Melodyn

Package leaflet: Information for the user

Melodyn, 35 micrograms/hour, transdermal system
Melodyn, 52.5 micrograms/hour, transdermal system
Melodyn, 70 micrograms/hour, transdermal system
(Buprenorphinum)
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• 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. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet

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

1. What Melodyn is and what it is used for

Melodyn is an analgesic (pain-relieving) medicine used to relieve moderate to severe pain associated with cancer and severe pain associated with other diseases that does not respond to non-steroidal analgesics. Melodyn acts through the skin. After application of the patch to the skin, the active substance buprenorphine passes through the skin into the bloodstream.
Buprenorphine belongs to the group of opioids (strong painkillers), which reduce pain by acting on the central nervous system (on specific nerve cells in the spinal cord and brain). The effect of the patches lasts up to three days. Melodyn is not recommended for the treatment of acute (short-term) pain.

2. Important information before using Melodyn

Do not use Melodyn:

• if the patient is allergic to buprenorphine, soy, peanuts, or any of the other ingredients of this medicine (listed in section 6);
• if the patient is dependent on strong painkillers (opioids);
• if the patient has a disease causing severe breathing difficulties;
• if the patient is taking monoamine oxidase inhibitors (MAO inhibitors – some medicines used to treat depression) or has taken them within the last two weeks (see section "Melodyn 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);
• if the patient is pregnant.

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

Warnings and precautions
Consult your doctor or pharmacist before using Melodyn if any of the following apply:

• after recent consumption of large amounts of alcohol;
• if the patient has seizures or convulsions;
• if the patient experiences unexplained disturbances in consciousness (e.g. dizziness or fainting);
• if the patient is in shock (symptoms of shock may include cold sweats);
• if the patient has increased intracranial pressure (e.g. after head surgery or due to brain disease) and artificial ventilation is not possible;
• if the patient has breathing difficulties or is taking other medicines that may cause respiratory depression or respiratory slowing (see section "Melodyn 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 antidepressant medicines. Concurrent use of these medicines with Melodyn may lead to serotonin syndrome, a potentially life-threatening condition (see section "Melodyn and other medicines").

Please also pay attention to the following warnings:
Fever and the use of external heat sources may increase the dose of buprenorphine released into the blood. 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 addiction
This medicine contains buprenorphine, which is an opioid. Repeated use of opioids may lead to the medicine becoming less effective (drug tolerance). Repeated use of Melodyn 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 developing dependence or addiction varies between individuals. The risk of dependence on Melodyn 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 disorders (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, this may indicate dependence:

• need to take the medicine longer than prescribed by the doctor;
• need to take a higher than recommended dose;
• need to continue taking the medicine, even if it does not help relieve pain;
• using the medicine for reasons other than 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 after re-taking it ("withdrawal symptoms").

If any of these symptoms occur, talk to your doctor to discuss the best treatment path for the patient, including when to stop taking the medicine and how to do so safely (see section 3, "Stopping treatment with Melodyn").

Athletes should be aware that this medicine may cause a positive result in anti-doping tests.

Sleep-related breathing disorders
Melodyn contains an active substance belonging to the group of opioids. Opioids may cause breathing disorders during sleep, such as central sleep apnoea (shallow breathing or breathing pauses during sleep) and nocturnal hypoxia (reduced oxygen levels in the blood).

The risk of central sleep apnoea depends on the opioid dose. The doctor may consider reducing the total opioid dose if central sleep apnoea occurs in the patient.

Children and adolescents
Do not use Melodyn in individuals under 18 years of age, as there is insufficient experience with the use of this medicine in this age group.

Melodyn and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.

Some medicines may intensify the adverse effects of Melodyn and, in some cases, cause very severe reactions. Do not take other medicines without prior consultation with your doctor while using Melodyn, especially:

