Bunondol

Package leaflet: Information for the patient

BUNONDOL, 0.2 mg, sublingual tablets
BUNONDOL, 0.4 mg, sublingual tablets
Buprenorphinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

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

Contents of the leaflet

1. What Bunondol is and what it is used for
2. What you need to know 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 Bunondol is and what it is used for

Bunondol contains buprenorphine, a very potent analgesic medicine.
Buprenorphine belongs to a group of medicines called opioid analgesics.
Bunondol is available in two strengths, in the form of tablets that are placed under the tongue.
Bunondol is used to treat acute and chronic pain of varying intensity, from moderate to severe.
Buprenorphine is used in postoperative and chronic pain, most commonly of cancer origin.

2. Important information before using Bunondol

When not to use 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 treatment with Bunondol, discuss with your doctor if the patient has:

• depression or other conditions treated with antidepressant medicines. Taking these medicines together with Bunondol may lead to serotonin syndrome, a potentially life-threatening condition (see section "Bunondol with other medicines").

Your doctor will exercise particular caution when prescribing buprenorphine to patients with:

• reduced thyroid function (hypothyroidism);
• reduced adrenal cortex function (insufficient hormone production);
• asthma or other breathing problems, such as chronic obstructive pulmonary disease (COPD);
• benign prostatic hyperplasia or difficulty in passing urine;
• muscle weakness (myasthenia gravis);
• frailty or debilitation due to illness, or opioid dependence;
• disorders of the biliary tract;
• impaired liver function;
• impaired kidney function;
• advanced age;
• head injury;
• increased intracranial pressure (symptoms such as headache, altered consciousness and balance, visual disturbances);
• neurological disorders, psychoses;
• alcoholism;
• spinal deformities.

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 (known as tolerance). Repeated use of Bunondol may also lead to dependence, misuse and addiction, which could result in life-threatening overdose. The risk of these adverse effects may increase with higher doses and longer duration of use.
Dependence or addiction may cause the patient to lose control over the amount and frequency of medicine intake.
The risk of developing dependence or addiction varies between individuals. The risk of dependence on Bunondol may be higher if:

• the patient or someone in their family has ever misused or been dependent on alcohol, prescription medicines or illegal substances ("substance abuse");
• the patient is a smoker or uses nicotine-containing products;
• 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 Bunondol, this may indicate dependence:

• need to take the medicine longer than prescribed by the doctor;
• need to take higher than the prescribed dose;
• need to continue taking the medicine even though it no longer helps relieve pain;
• using the medicine for reasons other than prescribed, e.g. "to calm down" or "to sleep better";
• repeated unsuccessful attempts to stop or control medicine use;
• feeling unwell after stopping the medicine, with improvement in well-being upon re-taking it ("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 stop taking the medicine safely (see section 3, Discontinuation of Bunondol treatment).

Sleep-related breathing disorders
Bunondol may cause sleep-related breathing disorders such as sleep apnoea (pauses in breathing during sleep) and hypoxemia (low blood oxygen levels). Symptoms may include breathing pauses during sleep, nocturnal awakenings due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If the patient or someone else notices these symptoms, contact the doctor. The doctor may consider reducing the dose.

Children
Bunondol may be used in children over 6 years of age (see section 3: "How to use Bunondol"). When using the medicine in children, ensure that the tablet is correctly placed under the tongue. If in doubt, consult your doctor.

Bunondol with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take.
Some medicines may intensify the adverse effects of Bunondol and sometimes cause very serious reactions. During treatment with Bunondol, do not take other medicines without prior consultation with your 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 eye movement muscles, agitation, hallucinations, coma, excessive sweating, tremor, increased reflexes, increased muscle tone, body temperature above 38°C. If such symptoms occur, contact your doctor.
• medicines used to treat allergies, motion sickness or nausea (antihistamines or antiemetics);
• medicines used to treat psychiatric disorders (antipsychotics or neuroleptics);
• muscle relaxants;
• medicines used to treat Parkinson's disease;
• sleeping medicines, e.g. phenobarbital;
• sedatives, anxiolytics, e.g. diazepam;
• phenothiazine derivatives, e.g. promethazine, chlorpromazine;
• rifampicin, troleandomycin (medicines used in bacterial infections);
• phenytoin, gabapentin or pregabalin used to treat epilepsy or nerve-related pain (neuropathic pain);
• contraceptives containing gestodene;
• antifungal medicines (ketoconazole);
• medicines for AIDS/HIV, e.g. ritonavir;
• medicines that reduce saliva secretion.

