Prospecto: information for the patient

Buprenorphine/Naloxone Aurovitas 8 mg/2 mg sublingual tablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to other people 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, even if they are not listed in this prospect. See section 4.

1. What isBuprenorphine/Naloxone Aurovitasand for what it is used

2. What you need to know before starting to takeBuprenorphine/Naloxone Aurovitas

3. How to takeBuprenorphine/Naloxone Aurovitas

4. Possible adverse effects

5. Storage ofBuprenorphine/Naloxone Aurovitas

6. Contents of the package and additional information

This medication is used to treat dependence on opioid drugs (narcotics), such as heroin and morphine, in individuals who have given their consent to be treated for their addiction.This medication is used in adults and older adolescents over 15 years old who are also receiving medical, social, and psychological support.

Do not take Buprenorfina/Naloxona Aurovitas

• If you are allergic to buprenorfina, naloxona or any of the components of this medication (listed in section 6).
• If you have severe respiratory problems.
• If you have severe liver problems.
• If you are intoxicated with alcohol, or if you have tremors, sweating, anxiety, confusion or hallucinations caused by alcohol.
• If you are taking naltrexona or nalmefeno for the treatment of alcohol or opioid dependence.

Warnings and precautions

Consult your doctor before starting this medication if you have:

• Asthma or other respiratory problems.
• Liver problems, such as hepatitis.
• Low blood pressure.
• A recent head injury or recent brain disease.
• Any urinary tract disorder (especially related to an enlarged prostate in men).
• Any kidney disease.
• Thyroid problems.
• Any corticosteroid disorder (e.g., Addison's disease).
• Depression or other conditions treated with antidepressants.
• The use of these medications with buprenorfina/naloxona may cause serotonin syndrome, a potentially fatal condition (see "Other medications and Buprenorfina/Naloxona Aurovitas").

Respiratory problems related to sleep

Buprenorfina/Naloxona Aurovitas may cause respiratory problems 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.

Important considerations

• In case of accidental ingestion or suspected ingestion, contact an emergency unit immediately.

• Additional monitoring

If you are over 65 years old, your doctor may monitor you more closely.

• Abuse and misuse

This medication may be a target for people who abuse prescription medications. Keep this medication in a safe place to protect it from theft (see section 5).Do not give this medication to anyone else.It may cause death or other harm.

• Respiratory problems

Some people have died from respiratory failure (inability to breathe) because they used buprenorfina improperly or took it in combination with other central nervous system depressants, such as alcohol, benzodiazepines (tranquilizers) or other opioids.

This medication may cause severe respiratory depression (difficulty breathing), possibly fatal, in children and non-dependent individuals if ingested accidentally or intentionally.

• Dependence

This medication may cause dependence.

• Withdrawal symptoms

This medication may cause opioid withdrawal symptoms if taken too soon after using opioids. You should wait at least 6 hours after using a short-acting opioid (e.g., morphine, heroin) or at least 24 hours after using a long-acting opioid, such as methadone.

This medication may also cause withdrawal symptoms if you stop taking it suddenly. See section 3 "If you interrupt treatment".

• Liver damage

There have been reports of liver damage after taking buprenorfina/naloxona, especially when the medication is used improperly. This may also be due to viral infections (e.g., chronic hepatitis C), alcohol abuse, anorexia, or the use of other medications that can damage the liver (see section 4).Your doctor may order frequent blood tests to monitor your liver function. Inform your doctor if you have had any liver problems before starting treatment with buprenorfina/naloxona..

• Blood pressure

This medication may cause a sudden drop in blood pressure, making you feel dizzy if you stand up too quickly after sitting or lying down.

• Diagnosis of unrelated medical conditions

This medication may mask the symptoms of pain that could help diagnose some diseases. You should inform your doctor that you are taking this medication.

Children and adolescents

Do not administer this medication to children under 15 years old. If you are between 15 and 18 years old, your doctor may monitor you more closely during treatment, due to a lack of data in this age group.

