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
Buprenorphinum
Read the entire leaflet carefully before using the medicine, because it contains important information for the patient.

• Keep this leaflet. You may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. The medicine may harm other people, even if their symptoms are the same as yours.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Melodyn Long is and what it is used for
2. What you need to know 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 cancer diseases, as well as severe pain that does not respond to other types of painkillers. Melodyn Long works through the skin. Buprenorphine is an opioid (a strong painkiller) 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 pain).

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 which 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 habitually consuming excessive amounts of alcohol, or occurring during an episode of excessive alcohol intake).

Melodyn Long must not be used in the treatment of withdrawal symptoms in individuals dependent on medicines.

Warnings and precautions

Contact 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 experiences unexplained disturbances in consciousness (such as 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. following 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 cause weakening or slowing of 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;
  Concurrent use of these medicines 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, nocturnal awakenings due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If the patient or another person observes 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. Discontinuation of these medicines may cause withdrawal reactions (see section "Stopping Melodyn Long").
• Fever and use of external heat sources may increase the dose of buprenorphine released into the bloodstream. External heat sources may also cause improper adhesion of the patch to the skin. Therefore, avoid using external heat sources (e.g. sauna, infrared lamp, electric blanket, hot water bottle). Consult a doctor if the patient develops 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 drugs ("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 during treatment with Melodyn Long, this may indicate dependence:

• need to take the medicine longer than prescribed by the doctor;
• need to take higher than the prescribed dose;
• need to continue taking the medicine even though it does not relieve pain;
• use of 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 in well-being upon resuming it ("withdrawal effects").

If any of these symptoms occur, speak with a doctor to discuss the best treatment approach for the patient, including when and how to stop taking the medicine safely (see section 3, Stopping Melodyn Long).

Athletes should be informed that this medicine may cause positive results in doping tests.

Children and adolescents

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

Melodyn Long and other medicines

Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for future use.

• Do not use Melodyn Long concurrently with monoamine oxidase inhibitors (MAO inhibitors – certain medicines used to treat depression) or if such medicines have been taken within the last two weeks.
• Melodyn Long may cause drowsiness, nausea or fainting and may lead to slowed or weakened breathing in some individuals. These adverse effects may be intensified when taken together with other medicines having similar effects. Such medicines include strong painkillers (opioids), certain sleeping medicines, anaesthetics, and medicines used to treat certain mental illnesses, such as sedatives, antidepressants and neuroleptics.
• Concurrent use of Melodyn Long with certain medicines may enhance the effect of the transdermal system. These medicines 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 Long with certain medicines may weaken the effect of the transdermal system. These medicines include dexamethasone; medicines used to treat epilepsy (e.g. containing carbamazepine or phenytoin); medicines used to treat tuberculosis (e.g. rifampicin).

Some medicines may intensify the adverse effects of Melodyn Long and sometimes cause very serious reactions. During treatment with Melodyn Long, do not take 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, coma, excessive sweating, tremors, increased reflexes, increased muscle tone, 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 a doctor prescribes Melodyn Long together with a sedative, the dose and duration of concurrent use should be limited.

Inform the doctor about all sedatives currently taken by the patient 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, food, drink and alcohol

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

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant or plans to become pregnant, she should consult a 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 in pregnant women or in women who 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 and blurred or double vision, which may affect the patient's reactions to such an extent that appropriate or sufficiently rapid responses in unexpected or sudden situations may not be possible. This is particularly relevant:

• at the beginning of treatment;
• during dose changes;
• 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 vehicles or operate machinery during treatment with Melodyn Long. This also applies to the period after stopping Melodyn Long. Do not drive vehicles or operate machinery for at least 24 hours after removing the patch.

