Leaflet: information for the user

Palexia 4 mg/ml oral solution

Tapentadol

Read this leaflet carefully before you start taking 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, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

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

1.What Palexia is and what it is used for

2.What you need to know before you start taking Palexia

3.How to take Palexia

4.Possible side effects

5.Storage of Palexia

6.Contents of the pack and additional information

Tapentadol - the active ingredient in Palexia - is a potent analgesic that belongs to the class of opioids. This medication is used for the treatment of moderate to severe acute pain that can only be adequately treated with an opioid analgesicin children and adolescents aged 2 years and olderand in adults.

Do not take Palexia:

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 to even coma,
• if you have had a head injury or brain tumors,
• if you have liver or kidney disease (see section “How to take Palexia”),
• if you have pancreatitis (inflammation of the pancreas) or biliary tract disease,
• if you are taking medications called mixed opioid agonist/antagonists (e.g. pentazocine, nalbuphine) or partial opioid agonists (e.g. buprenorphine),
• if you are prone to epilepsy or seizures, or if you are taking other medications known to increase the risk of seizures, as the risk of seizures may increase,
• if you or a family member has a history of alcohol abuse, prescription medication abuse, or illicit substance abuse (“addiction”),
• if you smoke,
• if you have ever had mood problems (depression, anxiety, or personality disorder) or received psychiatric treatment for other mental health conditions.

This medicine contains tapentadol, which is an opioid medication. Repeated use of opioid analgesics may reduce the effectiveness of the medication (you may become accustomed to it). It may also lead to dependence and abuse, which may result in a potentially fatal overdose.It is essential to inform your doctor if you think you may have developed dependence on Palexia. Its use (even at therapeutic doses) may cause physical dependence, which may lead to withdrawal symptoms and a recurrence of your problems if you stop taking this medication abruptly.

Palexia may cause physical and psychological addiction. If you have a tendency to abuse medications or have medication dependence, you should only take this medication for short periods under strict medical supervision.

Children with obesity should be closely monitored, and the maximum recommended dose should not be exceeded.

Do not administer this medication to children under 2 years old.

Sleep-related respiratory disorders

Palexia may cause sleep-related respiratory 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, nocturnal awakenings due to difficulty breathing, difficulty maintaining sleep, or excessive daytime somnolence. If you or someone else observes 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 taken recently, or may need to take any other medication.

• The risk of side effects increases if you are taking medications that may cause seizures (e.g. certain antidepressants or antipsychotics). The risk of seizures increases if you take Palexia simultaneously with these medications. Your doctor will tell you if Palexia is suitable for you.

• The concomitant use ofPalexia andsedatives such as benzodiazepines or related medications (certain sleeping pills or tranquilizers [e.g. barbiturates] or painkillers like opioids, morphine, and codeine [also used as a cough medication], antipsychotics, H1 antihistamines, alcohol) increases the risk of drowsiness, respiratory difficulties (respiratory depression), coma, and may be potentially fatal. Due to this, only consider concomitant use when other treatment options are not possible.

However, if your doctor prescribes Palexia with sedatives, you should limit the dose and duration of concomitant treatment.

The concomitant use of opioids and medications 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 doctorif you aretaking gabapentin or pregabalin or anyother sedative, and follow your doctor's dosage recommendations exactly. It may be helpful to inform your friends and family about the signs and symptoms mentioned above. Inform your doctor if you experience any of these symptoms.

If you are taking a type of medication that affects serotonin levels (e.g. certain antidepressants), talk to your doctor before taking Palexia, as there have been cases of “serotonin syndrome.” Serotonin syndrome is a rare but potentially fatal condition. Symptoms may include involuntary muscle contractions, including those that control eye movement, agitation, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, and a body temperature above 38°C. Your doctor may provide additional information.

• The concomitant administration of Palexia with other types of medications called mixed opioid agonist/antagonists (e.g. pentazocine, nalbuphine) or partial opioid agonists (e.g. buprenorphine) has not been studied. Palexia may not have the same effectiveness if taken with one of these medications. Inform your doctor if you are currently being treated with one of these medications.

• The administration of this medication with potent inhibitors or inducers (e.g. rifampicin, phenobarbital, St. John's Wort) of certain enzymes necessary for eliminating tapentadol from your body may affect the efficacy of tapentadol or cause adverse effects, especially when starting or stopping this other type of medication. Keep your doctor informed about all the medications you are taking.

• Palexia should not be taken with MAO inhibitors (medications for depression treatment). Inform your doctor if you are taking MAO inhibitors or have taken them in the last 14 days.

Taking Palexia with food, drinks, and alcohol

Do not consume alcohol while taking this medication, as some of its adverse effects, such as drowsiness, may increase. Food intake does not affect the effect of this medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Do not take this medication:

• if you are pregnant, unless your doctor has indicated it, as tapentadol may cause withdrawal symptoms in the newborn, which may put the newborn's life at risk if not detected and treated by a doctor.

Do not use Palexia:

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

Driving and operating machinery

Ask your doctor if you can drive or operate machinery during tapentadol treatment. It is essential to observe how this medication affects you before driving or operating machinery. Do not drive or operate machinery if you feel drowsy, dizzy, have blurred vision, or have difficulty concentrating. Be particularly cautious at the start of treatment, after a dose change, and when taking it with alcohol or tranquilizers.

Palexiacontains sodium

This medication contains less than 1 mmol of sodium (23 mg) per dose unit, which is essentially “sodium-free.”

Palexiacontains sodium benzoate

This medication contains 59 mg of sodium benzoate in each volume unit equivalent to 2.4 mg/ml. Sodium benzoate may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks old).

Palexiacontains propylene glycol

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will adjust the dose based on the intensity of your pain and your personal sensitivity to pain. Generally, you should take the minimum effective dose to relieve pain.

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.

Do not recommend daily total doses exceeding 700 mg of tapentadol on the first day of treatment or daily doses exceeding 600 mg of tapentadol on subsequent treatment days.

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

Older adults

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

Liver and kidney diseases (hepatic and renal insufficiency)

Patients with severe liver problems should not take this medication. If you have moderate liver problems, your doctor will prescribe a different dosing regimen. If you have mild liver problems, no dose adjustment is necessary.

Patients with severe kidney problems should not take this medication. If you have mild or moderate kidney problems, no dose adjustment is necessary.

Use in children and adolescents

This medicationshould only be administered to children in a hospital.

The dose ofPalexiafor children and adolescents from 2 years to 18 years is 1.25 mg/kg every 4 hours.

Wait 4 hours before giving the next dose. The dose can be reduced as the acute pain decreases.

The correct administration will be determined by your doctor.

Liver and kidney diseases (hepatic and renal insufficiency)

Children and adolescents with liver or kidney problems should not take this medication.

How and when to takePalexia

This medication should be taken orally.

You can take the oral solution on an empty stomach or with meals.

The package contains a dosing syringe with an adapter that should be used to extract the exact amount of tapentadol solution corresponding to the prescribed dose from the bottle.

Instructions for opening the bottle and using the dosing syringe

The bottle has a child-resistant 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.Ifthe safety seal is damaged, do not use this medication and consult your pharmacist.

Fig. 1

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

Fig. 2

To fill the dosing syringe, turn the bottle upside down.Whilekeeping the dosing syringe in place, pull the plunger (C) down slowly until it reaches the line corresponding to the dose prescribed by your doctor (see the section "How to takePalexia"). ¡Do not removethe dosing syringe yet!(Fig. 3).

Fig. 3

Turn the bottle back to its upright positionand then carefully extract the dosing syringe from the bottle. Once the dosing syringe is removed, carefully check that you have extracted the correct amount of solution. The adapter (B) that was previously attached to the dosing syringe should now remain in the bottle (Fig. 4).

Fig. 4

To take the medication, place the dosing syringe in your mouth and press the plunger gently.Press the plunger to the end to ensure that you take the entire solution.If you prefer, you can dilute the medication in a glass with water or a non-alcoholic beverage before taking it, in which case you will need to take the entire glass to ensure that you have taken the correct dose of medication (Fig. 5).

Fig. 5

Leave the adapter in the bottle, close the bottle tightly, and keep it upright. Rinse the dosing syringe after each use and let it dry. The next time you take the medication, place the dosing syringe in the adapter that will be in the neck of the bottle and follow the instructions mentioned above.

For how long to takePalexia

Do not take this medication for longer than your doctor has indicated.

If you take more Palexia than you should

After taking very high doses, you may experience some of the following effects:

• very small pupils, vomiting, decreased blood pressure, rapid heart rate, dizziness, altered consciousness or coma (deep loss of consciousness), seizures, slow or shallow breathing to dangerous levels or respiratory arrest.