Other medications and Buprenorfina/Naloxona Aurovitas

Inform your doctor if you are taking, have taken recently, or may need to take any other medication.

Some medications may increase the adverse effects of buprenorfina/naloxona and may be severe. Do not take other medications at the same time without consulting your doctor first, especially:

• Benzodiazepines(used to treat anxiety or sleep disorders) such as diazepam, temazepam or alprazolam. The concomitant use of buprenorfina/naloxona and sedatives such as benzodiazepines or related medications increases the risk of drowsiness, difficulty breathing (respiratory depression) and 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/naloxona with sedatives, your doctor should limit the dose and duration of concomitant treatment. Inform your doctor about all sedatives you take and follow your doctor's dosage recommendation strictly. It may be helpful to inform your friends or family to be aware of the previously mentioned symptoms. Contact your doctor if you experience these symptoms.
• Gabapentina or pregabalina used to treat epilepsy or pain due to nerve problems (neuropathic pain).
• Other medications that may cause drowsiness and are used to treat diseases such as anxiety, insomnia, seizures/epileptic crises or pain. This type of medication reduces your level of alertness, making it difficult to drive and use machines. They may also cause central nervous system depression, which is very severe. The following is a list of examples of this type of medication:

• Other medications that contain opioids, such as methadone, some analgesics or antitussives.
• Antidepressants (used to treat depression) such as isocarboxazida, fenelzina, selegilina, tranilcipromina and valproato, may potentiate the effects of this medication.
• Antihistamines (used to treat allergic reactions) such as difenhidramina and clorfenamina.
• Barbiturates (used to induce sleep or sedation) such as phenobarbital or secobarbital.
• Tranquilizers (used to induce sleep or sedation) such as chloral hydrate.

• Antidepressantssuch as moclobemida, tranilcipromina, citalopram, escitalopram, fluoxetina, fluvoxamina, paroxetina, sertralina, duloxetina, venlafaxina, amitriptilina, doxepina or trimipramina. These medications may interact with buprenorfina/naloxona 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.

• Clonidina (used to treat high blood pressure) may potentiate the effects of this medication.
• Antiretrovirals (used to treat HIV) such as ritonavir, nelfinavir or indinavir may potentiate the effects of this medication.
• Determined antifungals (used to treat fungal infections) such as ketoconazol, itraconazol or certain antibiotics may prolong the effects of this medication.
• Some medications may decrease the effect of buprenorfina/naloxona, such as medications used to treat epilepsy (carbamazepina and fenitoína) and medications used to treat tuberculosis (rifampicina).
• Naltrexona and nalmefeno (medications used to treat addictive disorders) may prevent the therapeutic effects of buprenorfina/naloxona. Do not take them at the same time as buprenorfina/naloxona treatment, as you may experience a sudden onset of prolonged and intense withdrawal symptoms.

Use of Buprenorfina/Naloxona Aurovitas with food, drinks and alcohol

Do not drink alcoholwhile receiving treatment with this medication. Alcohol may increase drowsiness and the risk of respiratory failure if taken with buprenorfina/naloxona. Do not swallow or consume food or drinks until the tablet has completely dissolved.

Pregnancy and breastfeeding

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

The risks of using buprenorfina/naloxona in pregnant women are unknown. Your doctor will decide whether your treatment should continue with another medication.

When taken during pregnancy, especially in the last months, medications like buprenorfina/naloxona may cause withdrawal symptoms, including respiratory problems in the newborn. This may occur several days after birth.

Do not breastfeed while taking this medication, as buprenorfina is excreted in breast milk.

Driving and using machines

Do not drive or ride a bike, do not use tools or machines, or perform hazardous activities until you know how this medication affects you. This medication may cause drowsiness, dizziness or altered thinking. This may occur more frequently in the first weeks of treatment, when the dose is changing, but it may also occur if you drink alcohol or take other sedatives at the same time as taking buprenorfina/naloxona.

Buprenorfina/Naloxona Aurovitas contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 23 mg of sodium (1mmol) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The treatment is prescribed and monitored by doctors who have experience in the treatment of addiction.

Your doctor will determine what is the best dose for you. During your treatment, the doctor may adjust your dose according to your response to the treatment.

Starting treatment

The initial recommended dose in adults and adolescents over 15 years old is 4 mg/1 mg in sublingual tablets.

This dose can be repeated up to a maximum dose of 12 mg/3 mg per day 1, according to your needs.

Before taking your first dose of buprenorphine/naloxone, you must know the clear symptoms of withdrawal. Your doctor will tell you when to take your first dose.

• Starting treatment with Buprenorphina/Naloxona Aurovitas if you are dependent on heroin:if you are dependent on heroin or a rapid-acting opioid, the first dose of buprenorphine/naloxone should be taken when withdrawal symptoms appear, at least6 hours after the last time you consumed opioids.

• Starting treatment with Buprenorphina/Naloxona Aurovitas if you are dependent on methadone:if you have been taking methadone or a long-acting opioid, it is best to reduce the dose to less than 30 mg/day before starting treatment with this medication. The first dose of buprenorphine/naloxone should be taken when withdrawal symptoms appear, and at least24 hours after the last time you consumed methadone.

How to take Buprenorphina/Naloxona Aurovitas

• Take the dose once a day by placing the tablet under the tongue.
• Keep the tablet under the tongue until it hascompletely dissolved. This may take 5-10 minutes.
• Do not chew or swallow the tablets, as the medication will not work and you will experience withdrawal symptoms.
• Do not consume food or drinks until the tablets have completely dissolved.

Dose adjustment and maintenance treatment

During the days after the start of treatment, your doctor may increase the dose of buprenorphine/naloxone you take, according to your needs. If you think the effect of buprenorphine/naloxone is too intense or too weak, inform your doctor or pharmacist.The maximum daily dose is 24 mg of buprenorphine.

After a satisfactory period of treatment, you can agree with your doctor to gradually reduce the dose to a lower maintenance dose.

Stopping treatment

Depending on your condition, the dose of buprenorphine/naloxone may continue to decrease under close medical supervision, until you can finally stop treatment.

Do not change the treatment in any way or stop it without the authorization of the doctor who is treating you.

If you take moreBuprenorphina/Naloxona Aurovitas than you should

If you or someone else takes an excessive amount of this medication, go or take them immediately to an emergency service or hospital to receive treatment, as aoverdoseof buprenorphine/naloxone can cause severe and potentially fatal respiratory problems.

The symptoms of an overdose may include a feeling of drowsiness and discoordination with slow reflexes, blurry vision and/or difficulty speaking. You may not be able to think clearly and breathe more slowly than usual for you.

You can also inform your doctor immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to takeBuprenorphina/Naloxona Aurovitas

If you forget to take a dose, inform your doctor as soon as possible.

If you interrupt treatment withBuprenorphina/Naloxona Aurovitas

Do not change the treatment in any way or stop it without the authorization of the doctor who is treating you.Stopping treatment abruptly can cause withdrawal symptoms.

If you have any other doubts 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.

Inform your doctor or seek urgent medical attention immediatelyif you experience side effects such as:

• Swelling of the face, lips, tongue, or throat, which can cause difficulty swallowing or breathing; rashes or intense eruptions. These may be signs of a potentially fatal allergic reaction.
• Feeling drowsy and disoriented, blurred vision, difficulty speaking, unable to think clearly, or your breathing is much slower than normal for you.

Also, inform your doctor immediatelyif you experience side effects such as:

• Intense fatigue, itching with yellowish discoloration of the skin or eyes. These may be signs of liver damage.
• Seeing or hearing things that do not exist (hallucinations).

Side effects reported with Buprenorphine/Naloxone Aurovitas

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

Insomnia (inability to sleep), constipation, nausea, excessive sweating, headache, withdrawal syndrome from drugs.

