Exbol

Package leaflet: Information for the patient

Exbol, 75 mg + 650 mg, tablets
Tramadoli hydrochloridum + Paracetamolum
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

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

Table of contents of the leaflet:

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

1. What is Exbol and what it is used for

Exbol contains two active substances with analgesic properties – tramadol and paracetamol.
Exbol is used to treat moderate to severe pain when a doctor recommends combined treatment with tramadol and paracetamol.
Exbol is intended for adults and adolescents aged 12 years and older.

2. Important information before using Exbol

When not to use Exbol

• if the patient is allergic to tramadol, paracetamol, or any of the other ingredients of this medicine (listed in section 6)
• in case of acute intoxication with alcohol, hypnotics, painkillers, or psychotropic medicines (affecting mood, emotions, and mental state)
• if the patient is currently taking or has taken within the last 14 days medicines called monoamine oxidase inhibitors (MAOIs). MAOIs are used in the treatment of depression and Parkinson's disease
• if the patient has severe liver function impairment
• if the patient has epilepsy that is not adequately controlled with medication
• if the patient is pregnant or breastfeeding.

Exbol is not recommended for children under 12 years of age.
Warnings and precautions
Before using Exbol, consult a doctor or pharmacist:

• if the patient is taking other medicines containing paracetamol or tramadol
• if the patient has liver disease; for example, if they have yellowing of the eyes and skin, which may indicate jaundice
• if the patient has kidney problems
• if the patient has serious breathing difficulties, for example due to asthma or severe lung diseases
• if the patient suffers from epilepsy or has previously experienced seizures
• if the patient has recently suffered a head injury, was in shock, or experienced severe headaches with vomiting
• if the patient may be dependent on other painkillers, such as morphine
• if the patient is taking other pain-relieving medicines containing buprenorphine, nalbuphine, or pentazocine
• if the patient has depression and is taking antidepressants, as some of these may interact with tramadol (see "Exbol with other medicines")
• if the patient is scheduled for a procedure under anesthesia (inform the doctor or dentist about taking Exbol).

If any of the above situations occur during treatment with Exbol or have occurred in the past, the patient should inform their doctor.
During treatment with Exbol, the patient should immediately inform the doctor if:
There is a small risk of a condition called serotonin syndrome when tramadol is taken with certain antidepressants or tramadol alone. If the patient experiences any symptoms of this serious condition, they should seek medical advice immediately (see section 4 "Possible side effects").
If the patient has severe illnesses, including severe kidney function impairment or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic).
Cases of a serious condition called metabolic acidosis (abnormality in blood and body fluids) have been reported in patients who take paracetamol regularly for a prolonged period or who take paracetamol together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.
Breathing disturbances during sleep
Exbol may cause breathing disturbances during sleep, such as sleep apnea (pauses in breathing during sleep) and hypoxemia (low oxygen levels in the blood). Symptoms may include breathing pauses during sleep, nighttime awakenings due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If the patient or another person observes these symptoms, contact a doctor. The doctor may recommend reducing the dose.
If the patient experiences any of the following symptoms while taking Exbol, inform the doctor: excessive fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. These may indicate adrenal insufficiency (low cortisol levels). If such symptoms occur, contact the doctor, who will decide whether hormone replacement is necessary.
Tolerance, dependence, and abuse
This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids may lead to reduced effectiveness (the patient becomes accustomed to the medicine, known as tolerance). Repeated use of Exbol may also lead to dependence, abuse, and addiction, which may result in life-threatening overdose. The risk of these adverse effects may increase with dose and prolonged duration of use.
Dependence may cause the patient to lose control over the dose or frequency of medicine intake.
The risk of dependence varies among individuals. The risk of dependence on Exbol may be higher if:

• the patient or someone in their family has ever abused or been dependent on alcohol, prescription medicines, or illegal drugs ("addiction")
• the patient smokes tobacco
• 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 during Exbol treatment, it may indicate dependence:
• the patient needs to take the medicine longer than prescribed by the doctor
• the patient needs to take a higher dose than recommended
• the patient uses the medicine for reasons other than prescribed, for example, "to calm down" or "to help sleep"
• the patient has made multiple unsuccessful attempts to stop or control medicine use
• after stopping the medicine, the patient feels unwell and feels better after taking the medicine again ("withdrawal effects").

If any of these symptoms occur, talk to the doctor to discuss the best treatment approach, including when and how to discontinue the medicine safely (see section 3 "Discontinuing Exbol").
Tramadol is metabolized in the liver by an enzyme. Some individuals have a variation of this enzyme, which may lead to different effects. In some people, pain relief may be insufficient, while in others, severe adverse effects may be more likely.
Discontinue the medicine and contact the doctor immediately if any of the following adverse effects occur: slowed or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea, or vomiting, constipation, loss of appetite.
Children and adolescents
Use in children with breathing disorders
Tramadol is not recommended for children with breathing disorders, as symptoms of tramadol toxicity may be intensified in them.
Exbol with other medicines
Inform the doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Exbol contains paracetamol and tramadol. Inform the doctor about taking other medicines containing paracetamol or tramadol. Do not exceed the total maximum daily dose of paracetamol or tramadol taken in this medicine or in other medicines.
Do not use Exbol with MAO inhibitors (see section "When not to use Exbol").
Exbol is not recommended if the following medicines are taken simultaneously:

• carbamazepine (a medicine used in the treatment of epilepsy and various types of pain)
• buprenorphine, nalbuphine, and pentazocine (opioid painkillers). Their pain-relieving effect may be reduced.

