Palexia 4 mg/ml oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Palexia 4 mg/ml oral solution

Tapentadol

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Palexia is and what it is used for
2. What you need to know 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 a pain medication belonging to the class of strong opioids. This medicine is used for the treatment of moderate to severe acute pain that can only be adequately managed with an opioid, in children and adolescents from 2 years of age and in adults.

2. What you need to know before starting to take Palexia

Do not take Palexia:

• if you are allergic to tapentadol or to any of the other ingredients of this medicine (listed in section 6),
• if you have asthma or if your breathing is slow or shallow to dangerous levels [respiratory depression; hypercapnia (higher than normal concentration of carbon dioxide in the blood)],
• if you have a condition in which the intestine does not function properly (intestinal paralysis),
• if you have consumed alcohol, sleeping pills, other analgesics, or other psychotropic medicines (medicines that affect mood and emotions) in high doses (see section "Taking Palexia with other medicines").

Warnings and precautions

Consult your doctor or pharmacist before starting to take Palexia:

• if your breathing is slow or shallow,
• if you have increased intracranial pressure or altered consciousness up to and including coma,
• if you have had a head injury or brain tumours,
• if you have liver or kidney disease (see section “How to take Palexia”),
• if you have a disease of the pancreas (such as inflammation of the pancreas) or of the biliary tract,
• if you are taking medicines called mixed opioid agonist/antagonists (e.g.: pentazocine, nalbuphine) or partial agonists of µ-opioid receptors (e.g.: buprenorphine),
• if you are prone to epilepsy or seizures, or if you are taking other medicines known to carry a risk of increasing seizures, as the risk of such seizures may increase.

Tolerance, dependence and addiction

This medicine contains tapentadol, which is an opioid medicine. Repeated use of opioids may reduce the effectiveness of the medicine (you may become accustomed to it, which is known as tolerance). Repeated use of Palexia may also lead to dependence, abuse, and addiction, which may result in potentially fatal overdose. The risk of adverse effects may increase with higher doses and longer duration of use.

Dependence or addiction may make you feel that you no longer have control over how much medicine you need to take or how often you need to take it. The risk of becoming dependent or addicted varies from person to person. You may be at higher risk of becoming dependent or addicted to Palexia if:

• you or a family member has a history of alcohol, prescription medicine, or illicit substance abuse or dependence (“addiction”),
• you are a smoker,
• you have ever had mood disorders (depression, anxiety, or a personality disorder) or have received treatment from a psychiatrist for other mental illnesses.

If you notice any of the following signs while taking Palexia, it could be a sign that you have become dependent or addicted:

• you need to take the medicine for longer than recommended by your doctor,
• you need to take higher doses than recommended,
• you may feel that you need to keep taking your medicine, even when it no longer helps relieve pain,
• you are using the medicine for reasons other than prescribed, for example, “to calm down” or “to help you sleep”,
• you have made repeated unsuccessful attempts to stop or control use of the medicine,
• you feel unwell when you stop taking the medicine and feel better when you start taking it again (“withdrawal symptoms”).

If you notice any of these signs, speak with your doctor to address the most appropriate therapeutic strategy in your case, including when it is appropriate to stop taking it and how to do so safely (see section 3 “If you stop taking Palexia”).

Children and adolescents

Obese children and adolescents should be closely monitored, and the maximum recommended dose must not be exceeded.

Do not administer this medicine to children under 2 years of age.

Sleep-related breathing disorders

Palexia may cause sleep-related breathing disorders such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to difficulty breathing, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, consult your doctor. Your doctor may consider reducing the dose.

Taking Palexia with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

• The risk of side effects increases if you are taking medicines that may cause seizures (fits), such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Palexia simultaneously with these medicines. Your doctor will tell you whether Palexia is suitable for you.

• Concomitant use of Palexia and sedative medicines such as benzodiazepines or related medicines (certain sleeping tablets or tranquilizers [e.g., barbiturates] or analgesics such as opioids, morphine, and codeine [also as a cough medicine]), antipsychotics, H1 antihistamines, or alcohol increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. Because of this, concomitant use should only be considered when no other treatment options are possible.

However, if your doctor prescribes Palexia together with sedative medicines, they will limit the dose and duration of concomitant treatment.

