TransTec

Package leaflet: Information for the user

TRANSTEC 35 micrograms/h / 52.5 micrograms/h / 70 micrograms/h

Transdermal patch
Buprenorphine
Read this entire leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What TRANSTEC is and what it is used for
2. What you need to know before using TRANSTEC
3. How to use TRANSTEC
4. Possible side effects
5. How to store TRANSTEC
6. Contents of the pack and other information

1. What TRANSTEC is and what it is used for

TRANSTEC is an analgesic medicine (for pain relief) indicated for the treatment of moderate to severe cancer-related pain and severe pain that does not respond to other types of painkillers. TRANSTEC acts by passing through the skin. When the transdermal patch is applied to the skin, the active substance, buprenorphine, enters the bloodstream through the skin. Buprenorphine is an opioid (a potent analgesic) that reduces pain by acting on the central nervous system (specific nerve cells in the spinal cord and brain). The effect of the transdermal patch lasts up to four days. TRANSTEC is not indicated for the treatment of acute pain (short-term pain).

2. What you should know before using TRANSTEC

Do not use TRANSTEC

• If you are allergic to buprenorphine or to any of the other ingredients of this medicine (listed in section 6);
• if you are dependent on strong analgesics (opioids);
• if you suffer from conditions that impair, or may severely impair, respiratory function;
• if you are taking MAO inhibitors (medicines for the treatment of depression), or have taken them within the last 2 weeks (see “Other medicines and TRANSTEC”);
• if you suffer from severe myasthenia (a severe form of muscle weakness);
• if you suffer from delirium tremens (confusion and tremor caused by alcohol withdrawal following excessive alcohol use or occasional excessive alcohol consumption);
• if you are pregnant.

TRANSTEC must not be used to treat withdrawal symptoms in patients with drug dependence.

Warnings and precautions

Talk to your doctor or pharmacist before using TRANSTEC

• if you have recently consumed large amounts of alcohol;
• if you suffer from seizures;
• if you suffer from disorders of consciousness (such as dizziness or fainting) due to unknown causes;
• if you are in shock (cold sweating may be a symptom);
• when intracranial pressure is increased (e.g. following head injury or brain disorders), without the possibility of artificial ventilation;
• if you have breathing problems or are taking medicines that may slow down or weaken your breathing (see “Other medicines and TRANSTEC”);
• if you have depression or other conditions treated with antidepressants.

Using these medicines together with TRANSTEC may lead to serotonin syndrome, a condition that can be fatal (see “Other medicines and TRANSTEC”).

• if your liver is not functioning properly;
• if you have a tendency to abuse medicines or narcotic substances.

Also follow these precautions:

• In some people, dependence on strong analgesics such as TRANSTEC may develop after prolonged treatment. In such individuals, withdrawal symptoms may occur when treatment is stopped (see “When treatment with TRANSTEC is stopped”);
• Fever and exposure to external heat sources may increase blood levels of buprenorphine beyond normal. In addition, excessive heat on the skin surface may prevent proper adhesion of the transdermal patch. Consult your doctor if you have a fever and avoid exposure to external heat sources (e.g. sauna, infrared lamps, electric blankets, hot water bottles).

For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

Sleep-related breathing disorders
TRANSTEC contains an active substance belonging to the opioid group. Opioids may cause sleep-related breathing disorders, such as central sleep apnea (shallow breathing or breathing pauses during sleep) and sleep-related hypoxemia (low blood oxygen levels).
The risk of central sleep apnea is dose-dependent with regard to opioids. Your doctor may consider reducing the total opioid dose if central sleep apnea occurs.

Children and adolescents

• TRANSTEC must not be used in patients under 18 years of age, as clinical data in this age group are currently not available.

