Buprenorphine Andromaco 35 micrograms/hour transdermal patch EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Buprenorphine Andrómaco 35 micrograms/hour transdermal patch EFG

Buprenorphine

Read all of 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of this leaflet

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

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

Buprenorphine Andrómaco is an analgesic (a medicine for pain relief) indicated for the relief of moderate to severe cancer pain and severe pain that does not respond to other types of analgesics. Buprenorphine Andrómaco acts through the skin. When the transdermal patch is applied to the skin, the active substance buprenorphine passes through the skin into the bloodstream. Buprenorphine is an opioid (a medicine for the relief of severe pain) 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 up to a maximum of four days. Buprenorphine Andrómaco is not suitable for the treatment of acute pain (short-term pain).

2. What you need to know before using Buprenorphine Andrómaco

Do not use Buprenorphine Andrómaco

• if you are allergic to buprenorphine or to any of the other ingredients of this medicine (listed in section 6),
• if you are addicted to strong painkillers (opioids),
• if you have a condition causing significant difficulty in breathing or in which this may occur,
• if you are taking monoamine oxidase inhibitors (MAO inhibitors) (certain medicines used to treat depression), or have taken them within the last two weeks before starting treatment with Buprenorphine Andrómaco (see "Use of Buprenorphine Andrómaco 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 following habitual excessive alcohol intake or during an episode of heavy alcohol consumption),
• in case of pregnancy.

Buprenorphine Andrómaco must not be used to treat withdrawal syndrome in drug-dependent individuals.

Warnings and precautions

Tolerance, dependence, and addiction

This medicine contains buprenorphine, an opioid substance. Repeated use of opioids may reduce the effectiveness of the medicine (your body becomes accustomed to the medicine, known as tolerance). Repeated use of Buprenorphine Andrómaco may also lead to dependence, abuse, and addiction, which could result in potentially fatal overdose. The risk of adverse effects may increase with higher doses and longer duration of use.

Dependence or addiction may make you feel that you no longer have control over how much 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 Buprenorphine Andrómaco if:

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

If you notice any of the following signs while taking Buprenorphine Andrómaco, it could indicate that you have become dependent or addicted:

• You need to take the medicine for longer than recommended by your doctor.
• You need to take higher doses than recommended.
• You are using the medicine for reasons other than prescribed, for example, "to calm down" or "to help you sleep".
• You have made repeated unsuccessful attempts to stop or control your use of the medicine.
• You feel unwell when you stop taking the medicine and feel better when you resume taking it ("withdrawal symptoms").

If you notice any of these signs, speak with your doctor to discuss the most appropriate therapeutic strategy for your case, including when it is appropriate to stop taking the medicine and how to do so safely (see section 3 "If you stop treatment with Buprenorphine Andrómaco").

Consult your doctor or pharmacist before starting to use Buprenorphine Andrómaco

• if you have recently consumed large amounts of alcohol,
• if you have epileptic seizures or convulsions (fits),
• if you have altered consciousness (dizziness or fainting) of unknown cause,
• if you are in shock (a possible sign could be cold sweating),
• if you have increased intracranial pressure (e.g., after head trauma or brain disease), without the possibility of artificial respiration,
• if you have difficulty breathing or are taking other medications that may cause slower or weaker breathing (see "Use of Buprenorphine Andrómaco with other medicines"),
• if you have depression or other conditions treated with antidepressants.

Using these medicines together with Buprenorphine Andrómaco may cause serotonin syndrome, a potentially life-threatening condition (see "Use of Buprenorphine Andrómaco with other medicines"),

• if you have liver problems.

Also consider the following precautions:

• Fever and high environmental temperature may lead to higher than normal levels of buprenorphine in the blood. In addition, high environmental temperature may prevent the transdermal patch from adhering 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 advised that this medicine may result in a positive doping test.

Sleep-related respiratory disorders

Buprenorphine Andrómaco 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 breathing pauses during sleep, nighttime 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

Buprenorphine Andrómaco must not be used in individuals under 18 years of age, as there is currently no experience with this medicine in this age group.

Use of Buprenorphine Andrómaco with other medicines

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

• Buprenorphine Andrómaco must not be used together with MAO inhibitors (certain medicines used to treat depression), or if you have taken them within the last two weeks.

• Buprenorphine Andrómaco may cause drowsiness, vomiting, dizziness, or slow or shallow breathing in some patients. These adverse effects may be intensified if taken at the same time as other medicines that produce similar effects. These other medicines include strong painkillers (opioids), certain sleeping medicines, anaesthetics, and medicines used to treat certain psychiatric conditions such as tranquilisers, antidepressants, neuroleptics, and gabapentin or pregabalin used to treat epilepsy or nerve-related pain (neuropathic pain).

Inform your doctor or pharmacist if you are taking:

• medicines for allergy, or for travel sickness (antihistamines or antiemetics);
• medicines for psychiatric disorders (antipsychotics or neuroleptics);
• muscle relaxants;
• medicines for Parkinson’s disease.

