PALEXIA 200 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Palexia retard, 50 mg, prolonged-release tablets
3. Palexia retard, 100 mg, prolonged-release tablets
4. Palexia retard, 150 mg, prolonged-release tablets
5. Palexia retard, 200 mg, prolonged-release tablets
6. Palexia retard, 250 mg, prolonged-release tablets
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient
   2. Table of contents of the leaflet
7. What is Palexia retard and what is it used for
8. Important information before taking Palexia retard
   1. When not to take Palexia retard:
   2. Warnings and precautions
   3. Palexia retard and other medicines
   4. Palexia retard with food, drink, and alcohol
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Palexia retard contains lactose
9. How to take Palexia retard
   1. Adults
   2. Elderly patients
   3. Patients with impaired liver or kidney function
   4. Use in children and adolescents
   5. Method of administration
   6. Duration of treatment
   7. Taking a higher than recommended dose of Palexia retard
   8. Missing a dose of Palexia retard
   9. Stopping treatment with Palexia retard
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. Reporting side effects
11. How to store Palexia retard
12. Contents of the packaging and other information
    1. What Palexia retard contains
    2. Marketing authorization holder and manufacturer
    3. This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Leaflet accompanying the packaging: patient information

Palexia retard, 50 mg, prolonged-release tablets

Palexia retard, 100 mg, prolonged-release tablets

Palexia retard, 150 mg, prolonged-release tablets

Palexia retard, 200 mg, prolonged-release tablets

Palexia retard, 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.
• If you have any doubts, you should consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Palexia retard and what is it used for

Tapentadol - the active substance of Palexia retard - is a strong pain-relieving opioid. Palexia retard is indicated for the treatment of:

• severe chronic pain in adults, where only opioid pain relief provides adequate treatment;
• severe chronic pain in children over 6 years of age and adolescents, where only opioid pain relief can be adequately controlled.

2. Important information before taking Palexia retard

When not to take Palexia retard:

• 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 drugs (mood and emotion-affecting drugs) (see "Palexia retard and other medicines").

Warnings and precautions

Before starting treatment with Palexia retard, the patient should discuss it with their doctor, pharmacist, or nurse:

• in case of slow or shallow breathing,
• in case of increased intracranial pressure or impaired consciousness up to coma,
• in patients after head injury or with brain tumors,
• in patients with liver or kidney disease (see "How to take Palexia retard"),
• in patients with pancreatic or biliary disorders, including pancreatitis,
• in patients taking mixed agonist-antagonist opioid receptor drugs (e.g., pentazocine, nalbuphine) or partial opioid receptor agonists (e.g., buprenorphine).
• in patients with a history of seizures or taking other medications that increase the risk of seizures and may increase the risk of seizures
• if the patient or a family member has ever abused 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. Repeated use of opioid painkillers can lead to reduced efficacy (tolerance) and may lead to dependence and abuse, which can be life-threatening. If the patient is concerned about becoming dependent on Palexia retard, it is essential to consult their doctor. Taking (even at therapeutic doses) can lead to physical dependence, which can cause withdrawal symptoms and recurrence of problems if treatment is suddenly stopped.
Palexia retard may cause physical and psychological dependence. In cases of a tendency to abuse drugs or addiction, treatment should be short-term and under close medical supervision.
Children and adolescents
Children and adolescents with obesity should be closely monitored and not exceed the recommended maximum dose.
The medicine should not be given to children under 6 years of age.
Sleep apnea
Palexia retard may cause sleep apnea, such as sleep apnea (pauses in breathing during sleep) and hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to shortness of breath, difficulty staying asleep, or excessive daytime sleepiness. If the patient or another person notices such symptoms, they should contact their doctor. The doctor may consider reducing the dose.