Concomitant use of Bunondol and sedatives, such as benzodiazepines or related substances, increases the risk of drowsiness, breathing difficulties (respiratory depression) or coma, which may be life-threatening. Therefore, combination therapy should only be considered when no other treatment options are available.
If Bunondol is used together with sedatives, the doctor should limit the dose and duration of concomitant use.
The patient should inform the doctor about all sedatives being taken and strictly follow the prescribed dose. It may be helpful to inform a relative or close friend about the possibility of the above-mentioned symptoms occurring. If the described symptoms occur, consult your doctor.

Bunondol and alcohol
Avoid drinking alcohol while taking buprenorphine.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Buprenorphine is not recommended during pregnancy. Buprenorphine may reduce milk production. The decision to use buprenorphine during pregnancy and breastfeeding will be made by the doctor.

Driving and operating machinery
Buprenorphine may cause drowsiness and impair psychomotor performance. Do not drive or operate machinery while taking this medicine.

Bunondol contains monohydrate lactose
If the patient has been previously diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to use Bunondol

This medicine should always be used exactly as directed by the doctor. If in doubt, consult the doctor.
Before starting treatment and regularly during treatment, the doctor will discuss with the patient what effects to expect from using Bunondol, when and for how long it should be taken, when to contact the doctor, and when the medicine should be discontinued (see also: Stopping Bunondol).

• The buprenorphine dosage is individually determined by the doctor for each patient.
• Depending on the patient's condition, the doctor will recommend sublingual tablets containing either 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 hold it there until completely dissolved.
• In case of dry mouth, rinse the mouth with water before placing the tablet.
• In children, ensure that the tablet is correctly placed under the tongue.
• Sublingual tablets should not be used in children under 6 years of age.

Recommended dose
Adults and adolescents over 12 years of age
The single analgesic dose is 0.2 mg to 0.4 mg. As needed, 0.2 mg to 0.4 mg may be administered every 6–8 hours.
For preoperative preparation (premedication), 0.4 mg is administered sublingually 2 hours before the procedure.
Dosage adjustment is not necessary in elderly patients.
Children aged 6 to 12 years
For various types of pain:
Children with body weight 16–25 kg: 0.1 mg;
Children with body weight 25–37.5 kg: 0.1 mg to 0.2 mg;
Children with body weight 37.5–50 kg: 0.2 mg to 0.3 mg.
Recommended doses should be administered every 6–8 hours.

Use of a higher than recommended dose of Bunondol
After using a higher than recommended dose, the following may occur: drowsiness, nausea, vomiting, very strong pupil constriction ("pinpoint pupils"), severe breathing difficulties.
If such symptoms occur, medical personnel should be informed immediately. They will initiate appropriate management.

Missed dose of Bunondol
Do not use a double dose to make up for a missed dose.

Stopping Bunondol
If buprenorphine is abruptly discontinued, withdrawal symptoms occur only sporadically and are generally mild, due to the medicine's low dependence potential.
Withdrawal symptoms include: nausea, diarrhea, cough, mood disturbances, lacrimation, pupil dilation, rhinorrhea, insomnia with persistent yawning, profuse sweating, increased blood pressure, muscle tremors, goosebumps, loss of appetite, slight increase in respiratory rate, a sensation of diffuse pain in multiple body areas, intense drug craving, and hallucinations.

If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Treatment must be discontinued and immediate medical advice sought if the patient develops
first signs of hypersensitivity (e.g. swelling of the face, lips, tongue, or throat, causing difficulty
in breathing or swallowing). Such symptoms are rare following the use of buprenorphine.
The physician will decide on further management.

Most commonly occurring:

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

May occur:

• low blood pressure (leading to fainting);
• restlessness, mood disturbances, hallucinations.

Additionally, the following have been reported sporadically:

• rashes;
• headache;
• difficulty in urination;
• visual disturbances;
• breathing problems.

Frequency unknown (frequency cannot be estimated from available data):

• dental caries.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 4921301
Fax: +48 22 4921309
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 the medicine.

5. How to store Bunondol

Store below 25°C.
Keep this medicine out of sight and reach of children.
This medicine should be stored in a safe place, inaccessible to other people. The medicine may
cause serious harm or even death to individuals 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 pack, vial, and carton.
The expiry date refers to the last day of the stated month.
The label on the packaging shows EXP followed by the expiry date, and Lot/LOT followed by the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Bunondol contains

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

What Bunondol looks like and contents of the pack
Bunondol is in the form of white to cream-coloured, round, biconvex tablets with bevelled edges.
Bunondol sublingual tablets 0.2 mg:
60 sublingual tablets in blisters made of Aluminium/PVC/PVDC or in amber glass bottles,
in a cardboard box.
Bunondol sublingual tablets 0.4 mg:
30 sublingual tablets in blisters made of Aluminium/PVC/PVDC or in amber glass bottles,
in a cardboard box.
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01
Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Production Plant in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba