TRANSTEC 52.5 mcg/h System

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Transtec 35 μg/h, 20 mg, transdermal system, patch
   1. Transtec 70 μg/h, 40 mg, transdermal system, patch Buprenorphinum
   2. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   3. Table of contents of the leaflet
   4. What is Transtec 35 μg/h, Transtec 52.5 μg/h, Transtec 70 μg/h and what is it used for
3. Important information before using Transtec 35 μg/h, Transtec 52.5 μg/h, Transtec 70 μg/h
   1. When not to use Transtec
   2. Warnings and precautions
   3. Tolerance, dependence, and addiction
   4. Children and adolescents
   5. Transtec and other medicines
   6. Transtec with food, drink, and alcohol
   7. Pregnancy, breastfeeding, and fertility
   8. Driving and using machines
4. How to use Transtec 35 μg/h, Transtec 52.5 μg/h, Transtec 70 μg/h
   1. Method of administration
   2. Using a higher dose of Transtec than recommended
   3. Missing a dose of Transtec
   4. Stopping Transtec
5. Possible side effects
6. How to store Transtec 35 μg/h, Transtec 52.5 μg/h, Transtec 70 μg/h
   1. The medicine should be stored in a place invisible and inaccessible to children.
7. Contents of the packaging and other information
   1. What Transtec contains
   2. What Transtec looks like and contents of the pack
   3. Marketing authorization holder and manufacturer

Leaflet accompanying the packaging: patient information

Transtec 35 μg/h, 20 mg, transdermal system, patch

Transtec 52.5 μg/h, 30 mg, transdermal system, patch

Transtec 70 μg/h, 40 mg, transdermal system, patch Buprenorphinum

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. 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, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Transtec 35 μg/h, Transtec 52.5 μg/h, Transtec 70 μg/h and what is it used for
• 2. Important information before using Transtec 35 μg/h, Transtec 52.5 μg/h, Transtec 70 μg/h
• 3. How to use Transtec 35 μg/h, Transtec 52.5 μg/h, Transtec 70 μg/h
• 4. Possible side effects
• 5. How to store Transtec 35 μg/h, Transtec 52.5 μg/h, Transtec 70 μg/h
• 6. Contents of the packaging and other information

1.

What is Transtec 35 μg/h, Transtec 52.5 μg/h, Transtec 70 μg/h and what is it used for

Transtec is a pain-relieving medicine used to treat moderate to severe pain in cancer and severe pain in other diseases, if it does not respond to non-opioid painkillers. Transtec works through the skin. After applying the transdermal system, the active substance (buprenorphine) is released and penetrates the skin into the blood. 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 pain-relieving effect lasts for up to 4 days. Transtec is not suitable for treating acute (short-term) pain.

2. Important information before using Transtec 35 μg/h, Transtec 52.5 μg/h, Transtec 70 μg/h

When not to use Transtec

• if the patient is allergic to buprenorphine or any of the other ingredients of this medicine (listed in section 6);
• in the treatment of patients addicted to opioids;
• in existing or threatened respiratory failure;
• in patients being treated with MAO inhibitors (medicines used to treat depression) and 2 weeks after discontinuing MAO inhibitors (see "Transtec and other medicines");
• if the patient has been diagnosed with muscle weakness (myasthenia gravis);
• if the patient experiences alcohol withdrawal delirium (delirium tremens - a state of confusion, tremors caused by alcohol withdrawal in addicted individuals or occurring during a drinking binge);
• if the patient is pregnant;

Transtec should not be used to treat withdrawal symptoms in individuals addicted to drugs.

Warnings and precautions

Tolerance, dependence, and addiction

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

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

If any of the following symptoms occur while taking Transtec, 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
• using the medicine for reasons other than prescribed, such as "to calm down" or "to sleep better"
• repeatedly attempting to stop or control the use of the medicine but failing
• feeling unwell after stopping the medicine and feeling better after taking it again ("withdrawal symptoms")

If any of these symptoms occur, the patient should talk to their doctor to discuss the best treatment option, including when to stop taking the medicine and how to do it safely (see section 3, Stopping Transtec). Before starting Transtec, the patient should discuss it with their doctor, pharmacist, or nurse. The patient should be cautious when:

• having acute alcohol intoxication;
• having seizures;
• having consciousness disorders of unknown etiology;
• being in shock (which may be characterized by cold sweats);
• having increased intracranial pressure and no possibility of assisted breathing;
• having breathing disorders or taking medicines that may inhibit the respiratory center (see "Transtec and other medicines");
• having depression or other diseases treated with antidepressant medicines.
• Using these medicines together with Transtec may lead to serotonin syndrome, a life-threatening disease (see "Transtec and other medicines").
• having liver function disorders.

