Bunondol

Package Leaflet: Information for the Patient

BUNONDOL, 0.2 mg, sublingual tablets

BUNONDOL, 0.4 mg, sublingual tablets

Buprenorphine

Read the package 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, pharmacist, or nurse.
• 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 any not listed in this leaflet, tell your doctor, 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, a strong pain-relieving medicine.
Buprenorphine belongs to a group of pain-relieving medicines called opioids.
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 you are allergic to buprenorphine, other opioid medicines, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Bunondol, discuss with your doctor if you have:

• depression or other diseases treated with antidepressant medicines. Taking these medicines together with 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 gravis);
• 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, 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 can 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 dependence on Bunondol varies from person to person. The risk of dependence on 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 relieve pain;
• taking the medicine for reasons other than prescribed, such as "to calm down" or "to sleep better";
• repeatedly attempting to stop or control the use of the medicine without success;
• feeling unwell after stopping the medicine, and feeling better after taking it again ("withdrawal symptoms"). If any of these symptoms occur, you should talk to your doctor to discuss the best treatment for you, 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 levels 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 another person notices these symptoms, they should contact a 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 is necessary to monitor whether the tablet has been properly placed under the tongue. If in doubt, consult a doctor.

Bunondol and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Some medicines may enhance the side effects of Bunondol, and sometimes cause very severe reactions. While taking Bunondol, do not take other medicines without consulting your doctor first, 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 you experience such symptoms, contact your 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;
• antifungal medicines (ketoconazole);
• AIDS/HIV medicines, 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 concurrent use.
The patient should tell the doctor about all calming medicines being taken 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 the above symptoms. If these symptoms occur, consult a doctor.

Bunondol and alcohol

Alcohol should be avoided while taking buprenorphine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Buprenorphine should not be used during pregnancy. Buprenorphine may reduce milk production. The decision to use buprenorphine during pregnancy and breastfeeding will be made by the doctor.

Driving and using machines

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

Bunondol contains lactose monohydrate

If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking the medicine.

3. How to take Bunondol

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.
Before starting treatment and regularly during treatment, your doctor will discuss with you what to expect from taking Bunondol, when and how long to take it, when to contact your 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

• Do not chew or swallow the tablets.
• Place the tablet under the tongue and keep it there until it is completely dissolved.
• In case of dry mouth, rinse your mouth with water before placing the tablet.
• In children, monitor whether the tablet has been 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 preoperative preparation, 0.4 mg is given sublingually 2 hours before the start of surgery.
No dose adjustment is necessary for elderly patients.
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.
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 may occur: drowsiness, nausea, vomiting, very severe narrowing of the pupils ("pinpoint pupils"), severe breathing difficulties.
If such symptoms occur, immediately inform medical personnel.
They will take appropriate action.

Missing a dose of Bunondol

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

Stopping Bunondol

In case of sudden cessation 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, pupil dilation, runny nose, insomnia with persistent yawning, sweating, increased blood pressure, muscle tremors, "goosebumps", loss of appetite, slight increase in breathing rate, feeling of pain in many parts of the body, very strong craving for the medicine, and hallucinations.
If you have any further questions about taking this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

Stop taking the medicine and contact your doctor immediately if you experience the first symptoms of an allergic reaction (such as swelling of the face, lips, tongue, or 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 outpatients.

Other possible side effects include:

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

Rare side effects include:

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

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

• tooth decay.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 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 this medicine.

5. How to store Bunondol

Store in a temperature below 25°C.
Keep the medicine out of sight and reach of children.
Store the medicine in a safe place, out of reach of other people. The medicine can seriously harm or even kill people who take it accidentally or intentionally if it has not been prescribed for them.
Do not use this medicine after the expiry date stated on the blister, vial, and carton. The expiry date refers to the last day of the 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. Ask your 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 cream-colored, 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.
Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

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