BUPRENORPHINE/NALOXONE AUROVITAS 8 mg/2 mg SUBLINGUAL TABLETS

2. What you need to know before you take 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

Tell your doctor before starting treatment with this medicine 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 that are treated with antidepressants.
• The use of these medicines with buprenorphine/naloxone may cause serotonin syndrome, a potentially life-threatening disease (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 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 things 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 medicine may be a target for people 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 may cause them death or other harm.

• Respiratory problems

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

This medicine may cause severe respiratory depression (difficulty breathing), possibly fatal, in children and non-dependent persons if ingested 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 treatment".

• Liver damage

Liver damage has been reported after taking buprenorphine/naloxone, especially when the medicine is misused. It may also be due to viral infections (e.g. chronic hepatitis C), alcohol abuse, anorexia, or the use of other medicines 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 medicine may cause a sudden drop in blood pressure, making you feel dizzy if you get up too quickly after sitting or lying down.

• Diagnosis of unrelated medical conditions

This medicine 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 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 the lack of data in this age group.

Other medicines and Buprenorphine/Naloxone Aurovitas

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

Some medicines may increase the adverse effects of buprenorphine/naloxone and may be severe. 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 like benzodiazepines or related medicines increases the risk of drowsiness, 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 strictly follow your doctor's dosage recommendation. It may be useful 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 medicines that may cause drowsiness and are usedto treat diseases such as anxiety, insomnia, seizures/epileptic fits or pain. This type of medicine 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 medicine:

• Other medicines that contain opioids, such as methadone, some painkillers or cough suppressants.
• Antidepressants (used to treat depression) such as isocarboxazid, phenelzine, selegiline, tranylcypromine and valproate, may enhance the effects of this medicine.
• 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 medicines 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, 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 the treatment of fungal infections) such as ketoconazole, itraconazole or certain antibiotics may prolong the effects of this medicine.
• Some medicines may decrease 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 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 being treated with this medicine. Alcohol may increase drowsiness 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The risks of using buprenorphine/naloxone in pregnant women are not known. Your doctor will decide if your treatment should continue with another medicine.

When taken during pregnancy, especially in the last months, medicines 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 medicine, as buprenorphine is excreted in breast milk.

Driving and using machines

Do not drive or ride a bike, do not use tools or machines, or engage in hazardous activities until you know how this medicine affects you. This medicine may cause drowsiness, 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 medicines at the same time as taking buprenorphine/naloxone.

Buprenorphine/Naloxone Aurovitas contains lactose

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

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

3. How to take Buprenorphine/Naloxone Aurovitas

Follow the instructions for administration of this medicine exactly as prescribed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Treatment is prescribed and monitored by doctors who have 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, according to 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 have clear signs 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 signs of withdrawal 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 recommended that the dose be reduced to less than 30 mg/day before starting treatment with this medicine. The first dose of buprenorphine/naloxone should be taken when signs of withdrawal 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 medicine 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, 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 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 who is treating you.

If you take more Buprenorphine/Naloxone Aurovitas than you should

If you or someone else takes too much of this medicine, you or they should go immediately to an emergency department or hospital for treatment, as an overdose of buprenorphine/naloxone can cause serious and potentially life-threatening breathing 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 should also inform your doctor immediately or call the Toxicology Information Service, telephone 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 treatment with Buprenorphine/Naloxone Aurovitas

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

If you have any further questions on 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 all people suffer from 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 can cause difficulty swallowing or breathing; hives or intense rash. These can be signs of a potentially life-threatening allergic reaction.
• Feeling of drowsiness and discoordination, blurred vision, difficulty speaking, inability to think clearly, or breathing much slower than normal for you.

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

• Intense fatigue, itching with yellowish skin or eye discoloration. These can 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, urinary 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 disorders, small pupils, difficulty urinating, eye inflammation or infection, rapid or slow heart rate, low blood pressure, palpitations, heart attack, feeling of chest compression, breathing difficulties, 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 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 medicine, 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 leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Buprenorphine/Naloxone Aurovitas

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

Do not use this medicine 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 medicine may be a target for people 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. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and medicines 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 8 mg/2 mg tablet contains 8 mg of buprenorphine (as hydrochloride) and 2 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.

Appearance of the Product and Package Contents

White to off-white sublingual tablets, 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 inside 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Spain Buprenorphine/Naloxone 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 tablets for sublingual use

Portugal Buprenorfina + Naloxona Generis

Date of the Last Revision of this Leaflet:February 2025

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