Prospecto:information for the user

PALEXIA 50 mg film-coated tablets

Tapentadol

Read this prospectus carefully before starting to take this medicine,because it contains important information for you.

• Keep this prospectus, as you may need to read it again.

• If you have any doubts, consult your doctor or pharmacist.

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

• Ifyou experienceadverse effects,consult your doctor or pharmacist,even if they are not listed in this prospectus.See section 4.

1.What is PALEXIA 50 mg and what is it used for

2.What you need to know before starting to take PALEXIA 50 mg

3.How to take PALEXIA 50 mg

4.Possible adverse effects

1. Storage of PALEXIA 50 mg

6.Contents of the pack and additional information

Tapentadol - the active ingredient in PALEXIA - is a potent analgesic thatbelongs to the class ofopioids.

PALEXIA 50 mg is used for the treatment of acutemoderate tointense painin adults, who can only be adequately treatedwith an opioid analgesic.

Do not take PALEXIA 50 mg:

Warnings and precautions

Consult your doctor or pharmacist before starting to take PALEXIA 50 mg:

• if your breathing is slow or shallow,
• if you have increased intracranial pressure or altered consciousness to the point of coma,
• if you have had a head injury or brain tumors,
• if you have liver or kidney disease (see section “How to take PALEXIA 50 mg”),
• if you have pancreatitis (inflammation of the pancreas) or biliary tract disease,
• if you are taking mixed agonist/antagonist opioid medications (e.g., pentazocine, nalbuphine) or partial agonists of the µ opioid receptors (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 have 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 50 mg. Your 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 50 mg may cause physical and psychological addiction. If you have a history of medication abuse or dependence, you should take these tablets only for short periods under strict medical supervision.

Respiratory problems related to sleep

PALEXIA 50 mg may cause respiratory problems related to sleep 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 50 mg 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 50 mg concurrently with these medications. Your doctor will tell you if PALEXIA 50 mg is suitable for you.

The concurrent use of PALEXIA 50 mg and sedatives such as benzodiazepines or related medications (certain sleeping pills or tranquilizers [e.g., barbiturates] or painkillers like opioids, morphine, and codeine [also used for coughing], antipsychotics, H1 antihistamines, alcohol) increases the risk of drowsiness, respiratory difficulties (respiratory depression), coma, and may be potentially fatal. Therefore, concurrent use should only be considered when other treatment options are not possible.

However, if your doctor prescribes PALEXIA 50 mg with sedatives, you should limit the dose and duration of concurrent treatment.

The concurrent 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 doctor if you are taking gabapentin or pregabalin or any other sedative, and follow your doctor's dosage recommendations exactly. It may be helpful to inform your friends and family about the 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 50 mg, as there have been cases of "serotonin syndrome." Serotonin syndrome is a rare but potentially fatal condition. Symptoms may include involuntary, rhythmic muscle contractions, including those that control eye movement, agitation, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, and body temperature above 38°C. Your doctor may provide additional information.

The concurrent administration of PALEXIA 50 mg with other types of medications called mixed agonist/antagonist µ opioid receptor agonists (e.g., pentazocine, nalbuphine) or partial agonists of the µ opioid receptors (e.g., buprenorphine) has not been studied. PALEXIA 50 mg may not be as effective if taken with one of these medications. Inform your doctor if you are currently being treated with one of these medications.

The administration of PALEXIA 50 mg with potent inhibitors or inducers (e.g., rifampicin, phenobarbital, St. John's Wort) of certain enzymes necessary for the elimination of tapentadol from the body may affect the efficacy of tapentadol or cause adverse effects, especially when starting or stopping this other type of medication. Inform your doctor about all the medications you are taking.

PALEXIA 50 mg 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 50 mg with food, drinks, and alcohol

Do not consume alcohol while taking PALEXIA 50 mg, 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 if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Do not take this medication:

• if you are pregnant, unless your doctor has indicated otherwise, 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,
• during labor, as it may cause slow or shallow breathing to dangerous levels (respiratory depression) in the newborn,

• during breastfeeding, as it may be excreted in breast milk.

Driving and operating machinery

Ask your doctor if you can drive or operate machinery during treatment with PALEXIA. 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.

PALEXIA 50 mg contains lactose

If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

PALEXIA 50 mg contains sodium

This medication contains less than 1 mmol (23 mg) of sodium per tablet, making it essentially "sodium-free."

Follow the exact administration instructions for 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 usual starting dose is 50 mgevery 4 to 6 hours.

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

Do not exceed a total daily dose of 700 mg of tapentadol on the first day of treatment or a daily dose of 600 mg of tapentadol on subsequent days of treatment.

Older patients

Generally, no dose adjustment is necessary for older patients (over 65 years old). 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 schedule.

Liver and kidney diseases (hepatic and renal insufficiency)

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

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

Use in children and adolescents

PALEXIA 50 mg is not indicated for children and adolescents under 18 years old.

How and when to take PALEXIA 50 mg

PALEXIA 50 mg should be taken orally.

Take the tablets with sufficient liquid. You can take them on an empty stomach or with meals.

For how long should PALEXIA 50 mg be taken

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

If you take more PALEXIA 50 mg 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 any of these things happen, 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 packaging and the medication leaflet to the healthcare professional.

If you forget to take PALEXIA 50 mg

If you forget to take a tablet, you are likely to feel pain again. Do not take a double dose to compensate for the missed doses, but continue taking the tablets as before.

If you interrupt treatment with PALEXIA 50 mg

If you interrupt or stop treatment too soon, you are likely to feel pain again. If you want to interrupt 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 the tablets for a long time may feel unwell if they stop taking them 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 these tablets, 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 is breathing more slowly or more shallowly than normal. It occurs mainly in elderly patients or 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, drowsiness, headache.

Common(may affect up to 1 in 10 people):loss of 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 weak, fatigue, feeling of change in body temperature.

Uncommon(may affect up to 1 in 100 people):depression, 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, withdrawal syndrome from medications (see section “If you stop treatment withPALEXIA 50 mg”), 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 rash, and 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(frequency cannot be estimated from available data): delirium.

In general, the likelihood of 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.

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.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the box and in the blister. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be thrown down the drains or in the trash.Dispose of the packaging and medications you no longer needat the Pharmaceutical Waste Collection Pointof the pharmacy. If in doubtplease ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so,you will help protect the environment.

Composition of PALEXIA 50 mg

The active principle is tapentadol.

Each tablet contains 50 mg of tapentadol (as 58.24 mg of tapentadol hydrochloride).

The other components are:

Tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, povidone K30, magnesium stearate. Tablet coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc.

Appearance of the product and content of the container

Coated tablets, round, white, 7 mm in diameter, with the Grünenthal logo engraved on one face and “H6” on the other.

PALEXIA coated tablets are packaged in blisters and supplied in containers of 5, 10, 10x1, 14, 14x1, 20, 20x1, 24, 28, 28x1, 30, 30x1, 40, 50, 50x1, 54, 56, 56x1, 60, 60x1, 90, 90x1, 100 and 100x1 tablets.

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

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: Palexia Akutschmerz

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

Last review date of this leaflet: February 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/