Other medicines and TRANSTEC

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

• TRANSTEC must not be used if you are taking MAO inhibitors (medicines for the treatment of depression) or have used them within the previous two weeks.
• TRANSTEC may cause drowsiness, nausea, weakness, or shortness of breath in some patients. These side effects may be more pronounced if you are also taking other medicines that cause similar side effects. Such medicines include other strong analgesics for pain treatment (opioids), certain medicines for insomnia, anaesthetics, and medicines used to treat certain psychiatric conditions such as tranquillisers, antidepressants, and neuroleptics.
• 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 should only be considered when no other treatment options are possible. However, if your doctor prescribes TRANSTEC together with sedative medicines, the dose and duration of concomitant treatment must be limited by your doctor. Inform your doctor about all sedative medicines you are taking and carefully follow the dosing recommendations provided by your doctor. It may be helpful to inform friends or relatives about the signs and symptoms listed above. Contact your doctor if these symptoms occur.
• If TRANSTEC is used together with certain medicines, the effect of the transdermal patch may be increased. These medicines include, for example, certain anti-infectives/antifungals (e.g. erythromycin or ketoconazole), or anti-HIV medicines (e.g. those containing ritonavir).
• If TRANSTEC is used together with other medicines, the effect of the transdermal patch may be reduced. These medicines include certain products, for example, dexamethasone, antiepileptic drugs (e.g. those containing carbamazepine or phenytoin), or medicines for tuberculosis (e.g. rifampicin).
• Some medicines may increase the side effects of TRANSTEC and sometimes cause very serious reactions. Do not take other medicines during treatment with TRANSTEC without first consulting 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 may cause symptoms such as involuntary rhythmic muscle contractions, including muscles controlling eye movements, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tone, and fever above 38°C. Contact your doctor if you experience these symptoms.

TRANSTEC with food and drink and alcohol

Do not drink alcohol while using TRANSTEC. Alcohol may intensify some of the side effects of the transdermal patch and cause discomfort. Drinking grapefruit juice may increase the effect of TRANSTEC.

Pregnancy, breastfeeding and fertility

If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

There is insufficient experience regarding the use of TRANSTEC during pregnancy. Therefore, TRANSTEC must not be used during pregnancy.

Buprenorphine, the active ingredient in the transdermal patch, inhibits milk production and passes into breast milk. Therefore, TRANSTEC must not be used during breastfeeding.

Driving and using machines

TRANSTEC may cause dizziness, drowsiness, blurred vision or double vision, and may impair your ability to react, so that you cannot respond adequately or quickly enough in unexpected or sudden situations.

This is especially true:

• at the beginning of treatment;
• when changing the dose;
• when starting TRANSTEC treatment instead of another analgesic;
• if you are also taking other medicines that act on the brain;
• if you drink alcohol.

If you experience these effects, do not drive or operate machinery while using TRANSTEC. This recommendation also applies at the end of treatment with TRANSTEC. Do not drive or use machinery for at least 24 hours after removing the patch. Talk to your doctor or pharmacist if you have any doubts.

3. How to use TRANSTEC

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
TRANSTEC is available in three dosage strengths: TRANSTEC 35 micrograms/h transdermal patches,
TRANSTEC 52.5 micrograms/h transdermal patches, and TRANSTEC 70 micrograms/h transdermal
patches.
Your doctor will decide which dosage strength of TRANSTEC is most suitable for you. During treatment,
your doctor may decide to switch you to a larger or smaller patch, if necessary.
The recommended dosage is:
Adults
Unless otherwise prescribed by your doctor, apply one transdermal patch of TRANSTEC (following the
instructions described below) and replace it no later than after 4 days. For convenience, you may change
the transdermal patch twice a week at regular intervals, for example always on Monday morning and
Thursday evening. To avoid forgetting when to change the patch, mark the patch change days on the
calendar provided in the carton. If your doctor has prescribed other analgesics in addition to the
transdermal patch, follow their instructions strictly; otherwise, you may not obtain the intended benefit
from using TRANSTEC.

Use in children and adolescents
TRANSTEC must not be used in individuals under 18 years of age, as there is no experience with the
use of this medicine in this age group.

Elderly patients
Dose adjustment is not required for elderly patients.

Patients with renal disease and patients on dialysis
No dosage adjustment is required for patients with renal disease or those undergoing dialysis.

Patients with hepatic disease
In patients with liver disease, the intensity and duration of the effect of TRANSTEC may be affected. In
such cases, your doctor will perform more frequent monitoring.

Method of application
Before applying the patch

• Choose a flat, clean, and hair-free area of skin on the

upper part of the body, preferably on the chest in the
subclavicular area or on the upper back (see illustrations
next to this text). Seek assistance if you are unable to
apply the patch by yourself.

