Bunorfin

LEAFLET INCLUDED IN THE PACKAGE: PATIENT INFORMATION

Bunorfin 2 mg sublingual tablets

Bunorfin 8 mg sublingual tablets

Buprenorphine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• -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 symptoms are the same as yours. If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. WHAT IS BUNORFIN AND WHAT IS IT USED FOR

Bunorfin contains the active substance buprenorphine.
Bunorfin is:

• intended for patients addicted to opioids, such as heroin or morphine, as part of pharmacological, social, and psychological treatment. Treatment is recommended and controlled by a doctor with experience in treating drug addiction.

2. IMPORTANT INFORMATION BEFORE TAKING BUNORFIN

When not to take Bunorfin:

• if the patient is allergic to buprenorphine or any of the other ingredients of this medicine (listed in section 6),
• if the patient has severe breathing problems,
• if the patient has significant liver function disorders,
• in patients with alcoholism or in a state of delirium tremens.

Warnings and precautions

Before starting to take Bunorfin, discuss it with your doctor or pharmacist:

• if morphine or heroin (opioids) was taken earlier than 6 hours before buprenorphine administration, it may cause withdrawal symptoms,
• if methadone was taken earlier than 24 hours before buprenorphine administration, it may cause withdrawal symptoms (in the case of methadone use, dose adjustment may be required before taking buprenorphine, see section 3),
• if the patient has asthma or breathing problems,
• if the patient has kidney or liver function disorders (in the case of acute liver failure, buprenorphine should not be taken),
• if the patient has low blood pressure,
• if the patient has problems with urination (due to prostate enlargement or urethral stricture),
• in the case of head injuries and increased intracranial pressure,
• if the patient has depression or other diseases treated with antidepressant medications. Taking these medications together with Bunorfin may lead to serotonin syndrome, a life-threatening disease (see section "Bunorfin and other medicines").

Breathing difficulties during sleep

Bunorfin may cause breathing difficulties during sleep, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen level in the blood).
Symptoms may include pauses in breathing during sleep, nighttime awakenings due to shortness of breath, difficulty maintaining sleep, or excessive daytime sleepiness. If the patient or another person notices these symptoms, they should contact a doctor. The doctor may consider reducing the dose.

Tolerance, dependence, and addiction

This medicine contains buprenorphine, which is an opioid medicine. Repeated use of opioids can make the medicine less effective (getting used to it, known as tolerance). Taking Bunorfin multiple times may also lead to dependence, abuse, and addiction, which can result in life-threatening overdose.
Dependence can make the patient lose control over the amount of medicine taken or the frequency of taking it.
The risk of becoming dependent on Bunorfin or addicted to it varies from person to person. The risk of dependence on Bunorfin may be higher if:

• the patient or someone in their family has ever abused or been dependent on alcohol, prescription drugs, or illegal substances ("addiction");
• the patient is a smoker;
• the patient has ever had mood problems (depression, anxiety, or personality disorders) or has been treated by a psychiatrist for other mental illnesses.

If any of the following symptoms occur while taking Bunorfin, it may indicate dependence:

• needing to take the medicine for longer than the doctor recommended;
• needing to take a higher dose than recommended;
• taking the medicine for reasons other than recommended, such as "to calm down" or "to sleep better";
• repeatedly attempting to stop or control the use of the medicine but failing;
• feeling unwell after stopping the medicine, and feeling better after taking it again ("withdrawal effects"). If any of these symptoms occur, the patient should talk to their doctor to discuss the best treatment path, including when to stop taking the medicine and how to do it safely (see section 3, Stopping Bunorfin).

Incorrect use, abuse, and theft

Severe cases of infection with potential risk of death may occur in the case of incorrect use of Bunorfin after intravenous administration.

Bunorfin may cause:

• dependence,
• a sudden drop in blood pressure, causing dizziness and weakness when changing position from sitting or lying down,
• masking other diseases in which pain is a symptom, due to the pain-relieving effect of buprenorphine.

