Buprex 0.2 mg sublingual tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Buprex 0.2 mg sublingual tablets

Buprenorphine

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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Buprex is and what it is used for

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

2. What you need to know before taking 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

Talk to your doctor or pharmacist before taking Buprex:

• if you have asthma or other breathing problems, or if you are taking medicines that may slow or weaken your breathing,
• if you currently have or have ever 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 recently suffered a head injury or brain disorder,
• if you have thyroid problems,
• if you have corticosuprarenal disorders (e.g., Addison's disease),
• if you have urinary problems (such as an enlarged prostate or urethral stricture),
• if you are 60 years of age or older,
• if you have depression or other conditions treated with antidepressants. Concomitant use of these medicines with Buprex may cause serotonin syndrome, a potentially life-threatening condition (see "Use of Buprex with other medicines").

Sleep-related breathing disorders

Buprex 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, nighttime awakenings 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 considerations:

• Misuse, abuse, and diversion

This medicine may be targeted by individuals who abuse prescription drugs. Keep this medicine in a secure place to protect it from theft. Do not give this medicine to anyone else. It could cause death or other serious harm.

• Breathing problems

Some people have died from respiratory failure (inability to breathe) due to misuse of this medicine or when taken together with other central nervous system depressants such as alcohol, benzodiazepines (tranquilizers), or other opioids.

• Tolerance, dependence, and addiction

This medicine contains buprenorphine, an opioid substance. Repeated use of opioids may reduce the medicine’s effectiveness (your body becomes accustomed to the medicine—this is known as tolerance). Repeated use of Buprex may also lead to dependence, abuse, and addiction, which may result in a potentially fatal overdose. The risk of adverse effects may increase with higher doses and longer duration of use.

Dependence or addiction may make you feel that you no longer have control over how much medicine you need or how often you take it.

The risk of becoming dependent or addicted varies from person to person. You may have a higher risk of dependence or addiction to Buprex if:

• You or a family member has a history of alcohol, prescription medicine, or illicit substance abuse or dependence ("addiction").
• You are a smoker.
• You have previously had mood disorders (depression, anxiety, or a personality disorder) or have received psychiatric treatment for other mental illnesses.

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

• You need to take the medicine for longer than your doctor recommended.
• You need to take higher doses than prescribed.
• You are using the medicine for reasons other than those prescribed, e.g., "to calm down" or "to help you sleep."
• You have made repeated unsuccessful attempts to stop or control your medicine use.
• You feel unwell when you stop taking the medicine and feel better when you take it again ("withdrawal symptoms").

If you notice any of these signs, speak with your doctor to determine the most appropriate treatment strategy for you, including when and how to safely stop taking the medicine (see section 3 "If you stop taking Buprex").

• Withdrawal symptoms

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

• Diagnosis of unrelated medical conditions

This medicine may mask pain symptoms that could assist in diagnosing certain diseases. Remember to inform your doctor if you are taking this medicine.

Use in athletes

Athletes are advised that this medicine contains a component that may lead to a positive result in doping control tests.

Use of Buprex with other medicines

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

Concomitant use of Buprex with sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when no other treatment options are possible.

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

Inform your doctor about all sedative medicines you are taking and follow your doctor’s dosage recommendations carefully. It may be helpful to inform friends or family members so they are aware of the signs and symptoms mentioned above. Inform your doctor if you experience these symptoms.

Some medicines, such as those listed below, may increase the adverse effects of Buprex and may cause various severe adverse reactions:

• Benzodiazepines (used to treat anxiety or sleep disorders), such as diazepam, temazepam, or alprazolam. Your doctor will advise you on the appropriate dose. Taking an incorrect dose of benzodiazepines could cause death due to respiratory failure (inability to breathe).

• 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 severe central nervous system depression. Examples of such medicines include:

  • other opioid-containing medicines, such as methadone, certain analgesics, or antitussives;
  • antidepressants (used to treat depression) such as isocarboxazid, phenelzine, selegiline, tranylcypromine, and valproate, which may enhance 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 muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, and body temperature above 38 °C. Inform 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 induce sleep or sedation) such as phenobarbital or secobarbital;
  • tranquilizers (used to induce sleep or sedation) such as chloral hydrate.