Concomitant use of opioids and medicines used to treat epilepsy, nerve pain, or anxiety (gabapentin and pregabalin) increases the risk of opioid overdose, respiratory depression, and may be potentially fatal.

Inform your doctor if you are taking gabapentin or pregabalin or any other sedative medicine, and strictly follow your doctor’s dosing recommendations. It may be helpful to inform your friends and family about the signs and symptoms listed above. Inform your doctor if you experience any of these symptoms.

If you are taking a type of medicine that affects serotonin levels (e.g., certain medicines to treat depression), talk to your doctor before taking Palexia, as cases of "serotonin syndrome" have been reported. Serotonin syndrome is a rare but potentially life-threatening condition. Symptoms may include involuntary rhythmic muscle contractions, including muscles controlling eye movement, agitation, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, and body temperature above 38 °C. Your doctor can provide additional information.

• The combined administration of Palexia with other types of medicines known as mixed µ-opioid receptor agonist/antagonists (e.g., pentazocine, nalbuphine) or partial µ-opioid agonists (e.g., buprenorphine) has not been studied. Palexia may not be as effective if administered together with one of these medicines. Inform your doctor if you are currently being treated with any of these medicines.

• Administration of this medicine together with strong inhibitors or inducers (e.g., rifampicin, phenobarbital, St. John’s wort) of certain enzymes required to eliminate tapentadol from your body may affect the efficacy of tapentadol or may cause adverse effects, especially when starting or stopping this other type of medication. Keep your doctor informed about all medicines you are taking.

• Palexia must not be taken together with MAO inhibitors (medicines for the treatment of depression). Inform your doctor if you are taking MAO inhibitors or have taken them within the last 14 days.

• If you use Palexia together with the following medicines that have anticholinergic effects, the risk of side effects may increase:

• medicines to treat depression,

• medicines used to treat allergies, dizziness, or nausea (antihistamines or antiemetics),

• medicines to treat psychiatric disorders (antipsychotics or neuroleptics),

• muscle relaxants,

• medicines to treat Parkinson’s disease.

Taking Palexia with food, drinks, and alcohol

Do not consume alcohol while taking this medicine, as some adverse effects, such as drowsiness, may be increased. Taking food does not affect the action of this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take this medicine:

• if you are pregnant, unless instructed by your doctor. If used for prolonged periods during pregnancy, tapentadol may cause withdrawal symptoms in the newborn, which may be life-threatening if not detected and treated by a doctor.

Use of Palexia is not recommended:

• during childbirth, because it may cause slow or shallow breathing to dangerous levels (respiratory depression) in the newborn,
• during breastfeeding, because tapentadol may be excreted in breast milk.

Driving and using machines

Ask your doctor whether you can drive or use machines while being treated with tapentadol. It is important to observe how this medicine affects you before driving or operating machinery. Do not drive or use machines if you feel drowsy, dizzy, have blurred vision, or have difficulty concentrating. Exercise particular caution at the beginning of treatment, after a dose change, or when taking the medicine together with alcohol or tranquilizers.

Palexia contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose unit, i.e., essentially “sodium-free”.

Palexia contains sodium benzoate

This medicine contains 59 mg of benzoic acid salt per volume unit equivalent to 2.4 mg/ml. Benzoic acid salt may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

Palexia contains propylene glycol

This medicine contains 48 mg of propylene glycol in 25 ml of solution (maximum dose unit), equivalent to 2 mg/ml.

3. How to take Palexia

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Before starting treatment and periodically during treatment, your doctor will discuss with you what you can expect from using Palexia, when and for how long you should take it, when to contact your doctor, and when you should stop taking it (see also "If you stop taking Palexia").

Your doctor will adjust the dose according to the intensity of your pain and your individual sensitivity to pain. Generally, the lowest effective dose needed to relieve pain should be used.

Adults

The recommended dose is 50 mg of tapentadol (12.5 ml of oral solution), 75 mg of tapentadol (18.75 ml of oral solution), or 100 mg of tapentadol (25 ml of oral solution) every 4 or 6 hours.

Total daily doses exceeding 700 mg of tapentadol on the first day of treatment, or exceeding 600 mg of tapentadol on subsequent treatment days, are not recommended.

