ADOBEN 100 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Adoben, 50 mg, prolonged-release tablets
3. Adoben, 100 mg, prolonged-release tablets
4. Adoben, 150 mg, prolonged-release tablets
5. Adoben, 200 mg, prolonged-release tablets
6. Adoben, 250 mg, prolonged-release tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet
7. What is Adoben and what is it used for
8. Important information before taking Adoben
   1. When not to take Adoben
   2. Warnings and precautions
   3. Children and adolescents
   4. Adoben and other medicines
   5. Adoben and alcohol
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Adoben contains lactose
9. How to take Adoben
   1. Adults
   2. How and when to take Adoben
   3. Duration of treatment
   4. Elderly patients
   5. Patients with impaired liver or kidney function
   6. Use in children and adolescents
   7. Taking a higher dose of Adoben than recommended
   8. In case of overdose, the patient should immediately consult their doctor, even if they feel well.
   9. Missing a dose of Adoben
   10. Stopping treatment with Adoben
10. Possible side effects
    1. Important side effects or symptoms to watch out for and what to do if they occur:
    2. Other side effects that may occur:
    3. Very common (may affect more than 1 in 10 people)
    4. Common (may affect up to 1 in 10 people)
    5. Uncommon (may affect up to 1 in 100 people)
    6. Rare (may affect up to 1 in 1000 people)
    7. Frequency not known
    8. Reporting side effects
11. How to store Adoben
12. Contents of the package and other information
    1. What Adoben contains
    2. What Adoben looks like and contents of the package
    3. Marketing authorization holder
    4. Manufacturer
    5. This medicine is authorized in the Member States of the European Economic Area under the following names:

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

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• The package leaflet should be kept in case it needs to be read again.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for the patient. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Adoben and what is it 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 package and other information

1. What is Adoben and what is it used for

Tapentadol, the active substance of Adoben, is a strong pain-relieving medicine belonging to the opioid group. Adoben is indicated for the treatment of severe chronic pain in adults, for whom only opioid pain-relieving medication can provide adequate treatment.

2. Important information before taking 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 case of acute alcohol poisoning, sleeping pills, painkillers, or other psychotropic medicines (mood- and emotion-affecting medicines) (see "Adoben and other medicines").

Warnings and precautions

Before starting to take Adoben, the patient should discuss it with their doctor or pharmacist:

• in case of slow or shallow breathing,
• in case of increased intracranial pressure or impaired consciousness,
• in patients after head injury or with brain tumors,
• in patients with liver or kidney disease (see "How to take Adoben"),
• in patients with pancreatic or bile duct diseases, including pancreatitis,
• in patients taking mixed agonist/antagonist opioid receptor "mi" medicines (e.g., pentazocine, nalbuphine) or partial agonists of the opioid receptor "mi" (e.g., buprenorphine),
• in patients with a history of seizures or taking other medicines that increase the risk of seizures and may increase the risk of seizures,
• in patients with a tendency to abuse medicines or addiction, as Adoben may cause dependence. In this case, treatment should be short-term and under close medical supervision.

Respiratory disorders during sleep
Adoben contains an active substance belonging to the opioid group. Opioids can cause respiratory disorders during sleep, such as central sleep apnea (shallow breathing/lack of breathing during sleep) and sleep hypoxemia (low oxygen levels in the blood).
The risk of central sleep apnea depends on the dose of opioids. The doctor may consider reducing the total dose of opioids in case of central sleep apnea in the patient.

Children and adolescents

Adoben should not be used in children and adolescents under 18 years of age.

Adoben and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

• The risk of side effects increases if the patient takes medicines that can cause seizures (epileptic fits), such as antidepressants or antipsychotics. The risk of a seizure may increase if the patient takes Adoben at the same time. The doctor will inform the patient whether taking Adoben is suitable for them.
• Concomitant use of Adoben and sedating medicines, such as benzodiazepines or related medicines (some sleeping pills or sedatives, e.g., barbiturates) or painkillers, such as opioids, morphine, and codeine (also as a cough medicine), antipsychotics, antihistamines H1, alcohol, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, concomitant use of such medicines should only be considered when other treatment options are not possible. However, if the doctor prescribes Adoben in combination with sedating medicines, they should limit the dose and duration of concomitant treatment with such medicines. The patient should inform their doctor about all sedating medicines they are takingand strictly follow the doctor's dosage recommendations. It is recommended to inform friends or relatives about the possibility of the above-mentioned symptoms and to contact a doctor in case of their occurrence.
• If the patient takes medicines that affect serotonin levels (e.g., some medicines used to treat depression), they should consult their doctor before taking Adoben, due to the possibility of "serotonin syndrome". Serotonin syndrome occurs rarely but can be life-threatening. Its symptoms include: uncontrolled, rhythmic muscle contractions, including eye movements, agitation, excessive sweating, tremors, increased reflexes, including muscle tension and body temperature above 38°C. If this happens, the patient should consult their doctor.
• 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 cause side effects,

especially when starting or stopping their administration. The patient should tell their doctor about all medicines they are currently taking.

• Adoben should not be used concomitantly with monoamine oxidase inhibitors (MAOIs) (medicines used to treat depression). The patient should tell their doctor if they have taken MAOIs in the last 14 days.

The patient should tell their doctor about all medicines they are taking.

Adoben and alcohol

The patient should not drink alcohol while taking Adoben, as some side effects, such as drowsiness, may worsen.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Adoben should not be used:

• during pregnancy, unless the doctor decides to prescribe it. 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.
• during breastfeeding, as the medicine may be excreted in breast milk.
• if the patient becomes pregnant while taking Adoben. They should tell their doctor.
• during childbirth, as it may cause dangerous slowing or shallowing of the newborn's breathing (respiratory depression),

Driving and using machines

Adoben may cause drowsiness, dizziness, blurred vision, and affect reaction time.
These symptoms may occur especially at the beginning of treatment with Adoben, after a dose change prescribed by the doctor, or when taking alcohol or sedating medicines.
The patient should ask their doctor if they can drive or operate machinery after taking Adoben.

Adoben contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Adoben

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
The dose of Adoben should be adjusted according to the severity of the pain and the patient's individual sensitivity.
The smallest effective dose should be used to relieve pain.

Adults

Usually, a starting dose of 50 mg is used, taken twice a day, approximately every 12 hours.
The doctor may prescribe a different, more suitable dose or interval between doses if necessary. If the patient feels that the effect of the medicine is too strong or too weak, they should contact their doctor or pharmacist.
Adoben should be taken twice a day, approximately every 12 hours.
Total daily doses of Adoben above 500 mg of tapentadol are not recommended.

How and when to take Adoben

Adoben should be taken orally.
The tablet should be swallowed whole with a sufficient amount of liquid. The medicine can be taken on an empty stomach or with food. The tablets should not be chewed, broken, or crushed, as this may lead to overdose due to the rapid release of the medicine in the body.
The empty tablet shell may not be fully digested and may be present in the stool. The patient should not be concerned, as the medicine (active substance) has already been absorbed by the body, and only the tablet shell is present in the stool.

Duration of treatment

The patient should not take the tablets for longer than prescribed by their doctor.

Elderly patients

Dose adjustment is not usually necessary in elderly patients (over 65 years). However, the doctor may prescribe a different dosing regimen.

Patients with impaired liver or kidney function

Patients with severe liver or kidney impairment should not take Adoben.
In case of moderate liver impairment, the doctor will prescribe a different dosing regimen.
Patients with mild liver or kidney impairment do not require dose adjustment.

Use in children and adolescents

Adoben should not be used in children and adolescents under 18 years of age.

Taking a higher dose of Adoben than recommended

Taking Adoben in a quantity higher than recommended can be life-threatening.

In case of overdose, the patient should immediately consult their doctor, even if they feel well.

After taking very high doses, the following symptoms may occur:

• pupil constriction to the size of a pinhead,
• vomiting,
• blood pressure drop,
• rapid heartbeat,
• coma, impaired consciousness, or deep unconsciousness (loss of consciousness),
• seizures,
• dangerously slow or shallow breathing or respiratory arrest.

Missing a dose of Adoben

If the patient forgets to take a dose, their pain symptoms will likely return. They should not take a double dose to make up for the missed dose. The patient should return to their previous dosing schedule.

Stopping treatment with Adoben

If the patient stops taking Adoben or discontinues treatment before its completion, their pain symptoms will likely return. The patient should consult their doctor before stopping the medicine.
Generally, no side effects are observed after stopping the medicine, although in rare cases, patients taking the medicine for some time and stopping it abruptly may experience general malaise.
The following symptoms may occur:

• weakness, irritability, anxiety, nausea, loss of appetite, vomiting, diarrhea
• tearfulness, runny nose, pupil dilation,
• sleep disorders, fatigue or exhaustion (loss of strength), feeling of weakness, tremors, muscle cramps, abdominal cramps
• increased blood pressure, breathing rate, or heart rate.

If the patient experiences any of the above symptoms, they should immediately consult their doctor.
The patient should not suddenly stop taking Adoben, unless their doctor advises them to do so. The doctor will inform the patient how to stop taking the medicine. Stopping the medicine may involve gradually reducing the dose.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

Important side effects or symptoms to watch out for and what to do if they occur:

• This medicine may cause allergic reactions, including skin swelling, hives, and in severe cases, breathing difficulties, low blood pressure, fainting, or shock (rarely). Symptoms may include wheezing, breathing difficulties, swelling of the eyelids, face, or lips, rash, or itching, especially affecting the whole body.
• Another serious side effect is excessive slowing and shallowing of breathing (rarely). This occurs most often in elderly and frail patients.

If any of these important side effects affect the patient, they should immediately consult their doctor.

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)

• reduced appetite, anxiety, vomiting, diarrhea, indigestion,
• sleep disorders, fatigue or exhaustion (loss of strength), feeling of weakness, tremors, muscle cramps, shortness of breath,
• depressive mood, nervousness, anxiety, lack of attention,
• flushing, excessive sweating, feeling of temperature change, dryness of areas such as nostrils, mouth, lips, eyelids, ears, genitalia, and anus,
• itching, rash,
• fluid retention (edema).

Uncommon (may affect up to 1 in 100 people)

• weight loss,
• disorientation, confusion, agitation (excitement), perception disorders, unusual dreams, forgetfulness, mental impairment,
• euphoric mood, impaired consciousness, fainting, excessive sedation, uncertainty, speech disorders, numbness,
• abnormal skin sensations (e.g., tingling, prickling), skin reactions (hives)
• vision disorders,
• rapid heartbeat, slow heartbeat, palpitations, decreased blood pressure,
• abdominal discomfort, difficulty urinating, frequent urination,
• sexual dysfunction,
• withdrawal syndrome (see "Stopping treatment with Adoben"),
• feeling of abnormality, irritability.

Rare (may affect up to 1 in 1000 people)

• dependence on the medicine,
• thinking disorders, seizures, feeling of impending fainting, coordination disorders, feeling of intoxication, feeling of relaxation,
• impaired gastric emptying.

Frequency not known

• delirium.

Generally, the likelihood of suicidal thoughts and behaviors 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 from human use of the medicine have not provided evidence of an increased risk.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of 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.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Adoben

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the package and other information

What Adoben contains

• The active substance of Adoben is tapentadol. Adoben, 50 mg, prolonged-release tablets

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

• Other ingredients (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), iron oxide red (E 172) (only for 150 mg, 200 mg, and 250 mg), iron oxide black (E 172) (only for 250 mg).

What Adoben looks like and contents of the package

Adoben, 50 mg, prolonged-release tablets:White or almost white, oval, biconvex, film-coated tablets with the marking T1 on one side of the tablet.
Tablet dimensions: approximately 16 mm x 8.5 mm.
Adoben, 100 mg, prolonged-release tablets:Light brown-yellow, oval, biconvex, film-coated tablets with the marking T2 on one side of the tablet.
Tablet dimensions: approximately 16 mm x 8.5 mm.
Adoben, 150 mg, prolonged-release tablets:Light pink, oval, biconvex, film-coated tablets with the marking T3 on one side of the tablet.
Tablet dimensions: approximately 16 mm x 8.5 mm.
Adoben, 200 mg, prolonged-release tablets:Light brown-orange, oval, biconvex, film-coated tablets with the marking T4 on one side of the tablet.
Tablet dimensions: approximately 18 mm x 8 mm.
Adoben, 250 mg, prolonged-release tablets:Pink, oval, biconvex, film-coated tablets with the marking T5 on one side of the tablet.
Tablet dimensions: approximately 18 mm x 8 mm.
Adoben is available in an HDPE container with a PP child-resistant closure, placed in a cardboard box. The package contains 20 (only for 50 mg), 30, 60 (2x30), or 100 prolonged-release tablets.
Not all pack sizes may be marketed.

Marketing authorization 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet:28.03.2022