Palexia Retard 50 mg prolonged-release tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

PALEXIA retard 50 mg prolonged-release tablets

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 further questions, ask your doctor or pharmacist.

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

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

Contents of the leaflet

1. What PALEXIA retard 50 mg is and what it is used for
2. What you need to know before taking PALEXIA retard 50 mg
3. How to take PALEXIA retard 50 mg
4. Possible side effects
5. How to store PALEXIA retard 50 mg
6. Contents of the pack and other information

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

Tapentadol—the active substance in PALEXIA retard—is a pain medication belonging to the class of strong opioids. PALEXIA retard 50 mg is used for the treatment of

• severe chronic pain in adults, which can only be adequately managed with an opioid,
• severe chronic pain in children over 6 years of age and adolescents, which can only be adequately managed with an opioid.

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

Do not take PALEXIA retard 50 mg:

• if you are allergic to tapentadol or to any of the other components 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 retard 50 mg with other medicines").

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 impaired consciousness up to and including coma,
• if you have suffered a head injury or have brain tumors,
• if you have liver or kidney disease (see section “How to take PALEXIA retard 50 mg”),
• if you have a disease of the pancreas (such as inflammation of the pancreas) or of the bile ducts,
• 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 increase the risk of 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, known as tolerance). Repeated use of PALEXIA retard 50 mg may also lead to dependence, abuse, and addiction, which could result in a 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 have a higher risk of becoming dependent or addicted to PALEXIA retard 50 mg if:

• you or a family member have a history of alcohol, prescription medicine, or illicit substance abuse or dependence ("addiction"),
• you are a smoker,
• you have ever had problems with your mood (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 retard 50 mg, 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 feel you need to keep taking the medicine even when it is not helping relieve your 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 your use of the medicine,
• you feel unwell when you stop taking the medicine and feel better when you take it again ("withdrawal symptoms").

If you notice any of these signs, speak with your doctor to discuss the most appropriate treatment strategy for your case, including when it is appropriate to stop taking the medicine and how to do so safely (see section 3 "If you stop treatment with PALEXIA retard 50 mg").

Children and adolescents

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

Do not give this medicine to children under 6 years of age.

Sleep-related breathing disorders

PALEXIA retard 50 mg may cause sleep-related breathing disorders such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low levels of oxygen 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 retard 50 mg with other medicines

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

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 retard 50 mg at the same time as these medicines. Your doctor will tell you whether PALEXIA retard 50 mg is suitable for you.

The concomitant use of PALEXIA retard 50 mg 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. For this reason, concomitant use should only be considered when no other treatment options are possible.

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

The 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 mentioned 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 for treating depression), 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 rhythmic involuntary muscle contractions, including muscles controlling eye movement, agitation, excessive sweating, tremors, exaggerated reflexes, increased muscle tone, and body temperature above 38°C. Your doctor can provide additional information.

The co-administration of PALEXIA retard 50 mg with other types of medicines known as mixed agonists/antagonists of µ-opioid receptors (e.g., pentazocine, nalbuphine) or partial µ-opioid agonists (e.g., buprenorphine) has not been studied. PALEXIA retard 50 mg may not be as effective if taken together with one of these medicines. Inform your doctor if you are currently being treated with any of these medicines.

The administration of PALEXIA retard 50 mg 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 influence the efficacy of tapentadol or may cause adverse effects, especially when starting or stopping this other medication. Keep your doctor informed about all medicines you are taking.

PALEXIA retard 50 mg must not be taken together with MAO inhibitors (medicines used to treat depression). Inform your doctor if you are taking MAO inhibitors or have taken them within the last 14 days.

If you use PALEXIA retard 50 mg together with the following medicines that have anticholinergic effects, the risk of side effects may increase:

• medicines used to treat depression,
• medicines used to treat allergies, dizziness, or nausea (antihistamines or antiemetics),
• medicines used to treat psychiatric disorders (antipsychotics or neuroleptics),
• muscle relaxants,
• medicines used to treat Parkinson's disease.

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 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take this medicine:

• if you are pregnant, unless your doctor has instructed you to do so. If used for prolonged periods during pregnancy, tapentadol may cause withdrawal symptoms in the newborn, which could 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,
• while breastfeeding, as it may be excreted in breast milk.

Driving and using machines

Ask your doctor whether you can drive or use machines during treatment with PALEXIA retard. It is important to observe how this medicine affects you before driving or using machines. Do not drive or use machines if you feel drowsy, dizzy, have blurred vision, or have difficulty concentrating. Take special care at the beginning of treatment, after a dose change, and when taking it together with alcohol or tranquilizers.

