Transtec 35 mcg/h

Package leaflet: Information for the patient

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
Please read carefully the entire leaflet 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, pharmacist, or nurse.
• 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 you experience any adverse effects, including any not listed in this leaflet, inform your 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 pack 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 an analgesic medicine used to treat moderate to severe pain in cancer-related diseases and severe pain in other conditions when pain does not respond to non-opioid painkillers. Transtec acts through the skin.
After application of the transdermal system, the active substance (buprenorphine) is released and penetrates through the skin into the bloodstream. 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 analgesic effect lasts up to 4 days. Transtec is not suitable for the treatment of 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 dependent on opioids;
• in existing or impending respiratory failure;
• in patients treated with MAO inhibitors (medicines used to treat depression) and within 2 weeks after discontinuation of MAO inhibitors (see "Transtec and other medicines");
• if the patient has muscle weakness ( myasthenia gravis );
• if the patient is experiencing alcohol withdrawal delirium ( delirium tremens – a state of confusion and tremors caused by alcohol withdrawal in dependent individuals or occurring during continued drinking);
• if the patient is pregnant;

Transtec should not be used in the treatment of withdrawal symptoms in individuals dependent on drugs.
Warnings and precautions
Tolerance, dependence, and addiction
This medicine contains buprenorphine, which is an opioid medicine. Repeated use of opioids may lead to reduced effectiveness of the medicine (drug tolerance). Repeated use of Transtec may also lead to dependence, abuse, 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 from person to person. 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 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 Transtec, this may indicate dependence:

• need to take the medicine longer than prescribed by the doctor;
• need to take a higher dose than recommended;
• need to continue taking the medicine even if it does not help relieve pain;
• use of the medicine for reasons other than prescribed, e.g., "to calm down" or "to sleep easier";
• 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 symptoms").

If any of these symptoms occur, talk to your doctor to discuss the best treatment approach for you, including when and how to safely stop taking the medicine (see section 3, Stopping Transtec treatment).
Discuss this with your doctor, pharmacist, or nurse before starting Transtec treatment.
Special caution is required in patients:

• with acute alcohol intoxication;
• with seizures;
• with disturbances of consciousness of unknown origin;
• in shock (which may present with cold sweats);
• with increased intracranial pressure and no possibility of assisted ventilation;
• with respiratory disorders or taking medicines that may depress the respiratory centre (see "Transtec and other medicines");
• with depression or other conditions treated with antidepressant medicines.
• Concurrent use of these medicines with Transtec may lead to serotonin syndrome, a potentially life-threatening condition (see section "Transtec and other medicines");
• with impaired liver function.

Additional precautions should also be observed:

• Fever and high ambient temperature may increase drug penetration through the skin and may interfere with proper adhesion of the transdermal system to the skin. Therefore, avoid exposure to high external temperatures (e.g., saunas, infrared radiation sources, electric blankets, hot water bottles) and consult your doctor if high fever occurs.

Athletes should be aware that this medicine may lead to a positive result in anti-doping tests.
Sleep-related breathing disorders
Transtec may cause sleep-related breathing disorders, such as sleep apnoea (pauses in breathing during sleep) and hypoxemia (low blood oxygen levels). Symptoms may include breathing pauses during sleep, nocturnal awakenings due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If the patient or someone else observes these symptoms, contact a doctor. The doctor may consider reducing the dose.
Children and adolescents
Transtec should not be used in individuals under 18 years of age due to insufficient data from clinical studies in this patient group.
Transtec and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

• Concomitant use of MAO inhibitors (medicines used to treat depression) is contraindicated, including within 2 weeks prior to starting Transtec.
• Drowsiness, dizziness, weakness, or slower and weaker breathing may occur. These effects may be intensified if used together with other strong painkillers (opioids), certain sleeping medicines, anaesthetics, or medicines used to treat certain mental illnesses such as sedatives, antidepressants, neuroleptics, and gabapentin or pregabalin used to treat epilepsy or nerve-related pain (neuropathic pain).

