Package Insert: Information for the User

Transtec35 micrograms/hour Transdermal Patch

Buprenorphine

Read this package insert carefully before starting to use this medication,because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist,eveniftheyare not listed in this package insert.See section 4.

Transtecis an analgesic (a pain-relieving medication) indicated for the relief of moderate to severe oncological pain and severe pain that does not respond to other types of analgesics. Transtecacts through the skin. When the transdermal patch is applied to the skin, the active substance buprenorphine passes through it into the bloodstream. Buprenorphine is an opioid (a medication for intense pain relief) that reduces pain by acting on the central nervous system (on specific nerve cells in the spinal cord and the brain). The effect of the transdermal patch lasts for up to a maximum of four days. Transtec is not ideal for the treatment of acute pain (short-term pain).

No use Transtec

• if you are allergic to buprenorphine or any of the other components of this medication (listed in section 6),
• if you are addicted to potent analgesics (opioids),
• if you have a disease in which you have great difficulty breathing or in which this may occur,
• if you are taking monoamine oxidase inhibitors (certain medications for the treatment of depression) or have taken them in the last two weeks before treatment with Transtec (see “Use of Transtec with other medications”),
• in the case of myasthenia gravis (a severe type of muscle weakness),
• in the case of delirium tremens (confusion and tremors caused by withdrawal from alcohol after excessive consumption or during an episode of high alcohol consumption),
• in the case of pregnancy.

Transtec should not be used to treat withdrawal syndrome in drug-dependent individuals.

Warnings and precautions

Tolerance, dependence, and addiction

This medication contains buprenorphine, an opioid substance. Repeated use of opioids can reduce the effectiveness of the medication (your body becomes accustomed to the medication, which is known as tolerance). Repeated use of Transtec can also cause dependence, abuse, and addiction, which can lead to a potentially fatal overdose. The risk of adverse 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 medication you need to take or how often you need to take it.

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

- You or a family member has a history of abuse or dependence on alcohol, prescription medications, or illicit substances (“addiction”).

- You are a smoker.

- You have ever had mood problems (depression, anxiety, or personality disorder) or have received treatment from a psychiatrist 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 medication for a longer period than recommended by your doctor.

- You need to take more doses than recommended.

- You are using the medication for reasons other than those prescribed, for example, “to calm down” or “to help you sleep”.

- You have made repeated and unsuccessful attempts to stop or control the use of the medication.

- You do not feel well when you stop taking the medication 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 therapeutic strategy for your case, including when it is appropriate to stop taking it and how to do it safely (see section 3 “If you interrupt treatment with Transtec”).

Consult your doctor or pharmacist before starting to use Transtec

• if you have recently consumed a lot of alcohol,
• if you have seizures or convulsions (attacks),
• if you have altered consciousness (feeling dizzy or fainting), due to an unknown cause,
• if you are in shock (a sign could be cold sweat),
• if you have elevated intracranial pressure (for example, after head trauma or brain disease), without the possibility of artificial respiration,
• if you have difficulty breathing or are taking another medication that can make you breathe more slowly or weakly (see “Use of Transtec with other medications”),
• if you have depression or other illnesses treated with antidepressants.

The use of these medications together with Transtec can cause serotonin syndrome, a potentially fatal disease (see “Use of Transtec with other medications”),

• if you have liver problems.

Also, be aware of the following precautions:

• Fever and heat can cause higher-than-normal levels of buprenorphine in the blood. Heat can also prevent the transdermal patch from adhering properly. Therefore, consult your doctor if you have a fever and do not expose yourself to heat sources (e.g., sauna, infrared lamps, electric blankets, or hot water bags).

It should be warned to athletes that this medication can give a positive result in doping control 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 oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nocturnal awakenings due to difficulty breathing, difficulty maintaining sleep, or excessive daytime sleepiness. Contact your doctor if you or someone else observes these symptoms. Your doctor may consider reducing the dose.

Children and adolescents

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

Use of Transtec with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

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

• Transtec may cause drowsiness, vomiting, dizziness, or make you breathe more slowly or weakly in some patients. These adverse effects may intensify if taken at the same time as other medications that can cause the same effects. These other medications include other potent analgesics (opioids), certain sleep medications, anesthetics, and medications 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).

