Buprenorphine Andromaco 70 micrograms/hour transdermal patch EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Buprenorphine Andrómaco 70 micrograms/hour transdermal patch EFG

Buprenorphine

Read all of this leaflet carefully before you start using this medicine, as 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 may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the 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 disease in which you have great difficulty breathing or in which this could occur,
• if you are taking 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 after 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, which is known as tolerance). Repeated use of Buprenorphine Andrómaco may also lead to dependence, abuse, and addiction, which may 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 be at 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 ever had problems with your mood (depression, anxiety, or a personality disorder) or have received treatment from a psychiatrist for other mental illnesses.

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

• You need to take the medicine for longer than recommended by your doctor.
• You need to take higher doses than recommended.
• You are using the medicine for reasons other than those prescribed, for example, "to calm down" or "to help you sleep".
• You have made repeated unsuccessful attempts to stop or control the 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, speak with your doctor to discuss the most appropriate treatment 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 (feeling dizzy 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 injury or brain disease), without the possibility of artificial respiration,
• if you have difficulty breathing or are taking other medicines that may cause you to breathe more slowly or weakly (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. Also, 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 breathing disorders

Buprenorphine Andrómaco may cause sleep-related breathing disorders such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels during sleep). 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 notices 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 some patients to feel drowsy, vomit, feel dizzy, or to breathe more slowly or weakly. These adverse effects may be intensified if taken at the same time as other medicines that can produce similar effects. These other medicines include strong painkillers (opioids), certain sleeping medicines, anaesthetics, and medicines used to treat certain psychological conditions such as tranquilisers, antidepressants, antipsychotics, and gabapentin or pregabalin used to treat epilepsy or nerve-related pain (neuropathic pain).

Inform your doctor or pharmacist if you are taking:

• medicines used to treat allergies or travel sickness (antihistamines or antiemetics);
• medicines used to treat psychiatric disorders (antipsychotics or neuroleptics);
• muscle relaxants;
• medicines used to treat Parkinson’s disease.

The concomitant use of Buprenorphine Andrómaco with sedatives or medicines used to treat 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, your dose and duration of concomitant treatment should be limited. Inform your doctor about all sedative medicines you are taking and strictly follow your doctor’s dosing instructions. It may be helpful to inform your friends and family about the signs and symptoms described above. Contact your doctor if you experience any of these symptoms.

• If 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 medicines for HIV (e.g. those containing ritonavir).

• If 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 used to treat 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, in some cases, may 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, doxepin, or trimipramine. These medicines may interact with Buprenorphine Andrómaco and you may experience symptoms such as involuntary rhythmic muscle contractions, including in the 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 currently insufficient experience with the use of Buprenorphine Andromaco in pregnant women. Therefore, Buprenorphine Andromaco 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 Andromaco should not be used during breastfeeding.

Driving and use of machines

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

This especially applies:

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

If affected, you should not drive or operate machinery while using Buprenorphine Andromaco. This also applies at the end of treatment with Buprenorphine Andromaco. 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 Andromaco

Follow exactly the instructions for administration 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 Andromaco").

This medicine is available in three strengths: Buprenorphine Andromaco 35 micrograms/hour transdermal patch EFG, Buprenorphine Andromaco 52.5 micrograms/hour transdermal patch EFG, and Buprenorphine Andromaco 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 the transdermal patch you are using to one with a lower or higher strength if necessary.

The recommended dose is:

Adults

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

Apply the transdermal patch (as detailed below) and change it after four days at the latest. To make it easier to use, 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 carton. If your doctor has instructed you to take other analgesics in addition to the transdermal patch, follow your doctor's instructions strictly; otherwise, you will not fully benefit from treatment with this medicine.

Use in children and adolescents

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

Elderly patients

No dose adjustment is required in elderly patients.

Renal impairment patients / patients undergoing dialysis

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

Hepatic impairment patients

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 clavicle 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 has hair, trim it with scissors. Do not shave it!
• 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 side of the transdermal patch.
	Step 3: Apply the transdermal patch to the skin area you have chosen 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 transdermal 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 correctly applied, 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 carefully, 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 Andrómaco").

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

If you use more Buprenorphine Andrómaco than you should

If this happens, there may be signs of buprenorphine overdose. An overdose may 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 that you have used more buprenorphine transdermal patches than you should, remove the excess patches and contact 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 medication and the amount used.

If you forget to use Buprenorphine Andrómaco

If you forget to apply a patch, apply 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 apply the new patch until Wednesday, from now on you will need to change your patches on Wednesdays and Saturdays. Record the new pair of days on the calendar in the carton. 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 Andrómaco

If you interrupt or stop treatment with buprenorphine too early, your pain may 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 them. The risk of experiencing effects after discontinuing this medicine is very low. However, if you feel restless, 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 and hallucinations, anxiety, nightmares, decreased libido

Very rare: dependence, mood changes

Nervous system disorders

Common: dizziness, headache

Uncommon: various degrees of sedation (calmness), ranging from tiredness to confusion

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

Very rare: muscle twitching, taste disturbances

Eye disorders

Rare: visual disturbances, blurred vision, eyelid swelling

Very rare: pinpoint pupils

Ear and labyrinth disorders

Very rare: ear pain

Cardiac and vascular disorders

Uncommon: circulatory disturbances (such as hypotension or, rarely, fainting due to a drop in blood pressure)

Rare: hot flushes

Respiratory, thoracic and mediastinal disorders

Common: shortness of breath

Rare: breathing difficulty (respiratory depression)

Very rare: hyperventilation, hiccups

Gastrointestinal disorders

Very common: nausea

Common: vomiting, constipation

Uncommon: dry mouth

Rare: heartburn

Very rare: retching

Skin disorders (usually at the application site)

Very common: erythema, pruritus

Common: skin changes (rash, usually due to 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 burning sensation), skin discoloration

Urinary and renal disorders

Uncommon: urinary retention (less urine than normal), micturition disturbances

Reproductive system disorders

Rare: erection difficulties

General disorders

Common: edema (swelling of legs), fatigue

Uncommon: weakness (lassitude)

Rare: withdrawal symptoms, reactions at the application site

Very rare: chest pain

If you notice any of the adverse effects listed 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 your doctor.

If you experience swelling of the hands, feet, knees, face, lips, mouth or throat, which may cause difficulty swallowing or breathing, urticarial rash, 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 people 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, nervousness, hyperactivity, sleep disturbances, or digestive problems, consult your doctor.

Reporting of adverse reactions

If you experience any adverse reaction, talk to your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, 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 the 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. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the container and additional information

Composition of Buprenorphine Andrómaco

• The active substance is buprenorphine.

Buprenorphine Andrómaco 70 micrograms/hour transdermal patch EFG

Contains 40 mg of buprenorphine, releasing approximately 70 micrograms of buprenorphine per hour. The area of the transdermal patch containing the active substance is 50 cm2.

• 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 film 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: siliconized poly(ethylene terephthalate) film, coated on one side with aluminum.

Appearance of Buprenorphine Andrómaco and contents of the pack

Skin-colored transdermal patches with rounded corners labelled as: Buprenorphine Andrómaco 70 μg/hour EFG, buprenorphine 40 mg.

Supplied 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 marketed.

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 review of this leaflet: October 2025

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