TRANSTEC 52.5 micrograms/hour transdermal patch

2. What you need to know before you use Transtec

Do not useTranstec

• if you are allergic to buprenorphine or any of the other ingredients of this medicine (listed in section 6),
• if you are addicted to strong pain relievers (opioids),
• if you have a disease that makes it difficult for you to breathe or if this may occur,
• if you are taking MAO inhibitors (certain medicines for the treatment of depression) or have taken them in the last two weeks before treatment with Transtec (see "Using Transtec with other medicines"),
• in case of myasthenia gravis (a type of severe muscle weakness),
• in case of delirium tremens (confusion and tremors caused by alcohol withdrawal after habitual excessive alcohol consumption or during a high alcohol consumption episode),
• in case of pregnancy.

Transtec should not be used to treat withdrawal syndrome in drug addicts.

Warnings and precautions

Tolerance, dependence, and addiction

This medicine contains buprenorphine, an opioid substance. Repeated use of opioids can reduce the effectiveness of the medicine (your body gets used to the medicine, this is known as tolerance). Repeated use of Transtec can also cause dependence, abuse, and addiction, which can lead to a potentially life-threatening overdose. The risk of side effects may increase with a higher dose and longer duration of use.

Dependence or addiction can make you feel like you no longer have control over the amount of medicine you need to take or how often you need to take it.

The risk of becoming dependent or addicted varies from person to person. You may have a higher risk of becoming dependent or addicted to Transtec if:

• You or a family member have a history of alcohol, prescription medicine, or illicit substance abuse ("addiction").
• You are a smoker.
• You have ever had problems with your mood (depression, anxiety, or personality disorder) or have received psychiatric treatment for other mental illnesses.

If you notice any of the following signs while taking Transtec, it could be a sign that you have become dependent or addicted:

• You need to take the medicine for longer than recommended by your doctor.
• You need to take more doses than recommended.
• You are using the medicine for reasons other than those prescribed, for example, "to calm down" or "to help you sleep".
• You have made repeated attempts to stop or control the use of the medicine without success.
• You do not feel well when you stop taking the medicine and feel better when you take it again ("withdrawal symptoms").

If you notice any of these signs, talk to your doctor to address the most appropriate treatment strategy in your case, including when it is appropriate to stop taking it and how to do it safely (see section 3 "If you stop taking Transtec").

Consult your doctor or pharmacist before starting to use Transtec

• if you have recently drunk a lot of alcohol,
• if you have epileptic seizures or convulsions (fits),
• if you have altered consciousness (feeling dizzy or faint) for unknown reasons,
• if you are in shock (a sign could be cold sweat),
• if you have increased intracranial pressure (e.g., after head injury or brain disease) without the possibility of artificial respiration,
• if you have difficulty breathing or are taking other medication that can make you breathe more slowly or weakly (see "Using Transtec with other medicines"),
• if you have depression or other illnesses that are treated with antidepressants.

The use of these medicines with Transtec can cause serotonin syndrome, a potentially life-threatening disease (see "Using Transtec with other medicines"),

• if you have liver problems.

Also, note the following precautions:

• Fever and ambient heat can lead to higher than normal amounts of buprenorphine in the blood. Also, ambient heat can prevent the transdermal patch from sticking properly. Therefore, consult your doctor if you have a fever and avoid exposure to heat sources (e.g., sauna, infrared lamps, electric blankets, or hot water bottles).

Athletes should be warned that this medicine may give a positive result in doping tests.

Respiratory disorders related to sleep

Transtec can cause respiratory disorders related to sleep, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to difficulty breathing, difficulty maintaining sleep, or excessive daytime sleepiness. Contact your doctor if you or someone else notices these symptoms. Your doctor may consider a dose reduction.

Children and adolescents

Transtec should not be used in persons under 18 years of age, as there is no experience with its use in this age group to date.

Using Transtec with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

• Transtec should not be used with MAO inhibitors (certain medicines for the treatment of depression), or if you have taken them in the last two weeks.