If in doubt or if you have any questions, consult a 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,
you should consult your doctor or pharmacist.
Before starting treatment and regularly during treatment, your doctor will discuss with you what to
expect from using Melodyn Long, when and for how long it should be used, when to contact your
doctor, and when to stop using the medicine (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 the 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, for example always on Monday morning and Thursday evening. To help
remember when to change the patch, write the date on the calendar located on the outer packaging.
If your doctor prescribes additional pain-relieving medicines, you must follow the doctor's
instructions exactly. Otherwise, you may not achieve the full benefit of using Melodyn Long.
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 problems 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. Your 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 no
experience with the use of this medicine in this age group.
Route of administration
The patch is intended for application to the skin.
After application of the patch 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 illustration next to it), 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, or damaged skin, such as areas with extensive scarring.

• 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 impair proper adhesion of the patch.

Applying the transdermal system

• Step 1: Each individual patch is enclosed in a sealed pouch. Immediately before application, cut open the pouch with scissors along the edges and remove the patch from the pouch.

• 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 area of skin 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 well to the skin, especially around 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 low. The patient may normally take a shower, bathe, or swim. However, the patch should not be exposed to excessive heat (e.g. sauna, infrared radiation, electric blanket, heating pad, etc.).

If the patch detaches prematurely (which is unlikely), it must not be reused. A new transdermal system should be applied (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, taking appropriate precautions.

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

Duration of treatment
The physician will inform the patient how long treatment with Melodyn Long should continue. Do not discontinue treatment with Melodyn Long independently, as this may lead to recurrence of pain and worsening of well-being (see also section below "Discontinuing treatment with Melodyn Long").

If the patient feels that the effect of Melodyn Long is too strong or too weak, consult a physician 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 adverse effects of buprenorphine, such as drowsiness, nausea, and vomiting. The patient may develop pinpoint (markedly constricted) pupils, weakness, or respiratory depression. Circulatory collapse may also occur.

If the patient realizes that more patches have been applied than recommended, the additional patch should be removed immediately and the patient should contact a physician 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 normally changes patches on Mondays and Thursdays, but only remembered to apply a new patch on Wednesday, from that point onward the patches should be changed on Wednesdays and Saturdays. The new patch change days should be recorded on the calendar provided on the outer packaging.

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

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

Discontinuing treatment with Melodyn Long
Discontinuing or stopping treatment with Melodyn Long may result in recurrence of pain.

If the patient wishes to discontinue treatment with Melodyn Long due to unpleasant adverse effects, they should first consult a physician, who will advise on how to stop treatment and whether other medications are necessary.

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

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

4. Possible adverse reactions

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

If the 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), remove the transdermal system and contact a doctor immediately or seek help at the emergency department of the nearest hospital. These may be symptoms of a very serious allergic reaction.

The following adverse reactions have been reported:

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

• nausea (feeling sick),
• redness, itching

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

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

Uncommon (may affect up to 1 in 100 patients):

• confusion, sleep disorders, restlessness,
• various degrees of sedation (calming effect), ranging from fatigue to feeling of drowsiness,
• circulatory disorders (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 affect up to 1 in 1,000 patients):

• loss of appetite,
• hallucinations, restlessness and nightmares, decreased libido,
• difficulty concentrating, speech disturbances, feeling of 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 affect up to 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,
• pimples, small blisters,
• chest pain

Not known: frequency cannot be estimated from the 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 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 reactions 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 at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Tel.: +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, more information on the safety of this medicine can be collected.

5. How to store Melodyn Long

• The medicine should be stored in a place that is out of sight and out of reach of children.
• This medicine must be kept in a safe 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 for them.
• Do not use this medicine after the expiry date (EXP) stated on the carton and blister pack. The expiry date refers to the last day of the stated month.
• This medicine does not require any special storage conditions.
• Used patches should be folded in half with the adhesive side 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 in household waste. Ask your pharmacist how to dispose of medicines you no longer 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 foil for adhesive matrices:
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 Member States of 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 microgramov/h Transdermálna náplasť
Czech Republic Bupretec 35/52.5/70 mikrogramů/h transdermální náplast

For further information about this medicinal product, please contact the 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]