BUNORFIN 8 mg Tablets

Contents of the leaflet

1. LEAFLET INCLUDED IN THE PACKAGE: PATIENT INFORMATION
2. Bunorfin 2 mg sublingual tablets
3. Bunorfin 8 mg sublingual tablets
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
4. WHAT IS BUNORFIN AND WHAT IS IT USED FOR
5. IMPORTANT INFORMATION BEFORE TAKING BUNORFIN
   1. When not to take Bunorfin:
   2. Warnings and precautions
   3. Breathing disorders associated with sleep
   4. Tolerance, dependence, and addiction
   5. Improper use, abuse, and theft
   6. Bunorfin may cause:
   7. Children and adolescents
   8. Bunorfin and other medicines
   9. Bunorfin with food, drink, or alcohol
   10. Pregnancy and breastfeeding
   11. Driving and using machines
   12. Bunorfin contains lactose
6. HOW TO TAKE BUNORFIN
   1. How to take Bunorfin
   2. Usual dose:
   3. Taking a higher dose of Bunorfin than recommended
   4. Missing a dose of Bunorfin
   5. Stopping Bunorfin
7. POSSIBLE SIDE EFFECTS
   1. You should stop taking Bunorfin and immediately consult your doctor if you experience symptoms of angioedema (rare side effect), such as:
   2. Dependence on Bunorfin
8. HOW TO STORE BUNORFIN
9. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
   1. What Bunorfin contains
   2. What Bunorfin looks like and what the package contains
   3. Marketing authorization holder
   4. Manufacturers
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

LEAFLET INCLUDED IN THE PACKAGE: PATIENT INFORMATION

Bunorfin 2 mg sublingual tablets

Bunorfin 8 mg sublingual tablets

Buprenorphine

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• -You should keep this leaflet so that you can read it again if you need to. If you have any doubts, you should consult a doctor or pharmacist. This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same. If you experience any side effects, including any not listed in this leaflet, you should 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 package 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 you are allergic to buprenorphine or any of the other ingredients of this medicine (listed in section 6),
• if you have severe breathing problems,
• if you have significant liver function disorders,
• in patients with alcoholism or in a state of delirium tremens.

Warnings and precautions

Before starting to take Bunorfin, you should 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 you have asthma or breathing problems,
• if you have kidney or liver function disorders (in the case of acute liver failure, buprenorphine should not be taken),
• if you have low blood pressure,
• if you have problems with urination (due to prostate enlargement or urethral stricture),
• in the case of head injuries and increased intracranial pressure,
• if you have depression or other diseases treated with antidepressant medications. Taking these medications together with Bunorfin may lead to serotonin syndrome, a life-threatening disease (see the section "Bunorfin and other medicines").

Breathing disorders associated with sleep

Bunorfin may cause breathing disorders associated with 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 staying asleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, you should contact your doctor. Your doctor may consider
reducing the dose.

Tolerance, dependence, and addiction

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

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

If you experience any of the following symptoms while taking Bunorfin, it may mean that you are dependent:

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

Improper use, abuse, and theft

Severe cases of infection with potential risk of death can occur in the case of improper 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 18 years of age.

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 your 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 (antihistamine or antiemetic medicines),
• 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 those that control eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle tension, and body temperature above 38°C. If you experience such symptoms, you should contact your 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 (antipsychotic or neuroleptic medicines),
• 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).

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Bunorfin with food, drink, or alcohol

Bunorfin can be taken with or without food (see section 3).
You should not take Bunorfin with alcoholic beverages, as alcohol may increase the drowsiness caused by buprenorphine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
Pregnancy
Buprenorphine should not be used during pregnancy. Exceptionally, when the doctor considers it necessary, the medicine can be used during the first 3 months of pregnancy.
Breastfeeding
You should not take Bunorfin while breastfeeding.

Driving and using machines

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

Bunorfin contains lactose

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking this medicinal product.

3. HOW TO TAKE BUNORFIN

This medicine should always be taken according to your doctor's recommendations. If you have any doubts, you should consult your doctor or pharmacist.

How to take Bunorfin

The sublingual tablet is a tablet that you should place under your tongue. You should keep the tablet under your tongue until it dissolves, which usually takes 5-10 minutes. Do not swallow, chew, or bite the tablet.
You can take the medicine with or without food.

Usual dose:

• Adults and the elderly:Your doctor will decide what initial dose is suitable for you. Depending on your response, your 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. Your doctor will decide on the duration of treatment and gradual dose reduction in each individual case. You should not change the treatment in any way or stop it without the consent of the treating doctor.
• Children and adolescents (under 18 years of age):Children and adolescents under 18 years of age 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. You should talk to your doctor. In the case of liver failure, buprenorphine should not be taken.
• Patients being treated with methadone:The dose of methadone must be reduced to a maximum of 30 mg per day before starting treatment with Bunorfin. You should contact your doctor if you experience withdrawal symptoms (sweating, feeling anxious or nervous).

Taking a higher dose of Bunorfin than recommended

In the case of an overdose of buprenorphine, you 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 improper use (overdose or wrong route of administration), toxic poisoning can be observed, and in the worst case, respiratory arrest/heart failure and/or liver damage.

Missing a dose of Bunorfin

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

Stopping Bunorfin

You should not stop treatment on your own. You should ask your doctor how to stop treatment.
Sudden stopping of treatment may cause withdrawal symptoms (sweating, feeling anxious and nervous).
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

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

You should stop taking Bunorfin and immediately consult your doctor if you 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 disappear, 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 available data):
Tooth decay.
If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Aleje 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.
By reporting side effects, you can help provide 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.
You should not take Bunorfin after the expiry date stated on the carton and on the blister pack after: EXP. The expiry date refers to the last day of the 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 has not been prescribed for them.
There are no special precautions for the storage of the medicinal product.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer used. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Bunorfin contains

• The active substance of the medicine 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 package 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 blister pack, and the packs contain 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, you 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
(Molteni logo)