Bunondol

Package Leaflet: Information for the Patient

BUNONDOL, 0.2 mg, sublingual tablets

BUNONDOL, 0.4 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.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

1. What is Bunondol and what is it used for

Bunondol contains buprenorphine, which is a strong pain-relieving medicine.
Buprenorphine belongs to a group of medicines called opioid pain-relievers.
Bunondol is available in two strengths, in the form of tablets to be placed under the tongue.
Bunondol is used for acute and chronic pain of moderate to severe intensity.
Buprenorphine is used for post-operative and chronic pain, most often of cancer origin.

2. Important information before taking Bunondol

When not to take Bunondol:

• if the patient is allergic to buprenorphine, other opioid medicines, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to take Bunondol, the patient should discuss it with their doctor if they have:

• depression or other diseases treated with antidepressant medicines. Taking these medicines at the same time as Bunondol may lead to serotonin syndrome, a life-threatening condition (see section "Bunondol and other medicines").

The doctor will exercise special caution when prescribing buprenorphine to patients:

• with reduced thyroid function (hypothyroidism);
• with reduced adrenal gland function (insufficient hormone production);
• with asthma or other breathing problems, such as chronic obstructive pulmonary disease (COPD);
• with an enlarged prostate or difficulty urinating;
• with muscle weakness (myasthenia);
• who are weakened or exhausted by disease, or addicted to opioids;
• with bile duct disorders;
• with liver function disorders;
• with kidney function disorders;
• who are elderly;
• after head injuries;
• with increased intracranial pressure (symptoms such as headache, impaired consciousness and balance, vision problems);
• with nervous system disorders, psychoses;
• with alcoholism;
• with spinal curvature.

Tolerance, dependence, and addiction
This medicine contains buprenorphine, which is an opioid medicine. Repeated use of opioids can lead to the medicine becoming less effective (getting used to the medicine, known as tolerance). Taking Bunondol repeatedly may also lead to dependence, abuse, and addiction, which can result in life-threatening overdose. The risk of these side effects may increase with increasing dose and longer treatment duration.
Dependence or addiction can cause the patient to lose control over the amount of medicine taken and how often it is taken.
The risk of addiction varies from person to person. The risk of addiction to Bunondol may be higher if:

• the patient or someone in their family has ever abused or been dependent on alcohol, prescription medicines, or illegal substances ("addiction");
• the patient is a smoker or uses nicotine products;
• 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 Bunondol, it may indicate dependence:

• need to take the medicine for longer than prescribed by the doctor;
• need to take a higher dose than prescribed;
• need to continue taking the medicine even if it does not help relieve pain;
• taking the medicine for reasons other than prescribed, such as "to calm down" or "to fall asleep";
• repeatedly attempting to stop or control the use of the medicine;
• feeling unwell after stopping the medicine, and feeling better after taking it again ("withdrawal symptoms"). If any of these symptoms occur, the patient should talk to their doctor to discuss the best treatment option, including when to stop taking the medicine and how to do it safely (see section 3, Stopping Bunondol).

Breathing difficulties during sleep
Bunondol may cause breathing difficulties during sleep, such as sleep apnea (pauses in breathing during sleep) and 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 the patient or someone else notices these symptoms, they should contact their doctor. The doctor may consider reducing the dose.

Children

Bunondol can be used in children over 6 years old (see section 3: "How to take Bunondol"). When using the medicine in children, it should be ensured that the tablet is properly placed under the tongue. In case of any doubts, the patient should consult their doctor.

Bunondol and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.
Some medicines may increase the side effects of Bunondol, and sometimes cause very severe reactions. While taking Bunondol, the patient should not take other medicines without first consulting their doctor, especially:

• 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 Bunondol and cause symptoms such as involuntary, rhythmic muscle contractions, including those that control eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased muscle tone, body temperature above 38°C. If the patient experiences such symptoms, they should contact their doctor.
• medicines used to treat allergies, motion sickness, or nausea (antihistamines or antiemetics);
• medicines used to treat mental disorders (antipsychotics or neuroleptics);
• muscle relaxants;
• medicines used to treat Parkinson's disease;
• sleeping pills, such as phenobarbital;
• calming medicines, such as diazepam;
• phenothiazine derivatives, such as promazine or chlorpromazine;
• rifampicin, troleandomycin (medicines used to treat bacterial infections);
• phenytoin, gabapentin, or pregabalin used to treat epilepsy or pain caused by nerve problems (neuropathic pain);
• contraceptives containing gestodene;
• medicines for fungal infections (ketoconazole);
• medicines for AIDS/HIV, such as ritonavir;
• medicines that reduce saliva production.

Taking Bunondol and calming medicines, such as benzodiazepines or derivatives, increases the risk of drowsiness, breathing difficulties (respiratory depression), or coma, which can be life-threatening. Therefore, combined treatment should only be considered when other treatment options are not available.
If Bunondol is taken with calming medicines, the doctor should limit the dose and duration of treatment.
The patient should tell their doctor about all calming medicines they are taking and strictly follow the prescribed dose. It may be helpful to inform a family member or close friend of the patient about the possibility of these symptoms. If these symptoms occur, the patient should consult their doctor.

Bunondol and alcohol

The patient should avoid drinking alcohol while taking 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.
Buprenorphine is not recommended during pregnancy. Buprenorphine may reduce milk production. The doctor will decide whether to use buprenorphine during pregnancy and breastfeeding.

Driving and using machines

Buprenorphine may cause drowsiness and affect physical and mental performance. While taking the medicine, the patient should not drive vehicles or operate machines.

Bunondol contains lactose monohydrate

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Bunondol

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor.
Before starting treatment and regularly during treatment, the doctor will discuss with the patient what to expect from taking Bunondol, when and for how long to take it, when to contact the doctor, and when to stop taking the medicine (see also: Stopping Bunondol).

• The dose of buprenorphine is determined by the doctor individually for each patient.
• Depending on the patient's condition, the doctor will prescribe tablets containing 0.2 mg or 0.4 mg of buprenorphine.

Method of administration

• The tablets should not be chewed or swallowed.
• The tablet should be placed under the tongue and kept there until it is completely dissolved.
• In case of dry mouth, the patient should rinse their mouth with water before placing the tablet.
• In children, it should be ensured that the tablet is properly placed under the tongue.
• Sublingual tablets should not be used in children under 6 years old.

Recommended dose

Adults and adolescents over 12 years old
The single dose for pain relief is 0.2 mg to 0.4 mg. As needed, 0.2 mg to 0.4 mg is taken every 6-8 hours.
For premedication before surgery, 0.4 mg is given sublingually 2 hours before the start of surgery.
In elderly patients, no dose adjustment is necessary.
Children between 6 and 12 years old
For pain of various origins:
children weighing 16-25 kg: 0.1 mg;
children weighing 25-37.5 kg: 0.1 mg to 0.2 mg;
children weighing 37.5-50 kg: 0.2 mg to 0.3 mg.
The recommended doses should be given every 6-8 hours.

Taking a higher dose of Bunondol than recommended

After taking a higher dose of the medicine than recommended, the following symptoms may occur: drowsiness, nausea, vomiting, very severe narrowing of the pupils ("pinpoint pupils"), severe breathing difficulties.
If such symptoms occur, the patient should immediately inform the medical staff, who will take appropriate action.

Missing a dose of Bunondol

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

Stopping Bunondol

In case of sudden stop of buprenorphine, withdrawal symptoms occur rarely and are mild, as the medicine has a low potential for dependence.
Withdrawal symptoms include: nausea, diarrhea, cough, mood changes, tearing, dilated pupils, runny nose, insomnia with persistent yawning, sweating, increased blood pressure, muscle tremors, "goosebumps", loss of appetite, slight increase in breathing rate, feeling of widespread pain in the body, very strong craving for the medicine, and hallucinations.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist, or nurse.

4. Possible side effects

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

The patient should stop taking the medicine and immediately consult their doctor if they experience the first symptoms of an allergic reaction (e.g., swelling of the face, lips, tongue, throat, causing difficulty breathing or swallowing). Such symptoms are rare after taking buprenorphine.

The doctor will decide on further action.

The most common side effects are:

• nausea, vomiting;
• dizziness;
• drowsiness. The above side effects occur more frequently in patients treated on an outpatient basis.

Other possible side effects include:

• low blood pressure (leading to fainting);
• anxiety, mood changes, hallucinations.

Less common side effects include:

• rash;
• headache;
• difficulty urinating;
• vision problems;
• breathing difficulties.

Frequency not known (frequency cannot be estimated from the available data):

• tooth decay.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist, or nurse. 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
02-222 Warsaw
Phone: +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 gather more information on the safety of the medicine.

5. How to store Bunondol

Store in a temperature below 25°C.
The medicine should be stored out of sight and reach of children.
This medicine should be stored in a safe place, out of the reach of other people. The medicine can cause serious harm, even death, if taken accidentally or intentionally by someone who has not been prescribed it.
Do not use this medicine after the expiry date stated on the blister, vial, and carton.
The expiry date stated on the packaging means the last day of the stated month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
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 Bunondol contains

• The active substance of the medicine is buprenorphine hydrochloride. Each tablet contains 0.2 mg or 0.4 mg of buprenorphine.
• The other ingredients are: lactose monohydrate, cornstarch, povidone K-25, magnesium stearate.

What Bunondol looks like and contents of the pack

Bunondol is a white to creamy-white, round, flat tablet with a beveled edge.
Bunondol 0.2 mg sublingual tablets:
60 sublingual tablets in aluminum/PVC/PVDC blisters or in a brown glass vial, in a cardboard box.
Bunondol 0.4 mg sublingual tablets:
30 sublingual tablets in aluminum/PVC/PVDC blisters or in a brown glass vial, in a cardboard box.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
Production Plant in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba
Date of last revision of the leaflet:December 2024