Bunorfin

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Bunorfin 2 mg sublingual tablets
Bunorfin 8 mg sublingual tablets
Buprenorphinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary. If you have any further questions, please consult your doctor or pharmacist. This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm other people, even if their symptoms are the same. If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Bunorfin is and what it is 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 BUNORFIN IS AND WHAT IT IS USED FOR

Bunorfin contains the active substance buprenorphine.
Bunorfin medicine:

• is intended for patients dependent on opioids such as heroin or morphine, as part of pharmacological, social, and psychological treatment. The treatment should be prescribed and supervised by a doctor experienced in managing drug dependence.

2. IMPORTANT INFORMATION BEFORE USING BUNORFIN

When not to use 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 serious breathing problems,
• if the patient has severe liver function impairment,
• in patients with alcoholism or in a state of delirium tremens.

Warnings and precautions
Before starting treatment with Bunorfin, discuss the following with your doctor or pharmacist:

• if morphine or heroin (opioids) was taken less than 6 hours before administration of buprenorphine, this may trigger withdrawal symptoms,
• if methadone was taken less than 24 hours before administration of buprenorphine, this may trigger withdrawal symptoms (in case of methadone use, dose adjustment may be required before taking buprenorphine; see section 3),
• if the patient suffers from asthma or has breathing difficulties,
• if the patient has kidney or liver function disorders (buprenorphine should not be used in cases of acute liver failure),
• if the patient has low blood pressure,
• if the patient has problems with urination (due to benign prostatic hyperplasia or urethral stricture),
• in cases of head injury or increased intracranial pressure,
• if the patient has depression or other conditions treated with antidepressant medications. Concurrent use of these medicines with Bunorfin may lead to serotonin syndrome, a potentially life-threatening condition (see section "Bunorfin with other medicines").

Sleep-related breathing disorders
Bunorfin may cause sleep-related breathing disorders, such as sleep apnoea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels).
Symptoms may include pauses in breathing during sleep, nocturnal awakenings due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If the patient or someone else notices these symptoms, contact a doctor. The doctor may consider reducing the dose.
Tolerance, dependence, and abuse
This medicine contains buprenorphine, which is an opioid medicine. Repeated use of opioids may result in reduced effectiveness of the medicine (a phenomenon known as tolerance). Repeated use of Bunorfin may also lead to dependence, misuse, and addiction, which may result in life-threatening overdose.
Dependence may cause the patient to lose control over the amount or frequency of medicine intake.
The risk of developing dependence or addiction varies between individuals. The risk of dependence on Bunorfin may be higher if:

• the patient or a family member has ever misused or been dependent on alcohol, prescription medicines, or illegal substances ("addiction");
• the patient is a smoker;
• the patient has ever had mood disorders (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, this may indicate dependence:

• need to take the medicine longer than prescribed by the doctor;
• need to take a higher dose than recommended;
• use of the medicine for reasons other than prescribed, e.g., "to calm down" or "to fall asleep more easily";
• repeated unsuccessful attempts to stop or control medicine use;
• feeling unwell after stopping the medicine, with improvement in well-being upon re-taking the medicine ("withdrawal effects").
  If any of these symptoms occur, talk to your doctor to discuss the best treatment approach for the patient, including when and how to discontinue Bunorfin safely (see section 3, Discontinuation of Bunorfin treatment).

Misuse, abuse, and theft
Severe infections with potential fatal outcomes may occur in cases of misuse of Bunorfin when administered intravenously.
Bunorfin may cause:

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

Children and adolescents
This medicine should not be used in children and adolescents under 18 years of age.
Bunorfin with other medicines
Buprenorphine may affect the action of other medicines, and other medicines may affect the action of buprenorphine.
Therefore, it is important to inform your doctor if you are taking any of the following medicines:

• medicines used to treat anxiety and sleep disorders (benzodiazepines and non-benzodiazepine anxiolytics),
• medicines used to treat scalp infections (ketoconazole, itraconazole),
• medicines used to treat certain infections (rifampicin),
• medicines used to treat HIV infection (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, doxepine, or trimipramine. These medicines may interact with Bunorfin and cause symptoms such as involuntary, rhythmic muscle contractions, including eye muscles, agitation, hallucinations, coma, excessive sweating, tremor, increased reflexes, increased muscle tone, and body temperature above 38°C. If such symptoms occur, contact your doctor,
• medicines used to treat migraines, hot flashes, or medication-overuse dependence (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 psychiatric disorders (antipsychotics or neuroleptics),
• medicines used as sedatives and for seizure control (barbiturates),
• antidepressants known as "tricyclic antidepressants" (e.g. amitryptyline, clomipramine, doxepine, trimipramine),
• muscle relaxants,
• medicines used to treat Parkinson's disease,
• gabapentin or pregabalin used to treat epilepsy or pain caused by nervous system problems (neuropathic pain).

Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Bunorfin with food, drink, or alcohol
Bunorfin can be taken regardless of meals (see section 3).
Do not take Bunorfin with alcoholic beverages, as alcohol may intensify drowsiness caused by buprenorphine.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Buprenorphine should not be used during pregnancy. Exceptionally, if the doctor considers it necessary, the medicine may be used during the first three months of pregnancy.
Breastfeeding
Bunorfin should not be used during breastfeeding.
Driving and operating machinery
Bunorfin may cause drowsiness, fainting, and dizziness, thus it may impair the ability to drive or operate machinery. If the patient experiences dizziness or drowsiness, he or she should not drive or operate machinery. These symptoms usually occur at the beginning of treatment or when the dose is increased.
Bunorfin contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicinal product.

3. HOW TO USE BUNORFIN

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Method of administration of Bunorfin tablets
The sublingual tablet is a tablet that should be placed under the tongue. The tablet should be held under the tongue until it dissolves, which usually takes 5–10 minutes. The tablet must not be swallowed, chewed, or crushed.
This medicine may be taken regardless of meals.
Usual dosage:

• Adults and elderly patients: The doctor will decide the appropriate starting dose for the patient. Depending on the patient's response, the doctor may increase the dose until the appropriate maintenance dose is reached. A dose of 16 mg per day is usually sufficient. The maximum daily dose is 24 mg. The doctor will individually determine the duration of treatment and the gradual dose reduction. Do not alter or discontinue treatment without consulting your doctor.
• Children and adolescents (under 18 years of age): Bunorfin must not be used in children and adolescents under 18 years of age.
• Patients with impaired kidney or liver function: A dose reduction may be required in patients with kidney or liver problems. Please consult your doctor. Buprenorphine must not be used in patients with liver failure.
• Patients concurrently treated with methadone: The methadone dose must be reduced to a maximum of 30 mg per day before starting treatment with Bunorfin. Contact your doctor if withdrawal symptoms occur (sweating, restlessness, or anxiety). Use of a higher than recommended dose of Bunorfin In case of buprenorphine overdose, the patient should immediately go to, or be taken to, an emergency care center or hospital for treatment. Symptoms of overdose include: difficulty breathing, slowed breathing, or heart-related disturbances. Toxic poisoning may occur after improper use (overdose or incorrect route of administration), and in the worst case, respiratory arrest, heart failure, and/or liver damage.

Missed dose of Bunorfin
Do not take a double dose to make up for a missed dose.
Stopping Bunorfin treatment
Do not stop treatment on your own. Consult your doctor on how to discontinue treatment.
Abruptly stopping treatment may cause withdrawal symptoms (sweating, restlessness, anxiety).
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
You should stop taking Bunorfin and immediately contact a doctor if symptoms of angioedema
(rare adverse reaction) occur, such as:

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

Dependence on Bunorfin
Bunorfin may cause dependence.

Common adverse reactions (occurring in more than 1 but less than 10 patients per 100):

• Headache, fainting, dizziness
• Constipation, nausea, vomiting
• Insomnia, somnolence, feeling of weakness
• Drop in blood pressure upon changing position from sitting or lying to standing
• Sweating

With long-term use of buprenorphine, common adverse reactions gradually subside, but constipation and sweating often persist.

Rare adverse reactions (occurring in more than 1 but less than 10 patients per 10,000):
Hallucinations
Respiratory depression, bronchospasm
Liver damage, hepatitis
Anaphylactic shock, angioedema
Urinary retention

Adverse reactions of unknown frequency (frequency cannot be estimated from available data):
Dental caries

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. HOW TO STORE BUNORFIN

Keep the medicine in a place out of sight and reach of children.
Do not use Bunorfin after the expiry date stated on the carton and foil pack following: EXP. The expiry date refers to the last day of the specified month.
This medicine should be stored in a secure place inaccessible to other people. The medicine may cause serious harm or even death in individuals who take it accidentally or intentionally, if it has not been prescribed for them.
No special precautions for storage of the medicinal product are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Bunorfin contains

• The active substance 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: monohydrate lactose, mannitol (E421), corn starch, citric acid (E330), sodium citrate (E331), povidone K 30 (E1201), magnesium stearate (E470b).

What Bunorfin looks like and contents of the pack
Bunorfin 2 mg is a white, oval, biconvex sublingual tablet marked with the number “2” on one side.
Bunorfin 8 mg is a white, oval, biconvex sublingual tablet marked with the number “8” on one side.
Bunorfin is packed in foil blisters; the packs contain 7 or 28 tablets. Not all pack sizes may be marketed.

Marketing Authorisation 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

For further information, please contact the local representative of the Marketing Authorisation 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 authorised in the European Economic Area countries under the following names:
Italy: Buprenorfina Molteni
Poland: Bunorfin
Sweden: Molterfin
(Molteni logo)