Alghedon

Package leaflet: Information for the user

Alghedon 12 micrograms/hour transdermal patch, 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 (or for your child). Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Alghedon is and what it is used for

The name of this medicine is Alghedon.
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.

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

2. What you should know before using Alghedon

Do not use Alghedon:

• if you are allergic to fentanyl or to any of the other ingredients of this medicine (listed in section 6)
• if your pain is short-lived, such as sudden pain or post-operative 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, pharmacist, or nurse before using Alghedon.
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Warnings and precautions

• Alghedon may cause life-threatening side effects in people who are not already regularly using prescribed opioid medicines.
• Alghedon 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 the 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 others – 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 and causing severe 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 the patch immediately and contact a doctor.
Special precautions with Alghedon
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 conditions listed above apply to you (or if you have any doubts), consult your doctor, pharmacist, or nurse before using Alghedon.

While using the patch, inform your doctor if you experience breathing problems during sleep. Opioids such as Alghedon 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 difficulty breathing
• 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 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 cause pain.

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Do not change the dose on your own. Your doctor may decide to adjust the dose of the medicine or change the treatment.
Side effects and Alghedon

• Alghedon may make you feel unusually drowsy, and it may make your breathing slower and shallower. 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 Alghedon or morphine). If you or someone else notices that the person using the patch shows unusual drowsiness, with slow or shallow breathing:
  • remove the patch
  • contact a doctor immediately, or go to the nearest hospital
  • ensure the person moves and speaks as much as possible.
• If you develop a fever while using Alghedon, inform your doctor, as fever may increase the amount of medicine passing through the skin.
• Alghedon 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.

ALGHEDON, 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 ALGHEDON for a long
period of time. The effects of these hormonal changes may include nausea or vomiting, loss of appetite, fatigue, weakness, dizziness, low blood pressure, infertility, or decreased sexual desire. In addition, female patients may experience changes in their menstrual cycle, while male patients may experience impotence or breast 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 or tanning lamps. Avoid sunbathing and taking 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 during the use of Alghedon. 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. The doctor will decide whether it is better to increase the dose or gradually reduce the use of Alghedon.
Dependence and addiction
This medicine contains fentanyl, an opioid. It may cause dependence and/or addiction.
Repeated use of Alghedon may also lead to dependence, abuse, and addiction, which may
cause 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 as though you have lost control over the amount of medicine needed or the frequency with which 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 addiction varies from person to person. You may have a higher risk of becoming dependent or addicted to Alghedon if:

• you or a family member has previously suffered from alcohol, prescription medicine,
  or illegal substance abuse or addiction ("substance addiction");
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• 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 Alghedon 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 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 cases where it may be appropriate to discontinue treatment and how to do so safely.
Withdrawal symptoms when stopping Alghedon
Do not stop taking this medicine abruptly. Withdrawal symptoms 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 may occur. 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 Alghedon
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 Alghedon when purchasing any medicine from a pharmacy.
Your doctor will know which medicines are safe to take with Alghedon. If you are starting or stopping any of the medicines listed below, careful monitoring may be required, as this may affect the dose of Alghedon needed 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 (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)
• some antidepressants known as 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 Alghedon within 14 days of stopping these medicines – for more information see below
• some antihistamines, especially those causing drowsiness (e.g., chlorpheniramine, clemastine, cyproheptadine, diphenhydramine, or hydroxyzine)
• some antibiotics used to treat infections (e.g., erythromycin, clarithromycin)

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• some 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).

