PALEXIA 50 mg FILM-COATED TABLETS

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

Do not take PALEXIA 50 mg:

• if you are allergic to tapentadol or 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 (elevated carbon dioxide levels in the blood)],
• if you have a disease in which the intestine does not function properly (paralytic ileus),
• if you have consumed alcohol, sleeping pills, other pain relievers, or other psychotropic medications (medications that affect mood and emotions) at high doses (see section "Taking PALEXIA 50 mg with other medicines").

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 up to 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 a disease of the pancreas (such as pancreatitis) or bile ducts,
• if you are taking medications called mixed opioid agonist/antagonists (e.g., pentazocine, nalbuphine) or partial agonists of opioid μ receptors (e.g., buprenorphine),
• if you are prone to epilepsy or convulsive seizures, or if you are taking other medications with a known risk of increasing seizures, as the risk of these seizures may increase,
• if you or a family member have a history of substance abuse or dependence on prescription or illicit substances (“addiction”),
• if you smoke,
• if you have ever had problems with your mood (depression, anxiety, or personality disorder) or have received psychiatric treatment for other mental illnesses.

This medication contains tapentadol, which is an opioid medication. Repeated use of opioid pain relievers can reduce their effectiveness (you may get used to them). It can also lead to dependence and abuse, which can result in a potentially fatal overdose. It is essential that you inform your doctor if you think you may have developed dependence on PALEXIA 50 mg. Its use (even at therapeutic doses) can cause physical dependence, which may cause you to experience withdrawal symptoms and a recurrence of your problems if you stop taking this treatment abruptly.

PALEXIA 50 mg can cause physical and psychological dependence. If you have a tendency to abuse medications or have drug dependence, you should only take these tablets for short periods under strict medical supervision.

Sleep-related respiratory disorders

PALEXIA 50 mg 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, nighttime awakenings due to difficulty breathing, difficulty maintaining sleep, or excessive daytime sleepiness. 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

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The risk of side effects increases if you are taking medications that can cause seizures (attacks), such as certain antidepressants or antipsychotics. The risk of seizures increases if you take PALEXIA 50 mg simultaneously with these medications. Your doctor will tell you if PALEXIA 50 mg is suitable for you.

Concomitant use of PALEXIA 50 mg and sedative medications such as benzodiazepines or related medications (certain sleeping pills or tranquilizers [e.g., barbiturates] or pain relievers like opioids, morphine, and codeine [also as a cough medication], antipsychotics, antihistamines H1, alcohol) increases the risk of drowsiness, respiratory difficulties (respiratory depression), coma, and can be potentially fatal. Due to this, concomitant use should only be considered when no other treatment options are possible.

However, if your doctor prescribes PALEXIA 50 mg with sedative medications, they will limit the dose and duration of concomitant treatment.

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 can be potentially fatal.

Tell your doctor if you are taking gabapentin or pregabalin or any other sedative medication and follow your doctor's dosage recommendation to the letter. It may be helpful to inform your friends and family about the signs and symptoms indicated above. Tell your doctor if you experience any of these symptoms.

If you are taking a type of medication that affects serotonin levels (e.g., certain medications for treating depression), talk to your doctor before taking PALEXIA 50 mg, as there have been cases of "serotonin syndrome". Serotonin syndrome is a rare but potentially life-threatening disorder. Symptoms can include involuntary rhythmic muscle contractions, including muscles that control eye movement, agitation, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, and body temperature above 38°C. Your doctor can provide you with more information.

The concomitant administration of PALEXIA 50 mg with other types of medications called mixed opioid agonist/antagonists (e.g., pentazocine, nalbuphine) or partial agonists of opioid μ receptors (e.g., buprenorphine) has not been studied. It is possible that PALEXIA 50 mg may not have the same efficacy if administered with one of these medications. Tell your doctor if you are currently being treated with one of these medications.

Administration of PALEXIA 50 mg with potent inhibitors or inducers (e.g., rifampicin, phenobarbital, St. John's Wort) of certain enzymes necessary to eliminate 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 medications you are taking.

PALEXIA 50 mg should not be taken with MAO inhibitors (medications for treating depression). Tell your doctor if you are taking MAO inhibitors or if you 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 side 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, 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 it, if used during prolonged periods during pregnancy, tapentadol may cause withdrawal symptoms in the newborn, which can be life-threatening if not detected and treated by a doctor,
• during childbirth, 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 using machines

Ask your doctor if you can drive or use machines during treatment with PALEXIA. It is essential that before driving or using machines, you observe how this medication affects you. Do not drive or use machines if you feel drowsy, dizzy, have blurred vision, or have difficulty concentrating. Be particularly careful when starting treatment, after a dose change, and when administering it concomitantly with alcohol or tranquilizers.