The patient should also take the following precautions:

• Fever and high environmental temperature may increase the penetration of the medicine through the skin and disrupt the proper adhesion of the transdermal system to the skin. Therefore, the patient should avoid exposure to high external temperatures (e.g., sauna, infrared radiation, electric blankets, hot water bottles) and consult their doctor if they have a high fever.

Athletes should be aware that this medicine may cause a positive result in doping tests. Sleep apneaTranstec may cause sleep apnea, such as pauses in breathing during sleep, and hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to shortness of breath, difficulty staying asleep, or excessive daytime sleepiness. If the patient or someone else notices these symptoms, they should contact their doctor. The doctor may consider reducing the dose.

Children and adolescents

Transtec should not be used in patients under 18 years of age due to insufficient studies in this patient group.

Transtec and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

• Concomitant use of MAO inhibitors (medicines used to treat depression) is contraindicated, also within 2 weeks prior to using Transtec.
• The following may occur: drowsiness, illness, weakness, or slower and shallower breathing. These symptoms may be exacerbated when used concomitantly with other strong pain relievers (opioids), certain sedatives, anesthetics, and medicines used to treat certain mental illnesses, such as tranquilizers, antidepressants, neuroleptics, and gabapentin or pregabalin used to treat epilepsy or pain caused by nerve problems (neuropathic pain).

The patient should tell their doctor or pharmacist if they are taking:

• 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;

Concomitant use of Transtec and sedatives, such as benzodiazepines or related medicines, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use of such medicines should only be considered when other treatment options are not possible. If the doctor prescribes Transtec in combination with sedatives, they will use a limited dose and limited treatment duration with such medicines. The patient should inform their doctor about all sedatives they are taking and strictly follow the doctor's dosage instructions. It may be helpful to inform friends or relatives about the possibility of these symptoms. If such symptoms occur, the patient should contact their doctor.

• When using Transtec with certain medicines, the effect of the transdermal system may be enhanced. These medicines include certain antibacterial and antifungal medicines (e.g., containing erythromycin and ketoconazole) and medicines used to treat HIV (e.g., containing ritonavir).
• When using Transtec with certain medicines, the effect of the transdermal system may be reduced. These medicines include, for example, dexamethasone, antiepileptic medicines (e.g., containing carbamazepine, phenytoin), and antitubercular medicines (e.g., rifampicin).
• Certain medicines may enhance the side effects of Transtec and sometimes cause very severe reactions. While taking Transtec, the patient should not take other medicines without consulting their doctor, especially: antidepressants, such as citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepin, or trimipramine. These medicines may interact with Transtec and cause symptoms such as involuntary, rhythmic muscle contractions, including those affecting eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle tension, and body temperature above 38°C. If the patient experiences such symptoms, they should contact their doctor.

Transtec with food, drink, and alcohol

It is contraindicated to drink alcohol while using Transtec. Alcohol may enhance certain side effects of buprenorphine and cause malaise. Concomitant consumption of grapefruit juice may enhance the effect of Transtec.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine. There is insufficient experience with the use of Transtec in pregnant women. The use of Transtec during pregnancy is contraindicated. Buprenorphine, the active substance of Transtec, inhibits lactation and passes into human milk. Transtec should not be used during breastfeeding.

Driving and using machines

Transtec may cause dizziness, drowsiness, blurred or double vision, and affect the patient's reactions, impairing their ability to participate in traffic and operate machinery. This is especially true for:

• the start of treatment;
• dose changes;
• the period after stopping another pain reliever and switching to Transtec;
• cases of concomitant use with other centrally acting medicines;
• concomitant alcohol consumption. In these cases, the patient should not drive or operate machinery while using Transtec. This also applies to the situation of stopping Transtec. Patients using Transtec should not drive or operate machinery for at least 24 hours after removing the transdermal system.

In case of any doubts, the patient should consult their doctor or pharmacist.