• Antidepressants such as moclobemide, tranylcypromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepin, or trimipramine. These medicines may interact with Melodyn and cause symptoms such as involuntary rhythmic muscle contractions, including eye movement muscles, agitation, hallucinations, hyperthermia, excessive sweating, tremors, increased reflexes, increased muscle tone, body temperature above 38°C. If such symptoms occur, contact your doctor.
• Do not use Melodyn concurrently with monoamine oxidase inhibitors (MAO inhibitors – some medicines used to treat depression) or if the patient has taken such medicines within the last two weeks.
• Melodyn may cause drowsiness, nausea, or fainting and may lead to slowed or weakened breathing. These adverse effects may be intensified if other medicines with similar adverse effects are taken simultaneously. Such medicines include strong analgesics (opioids), certain sleeping medicines, anaesthetics, and medicines used to treat certain mental illnesses, such as sedatives, antidepressants, and neuroleptics.
• Concurrent use of Melodyn 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. However, if your doctor prescribes Melodyn together with a sedative, the dose and duration of concurrent use should be limited. Inform your doctor about all sedatives the patient is taking and strictly follow the doctor's instructions. It may be helpful to inform friends or family members about the above-mentioned symptoms. If such symptoms occur, contact your doctor.
• Concurrent use of Melodyn 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).
• Concurrent use of Melodyn with certain medicines may reduce the effect of the transdermal system. These include e.g. dexamethasone; medicines used to treat epilepsy (e.g. containing carbamazepine or phenytoin); medicines used to treat tuberculosis (e.g. rifampicin).
• Gabapentin or pregabalin used to treat epilepsy or nerve-related pain (neuropathic pain).
• Medicines used to treat depression.
• Medicines used for 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.

Using Melodyn with food, drink, and alcohol
Do not consume alcohol while using Melodyn. Alcohol may intensify some adverse effects and worsen the patient's condition.
Drinking grapefruit juice may enhance the effect of Melodyn.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
There is insufficient data on the use of Melodyn during pregnancy.
Therefore, Melodyn should not be used during pregnancy.
Buprenorphine, the active substance in Melodyn, inhibits milk production and passes into breast milk. Therefore, Melodyn should not be used during breastfeeding.

Driving and operating machinery
Melodyn 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 changes;
• when switching treatment from another analgesic to Melodyn;
• 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. This also applies to the period after stopping Melodyn. 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.
Melodyn contains soy oil. If the patient is allergic to peanuts or soy, this medicine should not be used.

3. How to use Melodyn

Always use Melodyn exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Before starting treatment and regularly during treatment, the doctor will discuss with the patient what to expect from using Melodyn, when and how long to use it, when to contact the doctor, and when to discontinue the medicine (see also: "Stopping treatment with Melodyn").

Melodyn is available in three strengths: Melodyn 35 micrograms/hour, transdermal system; Melodyn 52.5 micrograms/hour, transdermal system; Melodyn 70 micrograms/hour, transdermal system.
The doctor will decide which strength is appropriate for the patient. If necessary, the doctor may change the strength during treatment.

Recommended dose:
Adults
Unless otherwise prescribed by the doctor, apply one Melodyn patch as described below and replace it no later than after 3 days. To remember when to change the patch, write the date on the outer packaging. If the doctor prescribes additional analgesics, strictly follow the doctor's instructions. Otherwise, the full benefits of Melodyn may not be achieved.

Use in children and adolescents
Do not use Melodyn in individuals under 18 years of age due to insufficient data on its use in this age group.

Elderly patients
No dose adjustment is necessary in elderly patients.

Patients with renal impairment and dialysis patients
No dose adjustment is necessary in patients with renal impairment or in dialysis patients.

Patients with hepatic impairment
In patients with impaired liver function, the strength and duration of action of Melodyn may be altered. The doctor will monitor such patients more closely.

Instructions for opening child-resistant pouches

1. Cut along the lines indicated by arrows on the sides of the pouch.
2. Tear open at the cut areas along the sealed edge.
3. Open the pouch and remove the patch.

How to apply the patch

Before applying the patch

• Choose a flat, non-hairy, clean area of skin on the upper half of the body, preferably on the chest below the collarbone or on the upper arm. If the patient has difficulty applying the patch, ask for help.
• If hair is present in the chosen area, trim it with scissors. Do not shave the hair!
• Avoid areas of skin that are red, irritated, or have any lesions, e.g. large scars.
• The chosen skin area must be clean and dry. If necessary, wash the skin with cold or lukewarm water. Do not use any cleansing agents. After a hot bath or shower, wait until the skin is completely dry and cool. Do not apply lotions, creams, or oils to the chosen skin area, as this may impair patch adhesion.

Applying the patch

1. Open the pouch immediately before applying the patch. Each patch is individually sealed in a pouch.
2. First, gently peel off the loosely attached thin protective liner.

3. Then remove the foil backing from half of the patch, avoiding contact with the adhesive surface.
4. After attaching half of the patch, remove the foil backing from the other half.

