil Helm.

Warnings and precautions

• Fentanil Helm may cause life-threatening side effects in people who are not already regularly using prescribed opioid medicines.
• Fentanil Helm 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 be attractive to a child, and if it adheres to a child's skin or if the child puts it in their mouth, the result could be fatal.
• Keep 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 a child) may result in the medicine passing through that person's skin and causing serious side effects, such as difficulty breathing, with slow and shallow breathing, which can be fatal. If the patch sticks to another person’s skin, remove it immediately and contact a doctor.

Special precautions with Fentanil Helm
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 have/have had low blood pressure.
• If you have ever had a brain tumor.
• 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 are unsure), consult your doctor, pharmacist, or nurse before using Fentanil Helm.

While using the patch, inform your doctor if you have breathing problems during sleep.
Opioids such as Fentanil Helm can cause sleep-related breathing disorders such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Inform your doctor if you, your partner, or caregiver notice any of the following:

• Pauses in breathing during sleep
• Waking up at night due to lack of breath
• Difficulty staying asleep
• Excessive daytime sleepiness. Your doctor may decide to adjust your 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 cause pain. Do not change the dose on your own. Your doctor may decide to adjust the dose or change your treatment.

Side effects and Fentanil Helm

• Fentanil Helm may make you 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 used strong opioid painkillers before (such as Fentanil Helm or morphine). If you or someone else notices that the person using the patch is unusually drowsy, 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 Fentanil Helm, inform your doctor, as fever can increase the amount of medicine passing through the skin.
• Fentanil Helm can 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.

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 or tanning lamps. Avoid sunbathing and 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 during use of Fentanil Helm. This is known as hyperalgesia.
Increasing the dose of patches may help reduce pain further 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 Fentanil Helm transdermal patch.

Dependence and substance abuse
This medicine contains fentanyl, an opioid. It may cause dependence and/or substance abuse.
Repeated use of Fentanil Helm may also lead to dependence, abuse, and substance abuse, which may result in potentially fatal overdose. The risk of these side effects may increase with higher doses and prolonged duration of use. Dependence or substance abuse may make you feel you have lost 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 does not help relieve pain.
The risk of developing dependence or substance abuse varies from person to person. You may have a higher risk of becoming dependent or abusing Fentanil Helm transdermal patch if:

• You or a family member has previously suffered from alcohol, prescription medicine, or illegal substance abuse or dependence (‘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 use of Fentanil Helm transdermal patch may indicate dependence or substance abuse.

• 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 use of this medicine without success
• You feel unwell when stopping treatment with the medicine, and feel better when restarting it (“withdrawal effects”).

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 stop safely.

Withdrawal symptoms when stopping Fentanil Helm
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 or sick, diarrhea, 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 this, usually by gradually reducing the dose to minimize any unpleasant withdrawal effects.

For athletes
Using the medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

Other medicines and Fentanil Helm
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 must also inform the pharmacist that you are using Fentanil Helm when purchasing any medicine at the pharmacy.
Your doctor will know which medicines are safe to take together with Fentanil Helm. If you are taking or stop taking any of the medicines listed below, careful monitoring may be needed, as this can affect the dose of Fentanil Helm 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 some nerve pain medicines (gabapentin and pregabalin)
• Medicines that help you sleep (e.g., temazepam, zaleplon, or zolpidem)
• Medicines for anxiety (tranquilizers 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)
• Some medicines used to treat depression called SSRIs or SNRIs (e.g., citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine) – for more information see below
• Some medicines used to treat depression or Parkinson’s disease called MAOIs (e.g., isocarboxazid, phenelzine, selegiline, or tranylcypromine). You must not use Fentanil Helm within 14 days of stopping these medicines – for more information see below
• Some antihistamines, especially those that cause drowsiness (e.g., chlorpheniramine, clemastine, cyproheptadine, diphenhydramine, or hydroxyzine)
• Some 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)
• Some medicines used to treat epilepsy (e.g., carbamazepine, phenobarbital, or phenytoin)
• Some medicines used to treat nausea or motion sickness (e.g., phenothiazines)
• Some medicines used to treat heartburn or ulcers (e.g., cimetidine)
• Some medicines used to treat angina (chest pain) or high blood pressure (e.g., nicardipine)
• Some medicines used to treat blood cancer (e.g., idelalisib).

Fentanil Helm with antidepressants
The risk of side effects increases if you are taking medicines such as certain antidepressants.
Fentanil Helm may interact with these medicines, and changes in mental state may occur, 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 diarrhea (these may be signs of Serotonin Syndrome). If used together, your doctor may 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 Fentanil Helm and sedative medicines such as benzodiazepines or benzodiazepine-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 Fentanil Helm together with 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 follow your doctor’s dose recommendations carefully. It may be helpful to inform friends or family members to be aware of the signs and symptoms listed above. Contact your doctor if these symptoms occur.

Fentanil Helm and alcohol
Do not consume alcohol while using Fentanil Helm unless you have spoken with your doctor.
Fentanil Helm may cause drowsiness or slowed breathing. Drinking alcohol may worsen these effects.

Surgery
If you think you may need anesthesia, inform your doctor or dentist that you are using Fentanil Helm.

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.
Fentanil Helm must not be used during pregnancy unless discussed with your doctor.
Fentanil Helm must not be used during childbirth, as the medicine may affect the newborn’s breathing.
Prolonged use of Fentanil Helm during pregnancy may cause withdrawal symptoms in the newborn (such as high-pitched crying, restlessness, seizures, poor feeding, and diarrhea), which may be potentially fatal if not recognized and treated. Inform your doctor immediately if you think your baby may have withdrawal symptoms.
Do not use Fentanil Helm if you are breastfeeding. You must not breastfeed for 3 days after removing the Fentanil Helm patch. This is because the medicine can pass into breast milk.

