Tadomon

Patient Information Leaflet

Tadomon 25 mg prolonged-release tablets, 50 mg prolonged-release tablets, 100 mg prolonged-release tablets, 150 mg prolonged-release tablets, 200 mg prolonged-release tablets, 250 mg prolonged-release tablets

tapentadol
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this 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 of Tadomon, is a strong analgesic belonging to the opioid class. Tadomon is administered for the treatment of

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

2. What you should know before taking Tadomon

Do not take Tadomon

• if you are allergic to tapentadol or to any of the other ingredients of this medicine (listed in section 6),
• you suffer from asthma or have dangerously slow or weak breathing (respiratory depression, hypercapnia),
• you have no bowel movement due to severe constipation and bloating, which may be accompanied by pain or discomfort in the lower abdomen,
• you have severe intoxication from alcohol, sleeping medicines, painkillers, or other psychotropic medicines (medicines affecting mood and emotions) (see "Other medicines and Tadomon").

Warnings and precautions
Talk to your doctor or pharmacist before taking Tadomon if:

• you have slow or weak breathing;
• you have increased pressure in the brain or altered consciousness that may lead to coma;
• you have had a head injury or brain tumours;
• you have liver or kidney problems (see "How to take Tadomon");
• you have a pancreatic disorder, including inflammation of the pancreas (pancreatitis), or a disorder of the bile duct (biliary tract disease);
• you are taking medicines called mixed opioid agonist/antagonists (e.g., pentazocine, nalbuphine) or partial mu-opioid agonists (e.g., buprenorphine);
• you have a predisposition to epilepsy or seizures, or you are taking other medicines that may increase the risk of seizures, as the risk of convulsions may increase.

Tolerance, dependence and abuse
This medicine contains tapentadol, which is an opioid. It may cause dependence and/or abuse.
This medicine contains tapentadol, an opioid medicine. Repeated use of opioids may make the medicine less effective (you become accustomed to it, a phenomenon known as tolerance). Repeated use of Tadomon may also lead to dependence, abuse, and addiction, which could result in a potentially life-threatening overdose. The risk of these adverse effects may increase with higher doses and prolonged duration of use.
Dependence or addiction may make you feel you no longer have control over the amount of medicine you need or how often you must take it.
The risk of developing dependence or addiction varies from person to person. You may have a higher risk of becoming dependent or addicted to Tadomon if:

• you or a family member has previously suffered from alcohol, prescription medicine, or illegal substance abuse or dependence ("addiction");
• you are a smoker;
• you have previously had mood disorders (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

The appearance of any of the following signs during Tadomon use may indicate dependence or abuse:

• You feel the need to use the medicine for a longer period than prescribed by your doctor.
• You feel the need to use a higher dose than recommended.
• You think you need to continue using the medicine, even if it does not help relieve your pain.
• You use the medicine for reasons other than prescribed, e.g., "to stay calm" or "to help sleep."
• You have tried several times to stop or control the use of this medicine without success.
• When you stop taking the medicine, you feel unwell, and you feel better when you start taking it again ("withdrawal effects"). If you notice any of these signs, consult your doctor to discuss the best treatment approach for you, including when it may be appropriate to stop treatment and how to do so safely (see section 3, "If you stop taking Tadomon").

Children and adolescents
Obese children and adolescents should be closely monitored, and the maximum recommended dose must not be exceeded.
Do not administer this medicine to children under 6 years of age.
Sleep-related breathing disorders
Tadomon may cause sleep-related breathing disorders, such as sleep apnoea (pauses in breathing during sleep) and sleep-related hypoxaemia (low blood oxygen levels). Symptoms may include breathing pauses during sleep, nighttime awakenings due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, consult your doctor. Your doctor may consider reducing the dose.
Other medicines and Tadomon
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Your doctor will prescribe medicines that can be safely taken with Tadomon.

• The risk of side effects increases if you are taking medicines that may cause seizures (fits), such as certain antidepressants or antipsychotics. The risk of seizures may increase if you take Tadomon at the same time. Your doctor will advise whether Tadomon is suitable for you.
• Concomitant use of Tadomon and sedative medicines such as benzodiazepines or similar medicines (some sleeping medicines or tranquilizers (e.g., barbiturates) or painkillers such as opioids, morphine, and codeine (also used as a cough medicine), antipsychotics, anti-H\ antihistamines, alcohol) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are possible. However, if your doctor prescribes Tadomon together with sedative medicines, the dose and duration of concomitant treatment must be determined by your doctor. Concurrent use of opioids and medicines used to treat epilepsy, nerve pain, or anxiety (gabapentin and pregabalin) increases the risk of opioid overdose, respiratory depression, and may be potentially life-threatening. Inform your doctor if you are taking gabapentin or pregabalin or other sedative medicines and follow your doctor's dose recommendations carefully. It may be helpful to inform friends or family members about the signs and symptoms listed above. Consult your doctor if you experience such symptoms.
• If you are taking a medicine that affects serotonin levels (e.g., certain medicines for depression), consult your doctor before taking Tadomon, as cases of "serotonin syndrome" have been reported. Serotonin syndrome is a rare but life-threatening condition. Symptoms include involuntary and rhythmic muscle contractions, including muscles controlling eye movements, agitation, excessive sweating, tremor, exaggerated reflexes, increased muscle tone, and body temperature above 38°C. Your doctor can advise you accordingly.
• The concomitant use of Tadomon with other medicines belonging to the group of mixed μ-opioid receptor agonist/antagonists (e.g., pentazocine, nalbuphine) or partial μ-opioid receptor agonists (e.g., buprenorphine) has not been studied. Tadomon may be less effective 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 the enzymes needed to remove Tadomon from the body may influence the effectiveness of Tadomon or may cause adverse effects. These effects may occur especially when starting or stopping the other medicine.
• Tadomon must not be taken together with monoamine oxidase inhibitors (MAOIs – some medicines for depression). Inform your doctor if you are taking MAO inhibitors or have taken them within the last 14 days.
• The use of Tadomon with the following medicines that have anticholinergic effects may increase the risk of adverse effects:
  • medicines used to treat depression;
• medicines used to treat allergies, motion sickness, or nausea (antihistamines or antiemetics);
• medicines used to treat psychiatric disorders (antipsychotics or neuroleptics);
• muscle relaxants (muscle relaxers);
• medicines used to treat Parkinson's disease.

Keep your doctor informed about all medicines you are taking.
Tadomon with food, drinks and alcohol
Do not drink alcohol while taking Tadomon, as some side effects, such as drowsiness, may increase. Food does not affect the action of these tablets.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take these tablets:

• if you are pregnant, unless prescribed by your doctor; if used for prolonged periods during pregnancy, tapentadol may cause withdrawal symptoms in the newborn, which may be life-threatening if not recognised and treated by a doctor;
• during childbirth, as it may cause dangerously slow or weak breathing (respiratory depression) in the newborn;
• while breastfeeding, as it may be excreted in breast milk.

If you become pregnant while being treated with Tadomon, consult your doctor.
Driving and using machines
Tadomon may significantly affect your ability to drive or operate machinery, as it may cause drowsiness, dizziness, blurred vision, and impaired reaction times. This may occur especially when you first start taking Tadomon, when your dose is changed, or if you are taking alcohol or tranquilizers.

3. How to take Tadomon

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Before starting treatment and regularly during treatment, your doctor will discuss with you what you can expect from using Tadomon, when and for how long it is necessary to use it, when to contact the doctor, and when you should stop treatment (see also "If you stop taking Tadomon" below).
Your doctor will adjust the dose and dosing interval according to the intensity of your pain and your individual needs. In general, you should take the lowest dose that effectively relieves your pain.

Adults
The recommended starting dose is 50 mg every 12 hours.
Total daily doses of Tadomon exceeding 500 mg of tapentadol are not recommended.
Your doctor may prescribe a different or more appropriate dose or dosing interval if considered necessary. If you feel that the effect of these tablets is too strong or too weak, consult your doctor or pharmacist.

Elderly patients
In elderly patients (over 65 years of age), dose adjustment is generally not required. However, elimination of tapentadol may be slowed in some patients in this age group. If this applies to you, your doctor may prescribe a different dose.

Liver and kidney disorders (insufficiency)
Patients with severe liver problems must not take these tablets. If you have moderate liver impairment, your doctor will prescribe a different dose. In cases of mild liver impairment, no dose adjustment is necessary. Patients with severe kidney problems must not take these tablets. In cases of mild or moderate kidney impairment, no dose adjustment is necessary.

