Leaflet: information for the user

Buprex 0.2 mg sublingual tablets

Buprenorphine

Read this leaflet carefully before you start taking this medicine, because 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, even if they are not listed in this leaflet. See section 4.

1. What Buprex is and for what it is used

2. What you need to know before starting to take Buprex

3. How to take Buprex

4. Possible side effects

5. Storage of Buprex

6. Contents of the pack and additional information

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

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 breathing problems, or if you are taking medicines that can make your breathing slower or weaker,
• if you have or have had any addiction to medicines or substances,
• if you have liver disease (such as hepatitis),
• if you have kidney disease,
• if you have low blood pressure,
• if you have had a head injury or a recent brain disease,
• if you have thyroid problems,
• if you have any adrenal gland disorder (e.g. Addison's disease),
• if you have any urinary tract problems (e.g. an enlarged prostate or a narrowed urethra),
• if you are 60 years of age or older,
• if you have depression or other conditions treated with antidepressants. The use of these medicines together with Buprex may cause serotonin syndrome, a potentially fatal 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 oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nocturnal 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 reducing the dose.

Important points to consider:

• Abuse, misuse, 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 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 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 may reduce the effectiveness of the medicine (your body gets used to the medicine, this is known as tolerance). Repeated use of Buprex may also cause dependence, abuse, and addiction, which may lead to a potentially fatal overdose. The risk of adverse effects may increase with a higher dose and longer duration of use.

Dependence or addiction may 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 to Buprex varies from person to person. You may be at a higher risk of becoming dependent or addicted to Buprex if:

- You or a family member has a history of abuse or dependence on alcohol, prescription medicines, or illicit substances ("addiction").

- You are a smoker.

- You have had problems with your mood (depression, anxiety, or a personality disorder) or have received treatment from a psychiatrist for other mental health conditions.

If you notice any of the following signs while taking Buprex, it may 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 and unsuccessful attempts to stop or control the use of the medicine.

- 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 interrupt 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

Inform athletes that this medicine contains a component that may result in a positive analytical result for doping control.

Use of Buprex with other medicines

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

The concomitant use of Buprex and sedatives such as benzodiazepines or related medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may put your life at risk. Therefore, concomitant use should only be considered when other treatment options are not possible.

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

Inform your doctor about all sedatives you are taking and follow your doctor's recommended dose closely. It may be helpful to inform friends or family members to be 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 severe reactions:

• Benzodiazepines(used to treat anxiety or sleep disorders) such as diazepam, temazepam, or alprazolam. Your doctor will indicate the appropriate dose for you.The incorrect dose of benzodiazepines may 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/epilepsy, or pain. These types of medicines 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 analgesics, or antitussives;
  • 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 muscle contractions, including those that control 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;
  • antihistamines (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 allergies and to treat vomiting or nausea during travel (antihistamines or antiemetics).
• Medicines used to treat 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 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 symptoms.
• Antiretrovirals (used to treat HIV/AIDS) such as ritonavir, nelfinavir, or indinavir may potentiate the effects of this medicine.
• Some antifungals (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 those used to treat epilepsyor pain due to nerve problems (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 if combined with Buprex. Do not use Buprex with alcoholic beverages.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medicine.

No risks have been identified for using Buprex in pregnant women. Inform your doctor if you are pregnant or if you plan 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 breathing problems. This may not occur until several days after birth.

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

Driving and using machines

Buprex may cause drowsiness. This may occur more frequentlyinthe first weeks oftreatment or whenthe dose is changed, but it also happens if you take it with alcohol or sedatives. 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 certain sugars, consult with him before taking this medicine.

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

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

The usual dose isone tablet every 8 hours, which may be increased, as needed for pain, to 1-2 sublingual tablets every 6-8 hours.

Sublingual tablets are administered sublingually, by placing one Buprex tablet under the tongue and allowing 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 it, your doctor will discuss with you 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 interrupt Buprex treatment”).

If you take more Buprex than you should

If you or someone else takes too much of this medication, go or have them taken immediately to an emergency service or hospital for treatment, as a Buprex overdose can cause severe respiratory problems that may be life-threatening.

Overdose symptoms may include drowsiness, low blood pressure (hypotension), nausea, vomiting, pupil constriction (small pupils with blurred vision and difficulty focusing), and slower-than-normal breathing.

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

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 your next dose. Do not take a double dose to make up for the missed dose.

If you interrupt Buprex treatment

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Inform your doctor immediately 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 may be a sign of Buprex-induced respiratory depression (affects an unknown number of people).
• If you suddenly experience sounds like hissing while breathing, difficulty breathing, swelling of the eyelids, face, or lips, hives or rashes, especially those that cover the entire body. These may be signs of an allergic reaction (rare side effects that can affect up to 1 in 1,000 people).
• If you start feeling dizzy, as this may be a sign of low blood pressure (a frequent side 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 eruptions, 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 side effects that may occur with Buprex are listed below:

Reporting side effects

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

Keepout of the sight and reach of children.

Store this medication in a safe and protected place where other people cannot access it. It may cause severe harm and be fatal to individuals who take it accidentally or intentionally when not prescribed.

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

Do not store at a temperature 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.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Buprex

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

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

Appearance of the product and content of the container

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

Holder of the marketing authorization

EUMEDICA Pharmaceuticals GmbH

Basler Straβe 126

79540 Lörrach

Germany

Responsible for manufacturing

Indivior Europe Limited

27 Windsor Place

Dublin 2

D02 DK44

Ireland

EUMEDICA S.A.

Chemin de Nauwelette 1

7170 Manage

Belgium

Last review date of this leaflet: November 2024

The detailed and updated information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/