Melodyn long

Package leaflet: Information for the patient

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

Please read carefully all the information in this leaflet before using this medicine, because it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If any side effects occur in the patient, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Melodyn Long is and what it is 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 pack and other information

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

The active substance in Melodyn Long is buprenorphine.
Melodyn Long is an analgesic (pain-relieving) medicine used to treat moderate to severe pain associated with cancerous diseases, and also severe pain that does not respond to other types of painkillers. Melodyn Long works through the skin. Buprenorphine is an opioid (a strong pain-relieving agent) 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 up to 4 days (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:

• If the patient is allergic 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 significant breathing difficulties;
• If the patient is taking monoamine oxidase inhibitors (MAO inhibitors – certain medicines used to treat depression), or has taken them within the last two weeks (see section "Melodyn Long and other medicines");
• If the patient has myasthenia gravis (muscle weakness);
• If the patient has delirium tremens (confusion and tremors caused by sudden alcohol withdrawal in individuals who chronically consume excessive amounts of alcohol, or occurring during an episode of excessive alcohol consumption).

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

Warnings and precautions

Contact your doctor or pharmacist before using Melodyn Long if any of the following apply:

• After recent consumption of large amounts of alcohol;
• If the patient has epileptic seizures or convulsions;
• If the patient experiences disturbances in consciousness (such as dizziness or fainting) of unknown origin;
• If the patient is in shock (cold sweats may be a symptom of shock);
• If the patient has increased intracranial pressure (e.g. after head injury or due to brain disease) and artificial ventilation is not possible;
• If the patient has breathing difficulties or is taking other medicines that may weaken or slow respiratory function (see section "Melodyn Long and other medicines");
• If the patient has liver function disorders;
• If the patient has a tendency to misuse medicines or drugs;
• If the patient has depression or other conditions treated with antidepressants;
  Using these medicines together with Melodyn Long may lead to serotonin syndrome, a potentially life-threatening condition (see section "Melodyn Long and other medicines").

Sleep-related breathing disorders
Melodyn Long may cause sleep-related breathing disorders, such as
sleep apnoea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels during sleep). Symptoms may include breathing pauses during sleep, nighttime awakenings due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If the patient or someone else notices these symptoms, contact a doctor. The doctor may consider reducing the dose.

Also pay attention to the following warnings:

• Some individuals may become dependent on strong painkillers such as Melodyn Long if used for prolonged periods. Stopping these medicines may lead to withdrawal reactions (see section "Discontinuing Melodyn Long").
• Fever and the use of external heat sources may increase the amount of buprenorphine released into the bloodstream. External heat sources may also cause improper adhesion of the patch to the skin. Therefore, do not use external heat sources (e.g. sauna, infrared lamp, electric blanket, hot water bottle). Consult your doctor if the patient has a fever.

Tolerance, dependence and abuse

This medicine contains buprenorphine, an opioid medicine. Repeated use of opioids may lead to reduced effectiveness of the medicine (drug tolerance). Repeated use of Melodyn Long may also lead to dependence, misuse and addiction, which may result in life-threatening overdose. The risk of these adverse effects may increase with higher doses and longer duration of use.

Dependence or addiction may cause the patient to lose control over the amount and frequency of medicine intake.

The risk of dependence or addiction varies between individuals. The risk of dependence on Melodyn Long may be higher if:

• The patient or a family member has ever misused or been dependent on alcohol, prescription medicines 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, this may indicate dependence:

• Needing to take the medicine longer than prescribed by the doctor;
• Needing to take higher than the prescribed dose;
• Needing to continue taking the medicine even though it no longer helps relieve pain;
• Using the medicine for reasons other than those recommended, e.g. "to calm down" or "to fall asleep more easily";
• Repeated unsuccessful attempts to stop or control medicine use;
• Feeling unwell after stopping the medicine, with improvement in well-being upon re-taking it ("withdrawal effects").

If any of these symptoms occur, talk to your doctor to discuss the best treatment approach for the patient, including when and how to safely discontinue the medicine (see section 3, Discontinuing Melodyn Long).

Athletes should be informed that this medicine may lead to positive results in anti-doping tests.

Children and adolescents

Melodyn Long should not be used in individuals under 18 years of age, as there is currently insufficient experience with the use of this medicine in this age group.