Inform the doctor or pharmacist if the patient is taking:

• flucloxacillin (an antibiotic), due to the serious risk of a disorder affecting blood and body fluids (called metabolic acidosis), which requires urgent treatment (see section 2).

Exbol may increase the risk of adverse effects if taken simultaneously with the following medicines:

• Certain antidepressants. Exbol may interact with these medicines and cause serotonin syndrome (see section 4 "Possible side effects").
• Sedatives, sleeping medicines, other painkillers such as morphine and codeine (also in cough preparations), baclofen (a muscle relaxant), blood pressure-lowering medicines, antidepressants, or antihistamines. Report drowsiness and fainting to the doctor.
• Medicines that may cause seizures (epilepsy), such as antidepressants or antipsychotics. The risk of seizures may increase if Exbol is taken. The doctor will decide whether Exbol should be used.
• Concurrent use of Exbol with sedatives such as benzodiazepines or similar medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concurrent use should only be considered if other treatment options are not possible. However, if the doctor has prescribed Exbol together with sedatives, the dose and duration of concurrent use should be limited by the doctor. Inform the doctor about all sedatives taken and strictly follow the doctor's dosing instructions. It may be helpful to inform friends or family members to be aware of the above-mentioned symptoms. If such symptoms occur, contact the doctor.
• Gabapentin or pregabalin used in the treatment of epilepsy or nerve-related pain (neuropathic pain).
• Warfarin or acenocoumarol (anticoagulant medicines). The effectiveness of these medicines may change, and bleeding may occur (see section 4). Inform the doctor about any prolonged or unexpected bleeding.

The effectiveness of Exbol may also change when taken simultaneously with the following medicines:

• metoclopramide, domperidone, or ondansetron (used to treat nausea and vomiting)
• cholestyramine (used to lower blood cholesterol levels)
• ketoconazole or erythromycin (used to treat infections).

Exbol with food, drink, and alcohol
Do not consume alcohol while taking Exbol.
Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Do not use Exbol during pregnancy and breastfeeding (see section "When not to use Exbol").
Tramadol is excreted in breast milk. Therefore, do not take Exbol more than once during breastfeeding, or if Exbol has been taken more than once, discontinue breastfeeding.
Studies on the effects of the combination of tramadol and paracetamol on fertility have not been conducted.
Driving and operating machinery
If drowsiness occurs while taking Exbol, do not drive, use tools, or operate machinery.
Exbol contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Exbol

This medicine should always be used exactly as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Before starting treatment and regularly during treatment, the doctor will discuss with the patient what to
expect after taking Exbol, when and for how long it should be taken, when to contact the doctor, and when
the medicine should be discontinued (see also section 2).
Exbol should be taken for the shortest possible time and no longer than recommended by the doctor.
The dose should be adjusted according to the intensity of pain and the patient's sensitivity to pain. In general,
the lowest effective dose that relieves pain should be used.
Adults and adolescents aged 12 years and older
The recommended initial dose is 1 tablet, unless otherwise prescribed by a doctor. If necessary,
further doses may be taken according to the doctor's instructions.
There should be an interval of at least 6 hours between consecutive doses.
Do not take more than 4 tablets per day.
Elderly patients
In patients over 75 years of age, tramadol elimination from the body may be prolonged. In these
patients, the doctor may recommend extending the time interval between doses.
Patients with severe renal impairment, undergoing dialysis, or with hepatic impairment
Exbol should not be taken in cases of severe hepatic and/or renal impairment. In cases of mild or
moderate impairment, the doctor may recommend longer intervals between doses.
Method of administration
Tablets should be taken orally.
Tablets may be divided into equal doses. Swallow the tablet with sufficient fluid (e.g. one glass of water).
Exbol tablets may be taken with or without food.
If the effect of Exbol seems too strong (e.g. the patient feels drowsy or has difficulty breathing) or too weak
(pain does not subside), consult a doctor.
Children under 12 years of age
Exbol is not recommended for use in children under 12 years of age.
Taking more Exbol than recommended
In case of overdose or accidental ingestion by a child, seek immediate medical advice from a doctor or the
nearest hospital and provide the exact amount of medicine taken. Take any remaining tablets and this leaflet
with you. Paracetamol overdose can lead to serious consequences, including liver failure, which may be
fatal.
Missing a dose of Exbol
If a dose is missed, pain is likely to return.
Do not take a double dose to make up for a missed dose. Continue taking the medicine as prescribed.
Stopping Exbol treatment
Do not stop taking this medicine suddenly without medical advice. If the patient wishes to discontinue
treatment, this should be discussed with the doctor, especially if the medicine has been taken long-term.
The doctor will advise when and how to stop the medicine, possibly by gradually reducing the dose to
minimize the risk of withdrawal symptoms.
If the patient stops taking Exbol, pain is likely to return. If the patient wishes to discontinue treatment due to
unwanted side effects, this should be discussed with the doctor.
Stopping Exbol usually does not cause withdrawal symptoms. However, after discontinuation of long-term
treatment, some patients may experience symptoms such as restlessness, anxiety, nervousness, panic
attacks, hallucinations, unusual sensory sensations (itching, tingling, numbness), tinnitus, insomnia, tremor,
or gastrointestinal symptoms. If any of these symptoms occur after stopping Exbol, consult a doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Some adverse reactions may be serious. You must stop taking Exbol and
seek immediate medical advice if any of the following symptoms occur:

