Palexia retard

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

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your 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 pack 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 reliever belonging to the opioid group. Palexia retard is indicated for the treatment of:

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

2. Important information before taking Palexia retard

When not to take Palexia retard:

• if you are allergic to tapentadol or any of the other ingredients of this medicine (listed in section 6),
• in patients with asthma or life-threatening 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, pain relievers, or other psychotropic drugs (mood and emotion-affecting drugs) (see "Palexia retard and other medicines").

Warnings and precautions

Before starting treatment with Palexia retard, discuss it with your 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 you or a family member have ever abused or been dependent on alcohol, prescription drugs, or illegal substances ("addiction"),
• if you are a smoker,
• if you have ever had mood disorders (depression, anxiety, or personality disorder) or have been treated by a psychiatrist for other mental disorders.

This medicine contains tapentadol, which is an opioid. Repeated use of opioid pain relievers can lead to reduced efficacy (tolerance) and may lead to dependence and abuse, which can be life-threatening. If you are concerned about becoming dependent on Palexia retard, it is essential to consult your 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 history of drug abuse 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 you or someone else notices such symptoms, you should contact your doctor. Your doctor may consider reducing the dose.

Palexia retard and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
The risk of side effects increases if you take medicines that can cause seizures (epileptic seizures), such as antidepressants or antipsychotics. The risk of a seizure may increase if you take Palexia at the same time. Your doctor will inform you whether taking Palexia is suitable for you.
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 pain relievers, such as opioids, morphine, and codeine (also used as a cough suppressant), 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, your 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.
You should inform your doctor if you are taking gabapentin or pregabalin or any sedative and strictly follow your doctor's dosage instructions. It may be helpful to inform friends or relatives to be aware of the above-mentioned symptoms and contact a doctor if they occur.
If you are taking medicines that affect serotonin levels (e.g., certain antidepressants), you should consult your 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 those that control eye movements, agitation, excessive sweating, tremors, excessive muscle tone, and body temperature above 38°C. If this happens, you should consult your 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.
You should immediately inform your doctor about any of the above-mentioned medicines you are taking.
Concomitant use of Palexia retard 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 them. You should tell your doctor about all medicines you are currently taking.
Palexia retard should not be used concomitantly with MAO inhibitors (medicines used to treat depression). You should tell your doctor if you are taking or have taken these medicines in the last 14 days.

Palexia retard with food, drink, and alcohol

You 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 you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Palexia retard should not be used:

• during pregnancy, unless your 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 slowing or shallowing of the newborn's breathing (respiratory depression),
• while breastfeeding, as the medicine may be excreted in breast milk.

Driving and using machines

Palexia retard may cause drowsiness, dizziness, blurred vision, and affect your reaction ability. These symptoms may occur especially at the beginning of treatment with Palexia retard, after a dose change prescribed by your doctor, or when taking alcohol or sedatives. You should ask your doctor if you can drive or operate machinery after taking Palexia retard.

Palexia retard contains lactose

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Palexia retard

This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Dosage should be adjusted according to the severity of the pain and the individual sensitivity of the patient. The lowest effective dose for the relief of pain should be used.

Adults

The usual initial dose is 50 mg every 12 hours.
Your doctor may prescribe a different, more suitable dose or interval between doses if necessary.
If you feel that the effect of the medicine is too strong or too weak, you should contact your 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 therefore, your doctor may prescribe 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, your doctor will prescribe a different dosing schedule.
Patients with mild liver impairment do not need a dose adjustment.
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 your doctor. Do not exceed the total daily dose of 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 must not be chewed, broken, or crushed, as this may lead to overdose due to the rapid release of the active substance 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. Do not worry, as the active substance has already been absorbed by the body, and only the tablet shell is present in the stool.

Duration of treatment

Do not take the tablets for longer than your doctor has told you.

Taking a higher dose of Palexia retard than recommended

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, life-threatening slow or shallow breathing or respiratory arrest. In such cases, you should immediately contact your doctor!

Missing a dose of Palexia retard

If you miss a dose, your pain is likely to return.
Do not take a double dose to make up for a forgotten dose.
Resume dosing according to your previous schedule.

Stopping treatment with Palexia retard

If you stop or discontinue treatment with Palexia retard before the end of the treatment, your pain is likely to return. You should contact your doctor before stopping the medicine.
Generally, no side effects are observed after stopping the medicine; however, 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 you experience any of these symptoms, you should immediately consult your doctor.

Do not stop taking Palexia retard suddenly unless your doctor has told you to do so.
Your doctor will tell you how to stop taking the medicine. Stopping the medicine may involve gradually reducing the dose.
If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. In children and adolescents, no additional side effects have been observed compared to those observed 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 slowing and shallowing of breathing. This occurs most frequently in elderly and debilitated patients.
If any of these important side effects affect you, you should immediately contact your 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): loss of appetite, anxiety, depressive mood, sleep disorders, nervousness, restlessness, difficulty concentrating, 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, hives, 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, life-threatening 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 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 have not provided evidence of an increased risk.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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 this medicine.

5. How to store Palexia retard

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister.
The expiry date refers to the last day of the month.
There are no special precautions for the storage of this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Palexia retard contains

• The active substance 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).

• The marketing authorization holder is Grünenthal GmbH, Zieglerstrasse 6, 52078 Aachen, Germany.

What Palexia retard looks like and contents of the pack

Palexia retard, 50 mg, prolonged-release tablets: White, prolonged-release tablets, oval (6.5 mm x 15 mm), with the Grünenthal logo on one side and "H1" on the other.
Palexia retard, 100 mg, prolonged-release tablets: Light yellow, prolonged-release tablets, oval (6.5 mm x 15 mm), with the Grünenthal logo on one side and "H2" on the other.
Palexia retard, 150 mg, prolonged-release tablets: Light pink, prolonged-release tablets, oval (6.5 mm x 15 mm), with the Grünenthal logo on one side and "H3" on the other.
Palexia retard, 200 mg, prolonged-release tablets: Light orange, prolonged-release tablets, oval (7 mm x 17 mm), with the Grünenthal logo on one side and "H4" on the other.
Palexia retard, 250 mg, prolonged-release tablets: Brown-red, prolonged-release tablets, oval (7 mm x 17 mm), with the Grünenthal logo on one side and "H5" on the other.
Palexia retard, 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, you 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