Leaflet: information for the user

PALEXIA retard 50 mg prolonged-release tablets

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 is PALEXIA retard 50 mg and what it is used for

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

3.How to take PALEXIA retard 50 mg

4.Possible side effects

5.Storage of PALEXIA retard 50 mg

6.Contents of the pack and additional information

Tapentadol - the active ingredient of PALEXIA retard - is a potent analgesic that belongs to the class of opioids. PALEXIA retard 50 mg is used for the treatment of

• intense chronic pain in adults, which can only be adequately treated with an opioid analgesic,
• intense chronic pain in children over 6 years and adolescents, which can only be adequately treated with an opioid analgesic.

Do not take PALEXIA retard 50 mg:

Warnings and precautions

Consult your doctor or pharmacist before starting to take PALEXIA retard 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 retard 50 mg”),
• 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 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 retard 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 retard 50 mg may cause physical and psychological addiction. If you have a tendency to abuse medications or have medication dependence, you should take these tablets only for short periods of time under strict medical supervision.

Children and adolescents

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

Do not administer this medication to children under 6 years old.

Respiratory disorders related to sleep

PALEXIA retard 50 mg may cause respiratory disorders 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 retard 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 retard 50 mg simultaneously with these medications. Your doctor will tell you if PALEXIA retard 50 mg is suitable for you.

The concomitant use of PALEXIA retard 50 mg and sedatives such as benzodiazepines or related medications (certain sleeping pills or tranquilizers [e.g. barbiturates] or analgesics such as opioids, morphine, and codeine [also as a cough medication], antipsychotics, H1 antihistamines, alcohol) increases the risk of drowsiness, respiratory difficulties (respiratory depression), coma, and may be potentially fatal. Therefore, only consider concomitant use when other treatment options are not possible.

However, if your doctor prescribes PALEXIA retard 50 mg 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 doctor if you are taking gabapentin or pregabalin or any other sedative, and follow your doctor's recommended dose 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 retard 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 concomitant administration of PALEXIA retard 50 mg 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 retard 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 retard 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 retard 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 retard 50 mg with food, drinks, and alcohol

Do not consume alcohol while taking PALEXIA retard 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, 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,
• 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 retard. 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 retard 50 mg contains lactose

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

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 to pain. Generally, you should take the minimum effective dose to relieve pain.

Adults

The usual starting dose is 50 mg every 12 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 recommend daily total doses exceeding 500 mg of tapentadol.

Older patients

In older patients (over 65 years old), the dose usually does not need to be adjusted. However, the elimination of tapentadol may be delayed and slower in certain patients of 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. 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

For children and adolescents from 6 years old to less than 18 years old, the dose depends on age and body weight.

The appropriate dose should be prescribed by your doctor.Do not exceed a total daily dose of 500 mg, i.e., 250 mg administered every 12 hours.

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

PALEXIA retard 50 mg is not indicated in children under 6 years old.

How and when to take PALEXIA retard 50 mg

PALEXIA retard 50 mg should be taken orally.

Always take the tablets whole with a sufficient amount of liquid.

Do not chew, break, or crush them, as this could lead to an overdose because the active ingredient will be released in your body too quickly.

You can take them on an empty stomach or with meals.

The coating of the tablet may not be completely digested and may appear, apparently unchanged, in the stool. This should not worry you, as the active ingredient of the tablet will have already been absorbed by the body, and what you see is only the empty coating.

For how long should PALEXIA retard 50 mg be taken

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

If you take more PALEXIA retard 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 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 Toxicological 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 forgot to take PALEXIA retard 50 mg

If you forget to take a tablet, it is likely that you will 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 the treatment with PALEXIA retard 50 mg

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 the tablets for a long time may feel unwell if they stop taking them suddenly.

The symptoms may be:

• anxiety, 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 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 doubts 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. No additional side effects were observed in children and adolescents compared to adults.

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 breathing more slowly or more weakly 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, constipation, dizziness, drowsiness, headache.

Common(may affect up to 1 in 10 people):loss of appetite, anxiety,depression of mood,difficulty sleeping,nervousness, restlessness, alterations in attention,shakiness,muscle tics,headaches,shortness of breath, vomiting,diarrhea, poor digestion, itching, increased sweating, skin eruptions,sensation of weakness, fatigue, sensation of change in body temperature, dryness of mucous membranes, accumulation of water in tissues (edema).

Uncommon(may affect up to 1 in 100 people):allergic reaction to medication (including hives, urticarial rash, and in severe cases difficulty breathing, decreased blood pressure, collapse, or shock), weight loss, disorientation, confusion, excitability (agitation), alterations in perception, sleep, mood, and consciousness, memory deterioration, mental deterioration, fainting, sedation, balance disorders, difficulty speaking, numbness, abnormal sensations in the skin (e.g., tingling, itching), vision alteration, rapid heartbeats, slow heartbeats, palpitations, decreased blood pressure, abdominal discomfort, hives, delayed urination, frequent urination, sexual dysfunction, drug withdrawal syndrome (see section “If you stop treatment withPALEXIA retard 50 mg”), feeling unwell, irritability.

Rare(may affect up to 1 in 1,000 people):drug dependence, thought alteration, seizures, feeling of impending fainting, coordination alteration, slow or shallow breathing to dangerous levels (respiratory depression), alteration of gastric emptying, feeling of intoxication, feeling of relaxation.

Unknown frequency(frequency cannot be estimated from 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 (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 Medicines 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 usethis medicationafter the expiration date that appears on the box and on 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 disposed of through drains or in the trash.Deposit the packaging and medications that you no longer needat the SIGREcollection point of the pharmacy.In case of doubt, ask your pharmacist how to dispose of the packaging and medications that you no longer need. By doing so, you will help protect the environment.

Composition of PALEXIA retard 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: hypromellose, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate. Tablet coating: hypromellose, lactose monohydrate, talc, macrogol, propylene glycol, titanium dioxide (E 171).

Appearance of PALEXIA retard 50 mg and content of the container

Prolonged-release tablets, coated with a film, white in color, oblong (6.5 mm x 15 mm), with the Grünenthal logo engraved on one face and “H1” on the other.

The tablets are packaged in blisters and are supplied in containers of 7, 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 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 medicinal product is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Germany, Austria, Belgium, Cyprus, Croatia, Spain, Greece, Netherlands, Luxembourg, Poland, Portugal, Czech Republic, Slovak Republic: PALEXIA retard

Denmark, Norway, Sweden: PALEXIA Depot

Slovenia, Ireland, United Kingdom (Northern Ireland): PALEXIA SR

Italy: PALEXIA

Last review date of this leaflet: March 2024

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