Your doctor may prescribe a different or more suitable dosing regimen if necessary. If you think that the effect of this medicine is too strong or too weak, consult your doctor or pharmacist.

Elderly patients

In elderly patients (over 65 years of age), dose adjustment is usually not necessary. However, elimination of tapentadol may be delayed and slower in certain patients in this age group. If this applies to you, your doctor may prescribe a different dosing regimen.

Liver and kidney disease (hepatic and renal impairment)

Patients with severe liver problems must not take this medicine. If you have moderate liver problems, your doctor will prescribe a different dosing regimen. Dose adjustment is not necessary in cases of mild liver problems.

Patients with severe kidney problems must not take this medicine. Dose adjustment is not necessary in cases of mild or moderate kidney problems.

Use in children and adolescents

This medicine should only be administered to children in a hospital setting.

The dose of Palexia for children and adolescents from 2 years to 18 years of age is 1.25 mg/kg every 4 hours.

Always wait 4 hours before administering the next dose. The dose may be reduced as acute pain decreases.

The correct administration will be determined by your doctor.

Liver and kidney disease (hepatic and renal impairment)

Children and adolescents with liver or kidney problems must not take this medicine.

How and when to take Palexia

This medicine must be taken orally.

You may take the oral solution on an empty stomach or with food.

The container includes an oral dosing syringe with an adapter that should be used to withdraw the exact amount (volume) corresponding to the prescribed dose of tapentadol from the bottle.

Instructions for opening the bottle and using the dosing syringe

The bottle has a child-resistant screw cap. To remove the cap, press it down and turn it counterclockwise (Fig. 1). Remove the cap and peel off the safety seal from the top of the bottle. If the safety seal is damaged, do not use this medicine and consult your pharmacist.

Fig. 1

Place the bottle on a firm, flat surface. Open the plastic bag containing the dosing syringe and adapter at the perforated end and remove the dosing syringe (A) and the adapter (B), both included together. Insert the dosing syringe into the adapter and firmly place it into the neck of the bottle (Fig. 2).

Fig. 2

To fill the dosing syringe, turn the bottle upside down. While holding the dosing syringe in place, gently pull the plunger (C) down to the mark corresponding to the dose prescribed by your doctor (see section "How to take Palexia"). Do not remove the dosing syringe yet! (Fig. 3).

Fig. 3

Turn the bottle back to an upright position and then carefully remove the dosing syringe from the bottle. After removing the dosing syringe, carefully check that you have withdrawn the correct amount of solution. The adapter (B), previously attached to the dosing syringe, should remain in the bottle (Fig. 4).

Fig. 4

To take the medicine, place the dosing syringe in your mouth and gently press the plunger. Press the plunger completely to ensure you take all the solution. If preferred, you may dilute the medicine in a glass of water or a non-alcoholic drink before taking it; in this case, you must drink the entire glass to ensure you receive the correct dose of medicine (Fig. 5).

Fig. 5

Leave the adapter in the bottle, close the bottle tightly, and store it in an upright position. Rinse the dosing syringe with water after each use and let it dry. The next time you take the medicine, place the dosing syringe into the adapter that remains in the neck of the bottle and follow the instructions mentioned above.

How long to take Palexia

Do not take this medicine for longer than your doctor has instructed.

If you take more Palexia than you should

After taking very high doses, you may experience one or more of the following effects:

• very small pupils, vomiting, low blood pressure, rapid heartbeat, fainting, altered consciousness or coma (deep loss of consciousness), epileptic seizures, dangerously slow or shallow breathing, or respiratory arrest, which may lead to death.

If any of these occur, call a doctor immediately!

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to take Palexia

If you forget to take this medicine, you may start to feel pain again. Do not take a double dose to make up for a missed dose; instead, continue taking this medicine as before.

If you stop taking Palexia

If you stop or discontinue treatment too early, you may start to feel pain again. If you wish to stop treatment, consult your doctor before doing so.

Generally, patients do not experience any adverse effects after stopping treatment, but in rare cases, individuals who have taken this medicine for a prolonged period may feel unwell if they stop suddenly.

Symptoms may include:

• restlessness, watery eyes, runny nose, yawning, sweating, chills, muscle pain, and dilated pupils,
• irritability, anxiety, back pain, joint pain, weakness, abdominal cramps, difficulty sleeping, nausea, loss of appetite, vomiting, diarrhea, and increases in blood pressure, respiratory rate, or heart rate.

If you experience any of these symptoms after stopping treatment, consult your doctor.

You must not stop this medicine abruptly unless your doctor instructs you to do so. If your doctor wants you to stop taking this medicine, they will advise you on how to do so, which may involve gradually reducing the dose.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Important adverse effects or symptoms to watch for, and what to do if you experience them:

This medicine may cause allergic reactions. Symptoms may include wheezing (a whistling sound when breathing), difficulty breathing, swelling of the eyelids, face or lips, skin rash or itching, especially if affecting the whole body.

Another serious adverse effect is feeling drowsy and breathing more slowly or more weakly than normal. This occurs mostly in elderly or weakened patients.

If you experience any of these serious symptoms, consult your doctor immediately.

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, difficulty sleeping, sleep disturbances, tremors, hot flushes, constipation, diarrhoea, indigestion, dry mouth, itching, increased sweating, skin rashes, muscle cramps, feeling of weakness, fatigue, sensation of change in body temperature.

Uncommon (may affect up to 1 in 100 people): low mood, disorientation, excitability (agitation), nervousness, restlessness, euphoric mood, drug dependence, attention disturbances, memory impairment, feeling faint, sedation, difficulty controlling movements, difficulty speaking, numbness, abnormal skin sensations (e.g., tingling, itching), muscle tics, visual disturbances, rapid heartbeat, palpitations, decreased blood pressure, slow or shallow breathing up to dangerous levels (respiratory depression), reduced oxygen levels in the blood, shortness of breath, abdominal discomfort, rash, feeling of heaviness, delayed urination, frequent urination, drug withdrawal syndrome (see section "If you stop treatment with Palexia"), fluid accumulation in tissues (oedema), feeling unwell, sensation of drunkenness, irritability, feeling of relaxation.

Rare (may affect up to 1 in 1,000 people): allergic reaction to medicines (including swelling under the skin, hives, and in severe cases difficulty breathing, low blood pressure, collapse or shock), disturbance of thought, epileptic seizures, decreased level of consciousness, impaired coordination, slow heartbeat, delayed gastric emptying.

Frequency not known: delirium.

In general, the likelihood of having suicidal thoughts and behaviours increases in patients with chronic pain. In addition, some medicines used to treat depression (which affect the brain's neurotransmitter system) may increase this risk, especially at the beginning of treatment. Although tapentadol also affects neurotransmitters, experience in patients has not shown that it increases this risk.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Conservation of Palexia

Keep this medicine out of the sight and reach of children.

Store this medicine in a safe and secure place, where others cannot access it. It may cause serious harm or be fatal to individuals who take it accidentally or intentionally when it has not been prescribed for them.

Do not use this medicine after the expiry date stated on the carton and on the bottle after EXP. The expiry date refers to the last day of the month indicated.

Before first opening: this medicine does not require any special storage conditions.

The solution must not be used more than six weeks after the first opening of the bottle.

Keep the bottle in an upright position after first opening.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be taken to a pharmacy’s SIGRE Point. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Palexia

The active ingredient is tapentadol.

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

The other components are:

Sodium benzoate (E211)

Citric acid monohydrate

Sucralose (E955)

Raspberry flavour, containing propylene glycol (E1520)

Purified water

Appearance of the product and contents of the container

Palexia is a clear, colourless oral solution.

The oral solution is supplied in plastic bottles containing 100 millilitres of solution and includes a 5 ml dosing syringe graduated in 0.1 ml increments and an adapter attached to the dosing syringe.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder

Grünenthal Pharma, S.A.

Doctor Zamenhof, 36 – 28027 Madrid, Spain

Manufacturer

Grünenthal GmbH

Zieglerstrasse, 6 – D-52078 Aachen, Germany

This medicinal product is authorised in the European Economic Area (EEA) Member States and in the United Kingdom (Northern Ireland) under the following names:

Germany, Belgium, Cyprus, Croatia, Slovenia, Spain, Greece, Netherlands, Ireland, Italy, Luxembourg, Norway, Poland, Portugal, Czech Republic, Slovak Republic, United Kingdom (Northern Ireland): Palexia

Date of the most recent revision of this leaflet: January 2026

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/