BUPREX 0.2 mg SUBLINGUAL TABLETS

Introduction

Package Leaflet: Information for the User

Buprex 0.2 mg Sublingual Tablets

Buprenorphine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again. If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Buprex and what is it used for
2. What you need to know before you take Buprex
3. How to take Buprex
4. Possible side effects
5. Storing Buprex
6. Contents of the pack and other information

1. What is Buprex and what is it used for

Buprex is an opioid analgesic (narcotic) indicated for the treatment of moderate to severe pain of any etiology.

2. What you need to know before you take Buprex

Do not take Buprex

• if you are allergic (hypersensitive) to buprenorphine or any of the other ingredients of this medicine (listed in section 6),
• if you are under 14 years of age.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Buprex:

• if you have asthma or other respiratory problems, or if you are taking medicines that may make your breathing slower or weaker,
• if you have or have had any addiction to medicines or substances,
• if you have any liver disease (such as hepatitis),
• if you have any kidney disease,
• if you have low blood pressure,
• if you have had a recent head injury or brain disease,
• if you have thyroid problems,
• if you have any corticosteroid disorder (e.g., Addison's disease),
• if you have any urinary disorder (such as an enlarged prostate or narrowing of the urethra),
• if you are 60 years of age or older,
• if you have depression or other conditions treated with antidepressants. The concomitant use of these medicines with Buprex may produce serotonin syndrome, a potentially life-threatening disorder (see "Using Buprex with other medicines").

Sleep-related respiratory disorders

Buprex may cause sleep-related respiratory 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 staying asleep, 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:

• Misuse, abuse, and diversion

This medicine may be a target for people who abuse prescription medicines. Keep this medicine in a safe place to protect it from theft. 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 misused this medicine or taken it in combination with other central nervous system depressants, such as alcohol, benzodiazepines (tranquilizers), or other opioids.

Tolerance, dependence, and addictionThis medicine contains buprenorphine, an opioid substance. Repeated use of opioids can decrease the effectiveness of the medicine (your body gets used to the medicine, this is known as tolerance). Repeated use of Buprex can also cause dependence, abuse, and addiction, which can lead to a potentially life-threatening overdose. The risk of side effects may increase with a higher dose and longer duration of use.

Dependence or addiction can make you feel like you no longer have control over the amount of 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 have a higher risk of becoming dependent or addicted to Buprex if:

• You or a family member have a history of abuse or dependence on alcohol, prescription medicines, or illicit substances ("addiction").
• You are a smoker.
• You have ever had problems with your mood (depression, anxiety, or personality disorder) or have received psychiatric treatment for other mental illnesses.

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

• You need to take the medicine for a longer period than recommended by your doctor.
• You need to take more 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 attempts to stop or control the use of the medicine without success.
• 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, talk to your doctor to address the most appropriate therapeutic strategy for your case, including when it is appropriate to stop taking it and how to do it safely (see section 3 "If you stop treatment with Buprex").

• Withdrawal symptoms

This product may cause withdrawal symptoms if you take it with other opioids such as heroin or methadone.

• Diagnosis of unrelated medical conditions

This medicine may mask the symptoms of pain that could help in the diagnosis of some diseases. Do not forget to inform your doctor if you are taking this medicine.

Use in athletes

Athletes are informed that this medicine contains a component that may result in a positive doping test.

Using Buprex with other medicines

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

The concomitant use of Buprex and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can put your life at risk. Due to this, concomitant use should only be considered when no other treatment options are possible.

However, if your doctor prescribes Buprex with sedative medicines, the dose and duration of concomitant treatment must be limited by your doctor.

Tell your doctor about all sedative medicines you are taking and follow your doctor's dosage recommendation carefully. It may be useful to inform friends or family members so they are aware of the signs and symptoms indicated above. Tell your doctor if you experience these symptoms.

Some medicines, such as those listed below, may increase the side effects of Buprex and may cause very serious adverse reactions:

• Benzodiazepines(used to treat anxiety or sleep disorders) such as diazepam, temazepam, or alprazolam. Your doctor will indicate the appropriate dose for you. Taking an incorrect dose of benzodiazepines could cause death due to respiratory failure (inability to breathe).
• 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, as a very serious consequence, central nervous system depression. The following is a list of examples of this type of medicine:
• • other medicines 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 potentiate the effects of this medicine;
  • antidepressants such as moclobemide, tranylcypromine, citalopram, escitalopram, duloxetine, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine, amitriptyline, opipramol, doxepin, or trimipramine. These medicines may interact with Buprex and you may experience symptoms such as involuntary and rhythmic contractions of the muscles, including the muscles that control eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, and body temperature above 38°C. Tell your doctor if you experience any of these symptoms;
  • sedating H1 receptor antagonists (used to treat allergic reactions) such as diphenhydramine and chlorphenamine;
  • barbiturates (used to produce sleep or sedation) such as phenobarbital or secobarbital;
  • tranquilizers (used to produce sleep or sedation) such as chloral hydrate.