3. How to use Transtec 35 μg/h, Transtec 52.5 μg/h, Transtec 70 μg/h

This medicine should always be used exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist. Before starting treatment and regularly during treatment, the doctor will discuss with the patient what to expect from using Transtec, when and how long to take it, when to contact the doctor, and when to stop the medicine (see also: Stopping Transtec). Transtec transdermal system is available in 3 strengths: Transtec 35 micrograms/hour, Transtec 52.5 micrograms/hour, and Transtec 70 micrograms/hour. The choice of the appropriate strength of Transtec is up to the doctor. During treatment, if necessary, the doctor may change the strength of the medicine to a smaller or larger one. The recommended dose of Transtec is: Adults If the doctor has not prescribed otherwise, one Transtec transdermal system should be applied to the skin (as described in detail below) and changed no later than every 4 days. For convenience, it can be changed 2 times a week on the same days of the week, e.g., always on Mondays and Thursdays. To remind the patient to change the transdermal system, they should mark the day of the week on the calendar on the outer packaging. If the doctor prescribes an additional pain reliever, the patient should strictly follow the doctor's instructions to get the full benefits of using Transtec. Children and adolescents Transtec should not be used in patients under 18 years of age due to insufficient studies in this patient group. Elderly patients (over 65 years) In these patients, there is no need to change the dose of Transtec. Patients with renal impairment In patients with renal failure, there is no need to change the dose of Transtec. Patients with liver impairment The strength and duration of action of Transtec may change in patients with liver function disorders. The doctor will closely monitor patients with liver impairment.

Method of administration

Before applying the transdermal system, patch

• The patient should choose a flat, clean, and hairless area of skin on the upper part of the body, preferably the area around the collarbone or the upper back (see illustrations).

Potential places on the body to apply the transdermal system, patch Chest

or Back

In case of difficulties with applying the transdermal system, the patient should ask for help.

• If the chosen skin area is hairy, the hair should be removed with scissors. Do not shave!
• The patient should avoid areas of skin that are red, irritated, or have other lesions, such as extensive scars.
• The chosen skin area should be dry and clean. If the skin needs to be cleaned before applying the preparation, it should be washed with cold or lukewarm water. Do not use soap or any other cleaning agent. After a hot bath or shower, the patient should wait until the skin is completely dry and cool. The patient should avoid using skin care products (cosmetic milks, creams, ointments) on the skin areas where the transdermal system will be applied, as this may impair its adhesion.

Applying the transdermal system Stage 1: Each individual transdermal system is in a pouch. Cut the child-resistant pouch along the dotted line using scissors. Be careful not to damage the patch. or Remove the patch from the pouch.

Stage 2: The adhesive layer of the transdermal system is covered with a silver protective foil. Carefully separate half of the protective foil. The patient should try not to touch the adhesive layer of the transdermal system.

Stage 3: Apply the transdermal system to the chosen skin area and remove the remaining protective foil. Attach the system.

Stage 4: Press the transdermal system firmly with the palm of the hand and hold for about 30 seconds. The patient should make sure that the entire transdermal system adheres to the skin, especially the edges.

Wearing the transdermal system The patient can wear the Transtec transdermal system for up to 4 days. After proper application, the risk of the transdermal system detaching is small. During wear, the patient can bathe, shower, and swim. The patient should not expose the transdermal system to excessive heat from the outside (such as a sauna, infrared radiation, electric blankets, hot water bottles). In case of premature detachment of the transdermal system (very unlikely), the patient should not reuse it. A new transdermal system should be applied (see "Changing the transdermal system" below). Changing the transdermal system

• Fold the patch in half with the adhesive side inward.
• Dispose of it in a place invisible and inaccessible to children.
• Apply subsequent patches to different skin areas (as described above). The same area can be used again after at least one week.

Duration of use The doctor will determine the duration of use of Transtec. The patient should not stop treatment on their own, as pain and malaise may return (see also "Stopping Transtec"). If the patient feels that the effect of Transtec is too strong or too weak, they should consult their doctor or pharmacist.

Using a higher dose of Transtec than recommended

The following symptoms may occur: symptoms of buprenorphine overdose. Overdose may enhance the side effects of buprenorphine, such as drowsiness, nausea, and vomiting. The pupils may become constricted to the size of a pinhead, and breathing may become slow and shallow. Cardiac arrest may occur. If the patient realizes they have used a higher dose than recommended, they should immediately remove the transdermal system and consult their doctor or pharmacist.

Missing a dose of Transtec

If the medicine is used according to a fixed schedule and the patient forgets to take it on time, they should take the recommended dose as soon as possible. This may involve changing the days of the week, e.g., from Mondays and Thursdays to Wednesdays and Saturdays. The patient should mark this change on the outer packaging of the patches. If there is a significant delay, pain may return. In such a case, the patient should consult their doctor. The patient should not take a double dose to make up for the missed dose.