Inform your doctor or pharmacist if you are taking:

• allergy medications and anti-nausea medications for travel (antihistamines or antiemetics);
• psychiatric disorder medications (antipsychotics or neuroleptics);
• muscle relaxants;
• medications for the treatment of Parkinson's disease.

The concomitant use of Transtec with sedatives or sleep medications (such as benzodiazepines) increases the risk of drowsiness, respiratory difficulties (respiratory depression), coma, and can be potentially fatal. Therefore, only consider concomitant use when other treatment options are not possible. However, if your doctor prescribes Transtec with sedatives, you should limit the dose and duration of concomitant treatment. Inform your doctor about all sedatives you are taking and follow your doctor's dose recommendation strictly. 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 together with some medications, the action of the transdermal patch may be intensified. These medications include, for example, certain antibiotics and antifungals (e.g., those containing erythromycin or ketoconazole) or medications for HIV (e.g., those containing ritonavir).

• If Transtec is used together with other medications, the action of the transdermal patch may be reduced. These medications include, for example, dexamethasone, certain medications for epilepsy (e.g., those containing carbamazepine or phenytoin) or medications used to treat tuberculosis (e.g., rifampicin).

• Some medications may increase the side effects of Transtec and, in some cases, may cause very serious reactions. Do not take any other medication 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 medications may interact with Transtec and you may experience symptoms such as involuntary muscle contractions, including those 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 experience these symptoms.

Use of Transtec with food, drinks, and alcoholand alcohol

You should not drink alcohol while using Transtec. Alcohol can intensify certain adverse effects of the transdermal patch and you may not feel well.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

There is not enough experience with the use of Transtec to date in pregnant women. Therefore, Transtec should not be used during pregnancy.

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

Driving and operating machinery

Transtec may make you feel dizzy, drowsy, or have double or blurred vision and may alter your reflexes in such a way that you do not react adequately or quickly enough in unexpected situations.

This applies especially:

• at the beginning of treatment
• when changing the dose
• when changing from another medication to this one
• if you are also taking other medications 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.

Consult your doctor or pharmacist if you are unsure.

Follow exactly the administration instructions of this medication as indicated by your doctor.This medication is indicated for the treatment of moderate to severe pain.Consult your doctor or pharmacist again if you are unsure.

Before starting treatment and periodically during treatment, your doctor will discuss with you what you can expect from the use of 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 interrupt 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 make it easier to use, you can change the patch 2 times a week on fixed days, for example: “always on Mondays morning and Thursdays afternoon”. To help you remember when to change the transdermal patch, note it in the packaging. If your doctor has told you to take other painkillers in addition to the transdermal patch, follow your doctor's instructions strictly, or you will not benefit fully from the treatment with Transtec.

Use in children and adolescents

Transtec should not be used in people under 18 years old because there is no experience with this age group.

Older patients

No dose adjustment is required in older patients.

Patients with renal impairment / patients on dialysis

No dose adjustment is required in patients with renal impairment and patients on dialysis.

Patients with liver impairment

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

Administration form

Before applying a transdermal patch

• If the chosen area has hair, cut it with scissors. Do not shave it!
• Avoid areas of skin that are red, irritated, or have any other type of marks, for example large scars.
• The area of skin you choose must be dry and clean. If necessary, wash it with cold or warm 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.

Application of the transdermal patch:

While wearing the transdermal patch

You can wear the transdermal patch for a maximum of 4 days. If the transdermal patch has been applied correctly, the risk of it falling off is low. You can bathe, shower, 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 bags).

If the 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.
• Double the patch over with the adhesive side facing inwards.
• Dispose of it carefully,out of sight and reach of children.
• Apply a new transdermal patch to a different area of skin (as described above). It must be at least 1 week before you can apply a new patch to the same area of skin.

Duration of treatment

Your doctor will tell you 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 interrupt treatment with Transtec”).

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

If you use moreTranstec than you should

If this happens, there may be signs of 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, contact the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount used.

