Palexia

Leaflet attached to the packaging: patient information

Palexia, 50 mg, coated tablets

Palexia, 75 mg, coated tablets

Palexia, 100 mg, coated 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, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Palexia and what is it used for

Tapentadol, the active substance of Palexia, is a strong pain reliever belonging to the opioid group. Palexia is indicated for the treatment of moderate to severe acute pain in adults, when only opioid pain relief is necessary for adequate treatment.

2. Important information before taking Palexia

When not to take Palexia:

• if you are 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 and other medicines").

Warnings and precautions

Before starting treatment with Palexia, discuss it with your doctor, pharmacist, or nurse:

• in case of slow or shallow breathing,
• in case of increased intracranial pressure or consciousness disorders up to coma,
• in patients after head injury or with brain tumors,
• in patients with liver or kidney disease (see "How to take Palexia"),
• in patients with pancreatic or biliary tract diseases, including pancreatitis,
• in patients taking mixed agonist-antagonist opioid receptor "mi" drugs (e.g., pentazocine, nalbuphine) or partial agonists of the opioid receptor "mi" (e.g., buprenorphine),
• in patients with a history of seizure or taking other medicines that increase the risk of seizures and may increase the risk of attacks,
• 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 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 of the medicine (the body getting used to it). It can also lead to dependence and abuse, which can cause life-threatening overdose. If you are concerned about becoming dependent on Palexia, 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 can cause physical and psychological dependence. In case of a tendency to abuse drugs or addiction, treatment should be short-term and under close medical supervision.
Sleep apnea
Palexia can cause sleep apnea, such as sleep apnea (pauses in breathing during sleep) and hypoxemia during sleep (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 and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
The risk of side effects increases if you take medicines that can cause seizures (epileptic fits), such as antidepressants or antipsychotics. The risk of an attack may increase if you take Palexia at the same time. Your doctor will inform you if taking Palexia is suitable for you.
Taking Palexia and sedative medicines, such as benzodiazepine derivatives or benzodiazepine-like drugs [e.g., some sleeping pills or sedatives (e.g., barbiturates) or painkillers, 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, taking such medicines together should only be considered when there are no other treatment options available.
If your doctor prescribes Palexia with sedative medicines, they should limit the dose and duration of concomitant treatment.
Taking 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.
Tell your doctor if you are taking gabapentin or pregabalin or any sedative medicine and strictly follow your doctor's dosage instructions. It may be helpful to inform friends or relatives to be aware of the above symptoms. If such symptoms occur, you should contact your doctor.
If you are taking medicines that affect serotonin levels (e.g., some medicines used to treat depression), 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 eye movement muscles, agitation, excessive sweating, shivering, increased reflexes, including increased muscle tension and body temperature above 38°C. If this happens, you should consult your doctor.
The concomitant use of Palexia with opioid mixed agonist/antagonist "mi" receptor drugs (e.g., pentazocine, nalbuphine) or partial agonists of the "mi" receptor (e.g., buprenorphine) has not been studied. It is possible that Palexia will not work properly if taken with medicines from the above groups.
You should immediately inform your doctor about any of the above medicines you are taking.
The concomitant use of Palexia 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. You should tell your doctor about all medicines you are currently taking.
Palexia should not be taken 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 with food, drink, and alcohol

Do not drink alcohol while taking Palexia, 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 child, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Palexia:

• during pregnancy, unless your 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 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 can cause drowsiness, dizziness, blurred vision, and affect your reaction skills.
These symptoms may occur especially at the beginning of treatment with Palexia, after a dose change prescribed by your doctor, or when taking alcohol or sedative medicines. You should ask your doctor if you can drive or operate machinery after taking Palexia.
In general, your ability to drive or operate machinery is not recommended until you know how Palexia affects you.

Palexia contains lactose

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

Palexia contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is essentially "sodium-free".

3. How to take Palexia

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The dose will be adapted to your pain intensity and individual sensitivity. You should take the lowest effective dose for pain relief.

Adults

The usual starting dose is 50 mg every 4 to 6 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 greater than 700 mg of tapentadol on the first day of therapy and daily doses greater than 600 mg of tapentadol during subsequent days of therapy 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 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

Palexia is not recommended for use in children and adolescents below 18 years.

