Tadomon

Leaflet included in the packaging: information for the user

Tadomon, 25 mg, prolonged-release tablets

Tadomon, 50 mg, prolonged-release tablets

Tadomon, 100 mg, prolonged-release tablets

Tadomon, 150 mg, prolonged-release tablets

Tadomon, 200 mg, prolonged-release tablets

Tadomon, 250 mg, prolonged-release tablets

Tapentadol

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor for a specific person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any undesirable effects, including any undesirable effects not mentioned in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Tadomon and what is it used for

Tapentadol, the active substance in Tadomon, is a strong pain-relieving substance belonging to the opioid class. Tadomon is used to treat

• severe chronic pain in adults that can only be adequately controlled with opioid pain relievers.
• chronic pain in children over 6 years of age and adolescents that can only be adequately controlled with opioid pain relievers.

2. Important information before taking Tadomon

You should not take Tadomon if you

• are allergic to tapentadol or any of the other ingredients of this medicine (listed in section 6),
• have asthma or if your breathing is dangerously slow or shallow (respiratory depression, hypercapnia),
• have not been relieved, as evidenced by severe constipation and bloating, which may be accompanied by pain or discomfort in the lower abdomen,
• have recently taken alcohol, sleeping pills, pain relievers, or other psychoactive medicines (medicines that affect mood and emotions) (see "Other medicines and Tadomon").

Warnings and precautions

Before starting treatment with Tadomon, you should discuss with your doctor or pharmacist if you

• have slow or shallow breathing
• have increased intracranial pressure or impaired consciousness up to coma
• have had head injuries or brain tumors
• have liver or kidney disease (see "How to take Tadomon")
• have pancreatic disease with pancreatitis or biliary tract disease,
• are taking medicines with mixed agonist and antagonist properties for the μ (mi) opioid receptor (e.g., pentazocine, nalbuphine) or partial agonists of the μ opioid receptor (e.g., buprenorphine)
• have a history of seizures or are taking other medicines that may increase the risk of seizures and convulsions.
• if you or a family member have ever abused or been dependent on alcohol, prescription drugs, or illegal substances ("addiction");
• if you are a smoker;
• if you have ever had mood disorders (depression, anxiety, or personality disorder) or have been treated by a psychiatrist for other mental disorders.

Tadomon may cause physical or psychological dependence. In the case of drug abuse or addiction, treatment should be short-term and under close medical supervision. This medicine contains tapentadol, which is an opioid. Repeated use of opioid pain relievers can lead to reduced efficacy of the medicine (the body getting used to it). It can also lead to addiction and abuse, which can cause life-threatening overdose. If you are concerned that you may become addicted to Tadomon, it is essential to consult your doctor. Taking the medicine (even at therapeutic doses) can lead to physical dependence, which can cause withdrawal symptoms and recurrence of problems if treatment is stopped abruptly.

Tadomon and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or plan to take. Your doctor will inform you which medicines can be safely taken with Tadomon.

• The risk of side effects increases when taking medicines that can cause seizures, such as antidepressants or antipsychotics. The risk of seizures may increase when taking Tadomon. Your doctor will inform you if Tadomon is suitable for you.
• Taking Tadomon and sedating medicines, such as benzodiazepines or related medicines (some sleeping or sedating medicines, e.g., barbiturates), or pain relievers, such as opioids, morphine, and codeine (also as a cough medicine), antipsychotics, antihistamines H1, or alcohol, increases the risk of drowsiness, breathing difficulties (respiratory depression), dizziness, and can be life-threatening. Therefore, such therapy should only be considered if other treatment methods are not possible. If your doctor prescribes Tadomon to be taken with sedating medicines, the dose and duration of concurrent treatment should be limited by your doctor. Concurrent use of opioids and medicines used to treat epilepsy, neuralgia, or anxiety (gabapentin and pregabalin) increases the risk of opioid overdose, respiratory depression, and can be life-threatening. You should inform your doctor if you are taking gabapentin or pregabalin or any sedating medicine and strictly follow your doctor's dosage recommendations. It may be helpful to inform friends or relatives to look out for the above signs and symptoms. If such symptoms occur, you should contact your doctor.
• If you are taking a medicine that affects serotonin levels (e.g., some medicines used to treat depression), you should consult your doctor before starting treatment with Tadomon, as cases of "serotonin syndrome" have been reported. Serotonin syndrome is a rare but life-threatening condition. Symptoms include involuntary, rhythmic muscle contractions, including muscles that control eye movements, agitation, excessive sweating, shivering, increased reflexes, muscle tension, and body temperature above 38°C. If such symptoms occur, your doctor may provide advice.
• The use of Tadomon with other medicines belonging to the group of medicines with mixed agonist and antagonist properties for the μ (mi) opioid receptor (e.g., pentazocine, nalbuphine) or partial agonists of the μ opioid receptor (e.g., buprenorphine) has not been studied. Tadomon may not work effectively if taken with one of these medicines. You should inform your doctor if you are currently being treated with one of these medicines.
• Taking Tadomon with products (e.g., rifampicin, phenobarbital, or St. John's Wort) that affect the enzymes required to remove Tadomon from the body may affect the efficacy of Tadomon or cause side effects. These effects may occur especially when starting or stopping another medicine.
• Tadomon should not be taken with monoamine oxidase inhibitors (MAOIs - some medicines used to treat depression). You should inform your doctor if you are taking MAOIs or have taken them in the last 14 days.