• Common side effects (may affect up to 1 in 10 people):
• Weight loss, swelling of hands and feet, drowsiness, anxiety, nervousness, numbness, depression, decreased libido, increased muscle tension, abnormal thinking, increased tearing (tearful eyes) or other tear disorders, blurred vision, flushing, increased blood pressure, migraines, nasal secretion, sore throat, and difficulty swallowing, increased cough, stomach discomfort or other types of stomach upset, diarrhea, abnormal liver function, flatulence, vomiting, skin eruptions, itching, rashes, pain, joint pain, muscle pain, muscle cramps (muscle spasms), difficulty achieving or maintaining an erection, abnormal urination, abdominal pain, lower back pain, weakness, infection, chills, chest pain, fever, symptoms similar to the flu, general feeling of discomfort, accidental injury due to loss of alertness or coordination, fainting, and dizziness.

• Rare side effects (may affect up to 1 in 100 people):
• Lymph node inflammation, agitation, tremors, abnormal dreams, excessive muscle activity, depersonalization (not feeling like oneself), medication dependence, amnesia (memory disorder), loss of interest, exaggerated sense of well-being, convulsions (seizures), speech disorder, small pupil size, difficulty urinating, eye inflammation or infection, slow or rapid heart rate, low blood pressure, palpitations, heart attack, feeling of oppression in the chest, difficulty breathing, asthma, yawning, mouth pain and ulcers, tongue discoloration, acne, nodules on the skin, hair loss, dry or flaking skin, joint inflammation, urinary tract infection, abnormal blood test results, blood in the urine, abnormal ejaculation, menstrual or vaginal problems, kidney stones, proteins in the urine, pain or difficulty urinating, sensitivity to heat or cold, heatstroke, loss of appetite, feelings of hostility.

• Unknown frequency (cannot be estimated from available data)

Subcutaneous withdrawal syndrome caused by taking Buprenorphine/Naloxone Aurovitas too soon after using illegal opioids, drug withdrawal syndrome in newborns. Slow breathing or difficulty breathing, tooth decay, liver damage with or without jaundice, hallucinations, facial and throat swelling, or potentially fatal allergic reactions, decreased blood pressure when changing from a sitting or lying position to standing.

The misuse of this medication, injecting it, can cause withdrawal symptoms, infections, other skin reactions, and potentially serious liver problems (see Warnings and Precautions).

Reporting 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 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 medication.

Keep this medication out of the sight and reach of children and other family members. It may cause severe harm and be fatal to individuals who take this medication accidentally or intentionally when not prescribed.

Do not use this medication after the expiration date appearing on the blister and carton. The expiration date is the last day of the month indicated.

Store below 30°C.

This medication may be a target for individuals who abuse prescription medications. Keep this medication in a secure location to protect it from theft.

Medications should not be disposed of through drains or trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Composition ofBuprenorphine/Naloxone Aurovitas

• The active principles are buprenorphine and naloxone.

Each sublingual tablet of 8 mg/2 mg contains 8 mg of buprenorphine (as hydrochloride) and 2 mg of naloxone (as dihydrate hydrochloride).

• The other components are: lactose monohydrate, mannitol, maize starch, povidone, citric acid anhydrous, sodium citrate, magnesium stearate, potassium acesulfame, and lemon and lime flavor.

Appearance of the product and contents of the package

White to off-white, round, biconvex sublingual tablets with a notch on one face. The tablet can be divided into equal doses.

The tablets are packaged in blister packs within a cardboard box containing 7, 14, and 28 tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer:

G.L. Pharma GmbH

Schlossplatz 1

Lannach, 8502

Austria

or

Arrow Generiques – Lyon

26 avenue Tony Garnier,

Lyon, 69007

France

or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

SpainBuprenorphine/Naloxone Aurovitas 8 mg/2 mg sublingual tablets EFG

FranceBUPRÉNORPHINE/NALOXONE ARROW 8 mg/2 mg sublingual tablet

NetherlandsBuprenorphine/Naloxon Aurobindo 8 mg/2 mg tablets for sublingual use

PortugalBuprenorphine + Naloxone Generis

Last review date of this leaflet:February 2025

For detailed and updated information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es)