If you forgot to useTranstec

If you forgot to apply a patch, apply a new one as soon as you remember. This will change your routine, for example: if you normally applied your patch on Mondays and Thursdays, but forgot and didn't apply a new patch until Wednesday, from now on you will need to change your patches on Wednesdays and Saturdays. Note the new pair of days in the calendar of the packaging. If you change the patch too late, the pain may return. In this case, consult your doctor.

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

If you interrupt the treatment withTranstec

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

Some people may experience effects after using potent painkillers for a long time, when they stop using them. The risk of experiencing effects after stopping the application of Transtec is very low. However, if you feel agitated, anxious, nervous, or tremulous, if you are hyperactive, have difficulty sleeping, or have digestive problems, consult your doctor.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Side effects are classified as follows:

The following side effects 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 disorders, restlessness

Rare:illusions and hallucinations, anxiety, nightmares, decreased libido

Very rare:dependence, mood changes

Nervous system disorders

Common:dizziness, headache

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

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

Very rare:muscle cramps, taste disturbances

Eye disorders

Rare:visual disturbances, blurred vision, eyelid swelling

Very rare:small 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 blood pressure drop)

Rare:syncope

Respiratory, thoracic and mediastinal disorders

Common:shortness of breath

Rare:respiratory depression

Very rare:hyperventilation, hiccups

Gastrointestinal disorders

Very common:nausea

Common:vomiting, constipation

Uncommon:dry mouth

Rare:gastroesophageal reflux

Very rare:hiccups

Skin and subcutaneous tissue 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 hives

Very rare:pustules, vesicles

Frequency unknown:contact dermatitis (skin eruption with inflammation, which may include burning sensation), skin discoloration

Urinary and renal disorders

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

Reproductive system and breast disorders

Rare:erection difficulties

General disorders

Common:edema (swelling of the legs), fatigue

Uncommon:weakness (languor)

Rare:withdrawal symptoms, reactions at the application site

Very rare:chest pain

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

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

If you experience inflammation of the hands, feet, knees, face, lips, mouth or throat, which may cause difficulty swallowing or breathing, urticarial hives, fainting, yellowing of the skin and eyes (also known as 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 experience withdrawal symptoms after using potent analgesics for a prolonged period and then stopping them. After treatment with Transtec, the risk of experiencing withdrawal symptoms is low. However, if you feel agitation, anxiety, nervousness, hyperactivity, sleep disorders, or digestive problems, consult your doctor.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Conserve this medication in a safe and protected place, where other people cannot access it. It may cause serious harm and be fatal to individuals who take it accidentally or intentionally when not prescribed.

Keep this medication out of sight and reach of children..

Do not use this medicationafter the expiration date that appears on the packaging and on the overwrap 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 drains or trash.Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. In case of doubt, please ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition ofTranstec

• The active ingredient is buprenorphine.

• The other components are:

Adhesive matrix:oleate of (Z)-9-octadecen-1-yl; povidone K90; 4-oxopentanoic acid; poly[acrylic acid-co-butyl acrylate-co-(2-ethylhexyl)acrylate-co-vinyl acetate] (5:15:75:5), cross-linked (for the area containing buprenorphine) or not 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. Release liner on the front covering the adhesive matrix containing buprenorphine to remove before applying the transdermal patch: poly(ethylene terephthalate) film, siliconized, coated on one side with aluminum.

Appearance of the product andcontents of the package

Transtecare transdermal patches with a flesh-colored appearance and rounded corners identified as:Transtec 35 μg/hour, buprenorphine 20 mg.

Transtecare presented in packages containing 3, 4, 5, 6, 8, 10, 11, 12, 16, 18, 20 or 24 individually sealed transdermal patches in child-resistant pouches.

Only some package sizes may be commercially available.

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 medicinal product is authorized in the member states of the European Economic Areaand in the United Kingdom (Northern Ireland)with the following names:

GermanyTranstecPRO®

AustriaTranstec®

BelgiumTranstec®

SloveniaTranstec®

SpainTranstec®

IrelandTranstec®

ItalyTranstec®

LuxembourgTranstec®

PortugalTranstec®

United Kingdom (Northern Ireland)Transtec®

Last review date of this leaflet: November 2024

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/