Palexia

Leaflet accompanying the packaging: patient information

Palexia, 4 mg/ml, oral solution

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-relieving substance belonging to the group of opioids. Palexia is indicated for the treatment of moderate to severe acute pain in children and adolescents over 2 years of age and adults, for whom only opioid pain relief medication can provide 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, sedatives, 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 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"),
• in patients with pancreatic or biliary tract diseases, 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 painkillers 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.
Children with obesity should be closely monitored, and the recommended maximum dose should not be exceeded.
Do not give this medicine to children under 2 years of age.
Sleep apnea
Palexia 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 and other medicines

Tell your doctor or pharmacist about all medicines you are taking now 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 fits), 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 if taking Palexia is suitable for you.
• Concomitant use of Palexia 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 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 your doctor prescribes Palexia 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.
Tell your doctor if you are taking gabapentin or pregabalin or any sedative and strictly follow your doctor's dosage recommendations. It may be helpful to inform friends or relatives to be aware of the above 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 eye movements, agitation, excessive sweating, shivering, increased muscle tone, and body temperature above 38°C. If this happens, you should consult your doctor.
• Concomitant use of Palexia 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 may not work properly if taken concomitantly with drugs from the above groups. You should immediately inform your doctor if you are taking any of the above medicines.
• Concomitant use of Palexia 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 should not be used concomitantly with MAO inhibitors (drugs used to treat depression). You should tell your doctor if you 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 be exacerbated. 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 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.

Use of Palexia is not recommended:

• during labor, as it may cause dangerous respiratory depression or shallow breathing in the newborn (respiratory depression),
• while breastfeeding, as tapentadol may be excreted in breast milk.

Driving and using machines

Palexia may cause drowsiness, dizziness, blurred vision, and affect your reaction time.
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 sedatives. You should ask your doctor if you can drive or operate machinery after taking Palexia.

Palexia 4 mg/ml contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per maximum single dose, so it is considered "sodium-free".

Palexia 4 mg/ml contains sodium benzoate

This medicine contains 59 mg of sodium benzoate per unit of volume, which is equivalent to 2.4 mg/ml.
Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of life).

• 4. week of life.

Palexia 4 mg/ml contains propylene glycol

This medicine contains 48 mg of propylene glycol per 25 ml of solution (maximum single dose), which is equivalent to 2 mg/ml.

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 dosage should be adjusted according to the severity of the pain and the individual sensitivity of the patient. The smallest dose that effectively relieves the pain should be used.

Adults

Typically, 50 mg of tapentadol (12.5 ml of oral solution) is taken, 75 mg of tapentadol (18.75 ml of oral solution), or 100 mg of tapentadol (25 ml of oral solution) every 4 to 6 hours.
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.
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 consult your doctor or pharmacist.

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 require 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 should only be given to children in a hospital setting.
The dose of Palexia for children over 2 years of age and adolescents under 18 years of age is 1.25 mg/kg every 4 hours.
You should always wait 4 hours before giving the next dose. The dose may be reduced as the acute pain decreases.
The appropriate dose will be determined by your doctor.
Liver and kidney disease (impairment)
Children and adolescents with liver or kidney disease should not take this medicine.

Method of administration

Palexia should be taken orally.
The medicine can be taken with or without food.
The packaging includes a dosing pipette with a connector, which should be used to withdraw the correct amount (volume) of solution from the bottle, corresponding to the prescribed dose of tapentadol.

Instructions for opening the bottle and using the dosing pipette

The bottle has a child-resistant cap. To open the cap, press it down and turn it counterclockwise (Figure 1).
Remove the cap and the protective foil from the top of the bottle. If the protective foil is damaged, do not use the product and contact your pharmacist.
Figure 1

Place the bottle on a hard, flat surface. Open the plastic bag containing the dosing pipette with the connector by tearing the perforated part of the bag and remove the dosing pipette (A) with the attached connector (B). Screw the connector with the dosing pipette tightly into the neck of the bottle (Figure 2).
Figure 2

To fill the dosing pipette, turn the bottle upside down. Holding the dosing pipette, gently pull the plunger down (C) to the line marking the dose prescribed by your doctor (see "How to take Palexia"). Do not removethe dosing pipette during this operation! (Figure 3).
Figure 3

Turn the bottle backand carefully remove the dosing pipette from the bottle. After removing the dosing pipette, carefully check if the correct amount of solution has been withdrawn. The connector (B), which was previously attached to the dosing pipette, should now remain in the bottle (Figure 4).
Figure 4

Take the medicine by placing the dosing pipette in your mouth and gently pressing the plunger. Press the plunger all the way down to ensure you take the entire solution. You can, if you prefer, dilute the medicine in a glass of water or another non-alcoholic drink before taking it. In this case, you should drink the entire glass of liquid to ensure you take the correct dose of the medicine (Figure 5).
Figure 5
The connector should be left in the bottle, the bottle should be tightly closed, and stored upright.
After each use, the dosing pipette should be washed with water and left to dry.
Before taking the medicine again, place the dosing pipette in the connector in the neck of the bottle and follow the above instructions.

Duration of treatment

Do not take the medicine for longer than your doctor has prescribed.

Taking a higher dose of Palexia than recommended

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!

Missing a 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 missed dose.
Return to your previous dosing schedule.

Stopping treatment with Palexia

If you stop taking Palexia or discontinue treatment before it is completed, 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, 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, shivering, 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 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 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 drowsiness and respiratory depression. This occurs most commonly in elderly and frail 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, 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 of weakness, fatigue, feeling of temperature change.
Uncommon(may affect up to 1 in 100 people): low mood, disorientation, agitation, nervousness, restlessness, euphoric mood, concentration disorders, memory impairment, feeling of impending faint, excessive sedation, balance disorders, speech disorders, tingling, abnormal skin sensations (e.g., burning, prickling), 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"), water retention (edema), feeling of abnormality, feeling of intoxication, 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: 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 of the medicine have not provided evidence of an increased risk.

No other side effects have been observed in children and adolescents.

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 Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides, 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

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle. The expiry date refers to the last day of the month.
Unopened: there are no special precautions for storage of the medicinal product.
After opening the bottle, the solution should not be used for more than 6 weeks.
Store in an upright position.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Palexia contains

• The active substanceof Palexia is tapentadol.

1 ml of Palexia, 4 mg/ml, oral solution contains 4 mg of tapentadol (as tapentadol hydrochloride).

• The other ingredientsare: Sodium benzoate (E 211) Citric acid monohydrate Sucralose (E 955) Raspberry flavor, containing propylene glycol (E 1520) Purified water

What Palexia looks like and contents of the pack

Palexia is a clear, colorless oral solution.
Palexia, 4 mg/ml, oral solution is available in HDPE bottles with a child-resistant HDPE cap, containing 100 ml of solution, with a 5 ml dosing pipette with a 0.1 ml scale and an LDPE connector attached to the dosing pipette, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Grünenthal GmbH
Zieglerstrasse 6
52078 Aachen
Germany

For more information about this medicine, please 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

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:

Belgium, Croatia, Cyprus, Czech Republic, Netherlands, Germany, Greece, Italy, Luxembourg, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, United Kingdom (Northern Ireland): PALEXIA
Date of last revision of the leaflet:07/2024