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 doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 addicted to strong painkillers (opioids);
• If the patient has diseases that can cause severe breathing difficulties;
• If the patient is taking monoamine oxidase inhibitors (MAOIs - some 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 should not be used to treat withdrawal symptoms in people addicted to drugs.

Warnings and precautions

You should consult a doctor or pharmacist before using Melodyn Long in the following cases:

• After recent consumption of large amounts of alcohol;
• If the patient has 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 can 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; Taking 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 sleep-related respiratory disorders, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels 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 consult a doctor. The doctor may consider reducing the dose.
You should also pay attention to the following warnings:

• In some people, long-term use of strong painkillers like Melodyn Long may lead to addiction 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 the patch to adhere improperly 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 (the body gets used to the medicine, known as tolerance). Multiple uses of Melodyn Long can 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 how often it is taken.
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 addicted to 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 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 symptoms").

If any of these symptoms occur, you should talk to a doctor to discuss the best treatment plan for you, including when to stop taking the medicine and how to do it safely (see also "Discontinuation of Melodyn Long").
You should 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 because 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 - some 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 similar side effects. Such medicines include strong painkillers (opioids), some sleeping pills, 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 some antibacterial and antifungal medicines (e.g. those containing erythromycin or ketoconazole), and 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).

Some medicines may increase the side effects of Melodyn Long, and sometimes cause very severe reactions. While taking Melodyn Long, you should not take other medicines without first consulting a 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, sleepiness, excessive sweating, tremors, increased reflexes, increased muscle tension, and body temperature above 38°C. If you experience such symptoms, you should consult a 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 sedatives, such as benzodiazepines or related medicines, increases the risk of drowsiness, breathing difficulties (respiratory depression), sleepiness, and may be life-threatening. Therefore, taking these medicines at the same time should only be considered if other treatment options are not possible.
If a doctor prescribes Melodyn Long together with a sedative, the dose and duration of concurrent use should be limited.
You should inform your doctor about all sedatives 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 consult a doctor.

Melodyn Long with food, drink, and alcohol

While taking Melodyn Long, you should not drink alcohol. Alcohol may increase some side effects and worsen your condition.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be pregnant, or plan to have a child, you should consult a 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 machines while taking Melodyn Long. This also applies to the period after stopping Melodyn Long. You should not drive or operate machines for at least 24 hours after removing the patch.
If you are unsure or have questions, you should consult a doctor or pharmacist.

3. How to use Melodyn Long

This medicine should always be taken according to the doctor's or pharmacist's instructions. If you are unsure, you should consult a doctor or pharmacist.
Before starting treatment and regularly during treatment, the doctor will discuss with the patient what to expect from Melodyn Long, when and how long to take it, when to consult a doctor, and when to 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.
The doctor will choose the most suitable strength of Melodyn Long for the patient. If necessary, the doctor will decide to change the strength during treatment.
Usually, the recommended dose is:

Adults
If the 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 the doctor prescribes additional painkillers, you should follow the 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. The doctor will monitor these patients more closely.

Use in children and adolescents

Melodyn Long should not be used in people under 18 years of age because 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), 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 skin that is red, irritated, or has wounds, such as large scars.
• 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 sachet. Immediately before application, you should cut the sachet open with scissors. Remove the patch from the sachet.

• Step 2: The adhesive side of the patch is covered with a transparent protective foil. You should carefully peel off one partof the foil, trying not to touch the adhesive surface.

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

• 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 carefully. Do not use soap.

Wearing the transdermal system
The patient 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. The patient 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 use it again. You should apply a new transdermal system (see below "Changing the transdermal system").
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.

Duration of treatment
The doctor will inform the patient how long to use Melodyn Long. You should not stop taking 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 a doctor or pharmacist.

Using a higher dose of Melodyn Long than recommended

If a higher dose of Melodyn Long than recommended is used, buprenorphine overdose symptoms may occur. Overdose may lead to an increase in buprenorphine's side effects, such as drowsiness, nausea, and vomiting. The patient may have pinpoint pupils, and breathing may slow down or become shallow. Cardiac arrest may also occur.
If the patient notices that they have applied more patches than necessary, they should remove the extra patch and consult a doctor or pharmacist immediately.

Missing a dose of Melodyn Long

If the patient forgets to apply a patch, they should do so as soon as they remember.
In this case, the schedule for applying the patch will need to be changed, e.g. if the patient usually changes patches on Mondays and Thursdays, but now applies a new patch on Wednesday, they will need to change patches on Wednesdays and Sundays from now on. You should write the new patch change days on the calendar on the outer packaging.
If the patch is changed too late, the pain may return. In this situation, you should consult a doctor.
You should never take a double dose to make up for a missed dose.

Discontinuation of Melodyn Long

If the use of Melodyn Long is stopped or the treatment is finished, the pain may return.
If the patient wants to stop taking Melodyn Long due to unpleasant side effects, they should first consult a doctor, who will inform them how to stop the treatment safely and whether other medicines are needed.
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 the patient experiences symptoms such as agitation, anxiety, nervousness, or tremors, and increased alertness, difficulty sleeping, or digestive disorders, they should consult a doctor.
If you have any further doubts about using this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Melodyn Long can cause side effects, although not everybody gets them.
If the patient experiences 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), they should remove the transdermal system and consult a doctor or seek emergency help at the nearest hospital. These may be symptoms of a very severe 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 (from fatigue to a feeling of fogginess in the head),
• circulatory disorders (such as low blood pressure or, less frequently, cardiac arrest),
• 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 of fogginess in the head, balance disorders, abnormal skin sensations (tingling, prickling, burning),
• vision disorders, blurred vision, eyelid edema,
• hot flashes,
• breathing difficulties (respiratory arrest),
• 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),
• addiction, mood changes,
• muscle tremors, taste disorders,
• pupil constriction,
• ear pain,
• rapid breathing, hiccups,
• vomiting reflex,
• boils, 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 the patient experiences any of the side effects listed above, they should consult a doctor immediately.
In some cases, delayed allergic reactions may occur with visible symptoms of inflammation. In such cases, the use of Melodyn Long should be discontinued after consulting a 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 such symptoms occur, such as agitation, anxiety, nervousness, or tremors, and increased alertness, difficulty sleeping, or digestive disorders, the patient should inform their doctor.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps to gather more information on the safety of the medicine.

5. How to store Melodyn Long

• The medicine should be stored out of 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 someone who has not been prescribed it.
• Do not use this medicine after the expiry date stated on the carton and sachet. The expiry date refers to the last day of the month.
• This medicine does not require special storage conditions.
• Used patches should be folded in half, with the adhesive side inward, placed in the original sachet, 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 oleinate
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 foil:
Polyethylene terephthalate
Outer layer:
Polyester
Blue ink

What Melodyn Long looks like and contents of the packaging

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 sachet.
Available pack sizes: 4, 5, 8, 10, 16, or 24 patches.
Not all pack sizes may be marketed.

Marketing authorization holder

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

Manufacturer

G.L. Pharma GmbH
Schloßplatz 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 EEA 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