Palexia retard 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 seizures), such as antidepressants or antipsychotics. The risk of seizures may increase if the patient takes Palexia at the same time. The doctor will inform the patient whether taking Palexia is suitable for them.
Concomitant use of Palexia retard and sedatives, such as benzodiazepine derivatives or benzodiazepine-like drugs [e.g., certain sleeping pills or sedatives (e.g., barbiturates) or painkillers, such as opioids, morphine, and codeine (also used as an antitussive), antipsychotics, antihistamines H1, alcohol], increases the risk of drowsiness, breathing difficulties (respiratory depression), and coma and can be life-threatening. Therefore, concomitant use of such medicines should only be considered when there are no other available treatment options.
If, however, the doctor prescribes Palexia retard with sedatives, they should limit the dose and duration of concomitant treatment.
Concomitant 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.
The patient should inform their doctor if they are taking gabapentin or pregabalin or any sedative and strictly follow the doctor's dosage instructions. It may be helpful to inform friends or relatives to be aware of the above symptoms and contact a doctor if they occur.
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 Palexia, due to the possibility of "serotonin syndrome". Serotonin syndrome is rare but can be life-threatening. Its symptoms include: uncontrolled, rhythmic muscle contractions, including eye movements, agitation, excessive sweating, tremors, increased muscle tone, and body temperature above 38°C. If this happens, the patient should consult their doctor.
Concomitant use of Palexia retard with opioid receptor mixed agonist/antagonist drugs (e.g., pentazocine, nalbuphine) or partial opioid receptor agonists (e.g., buprenorphine) has not been studied. It is possible that Palexia retard may not work properly if taken concomitantly with medicines from the above groups.
The patient should immediately inform their doctor about any of the above medicines they are currently taking.
Concomitant use of Palexia retard with strong inhibitors or inducers (e.g., rifampicin, phenobarbital, St. John's Wort) of the 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 them. The patient should tell their doctor about all medicines they are currently taking.
Palexia retard should not be used concomitantly with MAO inhibitors (medicines used to treat depression). The patient should tell their doctor if they are taking or have taken these medicines in the last 14 days.

Palexia retard with food, drink, and alcohol

The patient should not drink alcohol while taking Palexia retard, as some side effects, such as drowsiness, may worsen. The medicine can be taken with or without food.

Pregnancy, breastfeeding, and fertility

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.
Palexia retard should not be used:

• during pregnancy, unless the doctor decides to use 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 childbirth, as it may cause dangerous respiratory depression or shallow breathing in the newborn (respiratory depression),
• during breastfeeding, as the medicine may be excreted in breast milk.

Driving and using machines

Palexia retard may cause drowsiness, dizziness, blurred vision, and affect reaction time. These symptoms may occur especially at the beginning of treatment with Palexia retard, after the doctor-recommended dose change, or when concomitantly taking alcohol or sedatives. The patient should ask their doctor if they can drive or operate machinery after taking Palexia retard.

Palexia retard 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 Palexia retard

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

Adults

The usual initial dose is 50 mg every 12 hours.
The doctor may recommend 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.
Total daily doses above 500 mg of tapentadol are not recommended.

Elderly patients

Dose adjustment is not usually necessary in elderly patients (over 65 years).
Elimination of the medicine may be prolonged in this age group, and the 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 case of moderate liver impairment, the doctor will recommend a different dosing schedule.
Patients with mild liver impairment do not need to adjust the dose.
Patients with severe kidney impairment should not take this medicine.
In case of mild or moderate kidney impairment, dose adjustment is not necessary.

Use in children and adolescents

The dose of Palexia retard in children and adolescents from 6 to less than 18 years of age depends on age and body weight.
The appropriate dose will be determined by the doctor. The total daily dose should not exceed 500 mg, i.e., 250 mg every 12 hours.
This medicine should not be used in children and adolescents with impaired kidney or liver function.
Palexia retard should not be used in children under 6 years of age.

Method of administration

Palexia retard should be taken orally.
The tablet should be swallowed whole, with enough liquid.
The tablet 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 medicine can be taken with or without food.
The empty tablet shell may not be completely digested and may be present in the stool. The patient should not be concerned, as the 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 the doctor.

Taking a higher than recommended dose of Palexia retard

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

• pupil constriction to the size of a pinhead, vomiting, blood pressure drop, rapid heartbeat, collapse, impaired consciousness or coma (deep state of loss of consciousness), seizures, dangerously slow or shallow breathing or respiratory arrest. In such cases, the patient should immediately contact their doctor!

Missing a dose of Palexia retard

If the patient forgets to take a dose, their pain symptoms will likely return.
The patient 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 Palexia retard

If the patient stops taking Palexia retard before the end of treatment, their pain symptoms will likely return. The patient should contact 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:

• restlessness, tearfulness, runny nose, yawning, sweating, chills, muscle pain, and pupil dilation,
• irritability, anxiety, back pain, joint pain, weakness, abdominal cramps, difficulty sleeping, nausea, loss of appetite, vomiting, diarrhea, increased blood pressure, respiratory rate, and heart rate. If these symptoms occur, the patient should immediately consult their doctor.

