Package Insert: Information for the User

Buprenorphine Andrómaco70 micrograms/hour transdermal patch EFG

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 only for you, 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.

Buprenorfina Andrómaco is an analgesic (a medication for pain relief) indicated for the relief of moderate to severe oncological pain and severe pain that does not respond to other types of analgesics. Buprenorfina Andrómaco acts through the skin. When the transdermal patch is applied to the skin, the active substance buprenorfina passes through it into the blood. Buprenorfina 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 in the brain). The effect of the transdermal patch lasts for up to a maximum of four days. Buprenorfina Andrómaco is not ideal for the treatment of acute pain (short-term pain).

No useBuprenorfina Andrómaco

• If you are allergic to buprenorphine or any of the other ingredients of this medication (listed in section 6),
• If you are addicted to powerful analgesics (opioids),
• If you have a disease in which you have great difficulty breathing or in which this may occur,
• If you are taking MAO inhibitors (certain medications for the treatment of depression) or have taken them in the last two weeks before treatment with Buprenorfina Andrómaco (see “Use of Buprenorfina Andrómaco 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 alcohol withdrawal after excessive consumption or during an episode of high alcohol consumption),
• In the case of pregnancy.

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

- You or a family member has a history of alcohol abuse, prescription medication abuse, 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 Andrómaco, 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, 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 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 Buprenorfina Andrómaco”).

Consult your doctor or pharmacist before starting to useBuprenorfina Andrómaco

• 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),
• If you are in shock (a sign may be cold sweat),
• If you have elevated intracranial pressure (for example, after head trauma or cerebral 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 Buprenorfina Andrómaco with other medications”),
• If you have depression or other conditions treated with antidepressants.

The use of these medications with Buprenorfina Andrómaco may cause serotonin syndrome, a potentially fatal disease (see “Use of Buprenorfina Andrómaco 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).

Inform athletes that this medication may give a positive result in doping control tests.

Respiratory disorders related to sleep

Buprenorfina Andrómaco may 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 somnolence. Contact your doctor if you or someone else observes these symptoms. Your doctor may consider reducing the dose.

Children and adolescents

Buprenorfina Andrómaco should not be used in individuals under 18 years of age, as there is no experience to date in this age group.

Use of Buprenorfina Andrómaco with other medications

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

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

• Buprenorfina Andrómaco 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 produce the same effects. These other medications include other powerful analgesics (opioids), certain sleep medications, anesthetics, and medications for the treatment of certain psychological conditions 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;
• parkinson's disease medications.

The concomitant use of Buprenorfina Andrómaco with sedatives or sleep medications (such as benzodiazepines) increases the risk of drowsiness, respiratory depression, coma, and may be potentially fatal. Therefore, only consider concomitant use when other treatment options are not possible. However, if your doctor prescribes Buprenorfina Andrómaco with sedatives, you should limit the dose and duration of concomitant treatment. Inform your doctor about all sedatives you are taking and strictly follow your doctor's recommended dose. It may be helpful to inform your friends and family about the signs and symptoms mentioned above. Inform your doctor if you experience any of these symptoms.

• If Buprenorfina Andrómaco is used with some medications, the action of the transdermal patch may intensify. These medications include, for example, certain antibiotics and antifungals (e.g., those containing erythromycin or ketoconazole) or HIV medications (e.g., those containing ritonavir).

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

• Some medications may increase the side effects of Buprenorfina Andrómaco and, in some cases, may cause severe reactions. Do not take any other medication while using Buprenorfina Andrómaco without consulting your doctor, especially antidepressants such as citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepin, or trimipramine. These medications may interact with Buprenorfina Andrómaco 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, high body temperature above 38°C. Contact your doctor if you experience these symptoms.

Use ofBuprenorfina Andrómacowith food, drinks, and alcohol

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

Drinking grapefruit juice during treatment may intensify the effects of Buprenorfina Andrómaco.

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 Buprenorfina Andrómaco to date in pregnant women. Therefore, Buprenorfina Andrómaco should not be used during pregnancy.

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

Driving and operating machinery

Buprenorfina Andrómacomay make you feel dizzy, drowsy, or have double vision or blurred vision andmay alter your reflexes in such a way 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 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 Buprenorfina Andrómaco. This also applies at the end of treatment withBuprenorfina Andrómaco. Do not drive or operate machinery for at least 24 hours after removing the patch.

Consult your doctor or pharmacist if in doubt.

Follow exactly the administration instructions of this medication as indicated by your doctor.This medication is available in three doses:Buprenorfina Andrómaco 35 micrograms/hour transdermal patch EFG, Buprenorfina Andrómaco 52.5 micrograms/hour transdermal patch EFG and Buprenorfina Andrómaco 70 micrograms/hour transdermal patch EFG.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 Buprenorfina Andrómaco, 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 Buprenorfina Andrómaco”).

Your doctor has chosen this Buprenorfina Andrómaco 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 Buprenorfina Andrómaco (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 carton 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 Buprenorfina Andrómaco.

Use in children and adolescents

Buprenorfina Andrómaco 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 Buprenorfina Andrómaco'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 the 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.

Applying 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. Apply 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 facing inwards.
• Dispose of it safely,out of sight and reach of children.
• Stick a new transdermal patch to a different area of skin (as described above). It should be at least 1 week before you can apply a new patch to the same area of skin.

Treatment duration

Your doctor will tell you the duration of your treatment with Buprenorfina Andrómaco.Do not stop treatment on your own, as the pain may return and you may feel unwell (see also “If you interrupt treatment with Buprenorfina Andrómaco”).

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

If you use more Buprenorfina Andrómaco 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 of Buprenorfina Andrómaco 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 use Buprenorfina Andrómaco

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 did not 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 carton 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 treatment with Buprenorfina Andrómaco

If you interrupt or stop treatment with Buprenorfina Andrómaco 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 you can 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 Buprenorfina Andrómaco 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 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

Mental disorders

Uncommon:confusion, sleep disorders, restlessness

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

Very rare:dependence, mood changes

Nervous system disorders

Common:dizziness, headache

Uncommon:different degrees of sedation (calmness), 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 alterations

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 alterations

Reproductive system and breast disorders

Rare:erection difficulties

General disorders

Common:edema (swelling of the legs), fatigue

Uncommon:weakness (lassitude)

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 withBuprenorfinaAndrómacoshould be discontinued 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, 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 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 BuprenorfinaAndrómaco, 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 can cause severe harm and be fatal to people 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 packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, please ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofBuprenorphine Andrómaco

• 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-butylacrylate-co-(2-ethylhexyl)acrylate-co-vinylacetate] (5:15:75:5), cross-linked (for the area containing buprenorphine) or not cross-linked (for the area without buprenorphine); separating film between the adhesive matrices with and without buprenorphine: poly(ethylene terephthalate) film, coating: poly(ethylene terephthalate) fabric. Release protective film 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 withaluminum.

Appearance of the product and contents of the packaging

Buprenorphine Andrómaco are transdermal patches with a flesh-colored appearance and rounded corners identified as: Buprenorphine Andrómaco 70 μg/hour EFG, buprenorphine 40 mg.

Buprenorphine Andrómaco is presentedin packaging containing 3, 4, 5, 6, 8, 10, 11, 12, 16, 18, 20 or 24 transdermal patches individually sealed in child-resistant pouches.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Andrómaco Pharma, S.L.

Doctor Zamenhof, 36 - 28027 Madrid, Spain

Responsible manufacturer

Grünenthal GmbH

Zieglerstrasse 6 - D - 52078 Aachen, Germany

Last review date of this leaflet: November 2024

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