Melodin Long

Leaflet included in the packaging: patient information

Melodyn Long, 35 micrograms/hour, transdermal system, patch
Melodyn Long, 52.5 micrograms/hour, transdermal system, patch
Melodyn Long, 70 micrograms/hour, transdermal system, patch
Buprenorphine
You should carefully read the contents of the leaflet before using the medicine, as it contains
important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Melodyn Long and what is it used for
• 2. Important information before using Melodyn Long
• 3. How to use Melodyn Long
• 4. Possible side effects
• 5. How to store Melodyn Long
• 6. Contents of the packaging and other information

1. What is Melodyn Long and what is it used for

The active substance of Melodyn Long is buprenorphine.
Melodyn Long is a pain-relieving medicine (analgesic) intended for the treatment of moderate to severe pain in cancer patients and severe pain that does not respond to other types of painkillers. Melodyn Long works through the skin. Buprenorphine is an opioid (strong pain reliever) that reduces pain by acting on the central nervous system (specialized nerve cells in the spinal cord and brain). The effect of the transdermal system lasts for up to 4 days. Melodyn Long is not intended for the treatment of acute pain (short-term).

2. Important information before using Melodyn Long

When not to use Melodyn Long:

• in case of allergy to buprenorphine or any of the other ingredients of the medicine (listed in section 6);
• if the patient is dependent on strong painkillers (opioids);
• if the patient has diseases that may cause severe breathing difficulties;
• if the patient is taking monoamine oxidase inhibitors (MAOIs - certain medicines used to treat depression) or has taken them in the last two weeks (see "Melodyn Long and other medicines");
• if the patient has myasthenia gravis (muscle weakness);
• if the patient has delirium tremens (a state of confusion and tremors caused by sudden withdrawal of alcohol in people who drink excessively or during an episode of excessive alcohol consumption).

Melodyn Long must not be used to treat withdrawal symptoms in people dependent on drugs.

Warnings and precautions

You should contact your doctor or pharmacist before using Melodyn Long in the following cases:

• after recent consumption of large amounts of alcohol;
• if the patient has a history of seizures or convulsions;
• if the patient has impaired consciousness (feeling dizzy or fainting) for unknown reasons;
• if the patient is in a state of withdrawal (a symptom of withdrawal may be cold sweats);
• if the patient has increased intracranial pressure (e.g. after a head injury or due to a brain disease) and it is not possible to use artificial respiration;
• if the patient has difficulty breathing or is taking other medicines that may cause weakness or slowing of respiratory function (see "Melodyn Long and other medicines");
• if the patient has kidney function disorders;
• if the patient has a tendency to abuse drugs or narcotics;
• if the patient has depression or other diseases treated with antidepressants; using these medicines at the same time as Melodyn Long may lead to serotonin syndrome, a life-threatening disease (see "Melodyn Long and other medicines").

Respiratory disorders associated with sleep
Melodyn Long may cause respiratory disorders associated with sleep, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen level in the blood). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to shortness of breath, difficulty maintaining sleep, or excessive daytime sleepiness. If the patient or another person notices these symptoms, they should contact a doctor. The doctor may consider reducing the dose.
You should also pay attention to the following warnings:

• Some people may become dependent on strong painkillers, such as Melodyn Long, if they are used for a long time. Stopping the use of these medicines may cause withdrawal reactions (see "Discontinuation of Melodyn Long").
• Heat and the use of external heat sources may increase the dose of buprenorphine released into the blood. The use of external heat sources may cause improper adhesion of the patch to the skin. Therefore, you should not use external heat sources (sauna, infrared lamp, electric blanket, hot water bottle). You should consult a doctor if you have a fever.

Tolerance, dependence, and addiction

This medicine contains buprenorphine, which is an opioid medicine. Repeated use of opioids can cause the medicine to become less effective (getting used to the medicine, known as tolerance). Repeated use of Melodyn Long may also lead to dependence, abuse, and addiction, which can result in life-threatening overdose. The risk of these side effects may increase with increasing dose and longer treatment duration.
Dependence or addiction can cause the patient to lose control over the amount of medicine taken and the frequency of its use.
The risk of becoming dependent on Melodyn Long is different for each person. The risk of dependence on Melodyn Long may be higher if:

• the patient or someone in their family has ever abused or been dependent on alcohol, prescription drugs, or illegal substances ("addiction");
• the patient is a smoker;
• the patient has ever had mood problems (depression, anxiety, or personality disorders) or has been treated by a psychiatrist for other mental illnesses.

