Package Leaflet: Information for the User

Buprenorphine Teva 35 micrograms/hour Transdermal Patch EFG

Buprenorphine

Read this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, as 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 pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Buprenorphine Teva is and what it is used for

2. What you need to know before you start using Buprenorphine Teva

3. How to use Buprenorphine Teva

4. Possible side effects

5. Storage of Buprenorphine Teva

6. Contents of the pack and additional informational

The active substance of Buprenorfina Teva is buprenorphine.

Buprenorfina Teva is 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. Buprenorfina Teva acts through the skin.When thetransdermal patchis applied to the skin,the active principle buprenorphinepasses through the skininto the blood.Buprenorphine is an opioid (intense pain-relieving medication) that reduces pain by acting on the central nervous system (on specific nerve cells in the spinal cord and brain). The effect of the transdermal patch lasts for up to a maximum of four days. Buprenorfina Teva is not ideal for the treatment of acute pain (short duration).

Do not use Buprenorfina Teva

• 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 painkillers (opioids),
• if you have a disease that makes it difficult to breathe or could lead to breathing difficulties,
• if you are taking monoamine oxidase inhibitors (certain depression medications) or have taken them in the last two weeks before treatment with Buprenorfina Teva (see “Other medicines and Buprenorfina Teva”),
• in case of myasthenia gravis (a severe muscle weakness condition),
• in case of delirium tremens (confusion and tremors caused by alcohol withdrawal after excessive alcohol consumption or during a period of high alcohol consumption),
• in case of pregnancy.

Buprenorfina Teva should not be used to treat withdrawal symptoms in drug-dependent individuals.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Buprenorfina Teva

• if you have recently drunk a lot of alcohol,
• if you have seizures or convulsions (attacks),
• if you have altered consciousness (feeling dizzy or fainting),
• if you are in shock (a sign could be cold sweat),
• if you have high intracranial pressure (for example after a head injury or in 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 “Other medicines and Buprenorfina Teva”),
• if you have depression or other diseases treated with antidepressants.

The use of these medicines together with Buprenorfina Teva may cause serotonin syndrome, a potentially fatal disease (see “Other medicines and Buprenorfina Teva”).

• if you have liver problems,
• if you have a tendency to abuse medicines or drugs.

Also note the following precautions:

• Some people may become dependent on strong painkillers such as Buprenorfina Teva when they use them for a long time. These patients may experience effects after they stop using them (see “If you stop treatment with Buprenorfina Teva”).
• Fever and heat can cause higher-than-normal levels of buprenorphine in the blood. Heat can also prevent the transdermal patch from sticking 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).
• Sleep-related respiratory disorders: Buprenorfina Teva may cause sleep-related respiratory disorders 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 somnolence. Contact your doctor if you or someone else observes these symptoms. Your doctor may consider reducing the dose.

• It should be warned to athletes that this medicine may give a positive result in doping control tests.

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 what is known as tolerance). Repeated use of Buprenorfina Teva 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 medicine you need to take or how often you need to take it.

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

• You or a family member has a history of alcohol, prescription medication, or illicit substance abuse (“addiction”).
• You are a smoker.
• You have had problems with your mood (depression, anxiety, or personality disorder) or have received treatment from a psychiatrist for other mental health conditions.

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

• You need to take the medicine for a longer time than recommended by your doctor.
• You need to take more doses than recommended.
• You may feel like you need to keep using the medicine, even if it no longer helps with pain relief.
• You are using the medicine for reasons other than those prescribed, such as “to calm down” or “to help you sleep”.
• You have made repeated and unsuccessful attempts to stop or control your use of the medicine.
• 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 suitable 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 stop treatment with Buprenorfina Teva”).

Children and adolescents

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

Other medicines and Buprenorfina Teva

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

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

• Buprenorfina Teva may cause drowsiness, vomiting, dizziness, or make you breathe more slowly or weakly in some patients. These adverse effects may intensify if taken together with other medicines that can cause the same effects. These other medicines include other strong painkillers (opioids), certain sleep medications, anesthetics, and medications for certain psychological conditions such as tranquilizers, antidepressants, and neuroleptics.

The concomitant use of Buprenorfina Teva and sedatives such as benzodiazepines or related medications increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. Therefore, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes Buprenorfina Teva together with sedatives, your doctor should limit the dose and duration of concomitant treatment.

Inform your doctor about all sedatives you are taking and follow the recommended dose closely. It may be helpful to inform friends or family members to be aware of the signs and symptoms mentioned above. Contact your doctor when you experience such symptoms.