• If the chosen area is not hair-free, trim any excess hair with scissors; do not shave.

Torso

Back

• Do not apply the patch to reddened, irritated, or otherwise altered skin, for example areas with extensive scarring.

• The selected skin area must be dry and clean. If necessary, wash the area with cold or lukewarm water. Do not use soap or other detergents. After a hot bath or shower, wait until the skin is completely dry and cool before applying the patch. Do not use lotions, creams, or ointments, as these may interfere with proper adhesion of the transdermal patch to the chosen area.

Applying the transdermal patch

Step 1:
Each transdermal patch is individually sealed in a child-resistant pouch.
Cut the pouch open along the perforated line using scissors, taking care not to damage the transdermal patch.
Remove the transdermal patch.

Step 2:
The adhesive side of the transdermal patch is covered with a silver protective film.
Carefully peel off half of the protective film, avoiding contact with the adhesive layer of the patch.

Step 3:
Apply the patch to the selected skin area and remove the remaining part of the protective film.

Step 4:
Press the patch firmly onto the skin with the palm of your hand for about 30 seconds.
Ensure that the entire patch adheres properly to the skin, especially along the edges.

Wearing the transdermal patch
The transdermal patch should be worn for up to 4 days. Make sure it has been correctly applied; there is a minimal risk that it may detach. You may take a shower, bath, or swim while wearing the patch. However, do not expose the transdermal patch to sources of excessive heat (e.g., saunas, infrared lamps, electric blankets, or hot water bottles).
In the unlikely event that the patch detaches before the next scheduled change, do not reuse the same patch; immediately apply a new one (see “Replacing the transdermal patch”).

Replacing the transdermal patch

• Remove the old transdermal patch.
• Fold it in half so that the adhesive sides stick together.
• Dispose of the patch out of sight and reach of children.
• Apply a new transdermal patch to a different area of skin, following the instructions described above. Do not apply a new patch to the same skin area within one week.

Duration of treatment
Your doctor will tell you how long you should use TRANSTEC. Do not stop treatment on your own initiative, as the pain may return and cause discomfort (see “If you stop using TRANSTEC”).
If you feel that the analgesic effect of TRANSTEC transdermal patches is too weak or too strong, consult your doctor or pharmacist.

If you use more TRANSTEC than you should
In this case, symptoms of buprenorphine overdose may occur.
An overdose may worsen the undesirable effects of buprenorphine, such as drowsiness, nausea, and vomiting. You may develop pinpoint pupils and breathing may become slow and weak. Cardiovascular collapse may occur. If you realize you have used more patches than required, remove the excess patches immediately and consult your doctor or pharmacist without delay.

If you forget to apply TRANSTEC
If you have forgotten to apply a patch, apply a new one as soon as possible. In this case, you will need to adjust your routine. For example, if you usually apply the patch on Monday and Thursday, but forgot and instead apply it on Wednesday, remember that from then on you must change the patch on Wednesday and Saturday.
Note the two new days on the calendar in the carton.
If you change the patch with a significant delay, the pain may return. In this case, contact your doctor.
Do not double the number of patches to make up for a missed application!

If you stop using TRANSTEC
If you stop or discontinue treatment with TRANSTEC prematurely, the pain may return.
If you wish to stop treatment due to side effects, consult your doctor, who will advise you on what can be done and whether you can be treated with other medicines.
Some people may experience withdrawal symptoms when they have used strong analgesics for a long time and then stop them. The risk of such effects after discontinuation of TRANSTEC treatment is very low. However, if you experience agitation, anxiety, nervousness, tremors, hyperactivity, insomnia, or gastrointestinal disturbances, consult your doctor.