Children and adolescents

This medicine should not be used in children and adolescents under the age of 18.

Bunorfin and other medicines

Buprenorphine may affect the action of other medicines, and other medicines may affect the action of buprenorphine.
Therefore, it is essential to tell the doctor about taking the following medicines:

• medicines used to treat anxiety and insomnia (benzodiazepines and anxiolytics other than benzodiazepines),
• medicines used to treat skin infections (ketoconazole, itraconazole),
• medicines used to treat certain infections (rifampicin),
• medicines used to treat HIV infections (ritonavir, indinavir, nelfinavir),
• certain types of medicines used to treat allergies, motion sickness, or nausea (antihistamines or antiemetics),
• certain types of medicines used to treat depression, such as moclobemide, tranylcypromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepin, or trimipramine. These medicines may interact with Bunorfin and cause symptoms such as involuntary, rhythmic muscle contractions, including eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle tension, and body temperature above 38°C. If the patient experiences such symptoms, they should contact their doctor,
• medicines used to treat migraines, hot flashes, and dependence resulting from drug abuse (clonidine),
• cough medicines (dextromethorphan, noscapine),
• painkillers (morphine and morphine derivatives),
• medicines containing alcohol,
• medicines used to treat epilepsy (phenobarbital, phenytoin, carbamazepine),
• medicines used to treat mental disorders (antipsychotics or neuroleptics),
• medicines used as sedatives and to treat seizures (barbiturates),
• medicines used to treat depression called "tricyclic antidepressants" (e.g., amitriptyline, clomipramine, doxepin, trimipramine),
• muscle relaxants,
• medicines used to treat Parkinson's disease,
• gabapentin or pregabalin used to treat epilepsy or pain caused by nerve problems (neuropathic pain).

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Bunorfin with food, drink, or alcohol

Bunorfin can be taken independently of meals (see section 3).
The patient should not take Bunorfin with alcoholic beverages, as alcohol may increase the drowsiness caused by buprenorphine.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Buprenorphine should not be used during pregnancy. Exceptionally, if the doctor considers it necessary, the medicine can be used during the first 3 months of pregnancy.
Breastfeeding
Bunorfin should not be used during breastfeeding.

Driving and using machines

Bunorfin may cause drowsiness, fainting, and dizziness, which may affect the ability to drive and use machines. If the patient feels dizzy or drowsy, they should not drive vehicles or operate machinery. These symptoms usually occur at the beginning of treatment and when the dose is increased.

Bunorfin contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicinal product.

3. HOW TO TAKE BUNORFIN

This medicine should always be taken according to the doctor's recommendations. If in doubt, the patient should consult their doctor or pharmacist.

How to take Bunorfin

The sublingual tablet is a tablet that should be placed under the tongue. The patient should keep the tablet under their tongue until it dissolves, usually within 5-10 minutes. The patient should not swallow, chew, or bite the tablet.
The patient can take the medicine independently of meals.

Usual dose:

• Adults and the elderly:The doctor will decide what initial dose is suitable for the patient. Depending on the patient's response, the doctor may increase the dose until an adequate dose is reached. A dose of 16 mg per day is usually sufficient. The maximum daily dose is 24 mg. The doctor will decide on the duration of treatment and gradual dose reduction in each individual case. The patient should not change the treatment in any way or stop it without the doctor's consent.
• Children and adolescents (under 18 years):Children and adolescents under the age of 18 should not take Bunorfin.
• Patients with kidney or liver function disorders:In the case of kidney or liver problems, a dose reduction may be required. The patient should consult their doctor. In the case of liver failure, buprenorphine should not be taken.
• Patients being treated with methadone:The methadone dose must be reduced to a maximum of 30 mg per day before starting treatment with Bunorfin. The patient should contact their doctor if they experience withdrawal symptoms (sweating, feeling anxious or nervous).

Taking a higher dose of Bunorfin than recommended

In the event of an overdose of buprenorphine, the patient should immediately go to or be taken to an emergency center or hospital for treatment.
Symptoms of overdose include: breathing difficulties, slow breathing, or heart problems.
After incorrect use (overdose or incorrect route of administration), toxic poisoning and, in the worst case, respiratory arrest/heart failure and/or liver damage can be observed.

Missing a dose of Bunorfin

The patient should not take a double dose to make up for a missed dose.

Stopping Bunorfin

The patient should not stop treatment on their own. They should ask their doctor how to stop treatment.
Sudden stopping of treatment may cause withdrawal symptoms (sweating, feeling anxious and nervous).
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Bunorfin can cause side effects, although not everybody gets them.

The patient should stop taking Bunorfin and immediately contact their doctor if they experience symptoms of angioedema (rare side effect), such as:

• swelling of the face, tongue, or throat,
• difficulty swallowing, hives, and breathing difficulties.

Dependence on Bunorfin

Bunorfin may cause dependence.
Common side effects(occurring in more than 1 patient, but less than 10 patients in 100):

• 100):
• Headache, fainting, dizziness
• Constipation, nausea, vomiting
• Insomnia, drowsiness, feeling weak
• Drop in blood pressure when changing position from sitting or lying down to standing
• Sweating.

With long-term use of buprenorphine, common side effects usually subside, but constipation and sweating often remain.
Rare side effects(occurring in more than 1 patient, but less than 10 patients in 10,000):
Hallucinations
Respiratory depression, bronchospasm
Liver damage, hepatitis
Anaphylactic shock, angioedema
Urinary retention.
Unknown frequency of side effects(frequency cannot be estimated from the available data):
Tooth decay.
If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-02 222 Warsaw, Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309. Website: https://smz.ezdrowie.gov.pl .
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. HOW TO STORE BUNORFIN

The medicine should be stored out of sight and reach of children.
Bunorfin should not be used after the expiry date stated on the carton and on the foil packaging after: EXP. The expiry date refers to the last day of the given month.
This medicine should be stored in a safe place, out of the reach of other people. The medicine can cause serious harm, even death, to people who take it accidentally or intentionally, if it was not prescribed to them.
There are no special precautions for the storage of the medicinal product.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Bunorfin contains

• The active substance of Bunorfin is buprenorphine in the form of buprenorphine hydrochloride.
• Each 2 mg sublingual tablet contains 2 mg of buprenorphine.
• Each 8 mg sublingual tablet contains 8 mg of buprenorphine. The other ingredients are: lactose monohydrate, mannitol (E421), cornstarch, citric acid (E330), sodium citrate (E331), povidone K 30 (E1201), magnesium stearate (E470b).

What Bunorfin looks like and what the pack contains

Bunorfin 2 mg is a white, oval, biconvex sublingual tablet with the inscription "2" on one side.
Bunorfin 8 mg is a white, oval, biconvex sublingual tablet with the inscription "8" on one side.
Bunorfin is packaged in a foil packaging, which contains 7 or 28 tablets. Not all pack sizes may be marketed.

Marketing authorization holder

• L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A., Strada Statale 67, Fraz. Granatieri 50018 Scandicci (Firenze), Italy

Manufacturers

Fine Foods & Pharmaceuticals N.T.M. S.p.A.
Via Grignano 43
24041 Brembate (Bergamo)
Italy

• L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A., Strada Statale 67, Fraz. Granatieri 50018 Scandicci (Firenze), Italy To obtain more detailed information, the patient should contact the local representative of the marketing authorization holder: Molteni Farmaceutici Polska Sp. z o.o., ul. Józefa Korzeniowskiego 39, 30-214 Kraków, tel. (12) 653 15 71 or 72, fax (12) 653 29 87

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Italy:
Buprenorfina Molteni
Poland:
Bunorfin
Sweden:
Molterfin
Date of last revision of the leaflet:11/2024
(logo Molteni)