PALEXIA 50 mg contains lactose

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

PALEXIA 50 mg contains sodium

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

3. How to take PALEXIA 50 mg

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

Adults

The usual starting dose is 50 mg every 4 to 6 hours.

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

Daily doses above 700 mg of tapentadol on the first day of treatment and doses above 600 mg of tapentadol on subsequent days of treatment are not recommended.

Elderly patients

In elderly patients (over 65 years of age), the dose does not usually need to be adjusted. However, tapentadol elimination may be delayed and slower in some patients in this age group. If this happens to you, your doctor may prescribe a different dosing regimen.

Liver and kidney diseases (liver and kidney failure)

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

Patients with severe kidney problems should not take these tablets. In case of mild or moderate kidney problems, no dose adjustment is necessary.

Use in children and adolescents

PALEXIA 50 mg is not indicated in children and adolescents under 18 years of age.

How and when to take PALEXIA 50 mg

PALEXIA 50 mg should be taken orally.

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

How long to take PALEXIA 50 mg

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:

• pupils very reduced, vomiting, decreased blood pressure, rapid heartbeats, fainting, altered consciousness or coma (deep loss of consciousness), epileptic seizures, slow or shallow breathing to dangerous levels or respiratory arrest.

If any of these things happen to you, 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 leaflet of the medication to the healthcare professional.

If you forget to take PALEXIA 50 mg

If you forget to take a tablet, you will probably feel pain again. Do not take a double dose to make up for forgotten doses, but continue taking the tablets as before.

If you stop taking PALEXIA 50 mg

If you stop or discontinue treatment too early, you will probably feel pain again. If you want to stop treatment, consult your doctor before doing so.

Generally, patients do not experience any side effects after stopping treatment, but in rare cases, people who have taken the tablets for a long time may feel unwell if they stop taking them abruptly.

The symptoms may be:

• restlessness, tearful 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 stopping treatment, consult your doctor.

Do 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 of the dose.

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

4. Possible side effects

Like all medicines, this medication can cause side effects, although not everybody gets them.

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

This medication can cause allergic reactions. Symptoms may include wheezing (a type of whistling when breathing), difficulty breathing, swelling of the eyelids, face, or lips, skin rash, or itching, especially if it affects the whole body.

Another serious side effect is breathing more slowly or more weakly than normal. This occurs mainly in elderly or debilitated 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): decreased appetite, anxiety, confusion, hallucinations, difficulty sleeping, sleep disturbances, tremors, hot flashes, constipation, diarrhea, indigestion, dry mouth, itching, increased sweating, skin rash, muscle cramps, feeling of weakness, fatigue, feeling of changed body temperature.

Uncommon(may affect up to 1 in 100 people): depression, disorientation, excitability (agitation), nervousness, restlessness, euphoric mood, attention disturbances, memory impairment, feeling of being about to faint, sedation, difficulty controlling movements, difficulty speaking, numbness, abnormal sensations in the skin (e.g., tingling, itching), muscle twitches, 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, rash, feeling of heaviness, frequent urination, drug withdrawal syndrome (see section “If you stop taking PALEXIA 50 mg”), fluid retention in the 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 swelling under the skin, hives, and in severe cases difficulty breathing, decreased blood pressure, collapse, or shock), altered thinking, epileptic seizures, decreased level of consciousness, altered coordination, slow heartbeats, altered gastric emptying.

Frequency not known(frequency cannot be estimated from the available data): delirium.

In general, the possibility of having suicidal thoughts and behaviors increases in patients with chronic pain. Additionally, some medications for treating depression (with an impact on the brain's neurotransmitter system) may increase this risk, especially at the start of treatment. Although tapentadol also affects neurotransmitters, experience in patients has not shown that it increases this risk.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects that are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of PALEXIA 50 mg

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

Do not use this medicine after the expiry date which is stated on the carton and on the blister. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of PALEXIA 50 mg

The activeingredient is tapentadol.

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

The otheringredients 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 package contents

Film-coated tablets, round, white, 7 mm in diameter, with the Grünenthal logo embossed on one side and "H6" on the other.

PALEXIA film-coated tablets are packaged in blisters and supplied in packs 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.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Grünenthal Pharma, S.A.

Doctor Zamenhof, 36 – 28027 Madrid, Spain

Manufacturer:

Grünenthal GmbH

Zieglerstrasse, 6 – D-52078 Aachen, Germany

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under 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

Date of last revision of this leaflet: February 2024

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