For any questions regarding the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Side effects are classified as follows:

The following adverse reactions have been reported:
Immune system disorders
Very rare: severe allergic reactions (see below).
Metabolism and nutrition disorders
Rare: loss of appetite.
Psychiatric disorders
Uncommon: confusion, sleep disturbances, restlessness.
Rare: false sensations such as hallucinations, anxiety, nightmares, decreased libido.
Very rare: dependence, mood swings.
Nervous system disorders
Common: dizziness, headache.
Uncommon: sedation of varying severity (calmness), ranging from fatigue to drowsiness.
Rare: difficulty concentrating, speech disorders, numbness, impaired balance,
abnormal skin sensations (tingling, prickling, or burning).
Very rare: muscle spasms, altered taste.
Eye disorders
Rare: visual disturbances, blurred vision, swollen eyelids.
Very rare: pinpoint pupils.
Ear disorders
Very rare: ear pain.
Cardiovascular disorders
Uncommon: circulatory disturbances (such as hypotension or, rarely, circulatory collapse).
Rare: hot flushes.
Chest and lung disorders
Common: shortness of breath.
Rare: breathing difficulties (respiratory depression).
Very rare: rapid breathing, hiccups.
Gastrointestinal disorders
Very common: nausea.
Common: vomiting, constipation.
Uncommon: dry mouth.
Rare: heartburn.
Very rare: retching.
Skin disorders (generally at the application site)
Very common: redness, itching.
Common: skin changes (rash, usually after prolonged treatment), sweating.
Uncommon: skin eruption.
Rare: urticaria.
Very rare: pustules and small blisters.
Urinary disorders
Uncommon: urinary problems, urinary retention (reduced urine output).
Reproductive system disorders
Rare: difficulty in achieving erection.
General disorders
Common: edema (e.g., swelling of legs), fatigue.
Uncommon: weakness.
Rare: withdrawal symptoms (see below), reactions at the site of administration.
Very rare: chest pain.
If you notice any of the adverse effects listed above, contact your doctor as soon as possible.
In some cases, delayed allergic reactions may occur, with clear signs of inflammation.
In such cases, discontinue treatment with TRANSTEC after consulting your doctor.
If you experience swelling of the hands, feet, ankles, face, lips, mouth, or throat
causing difficulty in swallowing or breathing, hives, fainting, or yellowish discoloration of the skin or eyes (also known as jaundice), remove the transdermal patch and
contact your doctor immediately or go to the nearest hospital emergency department.
These could be symptoms of a very rare but serious allergic reaction.
In some individuals, withdrawal symptoms may occur when strong painkillers are used for a long time and then discontinued. The risk of experiencing such withdrawal effects after stopping treatment with TRANSTEC is low. However, if you experience agitation, anxiety, nervousness, tremors, hyperactivity, insomnia, or digestive disturbances, consult your doctor.
Reporting of adverse reactions
If you experience any adverse reaction, inform your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at the following website:
http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store TRANSTEC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the pouch after the wording: "Exp." (month/year). The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of medicines via wastewater 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 TRANSTEC contains
The active substance is buprenorphine.

The other components are:
adhesive matrix: [(Z)-octadec-9-en-1-yl] oleate, povidone K90, 4-oxopentanoic acid, poly[acrylic acid-co-butylacrylate-co-(2-ethylhexyl)acrylate-co-vinylacetate] cross-linked (area containing buprenorphine) or non-cross-linked (area without buprenorphine); spacer layer between the two matrices: poly(ethylene terephthalate) – backing layer: poly(ethylene terephthalate) fabric. The protective liner (to be removed before applying the transdermal patch) consists of a poly(ethylene terephthalate) film, siliconized and aluminum-coated on one side.

What TRANSTEC looks like and contents of the pack
TRANSTEC transdermal patches are skin-coloured, with rounded corners, printed with:
TRANSTEC 35 micrograms/h, buprenorphinum 20 mg.
TRANSTEC 52.5 micrograms/h, buprenorphinum 30 mg.
TRANSTEC 70 micrograms/h, buprenorphinum 40 mg.

TRANSTEC is supplied in cartons containing: 3, 5, 10 or 30 transdermal patches individually packed in child-resistant pouches.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GRÜNENTHAL ITALIA S.r.l. – Via Carlo Bo, 11 – 20143 Milano, Italy

Manufacturer
LTS Lohmann Therapie-Systeme GmbH – Andernach (Germany)
Batch release: Grünenthal GmbH – Aachen (Germany)

This medicinal product is authorised in the following European Union countries under the following names:
Austria Transtec
Belgium Transtec
Denmark Transtec
Germany Transtec PRO
Ireland Transtec
Italy Transtec
Luxembourg Transtec
Portugal Transtec
United Kingdom Transtec
Slovenia Transtec
Spain Transtec

Date of latest approval: