PALEXIA RETARD 25 mg PROLONGED-RELEASE TABLETS

2. What you need to know before you take PALEXIA retard 25 mg

Do not take PALEXIA retard 25 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 too shallow to a life-threatening degree [respiratory depression; hypercapnia (elevated carbon dioxide levels in the blood)],
• if you have a condition where your intestines do not work properly (paralytic ileus),
• if you have consumed alcohol, sleeping pills, other pain relievers, or other psychoactive medicines (medicines that affect mood and emotions) at high doses (see section "Taking PALEXIA retard 25 mg with other medicines").

Warnings and precautions

Consult your doctor or pharmacist before starting PALEXIA retard 25 mg:

• if your breathing is slow or too shallow,

• if you have increased intracranial pressure or altered consciousness up to and including 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 25 mg"),

• if you have pancreas disease (such as pancreatitis) or bile duct disease,

• if you are taking medicines called mixed opioid agonist/antagonists (e.g., pentazocine, nalbuphine) or partial agonists of the opioid μ-receptors (e.g., buprenorphine),

• if you are prone to epilepsy or convulsive seizures, or if you are taking other medicines 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, alcohol abuse, or dependence on prescription medicines 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 medicine contains tapentadol, which is an opioid medicine. Repeated use of opioid analgesics may lead to a decrease in their effectiveness (you may get used to it). It can also lead to dependence and abuse, which can result in a potentially life-threatening overdose. It is essential that you inform your doctor if you think you may have developed dependence on PALEXIA retard 25 mg. Its use (even at therapeutic doses) can cause physical dependence, which may lead to withdrawal symptoms and a recurrence of your problems if you stop taking this treatment abruptly.

PALEXIA retard 25 mg can cause physical and psychological dependence. If you have a tendency to abuse medicines or have a history of medicine dependence, you should only take these tablets for short periods 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 give this medicine to children under 6 years of age.

Sleep-related breathing disorders

PALEXIA retard 25 mg can cause sleep-related breathing 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 retard 25 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 medicines that can cause seizures (fits), such as certain antidepressants or antipsychotics. The risk of seizures increases if you take PALEXIA retard 25 mg at the same time as these medicines. Your doctor will tell you if PALEXIA retard 25 mg is suitable for you.

Taking PALEXIA retard 25 mg with sedative medicines such as benzodiazepines or related medicines (certain sleeping pills or tranquilizers [e.g., barbiturates] or pain relievers like opioids, morphine, and codeine [also as a cough medicine], antipsychotics, antihistamines H1, alcohol) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Due to this, concomitant use should only be considered when no other treatment options are possible.

However, if your doctor prescribes PALEXIA retard 25 mg with sedative medicines, they will limit the dose and duration of concomitant treatment.

Taking opioids and medicines used to treat epilepsy, nerve pain, or anxiety (gabapentin and pregabalin) increases the risk of opioid overdose, respiratory depression, and can be life-threatening.

Tell your doctor if you are taking gabapentin or pregabalin or any other sedative medicine 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 mentioned above. Tell 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 25 mg, as there have been cases of "serotonin syndrome". Serotonin syndrome is a rare but potentially life-threatening disorder. Symptoms can include involuntary 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.

Concomitant administration of PALEXIA retard 25 mg with other types of medicines called mixed opioid agonist/antagonists (e.g., pentazocine, nalbuphine) or partial agonists of the opioid μ-receptors (e.g., buprenorphine) has not been studied. PALEXIA retard 25 mg may not have the same effectiveness if administered with one of these medicines. Tell your doctor if you are currently being treated with one of these medicines.

Concomitant administration of PALEXIA retard 25 mg and potent inhibitors or inducers (e.g., rifampicin, phenobarbital, St. John's Wort) of certain enzymes necessary for the elimination of tapentadol from your body may affect the efficacy of tapentadol or cause adverse effects, especially when starting or stopping this other type of medicine. Keep your doctor informed about all medicines you are taking.

PALEXIA retard 25 mg must not be taken with monoamine oxidase inhibitors (MAOIs) (medicines for treating depression). Tell your doctor if you are taking MAOIs or have taken them in the last 14 days.

Taking PALEXIA retard 25 mg with food, drinks, and alcohol

Do not consume alcohol while taking PALEXIA retard 25 mg, as some of its side effects, such as drowsiness, may increase. Taking food does not affect the effect of this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take this medicine:

• if you are pregnant, unless your doctor has told you to do so. If used during prolonged periods in pregnancy, tapentadol can cause withdrawal symptoms in the newborn, which can be life-threatening if not detected and treated by a doctor,

• during labor, as it may cause slow or shallow breathing to life-threatening levels (respiratory depression) in the newborn,

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

Driving and using machines

Ask your doctor if you can drive or use machines while taking PALEXIA retard. It is essential that before driving or using machines, you observe how this medicine affects you. Do not drive or use machines if you feel drowsy, dizzy, have blurred vision, or have difficulty concentrating. Be particularly careful at the start of treatment, after a dose change, and when taking it with alcohol or tranquilizers.

