Tadomon

Package leaflet: 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
Tapentadolum
Read the entire leaflet carefully before starting to use the medicine, because it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
  Contents of the leaflet:
  1. What Tadomon is and what it is used for
  2. What you need to know before taking Tadomon
  3. How to take Tadomon
  4. Possible side effects
  5. How to store Tadomon
  6. Contents of the pack and other information

1. What Tadomon is and what it is used for

Tapentadol, the active substance in Tadomon, is a potent analgesic belonging to the opioid class. Tadomon is used in the treatment of:

• severe, chronic pain in adults, which can only be adequately managed with opioid analgesics.
• severe, chronic pain in children over 6 years of age and adolescents, which can only be adequately managed with opioid analgesics.

2. Important information before taking Tadomon

Do not take Tadomon if the patient:

• is allergic to tapentadol or any of the other ingredients of this medicine (listed in section 6),
• has asthma or dangerously slowed or shallow breathing (respiratory depression, hypercapnia),
• is not passing stools, which may be accompanied by severe constipation, bloating, abdominal pain or discomfort,
• has recently suffered acute poisoning with alcohol, sleeping medicines, painkillers or other psychotropic medicines (medicines affecting mood and emotions) (see "Other medicines and Tadomon").

Warnings and precautions

Before starting treatment with Tadomon, discuss this with your doctor or pharmacist if:

• slow or shallow breathing occurs,
• increased intracranial pressure or impaired consciousness up to coma is present,
• the patient has suffered head injury or has brain tumours,
• the patient has liver or kidney disease (see "How to take Tadomon"),
• the patient has pancreatic disease including pancreatitis or biliary tract disorders,
• the patient is taking medicines with mixed agonist-antagonist properties at the μ (mu) opioid receptor (e.g. pentazocine, nalbuphine) or medicines that are partial agonists at the μ (mu) opioid receptor (e.g. buprenorphine),
• the patient has a tendency to seizures or convulsions, or is taking other medicines that may increase the risk of seizures.

Tolerance, dependence and abuse

This medicine contains tapentadol, which is an opioid medicine. It may cause dependence and/or abuse.
Repeated use of opioid-containing medicines may lead to reduced effectiveness of the medicine (the patient's body becomes accustomed to it, known as tolerance). Repeated use of Tadomon may lead to dependence, abuse and misuse, which may result in life-threatening overdose. The risk of such adverse effects may increase with higher doses and prolonged duration of use.
Dependence or abuse may lead to the patient losing control over the amount or frequency of medicine intake.
The risk of developing dependence or abuse varies among individuals. Increased risk of developing dependence or abuse of Tadomon may apply to individuals in the following situations:

• the patient or anyone in their family has ever misused or been dependent on alcohol, prescription medicines or illegal drugs ("addiction"),
• the patient is a tobacco smoker,
• the patient has ever had mood disorders (depression, anxiety or personality disorders) or has been treated by a psychiatrist for other mental disorders.

If, while taking Tadomon, the patient notices any of the following symptoms, this may indicate developing dependence or abuse:

• need to take the medicine for longer than prescribed by the doctor,
• need to take a higher dose than recommended,
• feeling that the medicine must be continued, even if it does not help relieve pain,
• using the medicine for reasons other than recommended, e.g. "to calm down" or "to help sleep",
• repeated unsuccessful attempts to stop or control medicine use,
• feeling unwell after stopping the medicine and feeling better after resuming it ("withdrawal effect").

If any of these symptoms are observed, the patient should consult their doctor to discuss the best treatment plan, including the appropriate timing and safe way to discontinue treatment (see section 3 Discontinuation of Tadomon treatment).

Children and adolescents
Children and adolescents with obesity should be closely monitored and the maximum recommended dose should not be exceeded.
Tadomon must not be given to children under 6 years of age.

Sleep-related breathing disorders
Tadomon may cause breathing disorders during sleep, such as sleep apnoea (pauses in breathing during sleep) and nocturnal hypoxaemia (low oxygen levels in the blood during sleep). Symptoms may include breathing pauses during sleep, waking up at night due to breathlessness, difficulty maintaining sleep or excessive daytime sleepiness. If the patient or someone else notices such symptoms, medical advice should be sought. The doctor may consider reducing the dose.

Tadomon and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Your doctor will inform you which medicines can be safely taken with Tadomon.

• The risk of adverse effects increases when taking medicines that may cause seizures, such as antidepressants or antipsychotics. The risk of seizures may increase when Tadomon is taken concomitantly. Your doctor will advise whether Tadomon is suitable for you.
• Concomitant use of Tadomon and sedative medicines such as benzodiazepines or related drugs (some sleeping or calming medicines, e.g. barbiturates), opioid painkillers such as morphine and codeine (also used as cough suppressants), antipsychotics, H__1__ antihistamines, or alcohol increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and may be life-threatening. Therefore, such combination therapy should only be considered if other treatment options are not possible. If your doctor prescribes Tadomon to be taken together with sedative medicines, the dose and duration of concomitant treatment should be limited by the doctor. Concomitant use of opioids and medicines used to treat epilepsy, neuropathic pain or anxiety (gabapentin and pregabalin) increases the risk of opioid overdose, respiratory depression and may be life-threatening. Patients should inform their doctor if they are taking gabapentin or pregabalin or any sedative medicine and strictly follow the doctor's dosing instructions. It may be helpful to inform friends or family members to watch for the above-mentioned signs and symptoms. If such symptoms occur, contact your doctor.
• If the patient is taking a medicine that affects serotonin levels (e.g. certain medicines used to treat depression), they should consult their doctor before starting Tadomon therapy, 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 controlling eye movements, agitation, excessive sweating, tremor, increased reflexes, increased muscle tone and body temperature above 38°C. If such symptoms occur, the doctor may provide advice.
• The use of Tadomon together with other medicines with mixed agonist-antagonist properties at the μ (mu) opioid receptor (e.g. pentazocine, nalbuphine) or medicines that are partial agonists at the μ (mu) opioid receptor (e.g. buprenorphine) has not been studied. Tadomon may not work effectively if taken with any of these medicines. Inform your doctor if you are currently being treated with any of these medicines.
• Taking Tadomon with products (e.g. rifampicin, phenobarbital or St John's wort) that affect enzymes required for the elimination of Tadomon from the body may influence the effectiveness of Tadomon or cause adverse effects. These effects may occur especially when starting or stopping another medicine.
• Tadomon must not be taken concomitantly with monoamine oxidase inhibitors (MAOIs – certain medicines used to treat depression). Inform your doctor if you are taking MAO inhibitors or have taken them within the last 14 days.

The risk of adverse effects may increase if the patient takes Tadomon together with the following medicines with anticholinergic effects:

• antidepressants,
• medicines used to treat allergies, motion sickness or nausea (antihistamines and antiemetics),
• medicines used to treat mental disorders (antipsychotics or neuroleptics),
• muscle relaxants,
• medicines used to treat Parkinson's disease.

Inform your doctor about all medicines you are taking.

Taking Tadomon with food, drink and alcohol
Do not drink alcohol while taking Tadomon, as this may worsen certain adverse effects such as drowsiness. Food does not affect the action of this medicine.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a baby, she should consult her doctor or pharmacist before using this medicine.
Do not take these tablets:

• if the patient is pregnant, unless advised by a doctor; long-term use of tapentadol during pregnancy may cause withdrawal symptoms in newborns, which may be life-threatening if not recognised and treated by a doctor,
• during childbirth, as it may cause dangerously slowed or shallow breathing (respiratory depression) in the newborn,
• while breastfeeding, as the medicine may be excreted in breast milk.

If the patient becomes pregnant while taking Tadomon, she should talk to her doctor.

Driving and using machines
Tadomon may have a significant effect on the ability to drive or operate machinery, as it may cause drowsiness, dizziness and blurred vision and may impair reaction times. This may occur particularly during the initial phase of taking Tadomon, after a dose change, or when alcohol or sedative medicines are taken concomitantly.

3. How to use Tadomon

Tadomon must be taken as directed by the physician. In case of doubts, consult a doctor or pharmacist.
Before starting treatment and regularly during therapy, the doctor will discuss with the patient what to expect from using Tadomon, when and for how long the medicine should be taken, when to contact the doctor, and when the medicine should be discontinued (see also section "Stopping Tadomon").

The doctor adjusts the dose and the interval between doses according to the intensity of pain and the patient's needs. Usually, the lowest effective analgesic dose should be used.

Adults
The usual starting dose is 50 mg every 12 hours.
The total daily dose of Tadomon should not exceed 500 mg of tapentadol.
The doctor may prescribe a different, more appropriate dose or dosing interval if necessary. If the patient feels that the effect of the medicine is too strong or too weak, consult a doctor or pharmacist.

Elderly patients
Dosage adjustment is usually not necessary in elderly patients (over 65 years of age). Elimination of the drug may be prolonged in patients from this age group, and therefore the doctor may recommend a different dosing regimen.

Patients with impaired liver or kidney function
Patients with severe impairment of liver function should not take this medicine.
In case of moderate liver impairment, the doctor will recommend an alternative dosing regimen.
Patients with mild liver impairment do not require dose adjustment.
Patients with severe kidney impairment should not take this medicine.
Dose adjustment is not required in patients with mild or moderate kidney impairment.

Children and adolescents
The dose of Tadomon in children and adolescents aged 6 to less than 18 years depends on age and body weight.
The appropriate dose will be determined by the doctor. The total daily dose must not exceed 500 mg, i.e., 250 mg administered every 12 hours. This medicine should not be used in children and adolescents with kidney or liver impairment.
Tadomon is not recommended for use in children under 6 years of age.

How and when should Tadomon be taken?

• Tadomon tablets should be swallowed whole.
• Tablets should always be swallowed whole with an adequate amount of liquid.
• Do not chew, crush, or break the tablets—this may lead to overdose, as the drug would be released too quickly into the body.
• Tablets may be taken on an empty stomach or with food.
• The empty tablet shell may not be completely digested and therefore may be visible in the stool. This is not a cause for concern, as the active ingredient contained in the tablet has already been absorbed into the body; what is seen is only the empty shell.

How long should Tadomon be taken?
Do not take the tablets longer than prescribed by the doctor.

Taking more Tadomon than recommended
After taking very high doses, the following symptoms may occur:
constricted pupils, vomiting, drop in blood pressure, rapid heartbeat, disturbances of consciousness, collapse or coma (a deep state of unconsciousness), epileptic seizures, dangerously slowed or shallow breathing, or respiratory arrest, which may lead to death.
In such a case, call a doctor immediately!

If a dose of Tadomon is missed
If the patient forgets to take the tablet, pain may return. Do not take a double dose to make up for the missed dose; simply continue taking the tablets as previously prescribed.

Stopping Tadomon treatment
If treatment is stopped too early or discontinued, there is a risk of recurrence of pain symptoms. If the patient wishes to discontinue treatment, they should first inform the doctor.
Generally, withdrawal effects do not occur after stopping treatment. However, in rare cases, individuals who have taken the tablets for some time may experience discomfort after abruptly stopping them.
The following symptoms may occur:

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

If any of these symptoms occur after stopping treatment, consult a doctor.
Do not abruptly stop taking the medicine unless instructed by the doctor. If the doctor advises discontinuing the tablets, they will inform the patient how to do so, which may include gradually reducing the dose.

If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, Tadomon may cause adverse reactions, although not everyone experiences them.

No additional adverse reactions have been observed in children and adolescents compared to adults.
If any of the following adverse reactions occur in a patient, contact a doctor immediately or go to the nearest hospital.

• Allergic reactions. Symptoms may include: wheezing, difficulty breathing, swelling of the eyelids, face or lips, rash or itching, especially if widespread throughout the body. (Frequency: not very common)
• Slower or weaker breathing than expected. Most frequently observed in elderly and weakened patients. (Frequency: common)

Other possible adverse reactions:

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

• feeling unwell (nausea)
• constipation
• dizziness, drowsiness, headache

Common (may affect up to 1 in 10 people)

• loss of appetite
• anxiety
• low mood
• difficulty falling asleep
• nervousness
• restlessness
• difficulty concentrating
• tremor
• muscle spasms
• sudden flushing of the face
• shortness of breath
• vomiting
• diarrhoea
• indigestion
• itching
• increased sweating
• rash
• feeling of weakness
• fatigue
• sensation of body temperature changes
• dryness of mucous membranes
• fluid accumulation in tissues (oedema)

Not very common (less than 1 in 100 people)

• allergic reactions
• weight loss
• disorientation
• confusion
• agitation (excitement)
• perceptual disturbances
• unusual dreams
• euphoric mood
• reduced level of consciousness
• memory impairment
• psychiatric disturbances
• fainting
• excessive sedation
• balance disorders
• speech disorders
• tingling
• abnormal skin sensations (e.g. pins and needles, pricking)
• visual disturbances
• faster heartbeat
• slower heartbeat
• decreased arterial blood pressure
• abdominal discomfort
• urticaria
• difficulty in urinating
• frequent urination
• sexual dysfunction
• withdrawal syndrome
• feeling of abnormality, irritability

Rare (less than 1 in 1000 people)

• drug dependence
• thought disorders
• seizures
• feeling of impending fainting
• coordination disorders
• dangerously slow or shallow breathing (respiratory depression)
• delayed gastric emptying
• feeling of intoxication
• feeling of relaxation

Unknown frequency: cannot be estimated from available data

• delirium

In general, the likelihood of suicidal thoughts and behaviours is increased in patients suffering from chronic pain. Additionally, some medicines used in the treatment of depression (which affect neurotransmitter systems in the brain) may increase this risk, especially at the beginning of therapy. Although tapentadol also affects neurotransmitter systems, data from tapentadol use in humans do not provide evidence of an increased risk.

Reporting of adverse reactions
If any adverse reactions occur, including any 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 may also be reported directly to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Tadomon

Keep Tadomon out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after
EXP. The expiry date refers to the last day of the stated month.
No special storage instructions apply.
This medicine should be stored in a safe place inaccessible to others.
It may cause serious harm or even death to individuals for whom it has not been prescribed.
Medicines must not be disposed of via wastewater or household waste.
Ask your pharmacist how to properly dispose of medicines you no longer use.
This will help protect the environment.

6. Contents of the packaging and other information

What Tadomon contains
The active substance is tapentadol.
Each prolonged-release tablet contains 25, 50, 100, 150, 200 or 250 mg of tapentadol
(in the form of 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, iron oxide yellow (E 172), iron oxide black (E 172), iron oxide red (E 172).
Coating of 50 mg tablets: hypromellose (E 464), polydextrose (E 1200), titanium dioxide (E 171), maltodextrin, medium-chain triglycerides.
Coating of 100 mg tablets: hypromellose (E 464), polydextrose (E 1200), titanium dioxide (E 171), maltodextrin, medium-chain triglycerides, iron oxide yellow (E 172).
Coating of 150 mg and 200 mg tablets: hypromellose (E 464), polydextrose (E 1200), titanium dioxide (E 171), maltodextrin, medium-chain triglycerides, iron oxide yellow (E 172), iron oxide red (E 172).

What Tadomon looks like and contents of the pack
Tadomon 25 mg is a pale beige, round, biconvex prolonged-release tablet with a diameter of approximately 8 mm.
Tadomon 50 mg is a white or almost white, round, biconvex prolonged-release tablet with a diameter of approximately 12 mm.
Tadomon 100 mg is a pale yellow, oblong, biconvex prolonged-release tablet with a length of approximately 16 mm and a width of approximately 7 mm.
Tadomon 150 mg is a light pink, oblong, biconvex prolonged-release tablet with a length of approximately 18 mm and a width of approximately 7.5 mm.
Tadomon 200 mg is a light yellow-brown, oblong, biconvex prolonged-release tablet with a length of approximately 18 mm and a width of approximately 7.5 mm.
Tadomon 250 mg is a reddish-brown, oblong, biconvex prolonged-release tablet with a length of approximately 21 mm and a width of approximately 7.5 mm.
Tadomon is available in blister packs containing 7, 28, 30, 40, 60 or 100 prolonged-release tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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

For further information about this medicine, contact the local representative of the Marketing Authorisation Holder:
G.L. PHARMA POLAND Sp. z o.o.
ul. Sienna 75; 00-833 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
[email protected]

This medicine is authorised for marketing in the European Economic Area under the following names:
Sweden: Tapentadol Depot G.L. Pharma
Italy: Tadomon
Czech Republic: Taboxea
Slovakia: Taboxea 25/50/100/150/200/250 mg tablety s predĺženým uvoľňovaním
Austria: Tapentadol G.L. 25/50/100/150/200/250 mg Retardtabletten
Poland: Tadomon
Denmark: Tapentadol Medical Valley 25/50/100/150/200/250 mg depottabletter
France: Taboxea LP 25/50/100/150/200/250 mg, comprimés à libération prolongée