Alghedon with antidepressants
The risk of side effects increases if you are taking medicines such as certain antidepressants.
Alghedon may interact with these medicines, leading to changes in mental state, such as restlessness, seeing 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 could be signs of Serotonin Syndrome). If used together, your doctor may need 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 Alghedon 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 therapeutic options are possible.
However, if your doctor prescribes Alghedon together with sedative medicines, you should limit the dose and duration of concomitant treatment.
Inform your doctor of all sedative medicines you are taking and follow their dose recommendations strictly. It may be helpful to inform friends and family to watch for the signs and symptoms mentioned above. Contact your doctor if these symptoms occur.
Do not consume alcohol while using Alghedon unless you have discussed it with your doctor first.
Surgery
If you think you may need anaesthesia, inform your doctor or dentist that you are using Alghedon.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Alghedon should not be used during pregnancy unless you have discussed it with your doctor.
Alghedon patches must not be used during childbirth, as the medicine may affect the newborn's breathing.
Prolonged use of Alghedon 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.
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Do not use Alghedon if you are breastfeeding. You must not breastfeed for 3 days after removing the Alghedon patch. This is because the medicine may pass into breast milk.
Driving and using machines
Alghedon may impair your ability to drive or operate machinery or tools because it may cause drowsiness or dizziness. If this occurs, do not drive and do not 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 driving safety while using this
medicine.
For athletes: using the medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to use Alghedon

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 Alghedon 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 Alghedon, when and for how long it is necessary to use it, when to contact your doctor, and when treatment should be stopped (see also section 2, Withdrawal symptoms when stopping Alghedon).

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 of them 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 full effect. Therefore, the child may need to use other painkillers until the patch becomes effective. Your doctor will discuss this with you.

Adults and children:
Do not apply the patch

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

How to apply the patch
Step 1: Prepare the skin

• Make sure the skin is completely dry, clean, and intact before applying the patch.
• If cleaning 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.
• To open the pouch, cut it with scissors at the notch indicated by the arrow.
• Carefully tear or cut completely along the edge of the pouch (if using scissors, cut close to the sealed edge to avoid damaging the patch).

• 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 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
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• Make sure the patch will be covered by comfortable clothing and not constricted by tight or elastic bandages.
• Remove the easily removable protective liner.
• Carefully peel off the shiny plastic backing starting from one corner of the patch. Try not to touch the adhesive side of the patch.
• Press the adhesive side of the patch onto the skin with the palm of your hand.
• Apply firm pressure for at least 30 seconds, ensuring the patch adheres well, especially around the edges.

Step 4: Disposing 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 which could be dangerous or even fatal to children.

Step 5: Washing hands

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

Additional information for using Alghedon
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 engage in sports while wearing the patch.
• You may also swim while wearing the patch, but:
  • do not use hot whirlpool baths
  • do not place 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 you with additional painkillers for the first day or as long 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?

• Alghedon patches are intended for long-term pain. Your doctor will be able to tell you how long they are expected to be used.

If pain worsens

• If pain suddenly worsens after applying your last 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 pain worsens over time while using these patches, your doctor may try a patch with a higher dose, prescribe additional painkillers, or both.
• If increasing the patch dose does not help, your doctor may decide to stop using the patches.

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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, tiredness, extreme drowsiness, inability to think clearly, walk or speak normally, and feelings of faintness, dizziness, or confusion. An 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 arm
  • the upper back (in a child).
• Inform your doctor about what happened and leave the new patch in place for 3 days (72 hours) or as directed by your doctor before resuming the regular patch change schedule.
• 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 Alghedon’.
• 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 using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets 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 straight away, or go to the nearest
hospital as soon as possible, because they may need urgent medical treatment.

• Unusual drowsiness, with breathing slower or more shallow than normal. Follow the recommendations 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, especially in people who have never previously used strong opioid painkillers (such as Alghedon or morphine). (Uncommon, may affect up to 1 in 100 people).

• Sudden swelling of the face or throat, severe irritation, redness or blistering of the skin. These may be signs of a severe allergic reaction (frequency cannot be estimated from the available 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
• Feeling anxious or confused
• Seeing, hearing or smelling things that are not there (hallucinations)
• Tremors and muscle spasms
• Unusual skin sensations, such as tingling or touch-like sensations (paraesthesiae)
• Feeling dizzy (vertigo)
• Feeling your heart beat rapidly or irregularly (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 very tired, weak or generally unwell
• 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 movement (ileus)
• Itchy skin rash (eczema), allergic reaction or other skin disorders at the application site
• Flu-like illness
• Feeling 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)

• Constricted pupils (miosis)
• Periodic interruption of breathing (apnoea).

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The following side effects have also been reported, but their frequency is unknown:

• 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 Alghedon (see section 2).