The concomitant use of Buprenorfina Teva and gabapentinoids such as gabapentin or pregabalin used to treat epilepsy or pain due to nerve problems (neuropathic pain) may cause breathing difficulties (respiratory depression), low blood pressure, deep somnolence, coma, and may be potentially fatal.

• If Buprenorfina Teva is used together with anticholinergics or medications with anticholinergic activity, such as medications for depression, medications used to treat allergies, dizziness, or nausea (antihistamines or antiemetics), medications for psychiatric disorders (antipsychotics or neuroleptics), muscle relaxants, or medications for Parkinson's disease, anticholinergic side effects may increase.

• If Buprenorfina Teva 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 Buprenorfina Teva 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 Buprenorfina Teva and, in some cases, may cause severe reactions. Do not take any other medicine while taking Buprenorfina Teva without consulting your doctor, especially antidepressants such as moclobemide, tranylcypromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepin, or trimipramine. These medications may interact with Buprenorfina Teva 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 Buprenorfina Teva with food, drinks, and alcohol

You should not drink alcohol while using Buprenorfina Teva. Alcohol may intensify certain adverse effects of the transdermal patch and you may not feel well.You may experience increased effects of Buprenorfina Teva if you drink grapefruit juice.

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 medicine.

There is not enough experience with the use of Buprenorfina Teva to date in pregnant women. Therefore, do not use Buprenorfina Teva during pregnancy.

Buprenorphine, the active ingredient in the transdermal patch, inhibits milk production and passes into breast milk. Therefore, do not use Buprenorfina Teva during breastfeeding.

Driving and operating machinery

Buprenorfina Teva may make you feel dizzy, drowsy, or have double vision or blurred vision and may alter your reflexes so that you do not react quickly or adequately in unexpected situations. This applies especially:

• at the beginning of treatment
• when changing the dose
• when changing from another medicine to Buprenorfina Teva
• 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 Buprenorfina Teva. This also applies at the end of treatment with Buprenorfina Teva. 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. In case of doubt, consult your doctor or pharmacist again.

Before starting treatment and periodically during it, your doctor will talk to you about what you can expect from the use of this medication, 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 Buprenorphine Teva”).

This medicationis available in three doses: Buprenorphine Teva 35 micrograms/hour transdermal patch EFG, Buprenorphine Teva 52.5 micrograms/hour transdermal patch EFG and Buprenorphine Teva 70 micrograms/hour transdermal patch EFG.

Your doctor has chosen this buprenorphine patch, as the most suitable for you. During treatment, your doctor may change the transdermal patch you use to one of a lower or higher dose if necessary.

The recommended dose is:

Adults

Follow these instructions unless your doctor has given you different instructions. Apply the buprenorphine patch (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 Monday morning and Thursday afternoon”. To help you remember when to change the transdermal patch, note it in the calendar of 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 buprenorphine treatment.

Children and adolescents

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

Older adults

No dose adjustment is required in older adults.

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 buprenorphine action may be affected. If you belong to this group of patients, your doctor will monitor you with greater care.

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 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 take a shower, bath 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. Stick a new one immediately (see “Changing the transdermal patch” below).

Changing the transdermal patch

• Remove the old patch carefully.
• Double it over with the adhesive side inwards.
• Dispose of it carefully,out of sight and reach of children.
• Stick 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 this medication. Do not stop treatment with buprenorphine on your own, as the pain may return and you may feel unwell (see also “If you interrupt treatment with Buprenorphine Teva”).

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

If you use more Buprenorphine Teva 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 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 forgot to use Buprenorphine Teva

If you forgot to apply a patch, stick a new transdermal patch as soon as you remember. This will change your routine, for example: if you normally applied your transdermal patch on Mondays and Thursdays, but forgot and did not put on a new patch until Wednesday, from now on you will need to change your transdermal patches on Wednesdays and Saturdays. Note the new pair of days in the calendar of the packaging. 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 compensate for the one you forgot!

If you interrupt treatment with Buprenorphine Teva

If you interrupt or stop treatment with this medicationtoo 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 you can do and if you can be treated with other medications.

Some people may experience withdrawal effects after using strong painkillers for a long time, when they stop using them. The risk of experiencing these effects after stopping the application of buprenorphine patches is very low. However, if you feel agitated, anxious, nervous, or tremulous, if you are hyperactive, have difficulty sleeping or 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 may cause side effects, although not everyone will experience them.

