Transtec 70 µg/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 use, 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 strictly 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

1. What Transtec 35 μg/h, Transtec 52.5 μg/h, Transtec 70 μg/h is and what it is 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 Transtec 35 μg/h, Transtec 52.5 μg/h, Transtec 70 μg/h is and what it is used for
Transtec is an analgesic medicine used to treat moderate to severe pain in cancer diseases and severe pain in other conditions, when pain does not respond to non-opioid analgesics. 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 analgesic) 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 you are 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 threatened 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 you have muscle weakness ( myasthenia gravis );
• if you have alcohol delirium ( delirium tremens – a state of confusion and tremors caused by alcohol withdrawal in dependent individuals or occurring during continuous drinking);
• if you are pregnant;
  Transtec must not be used in the treatment of withdrawal symptoms in patients dependent on drugs.

Warnings and precautions
Tolerance, dependence, and addiction
This medicine contains buprenorphine, which is an opioid medicine. Repeated use of opioids may cause the medicine to become less effective (known as tolerance). Repeated use of Transtec 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 Transtec may be higher if:

• you or someone in your family has ever misused or been dependent on alcohol, prescription medicines, or illegal substances ("addiction");
• you are a smoker;
• you have ever had mood problems (depression, anxiety, or personality disorders) or have 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 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;
• use of the medicine for reasons other than recommended, e.g., "to calm down" or "to sleep better";
• repeated unsuccessful attempts to stop or control medicine use;
• feeling unwell after stopping the medicine, with improvement in well-being upon re-taking it ("withdrawal effects").

If any of these symptoms occur, talk to your doctor to discuss the best treatment approach for you, including when and how to stop taking the medicine safely (see section 3, Stopping Transtec).
Before starting Transtec, discuss this with your doctor, pharmacist, or nurse.
Exercise particular caution 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 without the possibility of assisted ventilation;
• with breathing 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.
  The following 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 you develop high fever. Athletes should be aware that this medicine may cause 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 you or someone else notices these symptoms, contact your doctor. Your doctor may consider reducing the dose.

Children and adolescents
Transtec must not be used in individuals under 18 years of age due to insufficient data in this patient group.

Transtec and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or 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 analgesics (opioids), certain sleeping medicines, anaesthetics, and medicines used to treat certain mental illnesses such as sedatives, antidepressants, neuroleptics, as well as gabapentin or pregabalin used to treat epilepsy or pain caused by nervous system disorders (neuropathic pain).

Tell 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 and sedative medicines, such as benzodiazepines or related drugs, 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 your doctor prescribes Transtec together with sedative medicines, the lowest effective dose and shortest possible duration of combined treatment will be used.
Inform your doctor about all sedative medicines you are taking and strictly follow the doctor's dosing instructions. It may be helpful to inform friends or family members about the possibility of the above-mentioned symptoms. If such symptoms occur, contact your doctor.

• When Transtec is used together with certain medicines, the effect of the transdermal system may be increased. These include: certain antibiotics and antifungals (e.g., containing erythromycin and ketoconazole) and antiviral medicines used to treat HIV (e.g., containing ritonavir).
• When Transtec is used together 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 those affecting eye movements, agitation, hallucinations, coma, excessive sweating, tremor, increased reflexes, increased muscle tone, and body temperature above 38°C. If you experience such symptoms, 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 you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a child, consult your 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 must not be used during breastfeeding.

Driving and operating machinery
Transtec may cause dizziness, drowsiness, blurred or double vision, and negatively affect your reactions, impairing your ability to participate in traffic and operate machinery.
This especially applies to:

• the beginning of treatment;
• changes in dosage;
• the period after discontinuation of another analgesic and switching to Transtec;
• cases of concomitant use with other centrally acting medicines (acting on the brain);
• concomitant alcohol consumption.
  In these cases, do not drive or operate machinery while using Transtec. This also applies to the period after stopping Transtec. 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, contact your 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 as directed by your doctor or pharmacist. If you have any doubts,
please consult your doctor or pharmacist.

Before starting treatment and regularly during treatment, your doctor will discuss with you what to
expect from using Transtec, when and for how long it should be used, when you should contact your
doctor, and when the medicine should be discontinued (see also: Discontinuation of Transtec).

