Adoben

Package leaflet: Information for the patient

Adoben, 50 mg, prolonged-release tablets
Adoben, 100 mg, prolonged-release tablets
Adoben, 150 mg, prolonged-release tablets
Adoben, 200 mg, prolonged-release tablets
Adoben, 250 mg, prolonged-release tablets
Tapentadol
Please read carefully the entire leaflet 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 doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are identical.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Adoben is and what it is used for

Tapentadol – the active substance in Adoben – is a potent analgesic belonging to the opioid group. Adoben is indicated for the treatment of:

• severe chronic pain in adults, where only treatment with an opioid analgesic is expected to provide proper pain relief;
• severe chronic pain in children above 6 years of age and adolescents, which can only be adequately managed with opioid analgesics.

2. Important information before using Adoben

When not to take Adoben

• if the patient is allergic to tapentadol or any of the other ingredients of this medicine (listed in section 6),
• in patients with asthma or dangerously slow and shallow breathing (respiratory depression, increased carbon dioxide levels in the blood),
• in patients with intestinal obstruction,
• in cases of acute alcohol intoxication, sedatives, analgesics or other psychotropic drugs (drugs affecting mood and emotions) (see "Adoben with other medicines").

Warnings and precautions
Before starting to take Adoben, discuss this with your doctor or pharmacist:

• if you have slow or shallow breathing,
• if you have increased intracranial pressure or impaired consciousness up to coma,
• in patients who have suffered head injury or have brain tumours,
• in patients with liver or kidney disease (see "How to take Adoben"),
• in patients with diseases of the pancreas or biliary tract, including pancreatitis,
• in patients taking medicines with mixed agonist and antagonist properties at opioid "mu" receptors (e.g. pentazocine, nalbuphine) or medicines that are partial agonists of the opioid "mu" receptor (e.g. buprenorphine),
• in patients with a history of seizures or convulsions, or when taking other medicines that increase the risk of seizures and may increase the risk of convulsions,
• if the patient or someone in their family has ever misused or been dependent on alcohol, prescription drugs or illegal substances ("addiction"),
• if the patient is a smoker,
• if the patient has ever had mood disorders (depression, anxiety or personality disorder) or has been treated by a psychiatrist for other mental disorders.

This medicine contains tapentadol, which is an opioid medicine. Repeated use of opioid analgesics may lead to reduced effectiveness of the medicine (tolerance). It may also lead to dependence and abuse, which could result in life-threatening overdose. If the patient is concerned about becoming addicted to Adoben, it is important to consult their doctor. Use (even at therapeutic doses) may lead to physical dependence, which may cause withdrawal symptoms and recurrence of problems if treatment with this medicine is suddenly stopped. Adoben may cause physical and psychological dependence. In cases of tendency to drug abuse or presence of addiction, treatment should be short-term and under strict medical supervision.

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

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

Adoben with 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.

The risk of adverse effects increases if the patient is taking medicines that may cause seizures (epileptic fits), such as antidepressants or antipsychotics. The risk of seizures may increase if the patient is also taking Adoben at the same time. The doctor will inform the patient whether taking Adoben is suitable for them.

Concomitant use of Adoben and sedative medicines, such as benzodiazepine derivatives or benzodiazepine-like drugs [e.g. certain sleeping tablets or sedatives (e.g. barbiturates) or analgesics such as opioids, morphine and codeine (also used as cough suppressants), antipsychotics, H1 antihistamines, alcohol], increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and may be life-threatening. Therefore, concomitant use of such medicines should only be considered when no other treatment options are available.

If, however, the doctor prescribes Adoben together with other sedative medicines, the doctor should limit the dose and duration of concomitant treatment.

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.

Inform your doctor if you are taking gabapentin or pregabalin, or any sedative medicine, and strictly follow the doctor's instructions regarding dosage. It may be helpful to inform friends or relatives so they are aware of the above-mentioned subjective and objective symptoms. If such symptoms occur, contact your doctor.

If the patient is taking medicines that affect serotonin levels (e.g. certain medicines used to treat depression), they should consult their doctor before taking Adoben due to the possibility of developing "serotonin syndrome". Serotonin syndrome is rare but may be life-threatening. Symptoms include uncontrolled, rhythmic muscle contractions, including eye movement muscles, agitation, excessive sweating, tremor, exaggerated reflexes, including increased muscle tone and body temperature above 38°C. If this occurs, seek medical advice.

The concomitant use of Adoben with opioid medicines belonging to mixed agonist/antagonist "mu" receptor drugs (e.g. pentazocine, nalbuphine) or partial agonists of the "mu" receptor (e.g. buprenorphine) has not been studied. It is possible that Adoben may not work properly if used simultaneously with the above-mentioned groups of medicines. Inform your doctor immediately if you are currently taking any of the medicines listed above.

Concomitant use of Adoben with strong inhibitors or inducers (e.g. rifampicin, phenobarbital, St. John's wort) of enzymes necessary for the elimination of tapentadol from the body may affect the action of tapentadol or may cause adverse effects, especially when starting or stopping their administration. Inform your doctor about all medicines currently being taken.

Adoben must not be used concomitantly with MAO inhibitors (medicines used to treat depression). Inform your doctor if these medicines have been or are being used within the last 14 days.

Adoben with food, drink and alcohol
Do not drink alcohol while taking Adoben, as some adverse effects, such as drowsiness, may be intensified. The medicine can be taken regardless of meals.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Do not take Adoben:

• during pregnancy, unless the doctor decides it should be used. 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 dangerous slowing or weakening of the newborn's breathing (respiratory depression).
• while breastfeeding, as the medicine may be excreted in breast milk.

Driving and operating machinery
Adoben may cause drowsiness, dizziness, blurred vision and affect reaction ability. These symptoms may occur especially at the beginning of Adoben treatment, after a dose adjustment recommended by the doctor, or when alcohol or sedative medicines are taken concomitantly. Ask your doctor whether driving and operating machinery are permitted after taking the medicine.

Adoben contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact their doctor before taking the medicine.

3. How to take Adoben

This medicine should always be taken as directed by a physician or pharmacist. In case of
doubt, consult a physician or pharmacist.
The dosage of Adoben should be adjusted according to the intensity of pain and individual patient sensitivity.
The lowest effective dose providing adequate pain relief should be used.
Adults
The usual initial dose is 50 mg every 12 hours.
The physician may recommend a different dose or dosing interval if necessary. If you feel that the medicine's effect is too strong or too weak, contact your physician or pharmacist.
Total daily doses of Adoben exceeding 500 mg of tapentadol are not recommended.
Elderly patients
Dosage adjustment is usually not required in elderly patients (over 65 years of age). However, elimination of the drug may be prolonged in patients in this age group, and therefore the physician may recommend a different dosing regimen.
Patients with impaired liver or kidney function
This medicine should not be used in patients with severe impairment of liver function. In cases of moderate impairment of liver function, the physician will recommend an adjusted dosing regimen. Patients with mild liver function impairment do not require dose adjustment.
This medicine should not be used in patients with severe impairment of kidney function. In cases of mild or moderate kidney function impairment, dose adjustment is not required.
Use in children and adolescents
The dose of Adoben 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 physician. The total daily dose should not exceed 500 mg, i.e., 250 mg administered every 12 hours.
Adoben should not be used in children and adolescents with impaired kidney or liver function.
Adoben should not be used in children under 6 years of age.
How and when to take Adoben
Adoben should be taken orally.
The tablet should be swallowed whole with sufficient liquid. Do not chew, break, or crush the tablet, as this may lead to overdose due to rapid release of the drug in the body. The medicine may be taken on an empty stomach or with food.
The empty tablet shell may pass undigested and may be visible in the stool. This is not a cause for concern, as the active substance has already been absorbed by the body, and only the tablet shell remains in the stool.
Duration of treatment
Do not take the tablets longer than recommended by your physician.
Taking more Adoben than recommended
After taking very high doses, the following symptoms may occur:

• pinpoint pupil constriction, vomiting, decreased blood pressure, rapid heartbeat, collapse, disturbances of consciousness or coma (deep unconsciousness), seizures, dangerously slow or shallow breathing, or respiratory arrest. In such cases, seek immediate medical attention!

If you miss a dose of Adoben
If the patient forgets to take the medicine, pain symptoms may return. Do not take a double dose to make up for the missed dose. Resume the regular dosing schedule.
Stopping treatment with Adoben
If treatment with Adoben is interrupted or discontinued before the end of the prescribed course, pain symptoms are likely to return. Consult your physician before stopping the medicine.
Generally, no adverse effects are observed upon discontinuation of the medicine. However, in rare cases, patients who have been taking the medicine for some time and stop it abruptly may experience general malaise.
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 sleeping, nausea, loss of appetite, vomiting, diarrhea, increased blood pressure, respiratory rate, and heart rate.

If any of the above symptoms occur, consult a physician immediately.
Do not stop taking the medicine suddenly unless directed by a physician. The physician will inform the patient how to discontinue the medicine. Discontinuation may involve gradually reducing the dose.
If you have any further doubts regarding the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
No additional adverse reactions have been observed in children and adolescents compared to those occurring in adults.
Important adverse reactions or symptoms to watch for and what to do if they occur:
This medicine may cause allergic reactions including wheezing, difficulty breathing, swelling of the eyelids, face or lips, rash or itching, particularly affecting the whole body.
Another serious adverse reaction is excessive slowing and shallowness of breathing. This most commonly occurs in elderly and weakened patients.
If any of these serious adverse reactions affect you, contact your doctor immediately.
Other adverse reactions 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, depressed mood, sleep disturbances, nervousness, motor restlessness, difficulty concentrating, tremor, muscle spasms, flushing, shortness of breath, vomiting, diarrhoea, indigestion, itching, excessive sweating, rash, feeling of weakness, fatigue, sensation of body temperature changes, dryness of mucous membranes, fluid retention in tissues (oedema).
Uncommon (may affect up to 1 in 100 people): allergic reactions to the medicine (including skin swelling, urticaria, and in severe cases difficulty breathing, drop in blood pressure, collapse or shock), weight loss, disorientation, confusion, agitation, perceptual disturbances, unusual dreams, euphoric mood, reduced level of consciousness, memory impairment, psychiatric disturbances, fainting, excessive sedation, balance disorders, speech disturbances, tingling, abnormal skin sensations (e.g. numbness, prickling), visual disturbances, faster heartbeat, slower heartbeat, palpitations, decreased blood pressure, discomfort in the abdominal cavity, urticaria, difficulty urinating, frequent urination, sexual dysfunction, withdrawal syndrome (see "Stopping Adoben treatment"), feeling of abnormality, irritability.
Rare (may affect up to 1 in 1000 people): drug dependence, disturbances in thinking, seizures, feeling of impending fainting, coordination disorders, dangerously slow or shallow breathing (respiratory depression), impaired gastric emptying, sensation of alcohol intoxication, feeling of relaxation.
Frequency not known (frequency cannot be estimated from available data): hallucinations.
Generally, the likelihood of suicidal thoughts and behaviours is higher in patients with chronic pain. Additionally, medicines used to treat depression (which affect the neurotransmitter system in the brain) may increase this risk, especially at the beginning of treatment.
Although tapentadol also affects neurotransmitters, data obtained from its use in humans have not provided evidence of an increased risk of such events.
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 Drug Reactions, 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 authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Adoben

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions apply for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Adoben contains

• The active substance is tapentadol.
  Adoben 50 mg prolonged-release tablets: Each prolonged-release tablet contains 50 mg of tapentadol (as tapentadol hemimalenate).
  Adoben 100 mg prolonged-release tablets: Each prolonged-release tablet contains 100 mg of tapentadol (as tapentadol hemimalenate).
  Adoben 150 mg prolonged-release tablets: Each prolonged-release tablet contains 150 mg of tapentadol (as tapentadol hemimalenate).
  Adoben 200 mg prolonged-release tablets: Each prolonged-release tablet contains 200 mg of tapentadol (as tapentadol hemimalenate).
  Adoben 250 mg prolonged-release tablets: Each prolonged-release tablet contains 250 mg of tapentadol (as tapentadol hemimalenate).

• Other components (excipients) are:

• Tablet core: hypromellose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate,

• Tablet coating: hypromellose, lactose monohydrate, titanium dioxide (E 171), macrogol, triacetin, iron oxide yellow (E 172) (only for 100 mg, 150 mg, 200 mg and 250 mg strengths), iron oxide red (E 172) (only for 150 mg, 200 mg and 250 mg strengths), iron oxide black (E 172) (only for 250 mg strength).

What Adoben looks like and contents of the pack
Adoben 50 mg prolonged-release tablets: White or almost white, oval, biconvex film-coated tablets with the imprint T1 on one side.
Tablet dimensions: approximately 16 mm x 8.5 mm.
Adoben 100 mg prolonged-release tablets: Light brownish-yellow, oval, biconvex film-coated tablets with the imprint T2 on one side.
Tablet dimensions: approximately 16 mm x 8.5 mm.
Adoben 150 mg prolonged-release tablets: Light pink, oval, biconvex film-coated tablets with the imprint T3 on one side.
Tablet dimensions: approximately 16 mm x 8.5 mm.
Adoben 200 mg prolonged-release tablets: Light brownish-orange, oval, biconvex film-coated tablets with the imprint T4 on one side.
Tablet dimensions: approximately 18 mm x 8 mm.
Adoben 250 mg prolonged-release tablets: Pinkish, oval, biconvex film-coated tablets with the imprint T5 on one side.
Tablet dimensions: approximately 18 mm x 8 mm.

Adoben is available in HDPE bottles with a PP child-resistant closure, placed in a cardboard box. The pack contains 20 (only for 50 mg strength), 30, 60 (2 x 30) or 100 prolonged-release tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia

Manufacturer
KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia

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