If you experience inflammation of the hands, feet, knees, face, lips, mouth, or throat, which may cause difficulty swallowing or breathing, 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 severe allergic reaction, which is very rare.

The following side effects have been reported:

Very common(may affect more than 1 in 10 people):

• Nausea (feeling sick)
• Erythema, pruritus

Common(may affect up to 1 in 10 people)

• Dizziness, headache
• Shortness of breath
• Vomiting, constipation
• Changes in the skin (exanthema, usually due to repeated use), increased sweating
• Edema (swelling of the legs), fatigue

Uncommon(may affect up to 1 in 100 people)

• Confusion, sleep disorders, restlessness
• Different degrees of sedation (calmness), ranging from fatigue to confusion
• Circulatory disorders (such as hypotension or rarely, loss of consciousness due to a drop in blood pressure)
• Dry mouth
• Rashes
• Urinary retention (less urine than normal), alterations in urination
• Weakness (languor)

Rare(may affect up to 1 in 1,000 people)

• Loss of appetite
• Illusions such as hallucinations, anxiety, nightmares, decreased sexual desire
• Difficulty concentrating, speech disorders, confusion, balance disorders, abnormal sensations in the skin (feeling of heat, tingling, or numbness)
• Visual disturbances, blurred vision, swelling of the eyelids
• Seizures
• Difficulty breathing (respiratory depression)
• Acid reflux
• Hives
• Difficulty achieving an erection
• Withdrawal symptoms, reactions at the site of administration

Very rare(may affect up to 1 in 10,000 people)

• Severe allergic reactions
• Dependence, mood changes
• Muscle contractions, alterations in taste
• Constricted pupils
• Ear pain
• Hyperventilation, hiccups
• Cramps
• Pustules, vesicles
• Chest pain

Frequency not known(the frequency cannot be estimated from the available data)

• Contact dermatitis (skin rash with inflammation that may include a burning sensation), skin discoloration

If you notice any of the previously mentioned side effects, 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 Buprenorfina Teva should be discontinued after consulting your doctor.

Some people may experience withdrawal symptoms after using potent analgesics for a prolonged period and then stopping them. After treatment with Buprenorfina Teva, 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 Pharmacovigilance 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.

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

Do not use this medication after 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.

Store this medication in a safe and secure location, where other individuals cannot access it. It may cause severe harm and be fatal to people who may use it accidentally or intentionally when not prescribed.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE drop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Buprenorfina Teva

The active ingredient is buprenorphine.

Each transdermal patch of 25 cm2contains 20 mg of buprenorphine and releases 35 micrograms of buprenorphine per hour.

The other components are:

• Adhesive matrix (with buprenorphine) povidone K90, levulinic acid, oleic oleate, poly[acrylic acid-co-butylacrylate-co-(2-ethylhexyl)acrylate-co-vinyl acetate] (5:15:75:5)
• Adhesive matrix (without buprenorphine): poly[(2-ethylhexyl)acrylate-co-glycidyl methacrylate-co-(2-hydroxyethyl)acrylate-co-vinyl acetate] (68:0.15:5:27)
• Separator film between the adhesive matrices with and without buprenorphine: poly(ethylene terephthalate) film.
• Coating layer: polyester.
• Release-protecting film (on the front covering the adhesive matrix containing buprenorphine): siliconized poly(ethylene terephthalate) film.
• Blue printing ink

Appearance of Buprenorfina Tevaand contents of the package

Rectangular patch with rounded edges of beige color and printed “Buprenorphine” and “35 μg / h”

Each transdermal patch is sealed in a child-resistant package. The patches are available containing 3, 4, 5, 6, 8, 10, 12, 16, 18 or 20 transdermal patches.

Only some package sizes may be marketed.

Marketing Authorization Holder

Teva Pharma S.L.U.

C/ Anabel Segura, 11 Edificio Albatros B, 1st floor

28108 Alcobendas (Madrid)

Spain

Responsible for manufacturing

Labtec GmbH

Heykenaukamp 10, Hamburg

21147 Germany

or

Merckle GmbH

Ludwig-Merckle-Straße 3, Blaubeuren

89143 Germany

or

Teva Operations Poland Sp.z.o.o

ul. Mogilska 80, Krakow

31-546 Poland

This medicine is authorized in the Member States with the following names:

Last review date of this leaflet:October 2024

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

You can access detailed and updated information on this medicine by scanning the QR code with your smartphone (smartphone) included in the packaging. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/80609/P_80609.html

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