Transtec transdermal system is available in three strengths: Transtec 35 micrograms/hour, Transtec
52.5 micrograms/hour, and Transtec 70 micrograms/hour. The choice of appropriate strength of
Transtec is made by the doctor. During treatment, if necessary, your doctor may change the strength
of the patch 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 changed no later than every 4 days. For convenience, it may
be changed twice a week on the same days, e.g. always on Mondays in the morning and Thursdays in
the evening. To help remember when to change the transdermal system, mark the day of the week on
the outer packaging. If your doctor prescribes an additional pain-relieving medicine, strictly follow
the doctor's instructions to achieve the full benefit of Transtec treatment.

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

Elderly patients (over 65 years)
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.
Patients with liver impairment should be closely monitored by their doctor.

Instructions for use

Before applying the transdermal system, plaster

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

Potential sites on the body for application of the transdermal system, patch
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 scarring.
• 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. After a hot bath or shower, wait until the skin is completely dry and cool. Avoid applying skin care products (e.g. lotions, creams, ointments) to the area where the transdermal system will be applied, as this may reduce its adhesion.

Applying the transdermal system

Step 1:
Each transdermal system is contained in a child-resistant pouch. Cut along the dotted line of the
pouch 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. Press the patch firmly in place.

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. Once properly applied, the risk of
the patch detaching is low. You may bathe, shower, or swim while wearing the transdermal system.
However, do not expose the patch 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 sides together.
• 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 reused until at least one week has passed.

Duration of treatment
Your doctor will determine how long you should use Transtec. Do not stop treatment on your own, 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.

Overdose 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 constrict to the size of a pinhead, and breathing may become slow and shallow.
Cardiovascular collapse may occur.

If you realize that you have used more than the recommended dose, 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 mean 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 use a double dose to make up for a missed dose.

Discontinuation of Transtec
If Transtec is stopped or treatment is ended too early, pain may return.
If discontinuation is due to unpleasant side effects, consult your doctor before stopping. Your
doctor will advise you on what to do and may consider changing your treatment.

In some individuals, withdrawal symptoms may occur after stopping long-term treatment with strong
painkillers. The risk of withdrawal symptoms with Transtec is low. However, if symptoms such as
restlessness, anxiety, nervousness, shivering, hyperactivity, difficulty sleeping, or gastrointestinal
disturbances occur, inform your doctor.

If you have any further questions about the use of this medicine, please consult your doctor,
pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If swelling of the hands, feet, ankles, face, lips, mouth or throat occurs,
causing difficulty in swallowing or breathing, hives, weakness, or yellowing of the skin
and eyes (jaundice), the transdermal system must be removed and medical advice must be sought immediately from your doctor or at the (emergency department) Emergency Room of the nearest hospital.
These may be symptoms of a very rare severe allergic reaction.
In some cases, delayed allergic reactions with marked inflammatory features may occur. In such cases, after consulting a doctor, the Transtec medicine should be discontinued.
The following adverse reactions have been reported:
If any of the adverse reactions listed below occur, contact your doctor immediately.

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

Common adverse reactions (may occur in up to 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 up to 1 out of 100 people):
confusion, sleep disorders, restlessness
excessive sedation of varying severity, from fatigue to lethargy
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 up to 1 out of 1,000 people):
loss of appetite
psychotic symptoms (e.g. hallucinations, anxiety, nightmares), decreased libido
difficulty concentrating, speech disorders, lethargy, balance disorders, abnormal skin sensations (numbness, tingling or burning 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 up to 1 out of 10,000 people):
severe allergic reactions (see above)
dependence, sudden mood changes
muscle twitching, altered sense of taste
pupillary constriction to the size of a pinhead
ear pain
abnormal rapid breathing, hiccups
vomiting reflex

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, 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 restlessness, anxiety, nervousness, chills, excessive activity, difficulty falling asleep, or gastrointestinal disturbances occur, inform your doctor about these symptoms.

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 of Adverse Drug Reactions 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 may also be reported to the marketing authorization holder.

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

This medicine should be stored in a safe 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.
The medicine should be kept out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and sachet after “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 should 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 pack and other information

What Transtec contains
The active substance in Transtec is buprenorphine.

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 5:15:75:75.
Adhesive matrix (not containing buprenorphine): non-cross-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
Packaging 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
Grünenthal GmbH
Zieglerstrasse 6
52078 Aachen
Germany
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany