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

Patient Information Leaflet

Introduction

Patient Information Leaflet

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

Read the entire leaflet carefully before you start taking 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. Do not pass it on 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 adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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. How to store Buprenorphine/Naloxone Aurovitas
6. Contents of the pack and other information

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

This medicine is used to treat dependence on opioid drugs (narcotics), such as heroin and morphine, in individuals addicted to drugs who have consented to be treated for their addiction. This medicine 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 ingredients of this medicine (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

Talk to your doctor before starting this medicine if you have:

• Asthma or other respiratory problems.
• Liver problems, such as hepatitis.
• Low blood pressure.
• A head injury or recent brain illness.
• A urinary disorder (especially related to an enlarged prostate in men).
• Kidney disease.
• Thyroid problems.
• Adrenocortical insufficiency (e.g., Addison's disease).
• Depression or other conditions treated with antidepressants.
• Taking these medicines together with buprenorphine/naloxone may cause serotonin syndrome, a potentially life-threatening condition (see "Other medicines 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 breathing pauses during sleep, waking up at night due to difficulty breathing, trouble staying asleep, or excessive daytime sleepiness. Contact your doctor if you or someone else notices these symptoms. Your doctor may consider reducing your dose.

Important points 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.

• Misuse and abuse

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

• Respiratory problems

Some people have died from respiratory failure (inability to breathe) after misusing buprenorphine or taking it together with other central nervous system depressants such as alcohol, benzodiazepines (tranquilizers), or other opioids.

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

• Dependence

This medicine may cause dependence.

• Withdrawal symptoms

This medicine 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 medicine may also cause withdrawal symptoms if you stop taking it suddenly. See section 3 “If you stop taking the medicine”.

• Liver effects

Liver injury has been reported after taking buprenorphine/naloxone, especially with inappropriate use of the medicine. This may also be due to viral infections (e.g., chronic hepatitis C), alcohol abuse, anorexia, or use of other medicines that may harm the liver (see section 4). Your doctor may recommend 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 medicine may cause a sudden drop in blood pressure, making you feel dizzy when standing up quickly after sitting or lying down.

• Diagnosis of unrelated medical conditions

This medicine may mask pain symptoms that could help in diagnosing certain illnesses. You should inform your doctor that you are taking this medicine.

Children and adolescents

Do not give this medicine 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 limited data in this age group.

Other medicines and Buprenorphine/Naloxone Aurovitas

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

Some medicines may increase the adverse effects of buprenorphine/naloxone and may be serious. Do not take other medicines 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 such as benzodiazepines or related medicines increases the risk of drowsiness, difficulty breathing (respiratory depression), and coma, and could be potentially fatal. Therefore, concomitant use should only be considered when no other treatment options are available. However, if your doctor prescribes buprenorphine/naloxone together with sedatives, your doctor should limit the dose and duration of concomitant treatment. Inform your doctor about all sedatives you are taking and strictly follow your doctor’s dosing recommendations. It may be helpful to inform your friends or family to be alert for the signs and symptoms mentioned above. Contact your doctor if you experience these symptoms.

• Gabapentin or pregabalin used to treat epilepsy or nerve-related pain (neuropathic pain).

• Other medicines that may cause drowsiness and are used to treat conditions such as anxiety, insomnia, seizures/epileptic fits, or pain. These medicines may reduce your level of alertness, making driving and operating machinery difficult. They may also cause central nervous system depression, which is very serious. Listed below are examples of such medicines:

• Other medicines containing opioids, such as methadone, some painkillers, or cough suppressants.

• Antidepressants (used to treat depression) such as isocarboxazid, phenelzine, selegiline, tranylcypromine, and valproate, which may enhance the effects of this medicine.

• Sedating H1-receptor antagonists (for treating allergic reactions) such as diphenhydramine and chlorphenamine.

• Barbiturates (used to induce sleep or sedation) such as phenobarbital or secobarbital.

• Tranquilizers (used to induce sleep or sedation) such as chloral hydrate.

• Antidepressants such as moclobemide, tranylcypromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepin, or trimipramine. These medicines may interact with buprenorphine/naloxone 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 tone, 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 medicine.

• Antiretrovirals (used to treat HIV) such as ritonavir, nelfinavir, or indinavir may enhance the effects of this medicine.

• Certain antifungals (for treating fungal infections) such as ketoconazole, itraconazole, or certain antibiotics may prolong the effects of this medicine.

• Some medicines may reduce the effect of buprenorphine/naloxone, such as medicines used to treat epilepsy (carbamazepine and phenytoin) and medicines used to treat tuberculosis (rifampicin).

• Naltrexone and nalmefene (medicines used to treat addictive disorders) may block the therapeutic effects of buprenorphine/naloxone. They should not be taken at the same time as buprenorphine/naloxone treatment, as you may experience sudden, prolonged, and intense withdrawal symptoms.

Taking Buprenorphine/Naloxone Aurovitas with food, drinks, and alcohol

Do not drink alcohol while taking this medicine. Alcohol may increase drowsiness and the risk of respiratory failure when 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 medicine.

The risks of using buprenorphine/naloxone in pregnant women are unknown. Your doctor will decide whether your treatment should continue with another medicine.

Medicines such as buprenorphine/naloxone, when taken during pregnancy—especially in the last months—may cause withdrawal symptoms in the newborn, including breathing problems. This may occur several days after birth.

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

Driving and using machines

Do not drive or ride a bicycle, operate tools or machinery, or perform hazardous activities until you know how this medicine affects you. This medicine may cause drowsiness, dizziness, or impaired thinking. This is more likely during the first weeks of treatment or when your dose is being adjusted, but may also occur if you drink alcohol or take other sedative medicines together with buprenorphine/naloxone.

Buprenorphine/Naloxone Aurovitas contains lactose

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

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; hence, it is essentially “sodium-free”.

3. How to take Buprenorphine/Naloxone Aurovitas

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

Treatment is prescribed and monitored by doctors experienced in the treatment of opioid addiction.

Your doctor will determine the best dose for you. During your treatment, your doctor may adjust your dose 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 recognize clear symptoms of withdrawal. 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 your last opioid use.

• Starting treatment with Buprenorphine/Naloxone Aurovitas if you are methadone-dependent: If you have been taking methadone or a long-acting opioid, it is advisable to reduce your dose to less than 30 mg/day before starting treatment with this medicine. The first dose of buprenorphine/naloxone should be taken when withdrawal signs appear, and at least 24 hours after your last methadone use.

How to take Buprenorphine/Naloxone Aurovitas

• Take your dose once daily by placing the tablet under the tongue.
• Keep the tablet under the tongue until it has completely dissolved. This may take about 5–10 minutes.
• Do not chew or swallow the tablets, as the medicine will not work and you may experience withdrawal symptoms.
• Do not eat or drink until the tablets have completely dissolved.

Dose adjustment and maintenance treatment

In the days following the start of treatment, your doctor may increase your dose of buprenorphine/naloxone according to 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 continue to be reduced under close medical supervision until treatment can eventually be stopped.

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

If you take more Buprenorphine/Naloxone Aurovitas than you should

If you or someone else takes an excessive amount of this medicine, you must go immediately or be taken to an emergency department or hospital for treatment, as overdose of buprenorphine/naloxone can cause serious and potentially fatal breathing problems.

Symptoms of overdose may include drowsiness, lack of coordination, slow reflexes, blurred vision and/or difficulty speaking. You may be unable to think clearly and your breathing may become much slower than normal.

You should also contact your doctor immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine 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 taking Buprenorphine/Naloxone Aurovitas

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

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 can cause adverse effects, although not everyone experiences them.

Contact your doctor immediately or seek urgent medical attention if you experience adverse effects such as, for example:

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

Also, contact your doctor immediately if you experience adverse effects such as, for example:

• Severe tiredness, itching with yellowing of the skin or eyes. These may be signs of liver injury.
• Seeing or hearing things that are not really there (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 sex drive, increased muscle tension, abnormal thinking, increased tearing (watery eyes) or other crying disorders, blurred vision, flushing, increased blood pressure, migraine, runny nose, sore throat and pain when swallowing, increased cough, stomach discomfort or other stomach upset, 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, urinary abnormalities, abdominal pain, back pain, weakness, infection, chills, chest pain, fever, flu-like symptoms, general feeling of discomfort, accidental injury due to loss of alertness or coordination, fainting, and dizziness.

• Uncommon adverse effects (may affect up to 1 in 100 people):

• Swollen lymph nodes, agitation, tremors, abnormal dreams, excessive muscle activity, depersonalization (feeling detached from oneself), drug dependence, amnesia (memory disorder), loss of interest, feeling of exaggerated well-being, seizures (fits), speech disorder, pinpoint pupils, difficulty urinating, eye inflammation or infection, fast or slow heart rate, low blood pressure, palpitations, heart attack, feeling of chest tightness, 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 the newborn. Slow breathing or difficulty breathing, dental caries, liver injury with or without jaundice, hallucinations, swelling of the face and throat, or potentially life-threatening allergic reactions, drop in blood pressure upon changing position from sitting or lying down to standing.

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

Reporting of adverse effects

If you experience any adverse effect, consult 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Buprenorphine/Naloxone Aurovitas

Keep this medicine out of the sight and reach of children and other family members. It may cause serious harm and be fatal to individuals who take this medicine accidentally or intentionally when it has not been prescribed for them.

Do not use this medicine after the expiry date stated on the blister pack and carton. The expiry date is the last day of the month indicated.

Store below 30°C.

This medicine may be a target for individuals who abuse prescription medicines. Keep this medicine in a safe place to protect it from theft.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE point in your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Buprenorfina/Naloxona Aurovitas

• The active substances are buprenorphine and naloxone.

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

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

Appearance of the product and contents of the pack

Sublingual tablets, white to off-white, round and biconvex, with a score line on one side. The tablet can be divided into equal doses.

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

Only certain pack 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 medicinal product is authorized in the Member States of the European Economic Area (EEA) under the following names:

Spain: Buprenorfina/Naloxona Aurovitas 8 mg/2 mg sublingual tablets EFG

France: BUPRÉNORPHINE/NALOXONE ARROW 8 mg/2 mg sublingual tablet

Netherlands: Buprenorfine/Naloxon Aurobindo 8 mg/2 mg tabletten voor sublinguaal gebruik

Portugal: Buprenorfina + Naloxona Generis

Date of the most recent revision of this leaflet: February 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)