5. After application, press the patch firmly onto the skin with the palm of the hand for about 30–60 seconds. Ensure the patch adheres well to the skin, especially at the edges.
6. Wash hands after applying the patch. Do not use cleansing agents.

After applying the patch
The patch may remain on the skin for up to 3 days. If the patch has been correctly applied, there is little risk of it detaching. With a properly applied patch, you may take a shower, bathe, and swim. Do not expose the patch to heat (e.g. sauna, infrared lamp, electric blanket, hot water bottle).
If the patch unexpectedly detaches before the scheduled change, do not reapply it. Immediately apply a new patch (see "Changing the patch").

Changing the patch

• Remove the old patch from the skin.
• Fold it in half with the adhesive sides facing inward.
• Dispose of the used patch carefully, ensuring it is out of sight and out of reach of children.
• Apply a new patch to a different area of skin (following the instructions above). A new patch may be applied to the same skin area only after one week.

Duration of treatment
The doctor will inform the patient how long to use Melodyn. Do not stop using Melodyn on your own, as this may cause pain to return and worsen well-being (see also section "Stopping treatment with Melodyn").
If the effect of Melodyn seems too strong or too weak, consult your doctor or pharmacist.

Use of more than the recommended dose of Melodyn
If more than the recommended dose of Melodyn is used, symptoms of buprenorphine overdose may occur. Overdose may intensify adverse effects of buprenorphine, such as drowsiness, nausea, and vomiting. The patient may have pinpoint (severely constricted) pupils, respiratory depression or slowed breathing, and circulatory collapse.
If the patient realizes they have used more patches than necessary, remove the additional patch immediately and contact your doctor or pharmacist without delay.

Missed dose of Melodyn
If the patient forgets to apply a patch, do so as soon as they remember. If the patch change is delayed too long, pain may return. In this case, contact your doctor.
Do not apply two patches to make up for a missed dose.

Stopping treatment with Melodyn
Suddenly stopping or discontinuing Melodyn may lead to recurrence of pain symptoms.
If the patient wishes to stop using Melodyn due to unpleasant side effects, consult the doctor first. The doctor will inform the patient how to discontinue treatment and whether other medicines are necessary.
In some patients, withdrawal symptoms may occur after stopping long-term use of strong analgesics. The risk of withdrawal symptoms after stopping Melodyn is very low. However, if after stopping treatment the patient experiences agitation, anxiety, nervousness, chills, hyperactivity, difficulty sleeping, or gastrointestinal disturbances, consult your doctor.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicinal product may cause adverse reactions, although not in all patients do they occur.
Adverse reactions have been classified as follows:

The following adverse reactions have been reported:

Immune system disorders
Very rare: severe skin reactions (see below)

Metabolism and nutrition disorders
Rare: loss of appetite

Psychiatric disorders
Uncommon: confusion, sleep disturbances, psychomotor agitation
Rare: hallucinations, anxiety, nightmares
Very rare: dependence, mood changes

Nervous system disorders
Common: dizziness, headache
Uncommon: various degrees of sedation ranging from fatigue to feeling of mental clouding
Rare: difficulty concentrating, speech disorders, mental clouding, balance disorders, abnormal skin sensations (tingling, pricking, burning of the skin)
Very rare: muscle twitching, taste disturbances

Eye disorders
Rare: visual disturbances, blurred vision, eyelid swelling
Very rare: miosis (pupillary constriction)

Ear disorders
Very rare: ear pain

Cardiac and circulatory system disorders
Uncommon: circulatory disturbances (such as low blood pressure or, rarely, circulatory collapse)
Rare: hot flushes

Thoracic and respiratory disorders
Common: shortness of breath
Rare: breathing difficulties (respiratory depression)
Very rare: abnormally rapid breathing, hiccups

Gastrointestinal disorders
Very common: nausea
Common: vomiting, constipation
Uncommon: dry mouth
Rare: heartburn
Very rare: vomiting reflex

Skin disorders (usually at the application site)
Very common: redness, itching
Common: skin changes (rash, usually after repeated use), sweating
Uncommon: rash
Rare: urticaria
Very rare: pustules, small blisters
Frequency not known: contact dermatitis (skin rash with inflammation which may include a burning sensation), skin discoloration

Urinary system disorders
Uncommon: difficulty in urination, urinary retention (reduced volume of urine passed)

Reproductive system disorders
Rare: erectile dysfunction

General disorders
Common: swelling (e.g., of legs), fatigue
Uncommon: tiredness
Rare: withdrawal symptoms (see below), application site reactions
Very rare: chest pain

If any of the adverse reactions listed above occur, inform your doctor as soon as possible.