• Transtec can cause drowsiness, vomiting, dizziness, or make you breathe more slowly or weakly in some patients. These side effects can be intensified if you take other medicines that can cause the same effects at the same time. These other medicines include other strong pain relievers (opioids), certain sleep aids, anesthetics, and medicines for the treatment of certain psychological disorders, such as tranquilizers, antidepressants, neuroleptics, and gabapentin or pregabalin used to treat epilepsy or pain due to nerve problems (neuropathic pain).

Tell your doctor or pharmacist if you are taking:

• medicines for the treatment of allergies and for the treatment of vomiting or nausea during travel (antihistamines or antiemetics);
• medicines for the treatment of psychiatric disorders (antipsychotics or neuroleptics);
• muscle relaxants;
• medicines for the treatment of Parkinson's disease.

The concomitant use of Transtec with sedatives or medicines for the treatment of insomnia (such as benzodiazepines) increases the risk of drowsiness, respiratory difficulties (respiratory depression), coma, and can be potentially life-threatening. Due to this, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes Transtec with sedative medicines, they will limit the dose and duration of concomitant treatment. Inform your doctor about all sedative medicines you are taking and strictly follow your doctor's dosage recommendation. It may be helpful to inform your friends and family about the signs and symptoms indicated above. Inform your doctor if you experience any of these symptoms.

• If Transtec is used with some medicines, the effect of the transdermal patch can be intensified. These medicines include, for example, certain anti-infectives and antifungals (e.g., those containing erythromycin or ketoconazole) or medicines for HIV (e.g., those containing ritonavir).

• If Transtec is used with other medicines, the effect of the transdermal patch may be reduced. These medicines include, for example, dexamethasone, certain products for the treatment of epilepsy (e.g., those containing carbamazepine or phenytoin) or medicines used for the treatment of tuberculosis (e.g., rifampicin).

• Some medicines can increase the side effects of Transtec and may occasionally cause very serious reactions. Do not take any other medicine while using Transtec without consulting your doctor first, especially antidepressants such as citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepin, or trimipramine. These medicines can interact with Transtec, and you may experience symptoms such as involuntary rhythmic muscle contractions, including muscles that control eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, body temperature above 38 °C. Contact your doctor if you suffer from these symptoms.

Using Transtec with food, drinks, and alcohol

Do not drink alcohol while using Transtec. Alcohol can intensify certain side effects of the transdermal patch and may make you feel unwell.

Drinking grapefruit juice during treatment may intensify the effects of Transtec.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

There is no sufficient experience with the use of Transtec in pregnant women to date. Therefore, Transtec should not be used during pregnancy.

Buprenorphine, the active substance contained in the transdermal patch, passes into breast milk and inhibits milk production. Therefore, Transtec should not be used during breastfeeding.

Driving and using machines

Transtec can make you feel dizzy, drowsy, or have double or blurred vision and can affect your reflexes so that you do not react adequately or quickly enough in case of sudden or unexpected situations.

This applies especially:

• at the start of treatment
• when changing the dose
• when changing from another medicine to this one
• if you are also taking other medicines that act on the brain
• if you drink alcohol

If you are affected, you should not drive or operate machinery while using Transtec. This also applies at the end of treatment with Transtec. Do not drive or operate machinery for at least 24 hours after removing the patch.

In case of doubt, consult your doctor or pharmacist.

3. How to use Transtec

Follow the administration instructions for this medication exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Before starting treatment and periodically during treatment, your doctor will discuss with you what you can expect from using Transtec, when and for how long you should take it, when to contact your doctor, and when to stop taking it (see also "If you stop treatment with Transtec").

Transtec is available in three doses: Transtec 35 micrograms/hour transdermal patch, Transtec 52.5 micrograms/hour transdermal patch, and Transtec 70 micrograms/hour transdermal patch.

Your doctor has chosen this Transtec patch as the most suitable for you.

During treatment, your doctor may change the transdermal patch you use to a smaller or larger one if necessary.

The recommended dose is:

Adults

Follow these instructions unless your doctor has given you different instructions.

Apply Transtec (as detailed below) and change it after four days, at most. To facilitate use, you can change the patch 2 times a week on fixed days, e.g., "always on Mondays in the morning and Thursdays in the afternoon". To help you remember when to change the transdermal patch, note it on the carton packaging. If your doctor has instructed you to take other pain relievers in addition to the transdermal patch, strictly follow your doctor's instructions; otherwise, you will not fully benefit from treatment with Transtec.

Use in children and adolescents

Transtec should not be used in people under 18 years of age because there is no experience in this age group to date.

Elderly patients

No dose adjustment is required in elderly patients.

Patients with renal impairment/patients undergoing dialysis

In patients with renal impairment and patients undergoing dialysis, no dose adjustment is needed.

Patients with hepatic impairment

In patients with hepatic impairment, the intensity and duration of the action of Transtec may be affected. If you belong to this group of patients, your doctor will monitor you more closely.

Method of administration

Before applying a transdermal patch

• If the chosen area has hair, cut it with scissors. Do not shave!
• Avoid areas of skin that are red, irritated, or have any other type of spots, such as large scars.
• The area of skin you choose must be dry and clean. If necessary, wash it with cold or lukewarm water. Do not use soap or other detergents. After a hot bath or shower, wait until your skin is completely dry and cool. Do not apply lotions, creams, or ointments to the chosen area. This could prevent the transdermal patch from sticking properly.

Applying the transdermal patch:

While wearing the transdermal patch

You can wear the transdermal patch for up to 4 days. If you have applied the transdermal patch correctly, the risk of it coming off is low. You can shower, bathe, or swim while wearing it. However, do not expose the transdermal patch to extreme heat (e.g., sauna, infrared lamps, electric blankets, or hot water bottles).

In the unlikely event that your transdermal patch falls off before you need to change it, do not use the same transdermal patch again. Apply a new one immediately (see "Changing the transdermal patch" below).

Changing the transdermal patch

• Remove the old patch carefully.
• Fold it in half with the adhesive side facing inward.
• Dispose of it carefully, out of sight and reach of children.
• Apply a new transdermal patch to a different area of skin (as described before). At least 1 week should pass before you can apply a new patch to the same area of skin.

Duration of treatment

Your doctor will indicate the duration of your treatment with Transtec. Do not stop treatment on your own, as the pain may return and you may feel unwell (see also "If you stop treatment with Transtec").

If you think the effect of Transtec is too strong or too weak, tell your doctor or pharmacist.

If you use more Transtec than you should

If this happens, there may be signs of a buprenorphine overdose. An overdose can intensify the adverse effects of buprenorphine, such as drowsiness, nausea, and vomiting. You may have pinpoint pupils, and your breathing may become slow and weak. You may also experience a cardiovascular collapse.

As soon as you realize you have used more Transtec transdermal patches than you should, remove the excess patches and consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount used.

If you forget to use Transtec

If you forget an application, apply a new transdermal patch as soon as you remember. This will make you change your routine, e.g., if you normally apply your transdermal patch on Mondays and Thursdays, but you forget and do not apply the new transdermal patch until Wednesday, from then on you will need to change your transdermal patches on Wednesdays and Saturdays. Note the new pair of days on the carton calendar. If you change the transdermal patch too late, the pain may return. In this case, consult your doctor.

Never apply more than one transdermal patch to make up for the one you forgot!

If you stop treatment with Transtec

If you stop or finish treatment with Transtec too early, the pain will return. If you want to stop treatment due to unpleasant side effects, consult your doctor. Your doctor will tell you what you can do and if other medications can be administered.

Some people may have effects after using powerful pain relievers for a long time and stopping them. The risk of having effects after stopping Transtec is very low. However, if you feel agitated, anxious, nervous, or restless, if you are hyperactive, have difficulty sleeping, or have digestive problems, consult your doctor.