Stopping Transtec

After stopping or ending the use of Transtec too early, pain may return. If the reason for stopping is unpleasant side effects, the patient should consult their doctor before stopping. The doctor will determine what to do and assess the possibility of changing treatment. In some individuals, after stopping long-term treatment with strong pain relievers, withdrawal symptoms may occur. The risk of withdrawal symptoms after Transtec is low. However, if the patient experiences agitation, anxiety, nervousness, tremors, excessive restlessness, difficulty sleeping, digestive disorders, they should inform their doctor about these symptoms. In case of any further doubts related to the use of this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Transtec can cause side effects, although not everybody gets them. If the patient experiences swelling of the hands, feet, ankles, face, lips, mouth, or throat, causing difficulty swallowing or breathing, hives, weakness, or yellowing of the skin and eyes (jaundice), they should remove the transdermal system and immediately contact their doctor or go to the emergency department of the nearest hospital. These may be symptoms of a very rare, severe allergic reaction.In some cases, delayed allergic reactions with marked inflammation occur. In such cases, after consulting the doctor, Transtec should be discontinued. The following side effects have been reported: In case of the following side effects, the patient should immediately contact their doctor. Very common side effects(may occur in more than 1 in 10 people): nausea, redness, itching. Common side effects(may occur in up to 1 in 10 people): dizziness, headaches, shortness of breath, vomiting, constipation, skin changes (rash, usually with repeated use), excessive sweating, edema (e.g., swelling of the legs), feeling tired. Uncommon side effects(may occur in up to 1 in 100 people): confusion, sleep disorders, restlessness, excessive sedation of varying degrees, from fatigue to lethargy, circulation disorders (such as hypotension or rarely even circulatory collapse), dry mouth, hiccups, fatigue, urinary disorders, urinary retention (less urine than usual). Rare side effects(may occur in up to 1 in 1,000 people): loss of appetite, psychotic symptoms (e.g., hallucinations, anxiety, nightmares), decreased libido, concentration disorders, speech disorders, fatigue, balance disorders, abnormal skin sensations (numbness, tingling, or burning sensation), vision disorders, blurred vision, eyelid edema, hot flashes, breathing difficulties (respiratory depression), heartburn, erectile dysfunction, hives, withdrawal syndrome (see below), reactions at the site of application of the transdermal system. Very rare side effects(may occur in less than 1 in 10,000 people): severe allergic reactions (see above), dependence, sudden mood changes, muscle twitching, abnormal taste sensation, pinpoint pupils, ear pain, abnormal breathing, hiccups, skin rashes, small blisters, chest pain. Frequency not known(frequency cannot be estimated from the available data): contact dermatitis (skin rash with inflammation, which may include a burning sensation), skin discoloration. In some individuals, after stopping long-term treatment with strong pain relievers, withdrawal symptoms may occur. The risk of withdrawal symptoms after Transtec is low. However, if the patient experiences agitation, anxiety, nervousness, tremors, excessive restlessness, difficulty sleeping, digestive disorders, they should inform their doctor about these symptoms. Reporting side effects If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, more information can be collected on the safety of the medicine. Side effects can also be reported to the marketing authorization holder.

5. How to store Transtec 35 μg/h, Transtec 52.5 μg/h, Transtec 70 μg/h

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.

The medicine should be stored in a place invisible and inaccessible to children.

Do not use this medicine after the expiry date stated on the carton and pouch after "Expiry date (month/year)". The expiry date refers to the last day of the given month. There are no special precautions for storing the medicine. Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Transtec contains

The active substance of Transtec is buprenorphine.

The other ingredients are: Adhesive matrix (containing buprenorphine): oleate (Z)-octadeca-9-en-1-yl, povidone K90, 4-oxopentanoic acid, cross-linked poly(acrylic acid-co-butyl acrylate-co-2-ethylhexyl acrylate-co-vinyl acetate), in a ratio of 5:15:75:5. Adhesive matrix (not containing buprenorphine): non-cross-linked poly(acrylic acid-co-butyl acrylate-co-2-ethylhexyl acrylate-co-vinyl acetate), in a ratio of 5:15:75:5. Separating foil placed between the adhesive matrices with and without buprenorphine: foil made of poly(ethylene terephthalate). Outer covering layer: poly(ethylene terephthalate). Removable covering foil covering the surface of the adhesive matrix containing buprenorphine – (should be removed immediately before application) siliconized foil made of poly(ethylene terephthalate), one-sidedly aluminum-coated.

What Transtec looks like and contents of the pack

The transdermal systems, patches are flesh-colored with rounded edges and have printing: Transtec 35 μg/h, Buprenorphinum, 20 mg Transtec 52.5 μg/h, Buprenorphinum, 30 mg Transtec 70 μg/h, Buprenorphinum, 40 mg The packaging contains 3, 5, and 10 patches packaged individually in child-resistant pouches.

Marketing authorization holder and manufacturer

Grünenthal GmbH Zieglerstrasse 6 52078 Aachen Germany Date of last revision of the leaflet:11/2024