Inform your doctor or pharmacist if you 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 with sedative medicines such as benzodiazepines or related substances 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 if no other treatment options are available.
If your doctor prescribes Transtec together with sedative medicines, they will use a limited dose and limit the duration of concomitant treatment.
Inform your doctor about all sedative medicines you are taking and strictly follow the doctor's dosing instructions. It may be helpful to inform family members or friends about the possibility of the above-mentioned symptoms. If such symptoms occur, contact your doctor.

• When Transtec is used concomitantly with certain medicines, the effect of the transdermal system may be enhanced. These include certain antibiotics and antifungals (e.g., containing erythromycin and ketoconazole) and medicines used to treat HIV (e.g., containing ritonavir).
• When Transtec is used concomitantly with certain medicines, the effect of the transdermal system may be reduced. These include, for example, dexamethasone, antiepileptic medicines (e.g., containing carbamazepine, phenytoin), and antituberculosis medicines (e.g., rifampicin).
• Some medicines may increase the adverse effects of Transtec and sometimes cause very severe reactions. During treatment with Transtec, do not take other medicines without prior consultation with your 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 eye movement muscles), agitation, hallucinations, coma, excessive sweating, tremor, increased reflexes, increased muscle tone, and body temperature above 38°C. If such symptoms occur, contact your doctor.

Transtec with food, drink, and alcohol
Drinking alcohol while using Transtec is contraindicated. Alcohol may intensify certain adverse effects of buprenorphine and cause discomfort.
Drinking grapefruit juice concurrently may enhance the effect of Transtec.
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 experience with the use of Transtec in pregnant women.
Use during pregnancy is contraindicated.
Buprenorphine, the active substance in Transtec, inhibits lactation and passes into human milk.
Transtec should not be used during breastfeeding.
Driving and operating machinery
Transtec may cause dizziness, drowsiness, blurred or double vision, and negatively affect the patient's reactions, impairing the ability to participate in traffic or operate machinery.
This especially applies to:

• the beginning of treatment;
• changes in dosage;
• the period after discontinuation of another painkiller and switching to Transtec;
• cases of concomitant use with other centrally acting (on the brain) medicines;
• concomitant alcohol consumption. In these cases, patients should not drive or operate machinery while using Transtec. This also applies to the period after stopping Transtec treatment. Patients using Transtec must not drive or operate machinery for at least 24 hours after removal of the transdermal system.

If you have any doubts, please contact your doctor or pharmacist.

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

This medicine should always be used exactly as directed by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
Before starting treatment and regularly during treatment, your doctor will discuss with you what
you can expect from using Transtec, when and how long you should use it, when you should
contact your doctor, and when you should discontinue the medicine (see also: Discontinuation of Transtec).
The Transtec transdermal system is available in three strengths: Transtec 35 micrograms/hour,
Transtec 52.5 micrograms/hour, and Transtec 70 micrograms/hour.
Your doctor will decide which strength of Transtec is appropriate. During treatment, if necessary,
your doctor may change the strength to a lower or higher dose.

Recommended dose of Transtec:

Adults
Unless otherwise directed by your doctor, one Transtec transdermal system should be applied to the skin (as described in detail below) and replaced no later than after 4 days. For convenience, you may change it twice a week on the same days each week, e.g. always on Monday mornings and Thursday evenings. To help you remember when to change the transdermal system, mark the days of the week on the outer packaging. If your doctor advises you to use an additional pain-relieving medicine, you must strictly follow the doctor's instructions to achieve the full benefit of Transtec.

Children and adolescents
Transtec is not recommended for use in individuals under 18 years of age due to insufficient data in this patient group.

Elderly patients (over 65 years of age)
No dose adjustment is necessary for elderly patients.

Patients with renal impairment
No dose adjustment is necessary for patients with kidney dysfunction.

Patients with hepatic impairment
The strength and duration of action of Transtec may be altered in patients with liver dysfunction.
Your doctor will closely monitor patients with liver impairment.

Method of application

Before applying the transdermal system, plaster

• Select a flat, clean, non-hairy area of skin on the upper body, preferably the upper chest below the collarbone or the upper back (see illustrations).

Potential sites on the body for application of the transdermal system, plaster
Chest

or
OR
Back

If you have difficulty applying the transdermal system, ask for help.

