Transtec 52.5 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
Buprenorphine
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, 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.

Contents of the leaflet

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-related conditions and severe pain in other diseases when it 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 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 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 being treated with MAO inhibitors (medicines used to treat depression) or within 2 weeks after stopping MAO inhibitors (see "Transtec and other medicines");
• if you have muscle weakness ( myasthenia gravis );
• if you have alcohol withdrawal delirium ( delirium tremens — a state of confusion and tremors caused by alcohol withdrawal in dependent individuals or occurring during a drinking episode);
• if you are pregnant;
  Transtec must not be used to treat withdrawal symptoms in patients dependent on drugs.

Warnings and precautions
Tolerance, dependence and abuse
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 abuse, 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 abuse may cause you to lose control over the amount and frequency of medicine intake.
The risk of developing dependence or abuse varies between individuals. The risk of dependence on Transtec may be higher if:

• you or a family member have 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, this may indicate dependence:

• need to take the medicine longer than prescribed by your doctor;
• need to take a higher dose than recommended;
• need to continue taking the medicine even though it does not help relieve pain;
• use of the medicine for reasons other than prescribed, e.g., "to calm down" or "to fall asleep more easily";
• repeated unsuccessful attempts to stop or control use of the medicine;
• feeling unwell after stopping the medicine, with improvement in well-being upon re-taking it ("withdrawal effects").

If any of these symptoms occur, speak 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 treatment).
Discuss this with your doctor, pharmacist, or nurse before starting Transtec.

Special caution is required in patients:

• with acute alcohol intoxication;
• with seizures;
• with disturbances of consciousness of unknown origin;
• in shock (which may present as cold sweating);
• with increased intracranial pressure and without the 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.
  Concomitant 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 a high fever. 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, waking up at night 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 pills, anaesthetics, or medicines used to treat certain mental illnesses such as sedatives, antidepressants, neuroleptics, as well as gabapentin or pregabalin used to treat epilepsy or nerve-related pain (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 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 if no other treatment options are available.
If your doctor prescribes Transtec together with sedative medicines, they will use the lowest effective 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 friends or family members about the possibility of the above-mentioned symptoms. If such symptoms occur, contact your doctor.

• Concomitant use of Transtec with certain medicines may increase the effect of the transdermal system. These include certain antibiotics and antifungals (e.g., containing erythromycin or ketoconazole) and medicines used to treat HIV (e.g., containing ritonavir).
• Concomitant use of Transtec with certain other medicines may reduce the effect of the transdermal system. 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 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 unpleasant symptoms.
Drinking grapefruit juice 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 or operate machinery.
This is especially relevant:

• at the beginning of treatment;
• when changing the dose;
• after switching from another analgesic to Transtec;
• when used concomitantly with other centrally-acting (on the brain) medicines;
• when alcohol is consumed at the same time.
  In these cases, you must not drive or operate machinery while using Transtec. This also applies when stopping Transtec treatment. Patients using Transtec must not drive or operate machinery for at least 24 hours after removing the transdermal system. If in doubt, 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 exactly as directed by your doctor or pharmacist. If you are unsure,
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 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: Stopping use of 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 made by the doctor. During treatment, if necessary, the doctor may change the strength to a lower
or higher dose.
The recommended dose of Transtec is:
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 Monday mornings and Thursday evenings.
To remind yourself when to change the transdermal system, mark the day of the week on the outer
package. If your doctor recommends using an additional painkiller, 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)
No dose adjustment is necessary for these patients.
Patients with renal impairment
No dose adjustment is necessary for patients with kidney failure.
Patients with hepatic impairment
The strength and duration of action of Transtec may be altered in patients with liver dysfunction.
Patients with liver failure will be closely monitored by the doctor.
Instructions for use
Before applying the transdermal system, the patch

• Select a flat, clean, and hair-free area of skin on the upper part of the body, preferably the upper chest 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 scars.
• The selected area of skin 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 impair adhesion. Application of the transdermal system

Step 1:
Each transdermal system is contained in a child-resistant pouch. Cut the pouch along the dotted line
using scissors. Be careful not to damage the patch.

Remove the patch from the pouch.

Step 2:
The adhesive layer of the transdermal system is covered with a silver protective liner. Carefully peel
off half of the protective liner. Try not to touch the adhesive surface of the transdermal system.

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

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 sides together.
• Dispose of it in a place unseen and inaccessible to 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 use
Your doctor will determine how long Transtec should be used. Do not stop treatment on your own, as
pain and discomfort may return (see also "Stopping use of Transtec").
If you feel the effect of Transtec is too strong or too weak, consult your doctor or pharmacist.
Use of more than the recommended dose of Transtec
Symptoms of overdose of the active substance buprenorphine may occur.
Overdose may intensify buprenorphine side effects such as drowsiness, nausea, and vomiting.
Pupils may constrict to the size of a pinhead, breathing may become slow and shallow. Cardiovascular
collapse may occur.
If you realize 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 involve changing the days of the week, e.g. from
Mondays and Thursdays to Wednesdays and Saturdays. Mark this change on the outer package of the
patches. If the delay is significant, pain may return. In such a case, contact your doctor.
Do not use a double dose to make up for a missed dose.
Stopping use of Transtec
If Transtec is stopped or discontinued too early, pain may return.
If discontinuation is due to unpleasant side effects, consult your doctor before stopping. The doctor
will determine the appropriate action and assess whether treatment should be changed.
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, 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, yellowing of the skin
and eyes (jaundice), the transdermal system should be removed and you should immediately contact your
physician 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 pronounced inflammatory features may occur.
In such cases, after contacting a physician, Transtec 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
skin 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 disturbances, restlessness
excessive sedation of varying severity, from fatigue to lethargy
circulatory disturbances (such as hypotension or, rarely, even circulatory collapse)
dry mouth
urticaria
tiredness
urinary disturbances, urinary retention (less urine than usual)

Rare adverse reactions (may occur in up to 1 out of 1000 people):
loss of appetite
psychotic symptoms (e.g. hallucinations, anxiety, nightmares), decreased libido
difficulty concentrating, speech disturbances, lethargy, balance disturbances, 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
pimples, small blisters
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 restlessness, anxiety, nervousness, chills, hyperactivity, difficulty falling asleep, or gastrointestinal disturbances occur, inform your doctor.

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 Drug Reactions of 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 marketing authorization holder.

5. How to store Transtec 35 μg/h, Transtec 52,5 mcg/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 to individuals who take it accidentally or intentionally, if it has not been prescribed to 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 instructions for this medicine.
Medicines must not be disposed of via the sewage system or 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 Transtex 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 5:15:75:5.
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:
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