The patient should not suddenly stop taking the medicine unless their doctor recommends it.
The doctor will inform the patient about 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, Palexia retard can cause side effects, although not everybody gets them. In children and adolescents, no additional side effects have been observed compared to those in adults.

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

This medicine may cause allergic reactions. Symptoms may include wheezing, difficulty breathing, swelling of the eyelids, face, or lips, rash, or itching, especially affecting the whole body.
Another serious side effect is excessive respiratory depression. This occurs most frequently in elderly and frail patients.
If any of these important side effects affect the patient, they should immediately contact their doctor.

Other side effects that may occur:

Very common(may affect more than 1 in 10 people): nausea, constipation, dizziness, drowsiness, headaches.
Common(may affect up to 1 in 10 people): loss of appetite, anxiety, depressive mood, sleep disorders, nervousness, restlessness, concentration disorders, tremors, muscle spasms, flushing, shortness of breath, vomiting, diarrhea, indigestion, itching, excessive sweating, rash, feeling of weakness, fatigue, feeling of temperature change, dryness of mucous membranes, water retention (edema).
Uncommon(may affect up to 1 in 100 people): allergic reactions to the medicine (including skin swelling, urticaria, and in severe cases, difficulty breathing, blood pressure drop, collapse, or shock), weight loss, disorientation, confusion, agitation (excitement), perception disorders, unusual dreams, euphoric mood, impaired consciousness, memory impairment, mental disorders, fainting, excessive sedation, balance disorders, speech disorders, tingling, abnormal skin sensations (e.g., tingling, prickling), vision disorders, rapid heartbeat, slow heartbeat, palpitations, decreased blood pressure, abdominal discomfort, hives, difficulty urinating, frequent urination, sexual dysfunction, withdrawal syndrome (see "Stopping treatment with Palexia retard"), feeling of abnormality, irritability.
Rare(may affect up to 1 in 1,000 people): dependence on the medicine, thinking disorders, seizures, feeling of impending fainting, coordination disorders, dangerously slow or shallow breathing (respiratory depression), impaired gastric emptying, feeling of alcohol intoxication, feeling of relaxation.
Frequency not known(frequency cannot be estimated from the available data): delirium.
Generally, the risk 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 have not provided evidence of an increased risk.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 can help gather more information on the safety of the medicine.

5. How to store Palexia retard

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of the month.
There are no special precautions for storing this 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 packaging and other information

What Palexia retard contains

• The active substance of the medicine is tapentadol.

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

• Other ingredients are: Palexia retard, 50 mg, prolonged-release tablets Tablet core: hypromellose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate. Tablet coating Opadry II white 33G28488: hypromellose, lactose monohydrate, talc, macrogol, propylene glycol, titanium dioxide (E 171).

Palexia retard, 100 mg, prolonged-release tablets
Tablet core: hypromellose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate. Tablet coating Opadry II yellow 33G32826: hypromellose, lactose monohydrate, talc, macrogol, propylene glycol, titanium dioxide (E 171), yellow iron oxide (E 172).
Palexia retard, 150 mg, prolonged-release tablets
Tablet core: hypromellose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate. Tablet coating Opadry II pink 33G34210: hypromellose, lactose monohydrate, talc, macrogol, propylene glycol, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).
Palexia retard, 200 mg, prolonged-release tablets
Tablet core: hypromellose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate. Tablet coating Opadry II orange 33G23931: hypromellose, lactose monohydrate, talc, macrogol, propylene glycol, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).
Palexia retard, 250 mg, prolonged-release tablets
Tablet core: hypromellose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate. Tablet coating Opadry II red 33G35200: hypromellose, lactose monohydrate, talc, macrogol, propylene glycol, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).

• Palexia retard, 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg prolonged-release tablets are packaged in blisters and cartons of 20, 24, 30, 54, and 60 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Grünenthal GmbH
Zieglerstrasse 6
52078 Aachen
Germany

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria, Belgium, Croatia, Cyprus, Czech Republic, Germany, Greece, Luxembourg, Netherlands, Poland, Portugal, Slovakia, Spain: PALEXIA retard.
Denmark, Norway, Sweden: PALEXIA Depot.
Ireland, Slovenia, United Kingdom (Northern Ireland): PALEXIA SR.
Italy: PALEXIA.
To obtain more detailed information on this medicine, the patient should contact the representative of the marketing authorization holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Tel. +48 22 737 79 20
Date of last revision of the leaflet:03.2024