You should inform your doctor about all the medicines you are taking.

Taking Tadomon with food, drink, and alcohol

You should not drink alcohol while taking Tadomon, as it may increase the risk of certain side effects, such as drowsiness. Food does not affect the action of these tablets.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.

• you should not take these tablets if you are pregnant, unless your doctor has advised you to do so, as long-term use of tapentadol during pregnancy may cause withdrawal symptoms in newborns, which can be life-threatening if not recognized and treated by a doctor,
• you should not take these tablets during labor, as it may lead to dangerously slow or shallow breathing (respiratory depression) in the newborn,
• you should not take these tablets while breastfeeding, as the medicine may be excreted into breast milk.

If you become pregnant while taking Tadomon, you should consult your doctor.

Driving and using machines

Tadomon may have a significant impact on your ability to drive or operate machines, as it may cause drowsiness, dizziness, and blurred vision, and may slow down your reactions. This may occur especially in the initial phase of taking Tadomon, after changing the dose, or when taking Tadomon with alcohol and sedating medicines.

3. How to take Tadomon

You should take Tadomon as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist.

Adults

The usual starting dose is 50 mg every 12 hours.

The total daily dose of Tadomon should not exceed 500 mg of tapentadol.

Your doctor may prescribe a different, more suitable dose or interval between doses if necessary. If you feel that the effect of the medicine is too strong or too weak, you should consult your doctor or pharmacist.

Elderly patients

Dose adjustment is not usually necessary in elderly patients (over 65 years). The elimination of the medicine may be prolonged in this age group, and your doctor may recommend a different dosing schedule.

Patients with impaired liver or kidney function

Patients with severe liver impairment should not take this medicine.

In cases of moderate liver impairment, your doctor will recommend a different dosing schedule.

Patients with mild liver impairment do not require dose adjustment.

Patients with severe kidney impairment should not take this medicine.

In cases of mild or moderate kidney impairment, dose adjustment is not necessary.

Children and adolescents

The dose of Tadomon for children and adolescents from 6 to less than 18 years of age depends on their age and body weight.

Your doctor will determine the appropriate dose. You should not exceed the total daily dose of 500 mg.

You should not take this medicine if you have kidney or liver impairment.

Tadomon should not be used in children under 6 years of age.

How and when to take Tadomon?

• You should swallow Tadomon tablets.
• Tablets should always be swallowed whole, with a sufficient amount of liquid.
• You should not chew, break, or crush them, as this may lead to overdose, as the medicine will be released too quickly into the body.
• Tablets can be taken on an empty stomach or with food.
• The empty tablet shell may not be completely digested and may be visible in the stool. You should not be concerned, as the medicine (active substance) contained in the tablet has already been absorbed into the body, and what you see is just the empty shell.

How long to take Tadomon?

You should not take the tablets for longer than your doctor has recommended.

What to do if you take more Tadomon than you should

If you take very large doses, the following symptoms may occur: constricted pupils, vomiting, low blood pressure, rapid heartbeat, impaired consciousness, coma (deep state of unconsciousness), or seizures may occur, as well as dangerously slow or shallow breathing (respiratory depression).

In such a case, you should immediately call a doctor!

What to do if you forget to take Tadomon

If you forget to take a tablet, the pain will likely return. You should not take a double dose to make up for the missed dose; you should simply continue taking the tablets as before.

What to do if you stop taking Tadomon

If you stop treatment too early or abruptly, there is a risk of the pain returning. If you want to stop treatment, you should first consult your doctor.

Generally, after stopping treatment, no withdrawal effects occur. However, in rare cases, in people who have taken the tablets for some time, a feeling of unease may occur after abrupt cessation.

The following symptoms may occur:

• restlessness, tearing, runny nose, yawning, sweating, chills, muscle pain, and dilated pupils,
• irritability, anxiety, back pain, joint pain, weakness, abdominal cramps, difficulty sleeping, nausea, loss of appetite, vomiting, diarrhea, and increased blood pressure, respiratory rate, and heart rate.

If you experience any of these symptoms after stopping treatment, you should consult your doctor.

You should not stop taking Tadomon abruptly, unless your doctor advises you to do so. If your doctor advises you to stop taking the tablets, they will inform you how to do it, which may include gradually reducing the dose.

If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

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

No additional side effects have been observed in children and adolescents compared to adults.

If you experience any of the following side effects, you should immediately contact your doctor or go to the nearest hospital.

