Palexia

Package Leaflet: Information for the Patient

Palexia, 50 mg, Coated Tablets

Palexia, 75 mg, Coated Tablets

Palexia, 100 mg, Coated Tablets

Tapentadol

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

• You should 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 get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package 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 in Palexia, is a strong painkiller belonging to the opioid group. Palexia is indicated for the treatment of moderate to severe acute pain in adults, when other painkillers have not worked or are not suitable.

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),
• in patients with intestinal obstruction,
• in case of acute alcohol poisoning, sleeping pills, painkillers, or other psychotropic medicines (medicines that affect mood and emotions) (see "Palexia and other medicines").

Warnings and precautions

Before taking Palexia, discuss with your doctor, pharmacist, or nurse:

• if you have slow or shallow breathing,
• if you have increased intracranial pressure or impaired consciousness up to coma,
• if you have had a head injury or brain tumors,
• if you have liver or kidney disease (see "How to take Palexia"),
• if you have pancreatic or bile duct disease, including pancreatitis,
• if you are taking medicines with mixed agonist-antagonist properties for opioid receptors "mi" (e.g., pentazocine, nalbuphine) or partial agonists of the opioid receptor "mi" (e.g., buprenorphine),
• if you have a history of seizures or are taking other medicines that may 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 painkillers may lead to dependence and addiction, which can be life-threatening. If you are concerned about becoming dependent on Palexia, you should discuss this with your doctor. Taking this medicine (even at therapeutic doses) can lead to physical dependence, which can cause withdrawal symptoms and relapse of problems if treatment is stopped abruptly.

Palexia and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, and about any medicines you plan to 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 seizures may increase if you take Palexia at the same time. Your doctor will inform you whether taking Palexia is suitable for you.

Taking Palexia and sedative medicines such as benzodiazepine derivatives or benzodiazepine-like medicines (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 dose recommendations. 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.

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.
• do not take Palexia during labor, as it may cause dangerous slowing or shallowing of the newborn's breathing (respiratory depression),
• do not take Palexia while breastfeeding, as the medicine may be excreted in breast milk.

Driving and using machines

Palexia may cause drowsiness, dizziness, blurred vision, and affect your reaction skills.

These effects may occur especially when you start taking Palexia, when your doctor changes your dose, or when you take alcohol or sedative medicines. Ask your doctor if you can drive or use machines after taking Palexia.

Palexia contains lactose

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

Palexia contains sodium

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

3. How to take Palexia

Always take this medicine exactly as your doctor has told you.

The dose will be adapted to the intensity of your pain and your individual sensitivity.

Adults

The usual starting dose is 50 mg every 4 to 6 hours.

Your doctor may prescribe a different dose or interval between doses if necessary.

If you feel that the effect of the medicine is too strong or too weak, talk to your doctor or pharmacist.

Total daily doses above 700 mg of tapentadol on the first day of therapy and daily doses above 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 patients with moderate liver impairment, your doctor will prescribe a different dosing schedule.

Patients with mild liver impairment do not need dose adjustment.

Patients with severe kidney impairment should not take this medicine.

In patients with 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.

How to take it

Take Palexia orally.

Swallow the tablet with enough liquid.

You can take the medicine with or without food.

Duration of treatment

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

What to do if you take more Palexia than you should

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

• pupil constriction to the size of a pinhead, vomiting, low blood pressure, rapid heartbeat, collapse, impaired consciousness or coma (deep state of unconsciousness), seizures, dangerously slow or shallow breathing or respiratory arrest. In such cases, seek medical help immediately!

What to do if you forget to take 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.

Continue with your original dosing schedule.

What to do if you stop taking Palexia

If you stop taking Palexia before the end of the treatment, your pain is likely to return.

Consult 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, consult your doctor immediately.

Do not stop taking Palexia abruptly, unless your doctor has told you to do so.

Your doctor will inform you how to stop taking the medicine. Stopping the medicine may involve gradually reducing the dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Important side effects or symptoms to look out for and what to do if you are affected:

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. This occurs most often in elderly and weak patients.

If any of these important side effects affect you, seek medical help immediately.

Other side effects that may occur:

Very common(may affect more than 1 in 10 people): nausea, vomiting, dizziness, drowsiness, headache.

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 weak, fatigue, feeling of temperature change.

Uncommon(may affect up to 1 in 100 people): low mood, disorientation, agitation, nervousness, restlessness, euphoric mood, concentration disturbances, memory impairment, feeling of impending faint, excessive sedation, balance disturbances, speech disturbances, tingling, abnormal skin sensations (e.g., prickling, tingling), muscle spasms, vision disturbances, rapid heartbeat, palpitations, low blood pressure, 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 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 rash, hives, and in severe cases, difficulty breathing, low blood pressure, collapse, or shock), thought disturbances, seizures, decreased level of consciousness, coordination disturbances, slow heartbeat, impaired gastric emptying.

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 you experience any side effects, talk to 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.

No special precautions for storage are necessary.

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).

• 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, 7 mm in diameter, marked with the Grünenthal logo on one side and "H6" on the other.

Palexia, 75 mg, coated tablets: Light yellow, round, coated tablets, 8 mm in diameter, marked with the Grünenthal logo on one side and "H7" on the other.

Palexia, 100 mg, coated tablets: Light pink, round, coated tablets, 9 mm in diameter, marked with the Grünenthal logo on one side and "H8" on the other.

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