• If the selected skin area is hairy, trim the hair with scissors. Do not shave!
• Avoid areas of skin that are red, irritated, or otherwise damaged, such as extensive scars.
• The selected skin area should be dry and clean. If the skin needs to be cleaned before application, wash it with cool or lukewarm water. Do not use soap or any other cleansing agent for this purpose. After a hot bath or shower, wait until the skin is completely dry and cool. Avoid using skin care products (e.g. lotions, creams, ointments) on the areas where the transdermal system will be applied, as this may reduce its adhesion.

Application of the transdermal system
Step 1:
Each individual transdermal system is contained in a child-resistant pouch. Cut the pouch along the dotted line with scissors, taking care not to damage the patch.

Remove the patch from the pouch.

Step 2:
The adhesive layer of the transdermal system is covered by a silver protective liner. Carefully peel off half of the protective liner. Avoid touching the adhesive surface of the transdermal system.

Step 3:
Place the transdermal system onto the selected area of skin and remove the remaining protective liner. Apply the patch.

Step 4:
Press firmly with the palm of your hand and hold for about 30 seconds. Make sure the entire transdermal system adheres to the skin, especially the edges.

Wearing the transdermal system
You may wear the Transtec transdermal system for up to 4 days. When properly applied, the risk of the system detaching is low. While wearing the transdermal system, you may bathe, shower, or swim. Do not expose it to excessive external heat (e.g. saunas, infrared radiation, electric blankets, hot water bottles).
If the transdermal system detaches prematurely (very unlikely), do not reuse it. Apply a new transdermal system (see "Changing the transdermal system" below).

Changing the transdermal system

• Fold the used patch in half with the sticky side inward.
• Dispose of it in a place out of sight and out of reach of children.
• Apply subsequent patches to different skin areas (as described above). The same site should not be used again until at least one week has passed.

Duration of treatment
Your doctor will determine how long you should use Transtec. Do not stop treatment prematurely, as pain and discomfort may return (see also "Discontinuation of Transtec").
If you feel that the effect of Transtec is too strong or too weak, consult your doctor or pharmacist.

Use of a higher than recommended dose of Transtec
Symptoms of overdose of the active substance buprenorphine may occur.
Overdose may intensify the adverse effects of buprenorphine, such as drowsiness, nausea, and vomiting. Pupils may become constricted to the size of a pinhead, and breathing may become slow and shallow. Cardiovascular collapse may occur. Overdose may potentially lead to coma and death.
If you realize that you have used a higher dose than recommended, remove the transdermal system immediately and contact your doctor or pharmacist.

Missed dose of Transtec
If you are using the medicine according to a regular schedule but forget to apply it on time, apply the recommended dose as soon as possible. This may require changing the days of the week (e.g. from Mondays and Thursdays to Wednesdays and Saturdays). Mark this change on the outer packaging of the patches. If there is a significant delay, pain may return. In such a case, contact your doctor.
Do not apply a double dose to make up for a missed dose.

Discontinuation of Transtec
Stopping or ending treatment with Transtec too early may cause pain to return.
If discontinuation is due to unpleasant side effects, consult your doctor before stopping. Your doctor will advise you on what to do and assess whether a change in treatment is possible.
In some individuals, withdrawal symptoms may occur after stopping long-term treatment with strong pain medicines. The risk of withdrawal symptoms with Transtec is low. However, if symptoms such as restlessness, anxiety, nervousness, shivering, excessive activity, difficulty sleeping, or gastrointestinal disturbances occur, inform your doctor.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicinal product may cause adverse reactions, although not everyone experiences them.
If swelling of the hands, feet, ankles, face, lips, mouth or throat occurs,
causing difficulty in swallowing or breathing, hives, weakness, yellowing of the skin
and eyes (jaundice), the transdermal system must be removed and the prescribing physician contacted immediately
or the nearest hospital Emergency Department must be visited.
These may be symptoms of a very rare, severe allergic reaction.
In some cases, delayed allergic reactions with clear inflammatory features may occur.
In such cases, after contacting a physician, the medicine Transtec should be discontinued.
The following adverse reactions have been reported:
If any of the adverse reactions listed below occur, contact a physician immediately.