If you experience any of these things, call a doctor immediately!

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20 indicating the medication and the amount used. It is recommended to bring the package and the medication leaflet to the healthcare professional.

If you forget to take Palexia

If you forget to take this medication, it is likely that you will feel pain again. Do not take a double dose to compensate for the missed doses, but continue taking this medication as before.

If you interrupt the treatment with Palexia

If you interrupt or stop taking the treatment too soon, it is likely that you will feel pain again. If you want to interrupt the treatment, consult your doctor before doing so.

Generally, patients do not experience any adverse effects after interrupting treatment, but in rare cases, people who have taken this medication for a long time may feel unwell if they stop taking it suddenly.

The symptoms may be:

• anxiety, 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 increased blood pressure, respiratory rate, or heart rate.

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

You should not stop taking this medication abruptly, unless your doctor tells you to. If your doctor wants you to stop taking this medication, they will indicate how to do it, which may involve a gradual reduction in dose.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Important side effects or symptoms to be aware of and what to do if you are affected by them:

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

Another serious side effect consists of feeling drowsy and breathing more slowly or more shallowly than normal. It occurs mainly in elderly patients or in weakened patients.

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

Side effects that may occur:

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

Common(may affect up to 1 in 10 people):decreased appetite, anxiety, confusion, hallucinations, difficulty sleeping, sleep disturbances, tremors, hot flashes, constipation, diarrhea, poor digestion, dry mouth, itching, increased sweating, skin eruptions, muscle cramps, feeling of weakness, fatigue, feeling of change in body temperature.

Uncommon(may affect up to 1 in 100 people):depression of mood, disorientation, excitability (agitation), nervousness, restlessness, euphoric mood, attention disturbances, memory deterioration, feeling of fainting, sedation, difficulty controlling movements, difficulty speaking, numbness, abnormal skin sensations (e.g., tingling, itching), muscle tics, vision disturbances, rapid heartbeats, palpitations, decreased blood pressure, slow or shallow breathing to dangerous levels (respiratory depression), decreased oxygen levels in the blood, shortness of breath, abdominal discomfort, hives, feeling of heaviness, delayed urination, frequent urination, drug withdrawal syndrome (see section "If you stop treatment withPalexia"), fluid accumulation in tissues (edema), feeling of discomfort, feeling of intoxication, irritability, feeling of relaxation.

Rare(may affect up to 1 in 1,000 people):allergic reaction to medications (including hives, urticarial rashand in severe cases difficulty breathing, decreased blood pressure, collapse, or shock),thought disorder, seizures, decreased level of consciousness, coordination disturbances, slow heartbeats, gastric emptying disturbances.

Unknown frequency: delirium.

In general, the possibilityof having suicidal thoughts and behaviors increases in patients with chronic pain. Additionally, some medications for treating depression (affecting the neurotransmitter system in the brain) may increase this risk, especially at the beginning of treatment. Although tapentadol also affects neurotransmitters, through experience in patients it has not been proven to increase this risk.

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and on the bottle after CAD. The expiration date is the last day of the month indicated.

Before the first opening: this medication does not require special conservation conditions.

Do not use the solution after six weeks from the first opening of the bottle.

Store in an upright position after the first opening.

Medications should not be thrown down the drains or in the trash.Deposit the containers and medications that you do not need at the SIGRE collection point of the pharmacy.Ask your pharmacist if you are unsure how to dispose of the containers and medications that you do not need. In this way, you will help protect the environment.

Composition ofPalexia

The active principle is tapentadol.

1 ml of oral solution contains 4 mg of tapentadol (in the form of hydrochloride).

The other components are:

Sodium benzoate (E211)

Citric acid monohydrate

Sucralose (E955)

Strawberry flavor, contains propylene glycol (E1520)

Purified water

Appearance of the product and contents of the packaging

Palexia is a transparent and colorless oral solution.

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

Only some packaging sizes may be marketed.

Marketing Authorization Holder

Grünenthal Pharma, S.A.

Doctor Zamenhof, 36 – 28027 Madrid, Spain

Responsible for manufacturing

Grünenthal GmbH

Zieglerstrasse, 6 – D-52078 Aachen, Germany

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with 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

Last review date of this leaflet:July 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/