In some cases, delayed allergic reactions with visible signs of inflammation may occur. In such cases, discontinue use of the medicinal product Melodyn after prior consultation with your doctor.

If the patient develops swelling of the hands, feet, ankles, face, lips, mouth, or swelling of the throat causing difficulty in swallowing or breathing, urticaria, fainting, yellowing of the skin and eyes (so-called jaundice), remove the patch immediately and seek medical help without delay by contacting a doctor or going to the nearest hospital emergency department. These may be symptoms of a very rare but serious allergic reaction.

In some patients, withdrawal symptoms may occur after discontinuation of long-term treatment with strong analgesics. The risk of such symptoms occurring after stopping Melodyn is low. However, if symptoms such as restlessness, anxiety, nervousness, tremor, hyperexcitability, difficulty falling asleep, or gastrointestinal disturbances occur, inform your doctor.

If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to:
Department of Monitoring Adverse Reactions of Medicinal Products
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
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.

Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Melodyn

The medicine should be stored in a place inaccessible and not visible to children.
Do not use this medicine after the expiry date (EXP) stated on the cardboard packaging and
blister pack. The expiry date refers to the last day of the specified month.
Store below 25°C.
Do not freeze.
This medicine should be stored in a secure place, out of reach of other people. The medicine may cause serious harm, or even death, in individuals who take it accidentally or intentionally if it has not been prescribed for them.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Melodyn contains
The active substance is buprenorphine.
Melodyn 35 micrograms/hour, transdermal system: each transdermal system contains 20 mg of buprenorphine and releases 35 micrograms of buprenorphine per hour. The surface area of the patch containing the active substance is 25 cm².
Melodyn 52.5 micrograms/hour, transdermal system: each transdermal system contains 30 mg of buprenorphine and releases 52.5 micrograms of buprenorphine per hour. The surface area of the patch containing the active substance is 37.5 cm².
Melodyn 70 micrograms/hour, transdermal system: each transdermal system contains 40 mg of buprenorphine and releases 70 micrograms of buprenorphine per hour. The surface area of the patch containing the active substance is 50 cm².

Other components are:
Adhesive layer:
Styrene-butadiene-styrene (SBS) and styrene-butadiene block copolymers, rosin, antioxidants (2,4-bis(1,1-dimethylethyl)phosphine (3:1), tris(2,4-di-tert-butylphenyl) phosphite, oil extract from leaves of Aloe vera (also contains refined soybean oil and alpha-tocopherol acetate).

Outer layer:
Polyethylene/Polyester/Aluminium, blue ink.

Protective liner (to be removed):
Siliconized polyester.

What Melodyn looks like and contents of the pack
Transdermal patches are skin-coloured, rectangular in shape with rounded edges, printed with "Buprenorphin 35 µg/h".
Transdermal patches are skin-coloured, rectangular in shape with rounded edges, printed with "Buprenorphin 52.5 µg/h".
Transdermal patches are skin-coloured, rectangular in shape with rounded edges, printed with "Buprenorphin 70 µg/h".

Each transdermal system is individually packed in a sealed pouch.
Melodyn is available in packs containing 4, 5, 8, 10, 16 or 24 (6x4) patches, each packed in a pouch, in a cardboard carton.
Not all pack sizes may be marketed.

Available patch strengths:
Melodyn 35 micrograms/hour
Melodyn 52.5 micrograms/hour
Melodyn 70 micrograms/hour

Marketing Authorisation Holder and Manufacturer
G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

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.
Sienna 75
00-833 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
[email protected]

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Germany
Buvera 35 Micrograms/Hour Transdermal Patch
Buvera 52.5 Micrograms/Hour Transdermal Patch
Buvera 70 Micrograms/Hour Transdermal Patch

Czech Republic
Buprenorphine Teva 35 µg/h transdermal patch
Buprenorphine Teva 52.5 µg/h transdermal patch
Buprenorphine Teva 70 µg/h transdermal patch

Poland
Melodyn 35 micrograms/hour, transdermal system
Melodyn 52.5 micrograms/hour, transdermal system
Melodyn 70 micrograms/hour, transdermal system

Portugal
Buprenorphine Actavis 35 micrograms/h transdermal system
Buprenorphine Actavis 52.5 micrograms/h transdermal system
Buprenorphine Actavis 70 micrograms/h transdermal system