Very common adverse reactions (may occur in more than 1 out of 10 people):
nausea
flushing, itching

Common adverse reactions (may occur in no more than 1 out of 10 people):
dizziness, headache
shortness of breath
vomiting, constipation
skin changes (rash, usually upon repeated use), excessive sweating
swelling (e.g. swollen legs), feeling of fatigue

Uncommon adverse reactions (may occur in no more than 1 out of 100 people):
confusion, sleep disorders, motor restlessness
excessive sedation of varying intensity, from fatigue to somnolence
circulatory disorders (such as hypotension or, rarely, even circulatory collapse)
dry mouth
urticaria
fatigue
urinary disorders, urinary retention (less urine than usual)

Rare adverse reactions (may occur in fewer than 1 out of 1,000 people):
loss of appetite
psychotic symptoms (e.g. hallucinations, feeling of anxiety, nightmares), decreased libido
difficulty concentrating, speech disorders, somnolence, balance disorders, abnormal skin sensations (numbness, tingling or burning sensation of the skin)
visual disturbances, blurred vision, eyelid swelling
hot flushes
breathing difficulties (respiratory depression)
heartburn
erectile dysfunction
hives
withdrawal syndrome (see below), reactions at the site of application of the transdermal system

Very rare adverse reactions (may occur in fewer than 1 out of 10,000 people):
severe allergic reactions (see above)
dependence, sudden mood changes
muscle twitching, taste disturbances
pinpoint pupil constriction
ear pain
abnormal rapid breathing, hiccups
vomiting reflex
blisters, small vesicles
chest pain

Frequency not known (frequency cannot be estimated from available data):
contact dermatitis (skin rash with inflammation, which may include a burning sensation)
skin discoloration

In some individuals, withdrawal symptoms may occur after discontinuation of long-term treatment with strong painkillers. The risk of withdrawal symptoms with Transtec is low. However, if symptoms such as agitation, anxiety, nervousness, chills, excessive motor activity, difficulty falling asleep, or gastrointestinal disturbances occur, inform your doctor.

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 the Department of Monitoring Adverse Reactions of Medicinal Products at the 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.
Adverse reactions can also be reported to the responsible entity.

5. How to store the medicine Transtec 35 mcg/h, Transtec 52.5 mcg/h, Transtec 70 mcg/h

This medicine must be stored in a safe place, out of reach of 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.
The medicine must be stored out of sight and out of reach of children.
Do not use this medicine after the expiry date stated on the outer carton and sachet under “Expiry date (month/year)”. The expiry date refers to the last day of the specified month.
There are no special storage requirements for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Transtex contains
The active substance in Transtec is buprenorphine.

The other ingredients are:
Adhesive matrix (containing buprenorphine): (Z)-octadec-9-en-1-yl oleate,
povidone K90, 4-oxopentanoic acid, cross-linked poly(acrylic acid-co-butyl acrylate-co-2-ethylhexyl
acrylate-co-vinyl acetate) in the ratio 5:15:75:5.
Adhesive matrix (not containing buprenorphine): uncross-linked poly(acrylic acid-co-butyl acrylate-co-
2-ethylhexyl acrylate-co-vinyl acetate) in the ratio 5:15:75:5.
Separating foil placed between the adhesive matrices with and without buprenorphine:
poly(ethylene terephthalate) foil.
Outer covering layer: poly(ethylene terephthalate).
Removable protective liner covering the surface of the adhesive matrix containing buprenorphine –
(should be removed immediately before application): silicone-coated poly(ethylene terephthalate) foil,
aluminised on one side.
What Transtec looks like and contents of the pack
Transdermal systems, beige-coloured patches with rounded edges and printed with:
Transtec 35 μg/h, Buprenorphinum, 20 mg
Transtec 52.5 μg/h, Buprenorphinum, 30 mg
Transtec 70 μg/h, Buprenorphinum, 40 mg
Packs containing 3, 5 and 10 patches individually packed in child-resistant sachets.
Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
611118 Bad Vilbel
Germany
Grünenthal GmbH
Zieglerstrasse 6
52078 Aachen
Germany
For further information regarding this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warszawa
Tel. +48 22 737 79 20