If any of the following symptoms occur while taking Melodyn Long, it may indicate dependence:

• need to take the medicine for longer than prescribed by the doctor
• need to take a higher dose than prescribed
• need to continue taking the medicine even if it does not relieve pain
• taking the medicine for reasons other than those prescribed, such as "to calm down" or "to fall asleep".
• repeatedly attempting to stop or control the use of the medicine.
• feeling unwell after stopping the medicine, and feeling better after taking it again ("withdrawal effects").

If any of these symptoms occur, you should talk to your doctor to discuss the best treatment option for you, including when to stop taking the medicine and how to do it safely (see "Discontinuation of Melodyn Long").
You should also inform athletes that this medicine may cause positive doping test results.

Children and adolescents

Melodyn Long should not be used in people under 18 years of age, as there is no experience with the use of this medicine in this age group.

Melodyn Long and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

• You should not use Melodyn Long at the same time as monoamine oxidase inhibitors (MAOIs - certain medicines used to treat depression) or if you have taken these types of medicines in the last two weeks.
• Melodyn Long may cause drowsiness, nausea, or fainting, and may lead to slowed or weakened breathing. These side effects may be increased if you are taking other medicines that have the same side effects. Such medicines include strong painkillers (opioids), certain sleep aids, anesthetics, and medicines used to treat certain mental illnesses, such as sedatives, antidepressants, and neuroleptics.
• Taking Melodyn Long at the same time as certain medicines may increase the effect of the transdermal system. These medicines include certain antibacterial or antifungal medicines (e.g. those containing erythromycin or ketoconazole), medicines used to treat HIV infection (e.g. those containing ritonavir).
• Taking Melodyn Long at the same time as certain medicines may decrease the effect of the transdermal system. These medicines include dexamethasone; medicines used to treat epilepsy (e.g. those containing carbamazepine or phenytoin); medicines used to treat hyperthyroidism (e.g. rifampicin).

Certain medicines may increase the side effects of Melodyn Long, and sometimes cause very serious reactions. While taking Melodyn Long, you should not take other medicines without first consulting your doctor, especially:

• antidepressants, such as moclobemide, tranylcypromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepin, or trimipramine. These medicines may interact with Melodyn Long and cause symptoms such as involuntary, rhythmic muscle contractions, including those that control eye movements, agitation, hallucinations, drowsiness, excessive sweating, tremors, increased reflexes, increased muscle tone, and body temperature above 38°C. If you experience such symptoms, you should contact your doctor.
• gabapentin or pregabalin used to treat epilepsy or nerve pain (neuropathic pain).
• medicines used to treat allergies, motion sickness, or nausea (antihistamines or antiemetics).
• medicines used to treat mental disorders (antipsychotics or neuroleptics).
• muscle relaxants.
• medicines used to treat Parkinson's disease.

Taking Melodyn Long at the same time as sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), drowsiness, and may be life-threatening. Therefore, taking these medicines at the same time should only be considered when other treatment options are not possible.
If your doctor prescribes Melodyn Long with a sedative medicine, the dose and duration of concurrent use should be limited.
You should inform your doctor about all sedative medicines you are taking and follow your doctor's instructions for dosing carefully. It may be helpful to inform friends or family members to be aware of the above symptoms. If such symptoms occur, you should contact your doctor.

Melodyn Long with food, drink, and alcohol

You should not drink alcohol while using Melodyn Long. Alcohol may increase certain side effects and worsen your condition.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using Melodyn Long.
There is no sufficient experience with the use of Melodyn Long in pregnant women.
Therefore, Melodyn Long should not be used in pregnant women or if a woman may become pregnant during treatment.
Buprenorphine, the active substance in the transdermal system, inhibits milk production and passes into breast milk. Therefore, Melodyn Long should not be used during breastfeeding.