• Medicines used to treat allergy and travel-related nausea or vomiting (antihistamines or antiemetics).

• Medicines for psychiatric disorders (antipsychotics or neuroleptics).

• Muscle relaxants.

• Medicines used to treat Parkinson’s disease.

• Clonidine (used to treat high blood pressure) may prolong the effects of this medicine.

• Naltrexone may block the therapeutic effects of Buprex. If you are currently taking naltrexone and then use Buprex concomitantly, you may experience sudden, prolonged, and intense withdrawal symptoms.

• Antiretrovirals (used to treat AIDS) such as ritonavir, nelfinavir, or indinavir may enhance 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 reduce the effect of Buprex, such as medicines used to treat epilepsy or nerve pain/neuropathic pain (gabapentin or pregabalin, carbamazepine, and phenytoin) and medicines used to treat tuberculosis (rifampicin).

• Anesthetics (used during surgery, such as halothane).

Use of Buprex with food, drinks, and alcohol

Alcohol may increase drowsiness and the risk of respiratory failure when 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 plan to become pregnant, consult your doctor before using this medicine.

The risks of using Buprex in pregnant women are not fully known. Inform your doctor if you are pregnant or planning to become pregnant. Your doctor will decide whether 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 breathing problems. These symptoms may not appear until several days after birth.

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

Driving and use of machines

Buprex may cause drowsiness. This is more likely during the first weeks of treatment or when the dose is changed, but may also occur if taken with alcohol or sedative medicines. Do not drive or operate tools or machinery, or engage in hazardous activities, until you know how this medicine affects you.

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

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

3. How to take Buprex

Follow exactly the administration instructions for Buprex given by your doctor.

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

Sublingual tablets are administered sublingually; place one Buprex tablet under the tongue and allow it to dissolve. Do not chew or swallow the tablets.

Consult your doctor or pharmacist if you have any doubts.

Before starting treatment and periodically during treatment, your doctor will discuss with you what you can expect from using Buprex, when and for how long you should take it, when to contact your doctor, and when you should stop taking it (see also “If you stop taking Buprex”).

If you take more Buprex than you should

If you or someone else takes too much of this medicine, you must go or be taken immediately to an emergency department or hospital for treatment, as an overdose of Buprex may cause serious breathing problems that could be life-threatening.

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 breathing much more slowly than normal for you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist, 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 Buprex

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

If you stop taking Buprex

Stopping treatment suddenly may lead to a delayed-onset withdrawal syndrome.

If you have any other 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 will experience 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 could cause severe breathing problems that may be life-threatening:

• If you start breathing slower or weaker than normal for you. This may be a sign of respiratory depression induced by Buprex (affects an unknown number of people).
• If you suddenly experience whistling noises when breathing, difficulty breathing, swelling of the eyelids, face or lips, rash or hives, especially those covering the entire body. These may be signs of an allergic reaction (rare adverse effects that may affect up to 1 in 1,000 people).
• If you start feeling dizzy, as this may be a sign of low blood pressure (a common adverse effect that may affect up to 1 in 10 people).
• If you experience a sudden narrowing of the airways (bronchospasm) (affects an unknown number of people).
• If you experience a hypersensitivity reaction with fever, skin rashes, swelling, and sometimes a decrease in 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 listed below:

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, even if it involves possible adverse reactions not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Buprex

Keep out of the sight and reach of children.

Store this medicine in a safe and secure place, where others cannot access it. It may cause serious harm or be fatal to individuals 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you are unsure, please consult your pharmacist on how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Buprex

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

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

Appearance of the product and contents of the pack

Buprex 0.2 mg sublingual tablets are presented in blisters of 20 sublingual tablets.

Marketing Authorization Holder

EUMEDICA Pharmaceuticals GmbH

Basler Straβe 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 most recent revision of this leaflet: June 2025

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