Melodyn Long and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

• Do not use Melodyn Long together with monoamine oxidase inhibitors (MAO inhibitors – certain medicines used to treat depression), or if the patient has taken such medicines within the last two weeks.
• Melodyn Long may cause drowsiness, nausea or fainting in some individuals and may lead to slowed or weakened breathing. These adverse effects may be intensified if other medicines with similar effects are taken at the same time. Such medicines include strong painkillers (opioids), certain sleeping pills, anaesthetics, and medicines used to treat certain mental illnesses, such as sedatives, antidepressants and neuroleptics.
• Using Melodyn Long together with certain medicines may enhance the effect of the transdermal system. These include certain anticancer and antifungal medicines (e.g. containing erythromycin or ketoconazole), and medicines used to treat HIV infection (e.g. containing ritonavir).
• Using Melodyn Long together with certain medicines may reduce the effectiveness of the transdermal system. These include dexamethasone; medicines used to treat epilepsy (e.g. containing carbamazepine or phenytoin); and medicines used to treat tuberculosis (e.g. rifampicin).

Some medicines may intensify the adverse effects of Melodyn Long and, in some cases, cause very severe reactions. During treatment with Melodyn Long, do not take any other medicines without prior consultation with 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 eye movement muscles, agitation, hallucinations, hyperthermia, excessive sweating, tremor, increased reflexes, increased muscle tone, and body temperature above 38°C. If such symptoms occur, contact a doctor.
• Gabapentin or pregabalin, used to treat epilepsy or nerve-related 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.

Concurrent use of Melodyn Long and sedatives such as benzodiazepines or related medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and may be life-threatening. Therefore, concurrent use of these medicines should only be considered if no other treatment options are available.

If the doctor prescribes Melodyn Long together with a sedative, the dose and duration of concurrent use should be limited.

Inform the doctor about all sedatives the patient is taking and strictly follow the doctor's dosing instructions. It may be helpful to inform friends or family members so they are aware of the above-mentioned symptoms. If such symptoms occur, contact a doctor.

Melodyn Long with food, drink and alcohol

Do not consume alcohol during treatment with Melodyn Long. Alcohol may intensify certain adverse effects and worsen the patient's condition.

Pregnancy, breastfeeding and fertility

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using Melodyn Long.

There is insufficient evidence regarding the use of Melodyn Long in pregnant women. Therefore, Melodyn Long should not be used during pregnancy or if the 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 operating machinery

Melodyn Long may cause dizziness, drowsiness, blurred or double vision, which may affect the patient's reactions to such an extent that they may not respond appropriately or quickly enough in unexpected or sudden situations. This is particularly relevant:

• At the beginning of treatment;
• During dose adjustments;
• When switching treatment from another painkiller to Melodyn Long;
• When other medicines acting on the central nervous system are used;
• When alcohol is consumed.

In such cases, do not drive or operate machinery while using Melodyn Long. This also applies to the period after discontinuing Melodyn Long. Do not drive or operate machinery for at least 24 hours after removing the patch.

If in doubt or if you have any questions, consult your doctor or pharmacist.

3. How to use Melodyn Long

This medicine should always be used exactly as directed by the doctor or pharmacist. If in doubt,
consult the doctor or pharmacist.
Before starting treatment and regularly during treatment, the doctor will discuss with the patient what to
expect from using Melodyn Long, when and for how long it should be used, when to contact the doctor,
and when the medicine should be discontinued (see also: Stopping 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 choice of the most appropriate strength of Melodyn Long for the patient will be made by the doctor.
If necessary, the doctor may decide to change the strength during treatment.
The usual recommended dose is:
Adults
Unless otherwise directed by a doctor, one Melodyn Long patch (as described in detail below) should be
applied
and changed no later than every 4 days. For easier remembering, patches may be changed twice a
week, on the same days each week, e.g. always on Monday morning and Thursday evening. To help
remember when to change the patch, write the date on the calendar printed on the outer packaging. If the
doctor prescribes additional pain-relieving medicines, follow the doctor's instructions precisely. Otherwise,
the full benefits of Melodyn Long may not be achieved.
Elderly patients
There is no need to adjust the dose in elderly patients.
Patients with kidney dysfunction and dialysis patients
There is no need to adjust the dose in patients with kidney impairment or in patients undergoing dialysis.
Patients with liver function impairment
In patients with impaired liver function, the strength and duration of action of Melodyn Long may be
altered. The doctor will monitor such patients more closely.
Use in children and adolescents
Melodyn Long should not be used in individuals under 18 years of age, as there is currently insufficient
experience with the use of this medicine in this age group.
Route of administration
The patch is intended for skin application.
After application to the skin, the active substance, buprenorphine, passes through the skin into the
bloodstream.
Method of administration
Before applying the transdermal system

Select a flat, clean area of skin on the upper half of the body, preferably on the chest below the collarbone or on the upper back (see adjacent illustration), which is free of scars and hair. Ask for assistance if the patient cannot apply the patch themselves.