• Medicines used to treat allergy and to treat nausea and vomiting during travel (antihistamines or antiemetics).
• Medicines for the treatment of psychiatric disorders (antipsychotics or neuroleptics).
• Muscle relaxants.
• Medicines for the treatment of Parkinson's disease.
• Clonidine (used to treat high blood pressure) may prolong the effects of this medicine.
• Naltrexone may prevent the therapeutic effects of Buprex. If you are currently taking this medicine followed by concomitant use of naltrexone, you may experience a sudden onset of prolonged and intense withdrawal.
• Antiretrovirals (used to treat AIDS) such as ritonavir, nelfinavir, or indinavir may potentiate the effects of this medicine.
• Some antifungal agents (used to treat fungal infections) such as ketoconazole, itraconazole, and certain antibiotics (macrolides) may prolong the effects of this medicine.
• Some medicines may decrease the effect of Buprex, such as medicines used to treat epilepsy or pain due to nerve problems/neuropathic pain (gabapentin or pregabalin, carbamazepine, and phenytoin) and medicines used to treat tuberculosis (rifampicin).
• Anesthetics (used during surgery such as halothane).

Using Buprex with food, drinks, and alcohol

Alcohol may increase drowsiness and the risk of respiratory failure if combined with Buprex. Do not use Buprex with alcoholic beverages.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

The risks of using Buprex in pregnant women are not known. Tell your doctor if you are pregnant or if you are planning to become pregnant. Your doctor will decide if your treatment should continue with an alternative medicine.

When medicines like Buprex are used during pregnancy, especially in the last months, they may cause withdrawal symptoms in the newborn, including respiratory problems. This may not occur until several days after birth.

Since Buprex passes into breast milk, this medicine must not be used during breastfeeding.

Driving and using machines

Buprex may cause drowsiness. This may occur more frequently in the first few weeks of treatment or when the dose is changed, but it can also happen if you take it with alcohol or sedative medicines. Do not drive or use tools or machines, or engage in hazardous activities, until you know how this medicine affects you.

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 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Buprex

Follow exactly the administration instructions of Buprex indicated by your doctor.

The normal dose is one tablet every 8 hours, which may be increased, according to the intensity of the pain, to 1-2 sublingual tablets every 6-8 hours.

The sublingual tablets are administered sublingually, for this, place a Buprex tablet under your tongue and let it dissolve. Do not chew or swallow the tablets.

Ask your doctor or pharmacist if you have any doubts.

Before starting treatment and periodically during treatment, your doctor will talk to you about what you can expect from the use of Buprex, when and for how long you should take it, when to contact your doctor, and when to stop taking it (see also "If you stop treatment with Buprex").

If you take more Buprex than you should

If you or someone else takes too much of this medicine, you/they should go immediately to an emergency department or hospital for treatment, as an overdose of Buprex can cause serious breathing problems that can put your life at risk.

Symptoms of overdose may include drowsiness, low blood pressure (hypotension), nausea (feeling sick), vomiting, constricted pupils (small pupils characterized by blurred vision and difficulty focusing), and you may breathe much more slowly than normal for you.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount.

If you forget to take Buprex

If you forget to take a dose, take it as soon as you remember, unless it coincides with the next dose. Do not take a double dose to make up for forgotten doses.

If you stop treatment with Buprex

Sudden interruption of treatment may lead to a late-onset withdrawal syndrome.

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.

Immediately inform your doctor or seek urgent medical attention if you experience any of the following symptoms after taking this medicine. These symptoms can be serious and Buprex may cause severe respiratory problems that can put your life at risk:

• If you start breathing more slowly or weakly than normal for you. This can be a sign of respiratory depression induced by Buprex (affects an unknown number of people).
• If you suddenly experience whistling sounds when breathing, difficulty breathing, swelling of the eyelids, face, or lips, rashes, or hives, especially those that cover the entire body. These can be signs of an allergic reaction (rare adverse effects that can affect up to 1 in 1,000 people).
• If you start feeling dizzy, as this can be a sign of low blood pressure (frequent adverse effect that can affect up to 1 in 10 people).
• If you experience sudden narrowing of the airways (bronchospasm) (affects an unknown number of people).
• If you experience a sensitivity reaction with fever, skin rash, swelling, and sometimes decreased blood pressure (anaphylactic shock) (affects an unknown number of people).
• If you experience swelling of the face, tongue, or throat, or difficulty swallowing or breathing (angioedema) (affects an unknown number of people).

Other adverse effects that may occur with Buprex are presented below:

Reporting of Adverse Effects

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

5. Storage of Buprex

Keep out of sight and reach of children.

Store this medicine in a safe and protected place, where other people cannot access it. It can cause serious harm and be fatal for people who take it accidentally or intentionally when it has not been prescribed for them.

Keep the blister pack in the outer packaging to protect it from moisture.

Do not store above 30°C.

Do not use Buprex after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Buprex

The active ingredient is buprenorphine. Each tablet contains 0.2 mg of buprenorphine as buprenorphine hydrochloride.

This medicine contains cornstarch, lactose monohydrate, mannitol, povidone, anhydrous citric acid, sodium citrate, and magnesium stearate.

Appearance of the Product and Package Contents

Buprex 0.2 mg sublingual tablets are presented in blister packs of 20 sublingual tablets.

Marketing Authorization Holder

EUMEDICA Pharmaceuticals GmbH

Basler Straße 126

79540 Lörrach

Germany

Manufacturer

Medinfar Manufacturing S.A.

Parque Industrial Armando Martins Tavares

Rua Outeiro Da Armada No. 5

Condeixa-a-Nova

3150-194 Sebal

Portugal

EUMEDICA S.A.

Chemin de Nauwelette 1

7170 Manage

Belgium

Date of the Last Revision of this Prospectus: June 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/