If you have any other questions about using this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Side effects are classified as follows:

The following side effects have been reported:

Disorders of the immune system

Very rare: severe allergic reactions (see below)

Metabolic and nutritional disorders

R:

Psychiatric disorders

Uncommon: confusion, sleep disorders, restlessness

Rare: illusions and hallucinations, anxiety, nightmares, decreased sexual desire

Very rare: dependence, mood changes

Nervous system disorders

Common: dizziness, headache

Uncommon: various degrees of sedation (serenity), ranging from fatigue to confusion

Rare: difficulty concentrating, speech disorders, confusion, balance disorders, abnormal sensations in the skin (feeling of heat, tingling, or numbness)

Very rare: muscle contraction, taste disorders

Eye disorders

Rare: vision disturbances, blurred vision, eyelid swelling

Very rare: pinpoint pupils

Ear and labyrinth disorders

Very rare: ear pain

Cardiac and vascular disorders

Uncommon: circulatory disorders (such as hypotension or rarely, loss of consciousness due to a drop in blood pressure)

Rare: hot flashes

Respiratory, thoracic, and mediastinal disorders

Common: shortness of breath

Rare: difficulty breathing (respiratory depression)

Very rare: hyperventilation, hiccups

Gastrointestinal disorders

Very common: nausea

Common: vomiting, constipation

Uncommon: dry mouth

Rare: heartburn

Very rare: retching

Skin disorders (usually at the application site)

Very common: erythema, pruritus

Common: skin changes (exanthema, usually due to repeated use), increased sweating

Uncommon: eruptions

Rare: urticarial wheals

Very rare: pustules, vesicles

Frequency not known: contact dermatitis (skin rash with inflammation, which may include a burning sensation), skin discoloration

Urinary and renal disorders

Uncommon: urinary retention (less urine than normal), urination disorders

Reproductive system disorders

Rare: erection difficulties

General disorders

Common: edema (swelling of the legs), fatigue

Uncommon: weakness (exhaustion)

Rare: withdrawal symptoms, administration site reactions

Very rare: chest pain

If you notice any of the above side effects, consult your doctor as soon as possible.

In some cases, late local allergic reactions with marked signs of inflammation occur. In these cases, treatment with Transtec should be discontinued after consulting your doctor.

If you experience inflammation of the hands, feet, knees, face, lips, mouth, or throat, which can cause difficulty swallowing or breathing, urticarial wheals, fainting, yellowing of the skin and eyes (also called jaundice), remove the transdermal patch and consult your doctor or go to the nearest hospital immediately. These may be symptoms of a very rare severe allergic reaction.

Some people may have withdrawal symptoms after using powerful pain relievers for a long time and stopping them. After treatment with Transtec, the risk of experiencing withdrawal symptoms is low. However, if you feel agitated, anxious, nervous, or restless, if you are hyperactive, have difficulty sleeping, or have digestive problems, consult your doctor.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Information System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Transtec

Keep this medication in a safe place, protected from others. It can cause serious harm and be fatal if taken accidentally or intentionally by someone who has not been prescribed it.

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging and on the envelope after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Transtec

• The active ingredient is buprenorphine.

• Other components are:

Adhesive matrix: (Z)-9-octadecen-1-yl oleate; povidone K90; 4-oxopentanoic acid; poly[acrylic acid-co-butylacrylate-co-(2-ethylhexyl)acrylate-co-vinyl acetate] (5:15:75:5), cross-linked (for the area containing buprenorphine) or non-cross-linked (for the area without buprenorphine); separator film between the adhesive matrices with and without buprenorphine: poly(ethylene terephthalate) film, coating layer: poly(ethylene terephthalate) fabric. Protective release film on the front covering the adhesive matrix containing buprenorphine to be removed before applying the transdermal patch: siliconized poly(ethylene terephthalate) film, coated on one side with aluminum.

Appearance of the product and package contents

Transtec is a flesh-colored transdermal patch with rounded corners, identified as: Transtec 52.5 μg/hour, buprenorphine 30 mg.

Transtec is available in packages containing 3, 4, 5, 6, 8, 10, 11, 12, 16, 18, 20, or 24 transdermal patches, individually sealed in child-proof envelopes.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Grünenthal Pharma, S.A.

Doctor Zamenhof, 36 - 28027 Madrid, Spain

Manufacturer

Grünenthal GmbH

Zieglerstrasse 6 - D - 52078 Aachen, Germany

This medication is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names

Germany Transtec PRO®

Austria Transtec®

Belgium Transtec®

Slovenia Transtec®

Spain Transtec®

Ireland Transtec®

Italy Transtec®

Luxembourg Transtec®

Portugal Transtec®

United Kingdom (Northern Ireland) Transtec®

Date of the last revision of this leaflet: November 2024

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/