Front or Back or

• If the selected skin area is hairy, trim the hair using scissors. Do not shave the hair!

• Avoid applying the patch to reddened, irritated skin, or skin with lesions such as extensive scars.

• The selected skin area must be clean and dry. If necessary, wash the skin with cold or lukewarm water. Do not use soap or other detergents. After a hot bath or shower, wait until the skin is completely dry and cooled down. Do not apply balms, creams, or oils to the selected skin area, as this may cause poor adhesion of the patch.

Applying the transdermal system

• Step 1: Each individual patch is enclosed in a sachet. Immediately before application, cut open the sachet with scissors along the edge. Remove the patch from the sachet.

• Step 2: The adhesive side of the patch is protected by a transparent protective film. Carefully peel off one part of the film, taking care not to touch the adhesive surface.

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

• Step 4: Press the patch firmly onto the skin with the palm of your hand for approximately 30 to 60 seconds. Make sure the entire surface of the patch adheres to the skin, especially at the edges.

• Step 5: Wash your hands thoroughly. Do not use cleaning agents.

Wearing the transdermal system
The patient may wear the applied patch for up to 4 days. If the patch has been correctly applied, the risk of it detaching spontaneously is small. The patient may normally take showers, bathe, and swim. However, the patch should not be exposed to excessive heat (e.g., sauna, infrared radiation, electric blanket, hot water bottle, etc.).

If the patch detaches prematurely (which is unlikely), do not reuse it. Apply a new transdermal system (see section below "Changing the transdermal system").

Changing the transdermal system

• Remove the patch.

• Fold the patch in half with the adhesive sides together.

• Dispose of the used patch carefully and safely.

• Apply a new patch to a different area of skin (following the instructions described above). A new patch may be applied to the same skin site only after one week has passed.

Duration of treatment
The doctor will inform the patient how long Melodyn Long should be used. Do not discontinue using Melodyn Long on your own, as this may cause recurrence of pain and worsening of well-being (see also section below "Discontinuing use of Melodyn Long").

If the patient feels that the effect of Melodyn Long is too strong or too weak, consult a doctor or pharmacist.

Use of a higher than recommended dose of Melodyn Long
If a higher than recommended dose of Melodyn Long is used, symptoms of buprenorphine overdose may occur. Overdose may intensify the adverse effects of buprenorphine, such as drowsiness, nausea, and vomiting. The patient may have pinpoint (severely constricted) pupils, weakness, or slowed breathing. Cardiovascular collapse may also occur.

If the patient realizes that more patches have been applied than necessary, the additional patch should be removed immediately and the patient should contact a doctor or pharmacist without delay.

Missed dose of Melodyn Long
If the patient forgets to apply a patch, it should be applied as soon as the omission is noticed. In such a case, the patch application schedule will need to be adjusted. For example, if the patient usually changes patches on Mondays and Thursdays, but forgot and only applied a new patch on Wednesday, from that point onward the patches should be changed on Wednesdays and Saturdays. Record the new patch change days on the calendar located on the outer packaging.

If the patch change is delayed too long, pain may return. In such a case, contact the doctor.

Never use a double dose to make up for a missed dose.

Discontinuing use of Melodyn Long
If treatment with Melodyn Long is discontinued or stopped, pain may return.

If the patient wishes to discontinue Melodyn Long due to unpleasant adverse effects, consult the doctor first. The doctor will inform the patient how treatment should be ended and whether other medications are necessary.

In some patients, withdrawal symptoms may occur after discontinuation of long-term treatment with strong painkillers. The risk of withdrawal symptoms after stopping Melodyn Long is very low. However, if after stopping treatment the patient experiences restlessness, anxiety, nervousness, chills, hyperactivity, difficulty falling asleep, or gastrointestinal disturbances, consult a doctor.

If you have any further questions or doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

If a patient experiences any of the following symptoms: swelling of the lips, feet, joints, face, mouth or throat, which may cause difficulty in swallowing or breathing, hives, fainting, yellowing of the skin and eyes (jaundice), the transdermal system should be removed immediately and the patient should contact a doctor or seek help at the emergency department of the nearest hospital without delay. These may be symptoms of a very serious allergic reaction.