Driving and using machines

Melodyn Long may cause dizziness, drowsiness, and blurred or double vision, which may affect your reactions to the extent that you may not react properly or quickly enough in unexpected or emergency situations. This is especially true:

• at the start of treatment;
• when changing the dose;
• when switching from another painkiller to Melodyn Long;
• if other medicines that act on the central nervous system are used;
• if alcohol is consumed.

In such cases, you should not drive or operate machinery while using Melodyn Long. This also applies to the period after stopping the use of Melodyn Long. You should not drive or operate machinery for at least 24 hours after removing the patch.
If you are unsure or have questions, you should consult your doctor or pharmacist.

3. How to use Melodyn Long

You should always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, you should ask your doctor or pharmacist.
Before starting treatment and regularly during treatment, your doctor will discuss with you what you can expect from using Melodyn Long, when and for how long you should take it, when you should contact your doctor, and when you should stop taking the medicine (see also "Discontinuation of Melodyn Long").
Melodyn Long is available in three strengths: Melodyn Long 35 micrograms/hour, transdermal system, Melodyn Long 52.5 micrograms/hour, transdermal system, and Melodyn Long 70 micrograms/hour, transdermal system.
Your doctor will choose the most suitable strength of Melodyn Long for you. If necessary, your doctor will decide to change the strength during treatment.
Usually, the recommended dose is:

Adults
If your doctor does not prescribe otherwise, you should apply one Melodyn Long patch (as described in detail below)
and change it at least every 4 days. To make it easier to remember, you can change the patches twice a week, on the same days, e.g. always on Mondays and Thursdays. To remember when to change the patch, you should write the date on the calendar on the outer packaging. If your doctor prescribes additional painkillers, you should follow your doctor's instructions carefully. Otherwise, you will not get the full benefit of using Melodyn Long.
Elderly patients
There is no need to adjust the dose in elderly patients.
Patients with kidney function disorders and patients on dialysis
There is no need to adjust the dose in patients with kidney function disorders or patients on dialysis.
Patients with liver function disorders.
In patients with liver function disorders, the effect and duration of action of Melodyn Long may be changed. Your doctor will monitor such patients more closely.

Use in children and adolescents

Melodyn Long should not be used in people under 18 years of age, as there is no experience with the use of this medicine in this age group.

Method of administration

The patch is intended for use on the skin.
After applying the patch to the skin, the active substance, buprenorphine, passes through the skin into the blood.

Application

Before applying the transdermal system

Choose an area of skin on the upper part of the body, preferably on the chest below the collarbone or on the upper back (see illustration next to it), which is flat, clean, has no scars, and is hairless. You should ask for help if you cannot apply the patch yourself.

Front or Back or

• If the chosen skin area is hairy, you should cut the hair with scissors. Do not shave!
• You should avoid applying the patch to red, irritated, or damaged skin, e.g. extensive scarring.
• The chosen skin area must be clean and dry. If necessary, you should wash the skin with cold or warm water. Do not use soap or other detergents. After a hot bath or shower, you should wait until the skin is completely dry and cool. Do not apply creams, lotions, or oils to the chosen skin area, as this may cause the patch to adhere poorly.

Applying the transdermal system

• Step 1: Each individual patch is enclosed in a pouch. Immediately before application, you should cut the pouch open with scissors. Remove the patch from the pouch.

• Step 2: The adhesive side of the patch is protected by a transparent protective film. You should carefully remove one partof the film, trying not to touch the adhesive surface.

• Step 3: Apply the patch to the chosen skin area and remove the remaining film.

• Step 4: Press the patch onto the skin with your hand for about 30 to 60 seconds. You should make sure that the patch adheres to the skin with its entire surface, especially at the edges.
• Step 5: You should wash your hands thoroughly. Do not use cleaning agents.

Wearing the transdermal system
You can wear the applied patch for up to 4 days. If the patch is applied correctly, the risk of it coming off on its own is small. You can take a normal shower, bathe, or swim. However, you should not expose the patch to excessive heat (e.g. sauna, infrared radiation, electric blanket, hot water bottle).
If the patch comes off prematurely (which is unlikely), you should not reuse it. You should apply a new transdermal system (see "Changing the transdermal system" below).
Changing the transdermal system

• Remove the patch.
• Fold the patch in half, with the adhesive side inward.
• Dispose of the used patch with caution, preferably by taking it to a pharmacy to a container for unused medicines.
• Apply a new patch to a different area of skin (following the instructions above). You can apply a new patch to the same area of skin only after a week has passed.

Duration of treatment
Your doctor will inform you how long you should use Melodyn Long. You should not stop using Melodyn Long on your own, as this may cause the pain to return and worsen your condition (see also "Discontinuation of Melodyn Long").
If you feel that the effect of Melodyn Long is too strong or too weak, you should consult your doctor or pharmacist.

Using a higher dose of Melodyn Long than prescribed

If you use a higher dose of Melodyn Long than prescribed, you may experience symptoms of buprenorphine overdose. Overdose may lead to an increase in the side effects of buprenorphine, such as drowsiness, nausea, and vomiting. You may have pinpoint pupils, and you may experience respiratory depression or circulatory collapse. You may also experience anaphylactic shock.
If you notice that you have applied more patches than necessary, you should remove the extra patch and contact your doctor or pharmacist immediately.

Missing a dose of Melodyn Long

If you forget to apply a patch, you should do so as soon as you remember.
In this case, you will need to change your patch application schedule, e.g. if you normally change patches on Mondays and Thursdays, but now you apply a new patch on Wednesday, from then on you will need to change patches on Wednesdays and Sundays. You should write the new patch change days on the calendar on the outer packaging.
If you change the patch too late, the pain may return. In this situation, you should contact your doctor.
You should never take a double dose to make up for a missed dose.

Discontinuation of Melodyn Long

If you stop using or finish using Melodyn Long, you may experience a return of pain.
If you want to stop using Melodyn Long due to unpleasant side effects, you should first consult your doctor, who will inform you how to stop the treatment safely and whether you need to use other medicines.
In some patients, after stopping long-term use of strong painkillers, withdrawal symptoms may occur. The risk of withdrawal symptoms after stopping Melodyn Long is very low. However, if you experience symptoms such as agitation, anxiety, nervousness, or tremors, and increased alertness, difficulty falling asleep, or digestive disorders, you should consult your doctor.
If you have any further questions about using this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Melodyn Long can cause side effects, although not everybody gets them.
If you experience any of the following symptoms: swelling of the face, lips, tongue, or throat, which may cause difficulty swallowing or breathing, hives, fainting, yellowing of the skin and eyes (jaundice), you should remove the transdermal system and contact your doctor or seek emergency help at the nearest hospital. These may be symptoms of a very serious allergic reaction.
The following side effects have been reported:

Very common(may affect more than 1 in 10 people):

• nausea (vomiting),
• redness, sweating

Common(may affect up to 1 in 10 people):

• dizziness, headache,
• shallow breathing,
• vomiting, constipation,
• skin changes (generalized or recurrent rash), sweating,
• edema (e.g. edema of the legs), fatigue

Uncommon(may affect up to 1 in 100 people)

• confusion, sleep disorders, restlessness,
• various degrees of sedation (calmness) from fatigue to feeling dizzy,
• circulatory disorders (such as low blood pressure or, less frequently, circulatory collapse),
• dry mouth,
• rash,
• urination disorders, urinary retention (passing less urine than usual),
• fatigue

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

• loss of appetite,
• hallucinations, anxiety, and nightmares, decreased libido, concentration disorders, speech disorders, feeling dizzy, balance disorders, abnormal skin sensations (tingling, prickling, burning),
• vision disorders, blurred vision, eyelid edema,
• hot flashes,
• breathing difficulties (respiratory depression),
• heartburn,
• hives,
• erectile dysfunction,
• withdrawal symptoms (see below), reactions at the application site

Very rare(may affect up to 1 in 10,000 people)