• swelling of the face, lips or throat, difficulty swallowing or breathing, or a sudden drop in blood pressure and fainting. A rash or itching may also occur. These symptoms may indicate a serious allergic reaction;
• prolonged or unexpected bleeding when Exbol is taken together with anticoagulant medicines (warfarin or acenocoumarol).

In addition, the following adverse reactions may occur during treatment with Exbol:
Very common (affects more than 1 in 10 people):

• nausea;
• dizziness, drowsiness.

Common (affects 1 to 10 in 100 people):

• vomiting;
• gastrointestinal disturbances (constipation, bloating, diarrhoea), stomach pain, dry mouth;
• itching, sweating;
• headache, tremor;
• disorientation, sleep disturbances, mood changes (anxiety, nervousness, elevated mood).

Uncommon (affects 1 to 10 in 1,000 people):

• increased blood pressure, palpitations, rapid or irregular heartbeat;
• difficulty passing urine or pain during urination;
• skin reactions (e.g. rash, urticaria);
• tingling, numbness or a sensation of pins and needles in the limbs, tinnitus, involuntary muscle contractions;
• depression, nightmares, hallucinations (hearing, seeing or feeling things that are not there), memory lapses;
• difficulty swallowing, presence of blood in stool (black stool);
• chills, hot flushes, chest pain;
• difficulty breathing;
• protein in urine, increased liver enzyme levels.

Rare (affects fewer than 1 in 10,000 people):

• seizures, uncoordinated movements;
• dependence, delirium;
• blurred vision, pinpoint pupils;
• transient loss of consciousness (fainting).

Very rare (affects fewer than 1 in 10,000 people):

• abuse.

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

• speech disorders;
• significant pupil dilation;
• low blood sugar (hypoglycaemia);
• hiccups;
• serotonin syndrome, which may present with changes in mental status (e.g. agitation, hallucinations, coma), as well as other symptoms such as fever, tachycardia, unstable blood pressure, involuntary muscle contractions, muscle rigidity, loss of coordination, and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) (see section 2 "Important information before taking Exbol");
• a serious condition that may cause increased blood acidity (so-called metabolic acidosis) in patients with severe disease who are taking paracetamol (see section 2).

In addition, adverse reactions reported by individuals taking medicines containing tramadol only or paracetamol only include:

• feeling faint when standing up from a lying or sitting position, slowed heart rate, fainting, changes in appetite, muscle weakness, reduced frequency or shallow breathing, mood changes, changes in activity, changes in perception, worsening of asthma.

In rare cases, the use of tramadol may lead to dependence and difficulty discontinuing the medicine. In rare cases, patients who have taken tramadol for some time may experience withdrawal symptoms after abrupt discontinuation. These may include agitation, anxiety, nervousness or tremors. Patients may become hyperactive, have sleep disturbances and gastrointestinal problems. A very small number of patients may experience panic attacks, hallucinations, or unusual sensations such as itching, tingling, numbness, or tinnitus. If any of these symptoms occur in a patient after stopping Exbol, medical advice should be sought immediately.
In exceptional cases, blood tests may reveal abnormalities, for example, a low platelet count, which may result in nosebleeds or bleeding gums.
Serious skin reactions have been very rarely reported during the use of paracetamol.
Respiratory depression has been rarely reported during the use of tramadol.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 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 the medicine.

5. How to store Exbol

There are no special requirements for storing this medicinal product.
The medicine should be stored in a place out of sight and reach of children.
The medicine should be kept in a safe place inaccessible to others. It may cause serious harm or be fatal to individuals for whom it has not been prescribed.
Do not use this medicine after the expiry date (EXP) stated on the carton. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Exbol contains

• The active substances in Exbol are tramadol hydrochloride and paracetamol. Each tablet contains 75 mg of tramadol hydrochloride and 650 mg of paracetamol.
• Other ingredients: maize starch gelatinised, povidone 25, sodium croscarmellose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate.

What Exbol looks like and contents of the pack
Exbol is a white or almost white, elongated, biconvex tablet with a division line.
The tablet can be divided into equal doses.
Approximate dimensions of the tablet: 19 mm x 8.8 mm.
Exbol is available in blister packs containing 10, 30, 60 or 90 tablets, packed in a cardboard carton.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Tel: +48 17 865 51 00

Manufacturer
ICN Polfa Rzeszów S.A.
Przemysłowa 2 Street
35-105 Rzeszów
Poland