Use in children and adolescents
The dose of Tadomon for children and adolescents aged 6 to less than 18 years depends on age and body weight.
The correct dose will be determined by your doctor. A total daily dose exceeding 500 mg must not be exceeded, i.e., 250 mg administered every 12 hours.
Children and adolescents with kidney or liver problems must not take these tablets.
Tadomon is not suitable for children under 6 years of age.

How and when to take Tadomon?

• Tadomon must be swallowed.
• Always swallow the tablets whole with sufficient liquid.
• Do not chew, break, or crush the tablet: this could cause an overdose, as the medicine would be released into your body too quickly.
• You may take the tablets on an empty stomach or with food.
• The empty tablet coating may not be completely digested and may therefore appear in the stool. This should not concern you, as the medicine (active substance) has already been absorbed into your body, and what you see is only the empty coating.

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

If you take more Tadomon than you should
After taking very high doses, the following may occur:
pinpoint pupils, vomiting, low blood pressure, tachycardia, altered consciousness, collapse or coma (deep unconsciousness), seizures, dangerously slow or weak breathing, or respiratory arrest, which may lead to death.
If any of these occur, call a doctor immediately!

If you forget to take Tadomon
If you forget to take the tablets, your pain may return. Do not take a double dose to make up for a missed dose; simply continue taking the tablets as previously prescribed.

If you stop taking Tadomon
If you stop or discontinue treatment too early, your pain may return. If you wish to stop treatment, inform your doctor first.
Withdrawal effects usually do not occur when stopping treatment. However, on rare occasions, people who have taken the tablets for some time may experience unwanted effects if they stop taking them abruptly.
Symptoms may include:

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

If you experience any of these symptoms after stopping treatment, consult your doctor.
Do not stop taking this medicine suddenly unless your doctor tells you otherwise. If your doctor wants you to stop taking the tablets, they will advise you how to do so, which may involve gradually reducing the dose.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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, contact a doctor immediately or go to the nearest hospital.

• Allergic reactions. Symptoms may include shortness of breath, breathing difficulties, swelling of the eyelids, face or lips, skin rash or itching, especially if affecting the whole body. (Frequency: Uncommon)
• If you are breathing more slowly or with greater difficulty than expected. This occurs mostly in elderly and frail patients. (Frequency: Common)

Other possible side effects:

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
• depression
• difficulty sleeping
• nervousness
• restlessness
• attention disturbance
• tremor
• muscle contractions
• hot flushes
• shortness of breath
• vomiting
• diarrhoea
• indigestion
• itching
• increased sweating
• skin rashes
• feeling of weakness
• fatigue
• sensation of change in body temperature
• dryness of mucous membranes
• fluid accumulation in tissues (oedema).

Uncommon (may affect up to 1 in 100 people)

• allergic reactions
• weight loss
• disorientation
• confusion
• excitability (agitation)
• perception disorders
• abnormal dreams
• euphoria (feeling extremely happy)
• reduced level of consciousness
• memory impairment
• mental disorders
• fainting
• sedation
• balance disorder
• difficulty speaking
• numbness
• abnormal skin sensations (e.g. tingling, pricking)
• visual disturbances
• tachycardia (faster heartbeat)
• bradycardia (slower heartbeat)
• decrease in blood pressure
• abdominal discomfort
• urticaria (skin reactions)
• difficulty urinating
• increased frequency of urination
• sexual dysfunction
• drug withdrawal syndrome (see "If you stop taking Tadomon")
• feeling of abnormality, irritability.

Rare (may affect up to 1 in 1,000 people)

• drug dependence
• thought disorders
• epileptic seizures
• feeling faint
• coordination disorders
• dangerously slow or weak breathing (respiratory depression)
• altered gastric emptying
• sensation of drunkenness
• feeling of relaxation.

Not known (frequency cannot be estimated from the available data)

• delirium

In general, the likelihood of having suicidal thoughts and behaviour increases in patients suffering from chronic pain. In addition, some medicines used to treat depression (which affect neurotransmitter systems in the brain) may increase this risk, especially at the beginning of treatment. Although tapentadol also affects neurotransmitters, clinical data on the use of tapentadol in humans do not provide evidence of an increased risk.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tadomon

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging and blister after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Store this medicine in a safe and secure place, inaccessible to other people. Taking it by individuals
to whom it has not been prescribed may cause serious harm or be fatal.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents 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 (as tartrate).
• The other components are:

Tablet core: povidone, microcrystalline cellulose, hypromellose, anhydrous colloidal silica,
magnesium stearate.
Coating of 25 mg and 250 mg tablets: hypromellose (E464), polydextrose (E1200),
titanium dioxide (E171), maltodextrin, medium-chain triglycerides, yellow iron oxide (E172),
black iron oxide (E172), red iron oxide (E172).
Coating of 50 mg tablet: hypromellose (E464), polydextrose (E1200), titanium dioxide (E171),
maltodextrin, medium-chain triglycerides.
Coating of 100 mg tablet: hypromellose (E464), polydextrose (E1200), titanium dioxide (E171),
maltodextrin, medium-chain triglycerides, yellow iron oxide (E172).
Coating of 150 mg and 200 mg tablets: hypromellose (E464), polydextrose (E1200), titanium dioxide (E171),
maltodextrin, medium-chain triglycerides, yellow iron oxide (E172), red iron oxide (E172).

Description of the Appearance of Tadomon and Contents of the Pack

Tadomon 25 mg is a prolonged-release tablet, light beige in colour, round and biconvex, with a diameter of approximately 8 mm.
Tadomon 50 mg is a prolonged-release tablet, white to off-white in colour, round and biconvex, with a diameter of approximately 12 mm.
Tadomon 100 mg is a prolonged-release tablet, light yellow in colour, oblong and biconvex, with a length of approximately 16 mm and a thickness of approximately 7 mm.
Tadomon 150 mg is a prolonged-release tablet, light pink in colour, oblong and biconvex, with a length of approximately 18 mm and a thickness of approximately 7.5 mm.
Tadomon 200 mg is a prolonged-release tablet, light ochre in colour, oblong and biconvex, with a length of approximately 18 mm and a thickness of approximately 7.5 mm.
Tadomon 250 mg is a prolonged-release tablet, red-brown in colour, oblong and biconvex, with a length of approximately 21 mm and a thickness of approximately 7.5 mm.

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 and Manufacturer

Marketing Authorization Holder
G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria.

Manufacturer
G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria.
Laboratorios Liconsa S.A., Avenida Miralcampo 7, 19200 Azuqueca De Henares, Guadalajara, Spain.

Marketing Authorization Holder in Italy:
G.L. Pharma Italy S.r.l., [email protected].

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Sweden: Tapentadol Depot G.L. Pharma
Italy: Tadomon
Czech Republic: Taboxea
Slovak Republic: Taboxea 25 mg tablety s predĺženým uvoľňovaním
Taboxea 50 mg tablety s predĺženým uvoľňovaním
Taboxea 100 mg tablety s predĺženým uvoľňovaním
Taboxea 150 mg tablety s predĺženým uvoľňovaním
Taboxea 200 mg tablety s predĺženým uvoľňovaním
Taboxea 250 mg tablety s predĺženým uvoľňovaním
Austria: Tapentadol G.L. 25 mg Retardtabletten
Tapentadol G.L. 50 mg Retardtabletten
Tapentadol G.L. 100 mg Retardtabletten
Tapentadol G.L. 150 mg Retardtabletten
Tapentadol G.L. 200 mg Retardtabletten
Tapentadol G.L. 250 mg Retardtabletten
Poland: Tadomon
Denmark: Tapentadol Medical Valley 25 mg depottabletter
Tapentadol Medical Valley 50 mg depottabletter
Tapentadol Medical Valley 100 mg depottabletter
Tapentadol Medical Valley 150 mg depottabletter
Tapentadol Medical Valley 200 mg depottabletter
Tapentadol Medical Valley 150 mg depottabletter
France: Taboxea LP 25 mg, comprimés à libération prolongée
Taboxea LP 50 mg, comprimés à libération prolongée
Taboxea LP 100 mg, comprimés à libération prolongée
Taboxea LP 150 mg, comprimés à libération prolongée
Taboxea LP 200 mg, comprimés à libération prolongée
Taboxea LP 250 mg, comprimés à libération prolongée