PALEXIA retard 50 mg contains lactose

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

3. How to take PALEXIA retard 50 mg

Follow exactly the instructions for use of 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 to expect from using PALEXIA retard 50 mg, 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 retard 50 mg”).

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 usual starting dose is 50 mg every 12 hours.

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

Daily total doses exceeding 500 mg of tapentadol are not recommended.

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 dosage regimen.

Liver and kidney disease (hepatic and renal impairment)

Patients with severe hepatic problems must not take these tablets. If you have moderate liver problems, your doctor will prescribe a different dosage regimen. Dose adjustment is not necessary in cases of mild hepatic impairment.

Patients with severe renal problems must not take these tablets. Dose adjustment is not necessary in cases of mild or moderate renal impairment.

Use in children and adolescents

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

The appropriate dose must be prescribed by your doctor. A total daily dose exceeding 500 mg must not be exceeded, i.e., 250 mg administered every 12 hours.

Children and adolescents with renal or hepatic problems must not use this medicine.

PALEXIA retard 50 mg is not indicated for children under 6 years of age.

How and when to take PALEXIA retard 50 mg

PALEXIA retard 50 mg should be taken orally.

Always take the tablets whole with sufficient liquid.

Do not chew, break, or crush them, as this could lead to overdose because the active substance would be released too quickly into your body.

You may take them on an empty stomach or with food.

The tablet coating may not be completely digested and may therefore appear apparently unchanged in the faeces. This is not a cause for concern, as the active ingredient of the tablet will already have been absorbed by the body, and what you see is only the empty coating.

How long to take PALEXIA retard 50 mg

Do not take the tablets for a longer period than instructed by your doctor.

If you take more PALEXIA retard 50 mg than you should

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

• extremely constricted pupils, vomiting, decreased 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service at: 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 retard 50 mg

If you forget to take a tablet, you may experience a return of pain. Do not take a double dose to make up for the missed dose; instead, continue taking the tablets as before.

If you stop taking PALEXIA retard 50 mg

If you stop or discontinue treatment too early, you may experience a return of pain. If you wish to stop treatment, consult your doctor first.

Generally, patients do not experience any adverse effects after stopping treatment, but in rare cases, individuals who have taken the tablets 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, diarrhoea, 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 abruptly stop taking this medicine unless your doctor tells you to do so. If your doctor wants you to stop taking these tablets, they will instruct 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. No additional adverse effects were observed in children and adolescents compared to adults.

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 abnormally slow or weak breathing. 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, constipation, dizziness, drowsiness, headache.

Common (may affect up to 1 in 10 people): decreased appetite, anxiety, depressed mood, difficulty sleeping, nervousness, restlessness, attention disturbances, tremors, muscle tics, hot flushes, shortness of breath, vomiting, diarrhea, indigestion, itching, increased sweating, skin rashes, feeling of weakness, fatigue, sensation of change in body temperature, dryness of mucous membranes, fluid accumulation in tissues (edema).

Uncommon (may affect up to 1 in 100 people): allergic reaction to medicines (including swelling under the skin, urticaria, and in severe cases difficulty breathing, decreased blood pressure, collapse or shock), weight loss, disorientation, confusion, excitability (agitation), disturbances in perception, sleep disturbances, euphoric mood, decreased level of consciousness, memory impairment, mental deterioration, fainting, sedation, balance disorders, speech difficulties, numbness, abnormal skin sensations (e.g., tingling, itching), visual disturbances, rapid heartbeat, slow heartbeat, palpitations, low blood pressure, abdominal discomfort, rash, delayed urination, frequent urination, sexual dysfunction, drug withdrawal syndrome (see section “If you stop taking PALEXIA retard 50 mg”), feeling unwell, irritability.

Rare (may affect up to 1 in 1,000 people): drug dependence, thought disturbance, epileptic seizures, feeling faint, impaired coordination, slow or shallow breathing up to dangerous levels (respiratory depression), delayed gastric emptying, feeling of drunkenness, feeling of relaxation.

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

In general, the likelihood of having suicidal thoughts and behaviors 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.

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. Storage of PALEXIA retard 50 mg

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 blister pack. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of PALEXIA retard 50 mg

The active ingredient 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 film-coat: hypromellose, lactose monohydrate, talc, macrogol, propylene glycol, titanium dioxide (E 171).

Appearance of PALEXIA retard 50 mg and contents of the pack

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

The tablets are packed in blisters and supplied in pack sizes 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 certain pack sizes may be commercially available.

Marketing Authorization 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, 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

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

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