Concomitant use of Buprenorphine Andrómaco with sedatives or medicines for insomnia (such as benzodiazepines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. For this reason, concomitant use should only be considered when no other treatment options are possible. However, if your doctor prescribes Buprenorphine Andrómaco together 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 dosing recommendations. It may be helpful to inform your friends and family about the signs and symptoms listed above. Contact your doctor if you experience any of these symptoms.

• When Buprenorphine Andrómaco is used together with certain medicines, the effect of the transdermal patch may be increased. These medicines include, for example, certain anti-infectives and antifungals (e.g. those containing erythromycin or ketoconazole) or HIV medicines (e.g. those containing ritonavir).

• When Buprenorphine Andrómaco is used together with other medicines, the effect of the transdermal patch may be reduced. These medicines include, for example, dexamethasone, certain medicines for epilepsy (e.g. those containing carbamazepine or phenytoin), or medicines used to treat tuberculosis (e.g. rifampicin).

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

Use of Buprenorphine Andrómaco with food, drinks, and alcohol

You must not drink alcohol while using Buprenorphine Andrómaco. Alcohol may intensify certain adverse effects of the transdermal patch and you may feel unwell.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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

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

Driving and operating machinery

Buprenorphine Andrómaco may cause dizziness, drowsiness, or double or blurred vision, and may impair your reflexes so that you do not react adequately or quickly enough in sudden or unexpected situations.

This applies especially:

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

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

If in doubt, consult your doctor or pharmacist.

3. How to use Buprenorphine Andrómaco

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Before starting treatment and periodically during treatment, your doctor will discuss with you what to expect from using this medicine, when and for how long you should take it, when to contact your doctor, and when you should stop taking it (see also “If you stop treatment with Buprenorphine Andrómaco”).

This medicine is available in three strengths: Buprenorphine Andrómaco 35 micrograms/hour transdermal patch EFG, Buprenorphine Andrómaco 52.5 micrograms/hour transdermal patch EFG, and Buprenorphine Andrómaco 70 micrograms/hour transdermal patch EFG.

Your doctor has selected this buprenorphine patch as the most suitable one for you.

During treatment, your doctor may switch you from one transdermal patch to another with a lower or higher strength, if necessary.

The recommended dose is:

Adults

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

Apply the transdermal patch (as detailed below) and replace it after four days at the latest. To make treatment easier, you may change the patch twice a week on fixed days, for example: “always on Monday morning and Thursday afternoon”. To help you remember when to change the transdermal patch, write it down on the outer packaging. If your doctor has instructed you to take other painkillers in addition to the transdermal patch, follow your doctor’s instructions strictly; otherwise, you may not benefit fully from treatment with this medicine.

Use in children and adolescents

This medicine must not be used in individuals under 18 years of age, as experience in this age group is currently lacking.

Elderly patients

No dose adjustment is required in elderly patients.

Patients with renal disease / patients undergoing dialysis

No dose adjustment is required in patients with kidney disease or in patients undergoing dialysis.

Patients with hepatic disease

In patients with liver disease, the intensity and duration of action of this medicine may be affected. If you belong to this patient group, your doctor will monitor you more closely.

Method of administration

Before applying a transdermal patch

Choose a smooth, hairless area of skin on your upper body, preferably below the collarbone on the chest or on the upper back (see adjacent figure). Ask for help if you cannot apply the transdermal patch yourself.

Chest or Back or

• If the selected area is hairy, trim the hair with scissors. Do not shave!
• Avoid areas of skin that are red, irritated, or have any other type of lesions, such as large scars.
• The skin area you select should be dry and clean. If necessary, wash it with cool 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 selected area, as this could prevent the transdermal patch from adhering properly.

Applying the transdermal patch:

Step 1: Each transdermal patch is sealed in a child-resistant pouch. Cut the pouch with scissors along the dotted line. Be careful not to damage the transdermal patches.

	Remove the transdermal patch.
	Step 2: The adhesive side of the transdermal patch is covered by a silver protective liner. Carefully peel off half of the liner. Avoid touching the adhesive part of the transdermal patch.
	Step 3: Apply the transdermal patch to the chosen skin area and remove the rest of the liner.
	Step 4: Press the transdermal patch firmly against your skin with the palm of your hand and count slowly to 30. Make sure the entire patch is in contact with your skin, especially the edges.

While wearing the transdermal patch

You may wear the transdermal patch for up to 4 days. If the transdermal patch has been applied correctly, the risk of it detaching is low. You may 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 it needs to be changed, do not reuse the same transdermal patch. Immediately apply a new patch (see “Changing the transdermal patch” below).

Changing the transdermal patch

• Carefully remove the old patch.
• Fold it in half with the adhesive side facing inward.
• Dispose of it cautiously, out of sight and reach of children.
• Apply a new transdermal patch to a different area of skin (as described previously). At least 1 week must pass before applying a new patch to the same skin area.

Duration of treatment

Your doctor will determine how long you should be treated with this medicine. Do not stop treatment on your own, as pain may return and you may feel unwell (see also “If you stop treatment with Buprenorphine Andromaco”).

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

If you use more Buprenorphine Andromaco 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 breathing may become slow and weak. You could also experience cardiovascular collapse. An overdose may potentially lead to coma or death.

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

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and amount used.