PALEXIA retard 25 mg contains lactose

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

3. How to take PALEXIA retard 25 mg

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Your doctor will adjust the dose according to the severity of your pain and your individual sensitivity to pain. You should usually take the minimum effective dose for pain relief.

Adults

The usual starting dose is 50 mg every 12 hours.

Your doctor may prescribe a different dose or dosing regimen, which is more suitable for you. If you think that the effect of these tablets is too strong or too weak, talk to your doctor or pharmacist.

Daily doses above 500 mg of tapentadol 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 applies to you, your doctor may prescribe a different dosing regimen.

Liver and kidney problems (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 regimen. 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

For children and adolescents from 6 years up to less than 18 years, 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 medicine.

PALEXIA retard 25 mg is not indicated in children under 6 years of age.

How and when to take PALEXIA retard 25 mg

PALEXIA retard 25 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 substance will be released into your body too quickly.

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

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

For how long to take PALEXIA retard 25 mg

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

If you take more PALEXIA retard 25 mg than you should

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

• pupils very small, vomiting, decrease in blood pressure, rapid heartbeat, fainting, altered consciousness or coma (deep loss of consciousness), epileptic seizures, slow or shallow breathing to life-threatening levels or respiratory arrest.

If any of these 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, stating the medicine and the amount used. It is recommended to take the package and the package leaflet of the medicine to the healthcare professional.

If you forget to take PALEXIA retard 25 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 retard 25 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 suddenly.

Symptoms can be:

• restlessness, tearful eyes, runny nose, yawning, sweating, shivering, 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 medicine abruptly, unless your doctor tells you to do so. If your doctor wants you to stop taking these tablets, they will tell you how to do it, which may involve gradually reducing the dose.

If you have any further questions on 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 all people suffer from them. No additional side effects were observed in children and adolescents compared to adults.

Adverse Effects or Important Symptoms to Watch Out for and What to Do if You Are Affected by Them:

This medicine may cause allergic reactions. Symptoms may include wheezing (a kind of whistling when breathing), difficulty breathing, swelling of the eyelids, face, or lips, skin rash, or itching, especially if they affect the whole body.

Another serious adverse effect is breathing more slowly or more weakly than normal. It occurs mostly in elderly patients or weakened patients.

If you experience any of these important 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, depression, difficulty sleeping, nervousness, restlessness, attention disorders, tremors, muscle twitches, hot flashes, shortness of breath, vomiting, diarrhea, indigestion, itching, increased sweating, skin rashes, feeling of weakness, fatigue, feeling of change in body temperature, dryness of the mucous membranes, water retention in the tissues (edema).

Uncommon(may affect up to 1 in 100 people): allergic reaction to medicines (including swelling under the skin, hives, and in severe cases difficulty breathing, decreased blood pressure, collapse, or shock), weight loss, disorientation, confusion, excitability (agitation), perception disorders, sleep disorders, mood elevation, decreased level of consciousness, memory impairment, mental deterioration, fainting, sedation, balance disorders, speech difficulties, numbness, abnormal sensations in the skin (such as tingling, itching), vision disorders, rapid heartbeats, slow heartbeats, palpitations, decreased blood pressure, abdominal discomfort, rash, delayed urination, frequent urination, sexual dysfunction, drug withdrawal syndrome (see section "If you stop treatment with PALEXIA retard 25 mg"), feeling of discomfort, irritability.

Rare(may affect up to 1 in 1,000 people): drug dependence, thought disorders, epileptic seizures, feeling of being about to faint, altered coordination, slow or shallow breathing to dangerous levels (respiratory depression), altered gastric emptying, feeling of intoxication, feeling of relaxation.

Frequency Not Known(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 (with an impact on 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 proven 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 that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of PALEXIA retard 25 mg

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

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

This medicine does not require special storage conditions.

Medicines should not be thrown away through the drains or into the trash. Deposit the containers and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of PALEXIA retard 25 mg

The activeingredient is tapentadol.

Each tablet contains 25 mg of tapentadol (as 29.12 mg of tapentadol hydrochloride).

The othercomponents are:

Tablet core: hypromellose, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate. Tablet coating: hypromellose, lactose monohydrate, talc, macrogol, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).

Appearance of PALEXIA retard 25 mg and Package Contents

Prolonged-release tablets, film-coated, light orange-brown in color, oblong (5.5 mm x 10 mm), with the Grünenthal logo embossed on one side and "H9" on the other.

The tablets are packaged in blisters and 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 package sizes may be marketed.

Marketing Authorization Holder

Grünenthal Pharma, S.A.

Doctor Zamenhof, 36 – 28027 Madrid, Spain

Manufacturer

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) under the following names:

Germany, 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 Last Revision of this Prospectus:March 2024

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