• severe skin reactions (see below),
• dependence, mood changes,
• muscle tremors, taste disorders,
• pupil constriction,
• ear pain,
• rapid breathing, hiccups,
• vomiting reflex,
• pustules, small blisters,
• chest pain

Unknown: frequency cannot be estimated from the available data

• contact dermatitis (skin rash with inflammation, which may include a burning sensation), skin discoloration

If you experience any side effects, including those not listed in this leaflet, you should contact your doctor or pharmacist.
In some cases, delayed allergic reactions may occur with visible symptoms of inflammation. In such cases, you should stop using Melodyn Long after consulting your doctor.
In some patients, after stopping long-term use of strong painkillers, withdrawal symptoms may occur. The risk of such symptoms after stopping Melodyn Long is low. However, if you experience symptoms such as agitation, anxiety, nervousness, or tremors, and increased alertness, difficulty falling asleep, or digestive disorders, you should inform your doctor.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. You can report side effects directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Melodyn Long

• The medicine should be kept out of the sight and reach of children.
• This medicine should be stored in a safe place, out of the reach of other people. The medicine can cause serious harm or even death if taken accidentally or intentionally by people who have not been prescribed it.
• Do not use this medicine after the expiry date stated on the carton and pouch. The expiry date refers to the last day of the month.
• This medicine does not require any special storage conditions.
• Used patches should be folded in half, with the adhesive side inward, placed in the original pouch, and disposed of safely, preferably by taking them to a pharmacy to a container for unused medicines.
• Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Melodyn Long contains

The active substance is buprenorphine
Melodyn Long, 35 micrograms/hour, transdermal system, patch
Each transdermal system with a surface area of 25 cm contains 20 mg of buprenorphine and releases 35 micrograms of buprenorphine per hour.
Melodyn Long, 52.5 micrograms/hour, transdermal system, patch
Each transdermal system with a surface area of 37.5 cm contains 30 mg of buprenorphine and releases 52.5 micrograms of buprenorphine per hour.
Melodyn Long, 70 micrograms/hour, transdermal system, patch
Each transdermal system with a surface area of 50 cm contains 40 mg of buprenorphine and releases 70 micrograms of buprenorphine per hour.

Other ingredients are:

Povidone K90
Levulinic acid
Oleic acid oleate
Copolymer of 2-ethylhexyl acrylate, butyl acrylate, acrylic acid, and vinyl acetate (75:15:5:5)
The adhesive matrix does not contain the active substance:
Copolymer of 2-ethylhexyl acrylate, vinyl acetate, 2-hydroxyethyl acrylate, and glycidyl methacrylate (68:27:5:0.15)
Protective layer:
Siliconized polyethylene terephthalate
Separating layer for the adhesive matrix:
Polyethylene terephthalate
Outer layer:
Polyester
Blue ink

What Melodyn Long looks like and contents of the pack

Each transdermal system is a rectangular patch with a beige color and rounded edges, with the inscription:
Melodyn Long 35 micrograms/hour "Buprenorphin" and "35µg/h".
Melodyn Long 52.5 micrograms/hour "Buprenorphin" and "52.5µg/h".
Melodyn Long 70 micrograms/hour "Buprenorphin" and "70µg/h".
Each transdermal system is packaged in a separate child-resistant pouch.
The following pack sizes are available: 4, 5, 8, 10, 16, or 24 patches.
Not all pack sizes may be marketed.

Marketing authorization holder

G.L. Pharma GmbH
Schloβplatz 1
A-8502 Lannach
Austria

Manufacturer

G.L. Pharma GmbH
Schloβplatz 1
A-8502 Lannach
Austria
Labtec GmbH
Heykenaukamp 10
21147 Hamburg
Germany
To obtain more detailed information and information on the names of the medicinal product in other EU member states, you should contact the representative of the marketing authorization holder:
G.L. Pharma GmbH Sp. z o.o. Branch in Poland
Al. Jana Pawła II 61
01-031 Warsaw
Poland
Phone: 022/636 52 23; 636 53 02
Fax: 022/636 50 76

Date of last revision of the leaflet: 09.10.2024