If you forget to use Buprenorphine Andromaco

If you miss a dose, apply a new transdermal patch as soon as you remember. This will change your routine; for example: if you normally apply your transdermal patch on Mondays and Thursdays, but you forgot and only applied the new patch on Wednesday, from now on you will need to change your patches on Wednesdays and Saturdays. Record this new pair of days on the calendar provided in the packaging. If you change the patch too late, your pain may return. In this case, consult your doctor.

Never apply more than one transdermal patch to make up for a missed dose!

If you stop treatment with Buprenorphine Andromaco

If you interrupt or stop treatment with buprenorphine too early, your pain will return. If you wish to discontinue treatment due to unpleasant side effects, consult your doctor. Your doctor will advise you on what to do and whether other medications may be given.

Some people may experience effects after using strong painkillers for a long time, when stopping their use. The risk of experiencing effects after stopping this medicine is very low. However, if you feel agitated, anxious, nervous, or shaky, if you are hyperactive, have difficulty sleeping, or have digestive problems, consult your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Adverse effects are classified as follows:

Very common: May affect more than 1 in 10 people	Common: May affect more than 1 in 100 people
Uncommon: May affect less than 1 in 100 people	Rare: May affect less than 1 in 1,000 people
Very rare: May affect less than 1 in 10,000 people	Frequency not known: Frequency cannot be estimated from the available data

The following adverse 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 as well as hallucinations, anxiety, nightmares, decreased sexual desire

Very rare: dependence, mood changes

Nervous system disorders

Common: dizziness, headache

Uncommon: varying degrees of sedation (calmness), ranging from fatigue to confusion

Rare: difficulty concentrating, speech disorders, confusion, balance disturbances, abnormal skin sensations (feeling of warmth, tingling or numbness)

Very rare: muscle contraction, 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 a drop in blood pressure)

Rare: hot flushes

Respiratory, thoracic and mediastinal disorders

Frequent: shortness of breath

Rare: difficulty breathing (respiratory depression)

Very rare: hyperventilation, hiccups

Gastrointestinal disorders

Very frequent: nausea

Frequent: vomiting, constipation

Uncommon: dry mouth

Rare: stomach acid reflux

Very rare: retching

Skin disorders (usually in the application area)

Very frequent: erythema, pruritus

Frequent: skin changes (rash, usually after repeated use), increased sweating

Uncommon: rashes

Rare: urticarial rash

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), disturbances in urination

Disorders of the reproductive system

Rare: erectile difficulties

General disorders

Common: edema (swelling of the legs), fatigue

Uncommon: weakness (lassitude)

Rare: withdrawal symptoms, reactions at the site of administration

Very rare: chest pain

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

In some cases, delayed local allergic reactions with marked signs of inflammation may occur. In such cases, treatment with Buprenorphine Andrómaco should be discontinued after consulting with your doctor.

If you experience swelling of the hands, feet, knees, face, lips, mouth, or throat, which may cause difficulty swallowing or breathing, hives, fainting, or yellowing of the skin and eyes (also known as jaundice), remove the transdermal patch immediately and consult your doctor or go to the nearest hospital without delay. These may be symptoms of a very rare severe allergic reaction.

Some individuals may experience withdrawal symptoms after using strong painkillers for a prolonged period and then stopping them. After treatment with Buprenorphine Andrómaco, the risk of experiencing withdrawal symptoms is low. However, if you feel agitation, anxiety, restlessness, hyperactivity, sleep disturbances, or gastrointestinal problems, consult your doctor.

Reporting of adverse effects

If you experience any type of adverse effect, speak to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Buprenorphine Andrómaco

Keep this medicine in a safe and secure place, out of reach of others. It may cause serious harm or be fatal to individuals who take it accidentally or intentionally when it has not been prescribed for them.

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and sachet after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Buprenorphine Andromaco

• The active substance is buprenorphine.

Buprenorphine Andromaco 35 micrograms/hour transdermal patch EFG

Contains 20 mg of buprenorphine and releases approximately 35 micrograms of buprenorphine per hour. The area of the transdermal patch containing the active substance is 25 cm2.

• The other components are:

Adhesive matrix: (Z)-9-octadecen-1-yl oleate; 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 non-cross-linked (for the area without buprenorphine); separating layer between the adhesive matrices with and without buprenorphine: poly(ethylene terephthalate) film, coating layer: poly(ethylene terephthalate) fabric. Release liner on the front side covering the adhesive matrix containing buprenorphine, to be removed before applying the transdermal patch: poly(ethylene terephthalate) film, siliconized, coated on one side with aluminium.

Appearance of Buprenorphine Andrómaco and contents of the pack

Skin-coloured transdermal patches with rounded corners, labelled as: Buprenorphine Andrómaco 35 μg/hour EFG, buprenorphine 20 mg.

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

Only certain pack sizes may be commercially available.

Marketing Authorization Holder

Andrómaco Pharma, S.L.

Doctor Zamenhof, 36 - 28027 Madrid, Spain

Manufacturer

Grünenthal GmbH

Zieglerstrasse 6 - D - 52078 Aachen, Germany

Date of the most recent revision of this leaflet: October 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/