Palexia

Package leaflet: Information for the patient

Palexia, 20 mg/ml, oral solution
Tapentadol
Please read this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Table of contents

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

Tapentadol, the active substance in Palexia, is an analgesic belonging to the group of strong opioids. Palexia is indicated for the treatment of moderate to severe acute pain in children and adolescents above 2 years of age and weighing more than 16 kg, as well as in adults, when only an opioid analgesic can provide adequate pain management.

2. Important information before using Palexia

When not to use Palexia:

• 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 cases of acute alcohol intoxication, hypnotics, analgesics or other psychotropic medicines (medicines affecting mood and emotions) (see "Palexia with other medicines").

Warnings and precautions
Before starting Palexia, discuss this 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,
• in patients after head injury or with brain tumours,
• in patients with liver or kidney disease (see "How to use Palexia"),
• in patients with diseases of the pancreas or biliary tract, including pancreatitis,
• in patients taking medicines with mixed agonist/antagonist properties at the "mu" opioid receptors (e.g. pentazocine, nalbuphine) or medicines that are partial agonists at the "mu" opioid receptor (e.g. buprenorphine),
• in patients with a tendency to seizures or convulsions, or when taking other medicines that increase the risk of seizures and may increase the risk of fits.

Tolerance, dependence and addiction
This medicine contains tapentadol, which is an opioid medicine. Repeated use of medicines containing opioids may lead to reduced effectiveness of the medicine (the body becomes accustomed to it, known as tolerance). Repeated use of Palexia may lead to dependence, addiction and abuse, which may result in life-threatening overdose. The risk of such adverse effects may increase with higher doses and prolonged duration of use. Dependence or addiction may lead to the patient losing control over the amount or frequency of medicine intake. The risk of developing dependence or addiction varies among individuals. Increased risk of developing addiction or dependence on Palexia may occur in the following situations:

• the patient or any family member has ever abused or been dependent on alcohol, prescription medicines or illegal drugs ("addiction")
• the patient is a smoker
• the patient has ever had mood disorders (depression, anxiety or personality disorders) or has been treated by a psychiatrist for other psychiatric disorders.

If, while taking Palexia, the patient notices any of the following symptoms, this may indicate that dependence or addiction is developing:

• need to take the medicine longer than prescribed by the doctor
• need to take a higher dose than recommended
• feeling that the medicine must be continued, even if it does not help relieve pain
• using the medicine for reasons other than recommended, e.g. "to calm down" or "to help fall asleep"
• making repeated, unsuccessful attempts to stop or control medicine use
• feeling unwell after stopping the medicine and feeling better after resuming it ("withdrawal effect").

If any of these symptoms are observed, the patient should consult their doctor to discuss the best treatment plan, including the appropriate timing and safe way to discontinue treatment (see section 3 Discontinuing Palexia).

Children and adolescents
Children and adolescents with obesity should be carefully monitored, and the recommended maximum dose should not be exceeded. Do not give this medicine to children under 2 years of age or with body weight less than 16 kg.

Sleep-related breathing disorders
Palexia may cause breathing disorders during sleep, such as sleep apnoea (pauses in breathing during sleep) and hypoxaemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, waking up at night due to breathlessness, difficulty maintaining sleep or excessive daytime sleepiness. If the patient or another person notices such symptoms, contact a doctor. The doctor may consider reducing the dose.

Palexia with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

• The risk of adverse effects increases if the patient is taking medicines that may cause seizures (epileptic fits), such as antidepressants or antipsychotics. The risk of seizures may increase if Palexia is taken at the same time. Your doctor will inform you whether taking Palexia is suitable for you.

