BUPRENORPHINE/NALOXONE AUROVITAS 2 mg/0.5 mg SUBLINGUAL TABLETS

Introduction

Package Leaflet: Information for the Patient

Buprenorphine/Naloxone Aurovitas 2 mg/0.5 mg Sublingual Tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Buprenorphine/Naloxone Aurovitas is and what it is used for
2. What you need to know before taking Buprenorphine/Naloxone Aurovitas
3. How to take Buprenorphine/Naloxone Aurovitas
4. Possible side effects
5. Storage of Buprenorphine/Naloxone Aurovitas
6. Package Contents and Additional Information

1. What Buprenorphine/Naloxone Aurovitas is and what it is used for

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

2. What you need to know before taking Buprenorphine/Naloxone Aurovitas

Do not take Buprenorphine/Naloxone Aurovitas

• If you are allergic to buprenorphine, naloxone, or any of the other components of this medication (listed in section 6).
• If you have severe respiratory problems.
• If you have severe liver problems.
• If you are intoxicated due to alcohol or if you have tremors, sweating, anxiety, confusion, or hallucinations caused by alcohol.
• If you are taking naltrexone or nalmefene for the treatment of alcohol or opioid dependence.

Warnings and Precautions

Consult your doctor before starting to take this medication if you have:

• Asthma or other respiratory problems.
• Liver problems, such as hepatitis.
• Low blood pressure.
• A recent head injury or brain disease.
• Any urinary 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 illnesses treated with antidepressants.
• The use of these medications with buprenorphine/naloxone may cause serotonin syndrome, a potentially life-threatening disease (see "Other Medications and Buprenorphine/Naloxone Aurovitas").

Sleep-Related Breathing Disorders

Buprenorphine/Naloxone Aurovitas may cause sleep-related breathing disorders, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels). Symptoms may include pauses in breathing 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 a dose reduction.

Important Aspects to Consider

• 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 buprenorphine 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), potentially 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 stop treatment".

• Liver Damage

Liver damage has been reported after taking buprenorphine/naloxone, especially when the medication is misused. It 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 buprenorphine/naloxone.

• 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 in the diagnosis of some diseases. You should inform your doctor that you are taking this medication.

Children and Adolescents

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

Other Medications and Buprenorphine/Naloxone Aurovitas

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

Some medications may increase the adverse effects of buprenorphine/naloxone 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 buprenorphine/naloxone and sedatives like benzodiazepines or related medications increases the risk of somnolence, difficulty breathing (respiratory depression), and coma, and may be potentially fatal. For this reason, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes buprenorphine/naloxone with sedatives, your doctor should limit the dose and duration of concomitant treatment. Inform your doctor about all sedatives you are taking and follow your doctor's dosage recommendation strictly. It may be helpful to inform your friends or family to be alert to the signs and symptoms mentioned above. Contact your doctor if you experience these symptoms.
• Gabapentin or pregabalin used to treat epilepsy or nerve pain (neuropathic pain).
• Other medications that may cause somnolence and are usedto treat diseases such as anxiety, insomnia, seizures/epileptic fits, or pain. This type of medication will reduce your level of alertness, making it difficult to drive and use machines. They may also cause central nervous system depression, which is very serious. The following is a list of examples of this type of medication:

• Other medications that contain opioids, such as methadone, some pain relievers, or cough suppressants.
• Antidepressants (used to treat depression) such as isocarboxazid, phenelzine, selegiline, tranylcypromine, and valproate may enhance the effects of this medication.
• Sedating antihistamines (for the treatment of allergic reactions) such as diphenhydramine and chlorphenamine.
• Barbiturates (used to produce sleep or sedation) such as phenobarbital or secobarbital.
• Sedatives (used to produce sleep or sedation) such as chloral hydrate.

• Antidepressantssuch as moclobemide, tranylcypromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepin, or trimipramine. These medications may interact with buprenorphine/naloxone, and you may experience symptoms such as involuntary muscle contractions, including muscles that control eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, and body temperature above 38°C. Contact your doctor if you experience these symptoms.

• Clonidine (used to treat high blood pressure) may enhance the effects of this medication.
• Antiretrovirals (used to treat HIV) such as ritonavir, nelfinavir, or indinavir may enhance the effects of this medication.
• Certain antifungals (for the treatment of fungal infections) such as ketoconazole, itraconazole, or certain antibiotics may prolong the effects of this medication.
• Some medications may decrease the effect of buprenorphine/naloxone, such as medications used to treat epilepsy (carbamazepine and phenytoin) and medications used to treat tuberculosis (rifampicin).
• Naltrexone and nalmefene (medications used to treat addictive disorders) may prevent the therapeutic effects of buprenorphine/naloxone. They should not be taken at the same time as treatment with buprenorphine/naloxone, as you may experience a sudden onset of prolonged and intense withdrawal.

Use of Buprenorphine/Naloxone Aurovitas with Food, Drinks, and Alcohol

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

Pregnancy and Breastfeeding

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

The risks of using buprenorphine/naloxone 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 buprenorphine/naloxone may lead to withdrawal symptoms in the newborn, including respiratory problems. This may occur several days after birth.

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

Driving and Using Machines

Do not drive or ride a bicycle, do not use tools or machines, and do not engage in hazardous activities until you know how this medication affects you. This medication may cause somnolence, dizziness, or altered thinking. This may occur more frequently in the first weeks of treatment, when the dose is being changed, but it may also occur if you drink alcohol or take other sedative medications at the same time as taking buprenorphine/naloxone.

Buprenorphine/Naloxone 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 (1 mmol) per tablet; it is essentially "sodium-free".

3. How to Take Buprenorphine/Naloxone Aurovitas

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

Treatment is prescribed and monitored by doctors with experience in treating drug addiction.

Your doctor will determine the best dose for you. During your treatment, your doctor may adjust the dose of buprenorphine/naloxone you take based on your response to treatment.

Starting Treatment

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

This dose may be repeated up to a maximum dose of 12 mg/3 mg on day 1, depending on your needs.

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

• Starting Treatment with Buprenorphine/Naloxone Aurovitas if you are Heroin-Dependent:If you are dependent on heroin or a short-acting opioid, the first dose of buprenorphine/naloxone should be taken when withdrawal signs appear, at least 6 hours after the last time you used opioids.

• Starting Treatment with Buprenorphine/Naloxone Aurovitas if you are Methadone-Dependent:If you have been taking methadone or a long-acting opioid, it is ideal that the dose be reduced to less than 30 mg/day before starting treatment with this medication. The first dose of buprenorphine/naloxone should be taken when withdrawal signs appear, and at least 24 hours after the last time you used methadone.

How to Take Buprenorphine/Naloxone Aurovitas

• Take the dose once a day by placing the tablet under your tongue.
• Keep the tablet under your tongue until it has completely dissolved. This may take about 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 starting treatment, your doctor may increase the dose of buprenorphine/naloxone you take based on your needs. If you think the effect of buprenorphine/naloxone is too strong or too weak, inform your doctor or pharmacist. The maximum daily dose is 24 mg of buprenorphine.

After a period of satisfactory treatment, you may 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 be further reduced under close medical supervision until it can finally be stopped.

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

If you take more Buprenorphine/Naloxone Aurovitas than you should

If you or someone else takes an excessive amount of this medication, you or they should go immediately to an emergency department or hospital for treatment, as an overdose of buprenorphine/naloxone can cause severe and potentially life-threatening respiratory problems.

Symptoms of overdose may include drowsiness and disorientation with slow reflexes, blurred vision, and/or difficulty speaking. You may not be able to think clearly and breathe much more slowly than usual for you.

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

If you forget to take Buprenorphine/Naloxone Aurovitas

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

If you stop treatment with Buprenorphine/Naloxone Aurovitas

Do not change the treatment in any way or stop it without the authorization of the doctor treating you. Sudden stopping of treatment may cause withdrawal symptoms.

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

4. Possible Adverse Effects

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Report immediately to your doctor or seek urgent medical attentionif you feel adverse effects such as:

• Swelling of the face, lips, tongue, or throat, which may cause difficulty swallowing or breathing; hives or intense rash. These may be signs of a potentially life-threatening allergic reaction.
• Feeling of drowsiness and discoordination, blurred vision, difficulty speaking, inability to think clearly, or slower breathing than normal for you.

Also, report immediately to your doctorif you feel adverse effects such as:

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

Adverse Effects Reported with Buprenorphine/Naloxone Aurovitas

Very Common Adverse Effects (may affect more than 1 in 10 people):

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

• Common Adverse Effects (may affect up to 1 in 10 people):
• Weight loss, swelling of hands and feet, drowsiness, anxiety, nervousness, tingling, depression, decreased sexual desire, increased muscle tension, abnormal thinking, increased tear production (tearful eyes) or other crying disorders, blurred vision, flushing, increased blood pressure, migraines, nasal secretion, sore throat and difficulty swallowing, increased cough, stomach discomfort or other stomach disorders, diarrhea, liver function abnormalities, flatulence, vomiting, skin rash, itching, hives, pain, joint pain, muscle pain, leg cramps (muscle spasms), difficulty achieving or maintaining an erection, urine abnormalities, abdominal pain, lower back pain, weakness, infection, chills, chest pain, fever, flu-like symptoms, feeling of general discomfort, accidental injury due to loss of alertness or coordination, fainting, and dizziness.

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

• Frequency Not Known (cannot be estimated from available data)

Sudden withdrawal syndrome caused by taking Buprenorphine/Naloxone Aurovitas too soon after using illegal opioids, drug withdrawal syndrome in newborns. Slow or difficult breathing, tooth decay, liver damage with or without jaundice, hallucinations, swelling of the face and throat or potentially life-threatening allergic reactions, decrease in blood pressure when changing position from sitting or lying down to standing.

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Buprenorphine/Naloxone Aurovitas

Keep this medication out of sight and reach of children and other family members. It can cause serious harm and be fatal for people who take this medication accidentally or intentionally when it has not been prescribed for them.

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

Store below 30°C.

This medication may be a target for people who abuse prescription medications. Keep this medication in a safe place to protect it from theft.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE Point. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Buprenorphine/Naloxone Aurovitas

• The active ingredients are buprenorphine and naloxone.

Each 2 mg/0.5 mg tablet contains 2 mg of buprenorphine (as hydrochloride) and 0.5 mg of naloxone (as dihydrate hydrochloride).

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

Product Appearance and Package Contents

White to off-white, round, and biconvex sublingual tablets with a score line on one side. 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 marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

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 medication is authorized in the Member States of the European Economic Area under the following names:

Spain Buprenorphine/Naloxone Aurovitas 2 mg/0.5 mg sublingual tablets EFG

France BUPRÉNORPHINE/NALOXONE ARROW 2 mg/0.5 mg sublingual tablet

Netherlands Buprenorfine/Naloxon Aurobindo 2 mg/0.5 mg tablets for sublingual use

Portugal Buprenorfina + Naloxona Generis

Date of the Last Revision of this Prospectus:February 2025

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