Driving and using machines
Fentanil Helm may impair your ability to drive or use machines or tools because 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 Fentanil Helm

Use this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the most appropriate dose of Fentanil Helm for you, based on the intensity of your pain, your general health condition, and the type of pain treatment you have previously received.
Before starting treatment and regularly during treatment, your doctor will also discuss with you what you can expect from using Fentanil Helm, 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 Fentanil Helm).

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.
• 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 additional 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 consecutively.
• On areas that move frequently (joints), irritated skin, or skin with wounds.
• On areas with excessive 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 undamaged 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.

Step 2: Open the pouch

• Each patch is sealed in its individual pouch.
• 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).

• 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.
• 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, comfortable clothing and not 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 with the adhesive sides together.
• 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 a certain amount of medicine that could be dangerous or even fatal to children.

Step 5: Washing

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

Additional information for using Fentanil Helm
Daily activities while using the patch

• The patch is waterproof.
• You may take a shower or bath while wearing the patch, but avoid rubbing 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 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 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 stop using other analgesics. However, your doctor may still prescribe additional painkillers from time to time.

How long should you use the patches?

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

If pain worsens

• If your pain suddenly worsens after applying your last patch, check the patch. If it is not adhering properly or has come off, replace it (see also section “If a patch comes off”).
• If your pain increases 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 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 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. Then change the patch again 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. Apply it to a new skin site on:
  • the trunk or upper 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 changing it as usual.
• If patches continue to fall off, speak to your doctor, pharmacist, or nurse.

If you want 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 further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Fentanil Helm can cause side effects, although not everyone experiences them.
If you, or someone else, notice 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 above and keep the person who was using 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 painkillers (such as Fentanil Helm 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 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 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 touch sensations (paraesthesiae)
• 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 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)
• Reduced 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 disorder at the site of the patch
• Influenza-like illness
• Sensation of change in body temperature
• 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 cessation of breathing (apnoea)

Frequency not known (frequency cannot be estimated from available data)

• Lack of male sex hormones (androgen deficiency)
• Delirium (symptoms may include a combination of restlessness, agitation, disorientation, confusion, fear, seeing or hearing things that are not there, sleep disturbances, nightmares)
• You may become dependent on Fentanil Helm (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 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 cause the medicine to become less effective (you may become tolerant to it or may become more sensitive to pain), or you may become dependent on it.
If you switch to Fentanil Helm from another painkiller or if you stop using Fentanil Helm suddenly, 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 Fentanil Helm for prolonged periods during pregnancy.
An overdose may cause: signs of overdose include difficulty breathing or shallow breathing, fatigue, extreme drowsiness, inability to think clearly, walk or speak normally, and feeling faint, dizzy or confused. An overdose may also cause a brain disorder known as toxic leukoencephalopathy.

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 the website
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 Fentanil Helm

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

How long to store Fentanil Helm
Do not use Fentanil Helm 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.

How to dispose of used patches or patches no longer in use
A used or unused patch, if accidentally applied to another person, particularly 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 back in their original sachet and kept out of sight and reach of others, especially children, until safely disposed of. Ask your pharmacist how to properly dispose of medicines you no longer use. Do not flush any medicine down the toilet or pour it into household waste. These measures will help protect the environment.

6. Package contents and other information

What Fentanil Helm contains

• The active substance is fentanyl.
  Fentanil Helm 25 micrograms/hour: One transdermal patch (15 cm² active surface area) contains 4.8 mg of fentanyl, corresponding to a release rate of 25 micrograms of fentanyl per hour.

Fentanil Helm 50 micrograms/hour: One transdermal patch (30 cm² active surface area) contains 9.6 mg of fentanyl, corresponding to a release rate of 50 micrograms of fentanyl per hour.
Fentanil Helm 75 micrograms/hour: One transdermal patch (45 cm² active surface area) contains 14.4 mg of fentanyl, corresponding to a release rate of 75 micrograms of fentanyl per hour.
Fentanil Helm 100 micrograms/hour: One transdermal patch (60 cm² active surface area) contains 19.2 mg of fentanyl, corresponding to a release rate of 100 micrograms of fentanyl per hour.

• The other components are:
  Adhesive layer: Poly(2-ethylhexyl acrylate, vinyl acetate) (50:50), poly[2-ethylhexyl acrylate-co-methyl acrylate-co-acrylic acid-co-(2,3-epoxypropyl)methacrylate] (61.5:33:5.5:0.02), dodecan-1-ol
  Protective liner: Silicone-treated polyester sheet
  Backing layer: Polyester/ethylene vinyl acetate sheet
  Printing ink

Description of the appearance of Fentanil Helm and package contents
Fentanil Helm 25-50-75-100 micrograms/hour is a thin, transparent transdermal patch with rounded corners and the following printed text:
fentanyl 25 µg/h
fentanyl 50 µg/h
fentanyl 75 µg/h
fentanyl 100 µg/h
Fentanil Helm 25-50-75-100 micrograms/hour is available in packages containing 3 transdermal patches.
The following strengths are available: Fentanil Helm 25 micrograms/hour, Fentanil Helm 50 micrograms/hour, Fentanil Helm 75 micrograms/hour and Fentanil Helm 100 micrograms/hour.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Helm Pharmaceuticals GmbH
Nordkanalstraße 28
20097 Hamburg
Germany

Manufacturer
Helm AG
Nordkanalstr. 28
D-20097 Hamburg
Germany

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy:
Fentanil Helm 25 micrograms/h transdermal patch
Fentanil Helm 50 micrograms/h transdermal patch
Fentanil Helm 75 micrograms/h transdermal patch
Fentanil Helm 100 micrograms/h transdermal patch