You may experience a skin rash, redness or mild itching at the site where the patch was applied. These reactions 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 cause the medicine to become less effective (you may become accustomed to it or become more sensitive to pain), or you may become dependent.
If you switch to Alghedon from another painkiller, or if you stop using Alghedon 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 fentanyl transdermal patches for a long time 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 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 Alghedon

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

How long to store Alghedon
Do not use this medicine after the expiry date stated on the carton and sachet. The expiry date refers to the
last day of that month. Expired patches must be returned to a pharmacy.
Do not store above 25°C.
Keep in the original packaging to protect the medicine from moisture.

How to dispose of used or unused patches
A used or unused patch, if accidentally attached to another person, especially a child, may be fatal.
Used patches must be folded firmly in half so that the adhesive side sticks to itself. They must then be safely
placed back into 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.
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Do not flush any medicines down the sink or into household waste. These measures will help protect the environment.

6. Package contents and other information

What Alghedon contains
The active substance is fentanyl.
Each Alghedon transdermal patch 12 micrograms/hour contains 1.375 mg of fentanyl in a 5 cm patch that releases 12.5 micrograms of fentanyl per hour.
Each Alghedon transdermal patch 25 micrograms/hour contains 2.75 mg of fentanyl in a 10 cm patch that releases 25 micrograms of fentanyl per hour.
Each Alghedon transdermal patch 50 micrograms/hour contains 5.5 mg of fentanyl in a 20 cm patch that releases 50 micrograms of fentanyl per hour.
Each Alghedon transdermal patch 75 micrograms/hour contains 8.25 mg of fentanyl in a 30 cm patch that releases 75 micrograms of fentanyl per hour.
Each Alghedon transdermal patch 100 micrograms/hour contains 11 mg of fentanyl in a 40 cm patch that releases 100 micrograms of fentanyl per hour.

The other components of the patch are:
Drug adhesive layer and skin adhesive layer
Silicone adhesive (polydimethylsiloxane, silicate resin)
Polydimethylsiloxane

Outer backing layer and release liner
Polyethylene terephthalate film with fluorocarbon release coating

Support layer
Pigmented polyethylene terephthalate / ethylene-vinyl acetate copolymer film

Rate-controlling membrane
Ethylene vinyl acetate copolymer film

Printing inks
Beige and orange or red or green or blue or grey.

Description of the appearance of Alghedon and contents of the pack
Alghedon transdermal patch is rectangular in shape with rounded edges, printed on the support layer:

• Diagonal beige stripes with repeated “Fentanyl” in orange characters alternating with diagonal orange stripes with repeated “12 μg/h” in beige characters
• Diagonal beige stripes with repeated “Fentanyl” in red characters alternating with diagonal red stripes with repeated “25 μg/h” in beige characters
• Diagonal beige stripes with repeated “Fentanyl” in green characters alternating with diagonal green stripes with repeated “50 μg/h” in beige characters
• Diagonal beige stripes with repeated “Fentanyl” in blue characters alternating with diagonal blue stripes with repeated “75 μg/h” in beige characters
• Diagonal beige stripes with repeated “Fentanyl” in grey characters alternating with diagonal grey stripes with repeated “100 μg/h” in beige characters

Each patch has an adhesive layer allowing it to stick to the skin. The patch is covered by two oversized transparent protective films, both of which must be removed before application.
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Each transdermal patch is individually packaged in a child-resistant pouch.
Alghedon is available in packs containing 1, 3, 5, 10, 16 and 20 transdermal patches. Not all pack sizes may be marketed.

Marketing Authorization Holder:
Aziende Chimiche Riunite Angelini Francesco – A.C.R.A.F. S.p.A.
Viale Amelia, 70
00181 - ROMA
Under license from Lavipharm

Manufacturer responsible for batch release:
Lavipharm S.A.
Agias Marinas Street
GR-19002 Peania, Attica
Greece

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Germany: Fentapon <12> <25> <50> <75> <100> Microgramm/Stunde transdermales Pflaster
Italy: Alghedon <12> <25> <50> <75> <100> microgrammi/ora cerotto transdermico
Sweden: Fentanyl Lavipharm <12> <25> <50> <75> <100> mikrogram/timme depotplåster
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