The following adverse reactions have been reported:

Very common (may occur in more than 1 in 10 patients):

• nausea (feeling sick),
• redness, itching

Common (may occur in 1 in 10 patients):

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

Uncommon (may occur in 1 in 100 patients):

• confusion, sleep disorders, restlessness,
• various degrees of sedation (calming effect), ranging from fatigue to feeling drowsy,
• circulatory disturbances (such as low blood pressure or, less frequently, circulatory collapse),
• dry mouth,
• rash,
• difficulty in passing urine, urinary retention (passing less urine than usual),
• exhaustion

Rare (may occur in 1 in 1,000 patients):

• loss of appetite,
• hallucinations, restlessness and nightmares, decreased libido,
• concentration difficulties, speech disturbances, drowsiness, balance disorders, abnormal skin sensations (tingling, pricking, burning of the skin),
• visual disturbances, blurred vision, eyelid swelling,
• hot flushes,
• breathing difficulties (respiratory depression),
• heartburn,
• hives,
• erectile dysfunction,
• withdrawal symptoms (see below), application site reactions

Very rare (may occur in 1 in 10,000 patients):

• severe skin reactions (see below),
• dependence, mood changes,
• muscle tremors, taste disturbances,
• pinpoint pupils (miosis),
• ear pain,
• increased breathing rate, hiccups,
• vomiting reflex,
• pustules, small blisters,
• chest pain

Not known: frequency cannot be estimated from available data

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

If any of the adverse reactions listed above occur, medical advice should be sought immediately.

In some cases, delayed allergic reactions with visible signs of inflammation may occur. In such cases, treatment with the medicinal product Melodyn Long should be discontinued after prior consultation with a doctor.

In some patients, withdrawal symptoms may occur after discontinuation of long-term treatment with strong analgesic medicines. The risk of such symptoms occurring after stopping Melodyn Long is low. However, if such symptoms occur, such as agitation, restlessness, nervousness or tremors, hyperactivity, difficulty falling asleep or gastrointestinal disturbances, the doctor should be informed.

Reporting of adverse reactions

If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorization holder.

By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Melodyn Long

• Keep this medicine out of the sight and reach of children.
• This medicine should be stored in a secure place, inaccessible to other people. The medicine may cause serious harm or even death to individuals who take it accidentally or intentionally, if it has not been prescribed to them.
• Do not use this medicine after the expiry date (EXP) stated on the cardboard box and the blister pack. The expiry date refers to the last day of the specified month.
• This medicine does not require any special storage conditions.
• Used patches should be folded in half with the adhesive side turned inwards, placed back into the original sachet, and disposed of safely, preferably at a pharmacy in a container designated for unused medicines.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer in use. This will help protect the environment.

6. Contents of the pack 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 cm² contains 20 mg 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 cm² contains 30 mg 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 cm² contains 40 mg buprenorphine and releases 70 micrograms of buprenorphine per hour.

Other ingredients are:
Adhesive matrix containing the active substance:
Povidone K90
Levulinic acid
Oleyl oleate
Copolymer of 2-ethylhexyl acrylate, butyl acrylate, acrylic acid and vinyl acetate (75:15:5:5)
Adhesive matrix not containing the active substance:
Copolymer of 2-ethylhexyl acrylate, vinyl acetate, 2-hydroxyethyl acrylate and glycidyl methacrylate (68:27:5:0.15)
Protective layer:
Siliconized poly(ethylene terephthalate)
Separating layer for the adhesive matrix:
Poly(ethylene terephthalate)
Outer layer:
Polyester
Blue ink

What Melodyn Long looks like and contents of the pack
Each transdermal system is a rectangular, beige-coloured patch with rounded edges, printed with the following label:
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 individually packed in a child-resistant sachet.
Pack sizes available: 4, 5, 8, 10, 16 or 24 patches.
Not all pack sizes may be marketed.

Marketing Authorisation 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

This medicinal product is authorised in the European Economic Area under the following names:
Germany: Bupretec 35/52.5/70 Microgram/Hour Transdermal Patch
Austria: Bupretec 35/52.5/70 Microgram/Hour Transdermal Matrix Patch
Poland: Melodyn Long
Slovakia: Bupretec 35/52.5/70 mikrogramov/h Transdermálna náplasť
Czech Republic: Bupretec 35/52.5/70 mikrogramů/h transdermální náplast

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
G.L. PHARMA POLAND Sp. z o.o.
ul. Sienna 75; 00-833 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
[email protected]