• Allergic reactions. Symptoms may include: wheezing, breathing difficulties, swelling of the eyelids, face, or lips, rash, or itching, especially affecting the whole body. (Frequency: uncommon)
• Slower or shallower breathing than expected. This occurs most frequently in elderly and frail patients. (Frequency: common)

Other side effects that may occur:

Very common (may affect more than 1 in 10 people)

• nausea
• constipation
• dizziness, drowsiness, headache.

Common (may affect up to 1 in 10 people)

• loss of appetite
• anxiety
• low mood
• sleep disorders
• irritability
• anxiety
• concentration disorders
• shivering
• muscle spasms
• flushing
• shortness of breath
• vomiting
• diarrhea
• indigestion
• itching
• increased sweating
• rash
• feeling of weakness
• fatigue
• feeling of temperature change
• dryness of mucous membranes
• fluid retention (edema).

Uncommon (less common than 1 in 100 people)

• allergic reactions
• weight loss
• disorientation
• confusion
• agitation (excitement)
• perception disorders
• unusual dreams
• euphoric mood
• impaired consciousness
• memory impairment
• psychiatric disorders
• fainting
• excessive sedation
• balance disorders
• speech disorders
• tingling
• abnormal skin sensations (e.g., burning, prickling)
• vision disorders
• rapid heartbeat
• slow heartbeat
• decreased blood pressure
• abdominal discomfort
• hives
• urination disorders
• diarrhea
• sexual dysfunction
• withdrawal syndrome
• feeling of abnormality, irritability.

Rare (less common than 1 in 1000 people)

• addiction to the medicine
• thought disorders
• seizures
• feeling of impending fainting
• coordination disorders
• dangerously slow or shallow breathing (respiratory depression)
• gastric emptying disorders
• feeling of intoxication
• feeling of relaxation.

Unknown: frequency cannot be estimated from the available data

• delirium

Generally, the risk of thoughts and behaviors leading to self-harm is increased in patients with chronic pain. Additionally, some medicines used to treat depression (which affect neurotransmitters in the brain) may increase this risk, especially at the start of therapy. Although tapentadol also affects neurotransmitters, data from the use of tapentadol in humans do not provide evidence of an increased risk.

Reporting side effects

If you experience any side effects, including any side effects not mentioned in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tadomon

Keep the medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month stated.

There are no special precautions for storing the medicine.

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Tadomon contains

The active substance of Tadomon is tapentadol.

Each prolonged-release tablet contains 25, 50, 100, 150, 200, or 250 mg of tapentadol (as tapentadol hydrochloride).

The other ingredients are:

Tablet core: povidone K30, microcrystalline cellulose, hypromellose, colloidal anhydrous silica, magnesium stearate.

Coating of 25 mg and 250 mg tablets: hypromellose (E 464), polydextrose (E 1200), titanium dioxide (E 171), maltodextrin, medium-chain triglycerides, yellow iron oxide (E 172), black iron oxide (E 172), red iron oxide (E 172).

Coating of 50 mg tablet: hypromellose (E 464), polydextrose (E 1200), titanium dioxide (E 171), maltodextrin, medium-chain triglycerides.

Coating of 100 mg tablet: hypromellose (E 464), polydextrose (E 1200), titanium dioxide (E 171), maltodextrin, medium-chain triglycerides, yellow iron oxide (E 172).

Coating of 150 mg and 200 mg tablets: hypromellose (E 464), polydextrose (E 1200), titanium dioxide (E 171), maltodextrin, medium-chain triglycerides, yellow iron oxide (E 172), red iron oxide (E 172).

What Tadomon looks like and contents of the pack

Tadomon 25 mg is a pale beige, round, biconvex prolonged-release tablet, approximately 8 mm in diameter.

Tadomon 50 mg is a white or almost white, round, biconvex prolonged-release tablet, approximately 12 mm in diameter.

Tadomon 100 mg is a pale yellow, oval, biconvex prolonged-release tablet, approximately 16 mm long and 7 mm wide.

Tadomon 150 mg is a pale red, oval, biconvex prolonged-release tablet, approximately 18 mm long and 7.5 mm wide.

Tadomon 200 mg is a light yellow-brown, oval, biconvex prolonged-release tablet, approximately 18 mm long and 7.5 mm wide.

Tadomon 250 mg is a reddish-brown, oval, biconvex prolonged-release tablet, approximately 21 mm long and 7.5 mm wide.

Tadomon is available in blisters containing 7, 28, 30, 40, 60, or 100 prolonged-release tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

G.L. Pharma GmbH

Schlossplatz 1,

A-8502 Lannach,

Austria

Manufacturer

Laboratorios Liconsa, S.A.

Avenida Miralcampo 7

Polígono Industrial Miralcampo

19200 Azuqueca de Henares

Spain

G.L. Pharma GmbH

Schlossplatz 1,

8502 Lannach,

Austria