• Concomitant use of Palexia and sedative medicines, such as benzodiazepine derivatives or benzodiazepine-like medicines [e.g. certain sleeping tablets or sedatives (e.g. barbiturates) or analgesics such as opioids, morphine and codeine (also used as cough suppressants), antipsychotics, H1 antihistamines, alcohol], increases the risk of drowsiness, breathing difficulties (respiratory depression) and coma, and may be life-threatening. Therefore, concomitant use of such medicines should only be considered if no other treatment options are available. If your doctor prescribes Palexia together with sedative medicines, they should limit the dose and duration of concomitant treatment. Concomitant use of opioids and medicines used to treat epilepsy, neuropathic pain or anxiety (gabapentin and pregabalin) increases the risk of opioid overdose, respiratory depression and may be life-threatening. Inform your doctor if you are taking gabapentin or pregabalin or any sedative medicine and strictly follow your doctor's dosage recommendations. It may be helpful to inform friends or relatives so they are aware of the above-mentioned subjective and objective symptoms. If such symptoms occur, contact your doctor.

• 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 developing "serotonin syndrome". Serotonin syndrome is rare but may be life-threatening. Symptoms include: uncontrolled, rhythmic muscle contractions, including eye movement muscles, agitation, excessive sweating, tremor, exaggerated reflexes, including increased muscle tone and body temperature above 38°C. If this occurs, seek medical advice.

• Concomitant use of Palexia with opioid medicines that are mixed agonists/antagonists at the "mu" receptor (e.g. pentazocine, nalbuphine) or partial agonists at the "mu" receptor (e.g. buprenorphine) has not been studied. Palexia may not work properly if used simultaneously with the above-mentioned medicines. Inform your doctor immediately if you are currently taking any of the medicines listed above.

• Concomitant use of Palexia with strong inhibitors or inducers (e.g. rifampicin, phenobarbital, St. John's wort) of enzymes necessary for tapentadol elimination from the body may affect tapentadol's action or may cause adverse effects, especially when starting or stopping these medicines. Tell your doctor about all medicines you are currently taking.

• Palexia must not be used concomitantly with MAO inhibitors (medicines used to treat depression). Inform your doctor if these medicines have been used or were used within the last 14 days.

The risk of adverse effects may increase if the patient takes Palexia together with the following medicines with anticholinergic effects:

• antidepressants
• medicines used to treat allergies, motion sickness or nausea (antihistamines and antiemetics)
• medicines used to treat psychiatric disorders (antipsychotics or neuroleptics)
• muscle relaxants
• medicines used to treat Parkinson's disease

Palexia with food, drink and alcohol
Do not drink alcohol while taking Palexia, as certain adverse effects such as drowsiness may be intensified. The medicine can be taken independently of meals.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine. Do not use Palexia:

• during pregnancy, unless the doctor decides it is necessary. Long-term use of tapentadol during pregnancy may cause withdrawal symptoms in newborns, which may be life-threatening if not recognised and treated by a doctor.
• during childbirth, as it may cause dangerous slowing or weakening of the newborn's breathing (respiratory depression),
• during breastfeeding, as tapentadol may be excreted in breast milk.

Driving and operating machinery
Palexia may cause drowsiness, dizziness, blurred vision and affect reaction ability.
These symptoms may occur especially at the beginning of Palexia treatment, after a dose change as recommended by the doctor, or when alcohol or sedative medicines are used concomitantly. Ask your doctor whether driving and operating machinery are permitted after taking this medicine.

Palexia 20 mg/ml contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per maximum single dose and is therefore considered "sodium-free".

Palexia 20 mg/ml contains sodium benzoate
This medicine contains 5.9 mg of sodium benzoate in 5 ml of solution (maximum single dose), equivalent to 1.18 mg/ml.
Benzoic acid salts may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of age).

Palexia 20 mg/ml contains propylene glycol
This medicine contains 10 mg of propylene glycol in 5 ml of solution (maximum single dose), equivalent to 2 mg/ml.

3. How to take Palexia

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Before starting treatment and regularly during treatment, your doctor will discuss with you what you can expect from taking Palexia, when and for how long it should be taken, when you should contact your doctor, and when the medicine should be discontinued (see also section "Stopping Palexia").
The dosage should be adjusted according to the intensity of pain and individual patient sensitivity. The lowest effective dose for pain relief should be used.
Adults
The usual dose is 50 mg tapentadol (2.5 ml oral solution), 75 mg tapentadol (3.75 ml oral solution), or 100 mg tapentadol (5 ml oral solution) every 4 to 6 hours.
Total daily doses exceeding 700 mg tapentadol on the first day of therapy and daily doses exceeding 600 mg tapentadol on subsequent days of therapy are not recommended.
Your doctor may prescribe a different, more appropriate dose or dosing interval if necessary. If you feel the effect of the medicine is too strong or too weak, contact your doctor or pharmacist.
Elderly patients
Dosage adjustment is usually not necessary in elderly patients (over 65 years of age).
Elimination of the medicine may be prolonged in patients in this age group, and therefore your doctor may recommend a different dosing regimen.
Patients with impaired liver or kidney function
This medicine should not be used by patients with severe liver impairment.
In cases of moderate liver impairment, your doctor will recommend an adjusted dosing regimen.
Patients with mild liver impairment do not require dose adjustment.
This medicine should not be used by patients with severe kidney impairment.
Dose adjustment is not required in patients with mild or moderate kidney impairment.
Use in children and adolescents
Palexia should be administered to children only in a hospital setting. Palexia should only be given to children with a body weight above 16 kg.
The dose of Palexia for children aged over 2 years and adolescents under 18 years is 1.25 mg/kg every 4 hours.
Always wait at least 4 hours before administering the next dose. The dose may be reduced as acute pain decreases.
The appropriate dose will be determined by the doctor.
Liver and kidney diseases (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 on an empty stomach or with food.
The package contains a dosing pipette with a connector, which should be used to draw the correct amount (volume) of solution corresponding to the prescribed tapentadol dose from the bottle.
Instructions for opening the bottle and using the dosing pipette
The bottle has a child-resistant cap. To unscrew the cap,

press it down and turn it counterclockwise (Figure 1).
Unscrew the cap and remove the protective foil from the top of the bottle. If the protective seal is damaged, do not use the product and contact your pharmacist.
Figure 1
Place the bottle on a hard, flat surface. Open the plastic pouch

containing the dosing pipette with the connector by tearing along the perforated line 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 mark indicating the dose prescribed by the doctor (see section "How to take Palexia"). Do not remove the dosing pipette during this procedure! (Figure 3).
Figure 3
Turn the bottle right side up and carefully remove the dosing pipette from the bottle. After removing the dosing pipette,

carefully check whether the correct amount of solution has been drawn. The connector (B), previously attached to the dosing pipette, should remain in the bottle (Figure 4).
Figure 4
Take the medicine by placing the dosing pipette into the mouth and gently

pressing the plunger. Press the plunger completely to ensure the entire solution is administered. If preferred, the medicine may be diluted in a glass of water or another non-alcoholic drink before administration. In this case, the entire glass of liquid should be consumed to ensure the full dose is taken (Figure 5).
Figure 5
Leave the connector in the bottle, close the bottle tightly, and store it in an upright position.
After each use, wash the dosing pipette with water and allow it to dry.
Before drawing the next dose, reattach the dosing pipette to the connector in the bottle neck and follow the instructions described above.
Duration of treatment
Do not use longer than prescribed by your doctor. In children, treatment should not exceed 3 days.
Taking more Palexia than prescribed
After taking very high doses, the following symptoms may occur:

• pinpoint pupils, vomiting, low blood pressure, rapid heartbeat, collapse, disturbances of consciousness or coma (deep unconsciousness), seizures, dangerously slow or shallow breathing or respiratory arrest, which may lead to death. In such cases, seek immediate medical help!
  Missing a dose of Palexia
  If you miss a dose, your pain symptoms may return. Do not take a double dose to make up for a missed dose. Resume your regular dosing schedule.
  Stopping Palexia
  If you stop or discontinue Palexia before the end of treatment, your pain symptoms may return. Contact your doctor before stopping the medicine. Generally, no adverse effects are observed upon discontinuation of the medicine; however, in rare cases, patients who have been taking the medicine for some time and stop abruptly may experience general malaise. The following symptoms may occur:
• restlessness, lacrimation, runny nose, yawning, sweating, chills, muscle aches, and dilated pupils,
• irritability, anxiety, back pain, joint pain, weakness, abdominal cramps, difficulty falling asleep, nausea, loss of appetite, vomiting, diarrhea, increased blood pressure, respiratory rate, and heart rate.
  If any of these symptoms occur, consult your doctor immediately. Do not stop taking the medicine abruptly unless instructed by your doctor. Your doctor will inform you how to discontinue the medicine. Discontinuation may involve gradually reducing the dose.
  If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
Important adverse effects or symptoms to watch 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, particularly affecting the whole body.
Another serious adverse effect is marked drowsiness and excessive slowing and shallowing of breathing. This occurs most frequently in elderly and debilitated patients.
If any of these serious adverse effects affect you, contact your doctor immediately.