Method of administration

Palexia should be taken orally.
Swallow the tablet with a sufficient amount of liquid.
The medicine can be taken with or without food.

Duration of treatment

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

Overdose of Palexia

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

• constriction of the pupils to the size of a pinhead, vomiting, decreased blood pressure, 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, you should immediately contact your doctor!

Missed dose of Palexia

If you forget to take a dose, your pain is likely to return.
Do not take a double dose to make up for a forgotten dose.
You should continue with your original dosing schedule.

Stopping treatment with Palexia

If you stop taking Palexia or discontinue treatment 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, tearing, runny nose, yawning, sweating, chills, muscle pain, and dilation of the pupils,
• 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 suddenly, unless your doctor has told you to do so.
Your doctor will inform you about 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, Palexia 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 can 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. It occurs most often in elderly and weakened patients.
If any of these important side effects concern you, you should immediately contact your doctor.

Other side effects that may occur:

Very common(may affect more than 1 in 10 people): nausea, vomiting, dizziness, drowsiness, headaches.
Common(may affect up to 1 in 10 people): loss of appetite, anxiety, confusion, hallucinations, sleep disturbances, unusual dreams, tremors, flushing, constipation, diarrhea, indigestion, dry mouth, itching, excessive sweating, rash, muscle spasms, feeling of weakness, fatigue, feeling of temperature change.
Uncommon(may affect up to 1 in 100 people): low mood, disorientation, agitation (excitement), nervousness, restlessness, euphoric mood, concentration disorders, memory impairment, feeling of impending faint, excessive sedation, balance disorders, speech disorders, tingling, abnormal skin sensations (e.g., prickling, tingling), muscle spasms, vision disturbances, rapid heartbeat, palpitations, decreased blood pressure, dangerously slow or shallow breathing (respiratory depression), decreased oxygen saturation, shortness of breath, abdominal discomfort, hives, feeling of heaviness, difficulty urinating, frequent urination, withdrawal syndrome (see "Stopping treatment with Palexia"), fluid retention (edema), feeling of abnormality, feeling of drunkenness, irritability, feeling of relaxation.
Rare(may affect up to 1 in 1,000 people): allergic reactions to the medicine (including skin swelling, hives, and in severe cases, difficulty breathing, decreased blood pressure, collapse, or shock), thinking disorders, seizures, decreased level of consciousness, coordination disorders, slow heartbeat, impaired gastric emptying.
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, you should 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Palexia

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 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 contains

• The active substance is tapentadol.

Palexia, 50 mg, coated tablets:
Each tablet contains 50 mg of tapentadol (as hydrochloride).
Palexia, 75 mg, coated tablets:
Each tablet contains 75 mg of tapentadol (as hydrochloride).
Palexia, 100 mg, coated tablets:
Each tablet contains 100 mg of tapentadol (as hydrochloride).

• The other ingredients are: Palexia, 50 mg, coated tablets: Tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, povidone K30, magnesium stearate. Tablet coating Opadry II white 85F18422: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc.

Palexia, 75 mg, coated tablets:
Tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, povidone K30, magnesium stearate. Tablet coating Opadry II yellow 85F32072: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E 172), red iron oxide (E 172).
Palexia, 100 mg, coated tablets:
Tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, povidone K30, magnesium stearate. Tablet coating Opadry II pink 8524141: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).

What Palexia looks like and contents of the pack

Palexia, 50 mg, coated tablets: White, round, coated tablets with a diameter of 7 mm, marked with the Grünenthal logo on one side and "H6" on the other side.
Palexia, 75 mg, coated tablets: Light yellow, round, coated tablets with a diameter of 8 mm, marked with the Grünenthal logo on one side and "H7" on the other side.
Palexia, 100 mg, coated tablets: Light pink, round, coated tablets with a diameter of 9 mm, marked with the Grünenthal logo on one side and "H8" on the other side.
Palexia, coated tablets are packaged in blisters and cartons of 20, 24, 30, 54, and 60 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Grünenthal GmbH
Zieglerstrasse 6
52078 Aachen
Germany

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

Germany: Palexia Akutschmerz
Austria, Belgium, Croatia, Cyprus, Czech Republic, Denmark, Greece, Ireland, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, United Kingdom (Northern Ireland): PALEXIA
Date of last revision of the leaflet:02/2024