Other adverse 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, tremor, facial flushing, constipation, diarrhoea, indigestion, dry mouth, itching, excessive sweating, rash, muscle cramps, feeling of weakness, fatigue, sensation of body temperature changes.
Uncommon (may affect up to 1 in 100 people): depressed mood, disorientation, agitation (restlessness), nervousness, motor restlessness, euphoric mood, difficulty concentrating, memory impairment, feeling faint, excessive sedation, balance disorders, speech disturbances, tingling, abnormal skin sensations (e.g. numbness, pricking), muscle cramps, visual disturbances, faster heartbeat, palpitations, decreased blood pressure, dangerously slow or shallow breathing (respiratory depression), reduced blood oxygen saturation, shortness of breath, abdominal discomfort, urticaria, feeling of heaviness, difficulty in urination, frequent urination, withdrawal syndrome (see "Discontinuing Palexia treatment"), fluid retention (oedema), feeling of abnormality, sensation of alcohol intoxication, irritability, feeling of relaxation.
Rare (may affect up to 1 in 1,000 people): allergic reactions to the medicine (including skin swelling, urticaria, and in severe cases difficulty breathing, low blood pressure, collapse or shock), disturbances in thinking, seizures, reduced level of consciousness, coordination disorders, slower heartbeat, delayed gastric emptying.
Frequency not known: delirium.

Generally, the likelihood of suicidal thoughts and behaviours is higher in patients with chronic pain. Additionally, medicines used in the treatment of depression (which affect the neurotransmitter system in the brain) may increase this risk, particularly at the beginning of treatment. Although tapentadol also affects neurotransmitters, data obtained from human use of the medicine have not provided evidence of increased risk.

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

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse effects can be reported directly to:
Department of Monitoring Adverse Drug Reactions, 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
Adverse effects can also be reported to the marketing authorisation holder.
By reporting adverse effects, additional information on the safety of the medicine can be collected.

5. How to store the medicine Palexia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and on the bottle.
The expiry date refers to the last day of the stated month.
Unopened: no special storage conditions apply to this medicinal product.
After first opening of the bottle, the solution should not be used for longer than 6 weeks.
Store in an upright position.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Package contents and other information

What Palexia contains

• The active substance is tapentadol. 1 ml of Palexia 20 mg/ml oral solution contains 20 mg of tapentadol (as tapentadol hydrochloride).
• The other ingredients are: Sodium benzoate (E 211), monohydrate citric acid, sucralose (E 955), raspberry flavour containing propylene glycol (E 1520), sodium hydroxide (for pH adjustment), purified water.

What Palexia looks like and contents of the pack

Palexia is a clear, colourless oral solution. Palexia 20 mg/ml oral solution is available in HDPE bottles with an HDPE child-resistant cap, containing 100 ml or 200 ml of solution, supplied with a 5 ml dosing pipette with 0.1 ml graduations and an LDPE connector attached to the dosing pipette, all contained in a cardboard box. Additionally, a scale located on the right side shows single doses intended for adult patients. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Grünenthal GmbH
Zieglerstrasse 6
52078 Aachen, Germany

For further information about this medicinal product, contact the local representative of the Marketing Authorisation Holder:

Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warszawa, Poland
Tel. +48 22 737 79 20

This medicinal product is authorised for marketing in the European Economic Area and in the United Kingdom (Northern Ireland) under the following brand name:

PALEXIA: Austria, Belgium, Cyprus, Croatia, Czech Republic, Netherlands, Germany, Greece, Ireland, Italy, Luxembourg, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, United Kingdom (Northern Ireland).