Prospect: information for the user

Pagrentil Retard 25 mg prolonged-release tablets EFG

Pagrentil Retard 50 mg prolonged-release tablets EFG

Pagrentil Retard 100 mg prolonged-release tablets EFG

Pagrentil Retard 150 mg prolonged-release tablets EFG

Pagrentil Retard 200 mg prolonged-release tablets EFG

Pagrentil Retard 250 mg prolonged-release tablets EFG

tapentadol

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

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

If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed to you alone, 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Tapentadol - the active ingredient ofTapentadol Retard - is a potent analgesic that belongs to the class of opioids. Tapentadol Retard is used for the treatment of severe chronic pain in adults that can only be adequately treated with an opioid analgesic.

Do not take Pagrentil Retard:

• if you are allergic to tapentadol or any of the other ingredients of this medication (listed in section 6),
• if you have asthma or if your breathing is slow or shallow to dangerous levels (respiratory depression, hypercapnia),
• if you have intestinal paralysis,
• if you have consumed alcohol, sleeping pills, other painkillers, or other psychoactive medications (medications that affect mood and emotions) at high doses (see section "Other medications and Pagrentil Retard").

Warnings and precautions

Consult your doctor or pharmacist before starting to take tapentadol:

• if your breathing is slow or shallow,
• if you have increased intracranial pressure or altered consciousness to even coma,
• if you have had a head trauma or brain tumors,
• if you have liver or kidney disease (see section “How to take Pagrentil Retard”),
• if you have pancreas disease or bile duct disease, including pancreatitis,
• 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 or prescription medication or illegal substance addiction (“addiction”),
• if you are a smoker,
• if you have ever had mood problems (depression, anxiety, or personality disorder) or received psychiatric treatment for other mental illnesses.

This medication contains tapentadol, 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 tapentadol. 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 suddenly.

Tapentadol 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.

Sleep-related respiratory disorders

Tapentadol 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, 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.

Other medications and Pagrentil Retard

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

• The risk of adverse 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 tapentadol simultaneously with these medications. Your doctor will tell you if tapentadol is suitable for you.

• The concomitant use of tapentadol and sedatives such as benzodiazepines or related medications (certain sleep medications or tranquilizers, e.g., barbiturates) or analgesics like opioids, morphine, and codeine (also used for cough), antipsychotics, antihistamines-H1, alcohol) increases the risk of drowsiness, respiratory difficulties (respiratory depression), coma, and may put the patient's life at risk. Therefore, only consider concomitant use when other treatment options are not possible.

However, if your doctor prescribes tapentadol with sedatives, you should limit the dose and duration of concomitant treatment.

The concomitant use of opioids and medications used to treat epilepsy, neuropathic 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 strictly follow your doctor's dose recommendation. It may be helpful to inform your friends and family members 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 medications for depression), talk to your doctor before taking tapentadol, as there have been cases of "serotonin syndrome." Serotonin syndrome is a rare but potentially fatal condition. Symptoms 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 tapentadol 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. Tapentadol may not have the same effectiveness if administered with one of these medications. Inform your doctor if you are currently being treated with one of these medications.

• The administration of tapentadol with potent inhibitors or inducers (e.g., rifampicin, phenobarbital, St. John's wort) of certain enzymes necessary for eliminating tapentadol from the 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 the medications you are taking.

• Tapentadol should not be taken with MAO inhibitors (a type of medication for depression treatment). Inform your doctor if you are taking MAO inhibitors or have taken them in the last 14 days.

Taking Pagrentil Retard with food, drinks, and alcohol

Do not consume alcohol while taking tapentadol, as some of its adverse effects, such as drowsiness, may increase. Food 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. If used during prolonged periods during pregnancy, 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 breastfeeding, as it may be excreted in breast milk.

The use of tapentadol is not recommended

• during delivery, as it may cause slow or shallow breathing in the newborn.

Driving and operating machinery

Tapentadol may cause drowsiness, dizziness, and blurred vision, and may impair your reaction time. This may occur, especially at the beginning of treatment with tapentadol, after a dose change, or when drinking alcohol or tranquilizers. Ask your doctor if you can drive or operate machinery during treatment with tapentadol.

Follow exactly the administration instructions of 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 level of pain sensitivity. Generally, the minimum effective dose should be taken to relieve pain.

Adults

The recommended initial dose is 50 mg twice a day, approximately every 12 hours.

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

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

Older patients

In older patients (over 65 years old), it is usually not necessary to adjust the dose. However, tapentadol elimination may be delayed in certain patients in this age group. If this happens, your doctor may prescribe a different dosing regimen.

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 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

Tapentadol is not indicated in children and adolescents under 18 years old.

How and when to take Pagrentil Retard

Tapentadol should be taken orally.

Always swallow the tablet whole with a sufficient amount of liquid. Do not chew or crush it - this could lead to an overdose because the active ingredient will be released in your body too quickly. You can take the tablets on an empty stomach (with an empty stomach) or with meals.

The tablet can be divided into equal doses.

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

Instructions for opening the blister pack

This medication is packaged in single-dose, child-resistant blister packs. You cannot press the tablet through the blister pack. Please note the instructions for opening the blister pack as shown below:

1. Scratch a single dose along the perforation line of the blister pack.

1. In the single dose, you can access an uncovered area located in the position where the perforation lines crossed.

1. Pull the uncovered area to remove the cover.

For how long should you take Pagrentil Retard

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

If you take more Pagrentil Retard 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,
• syncope, 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 effects, contact 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 ingested.

If you forget to take Pagrentil Retard

If you forget to take the tablets, it is likely that you will feel pain again. Do not take a double dose to compensate for the missed doses, simply continue taking the tablets as before.

If you interrupt treatment with Pagrentil Retard

If you interrupt or stop treatment too soon, it is likely that you will 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 weakly than normal. This occurs mainly in elderly patients or in patients who are weakened.

If you experience any of these important symptoms, consult your doctor immediately.

Other 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, depressed mood, difficulty sleeping, nervousness, restlessness, attention disturbances,
• tremors, muscle tics,
• seizures,
• shortness of breath,
• vomiting, diarrhea, poor digestion,
• itching, increased sweating, skin rashes,
• 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, urticaria, and in severe cases difficulty breathing, decreased blood pressure, collapse, or shock),
• weight loss,
• disorientation, confusion, excitability (agitation), perception disturbances, sleep disturbances, euphoric mood, decreased level of consciousness, memory deterioration, mental deterioration,
• syncope, sedation, balance disorders, speech difficulties, numbness, abnormal skin sensations (e.g., tingling, itching),
• vision disturbances,
• rapid heart rate, slow heart rate, palpitations, decreased blood pressure,
• abdominal discomfort,
• urticaria,
• urinary retention, frequent urination,
• sexual dysfunction,
• medication withdrawal syndrome (see section “If you stop treatment with Pagrentil Retard”), feeling unwell, irritability.

Rare(may affect up to 1 in 1,000 people)

• dependence on the medication, thought disorder, seizures, sensation of impending syncope, coordination disturbances,
• slow or shallow breathing to dangerous levels (respiratory depression),
• gastrointestinal emptying disturbances,
• sensation of intoxication, sensation of relaxation.

Frequency not known(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 use this medication after the expiration date that appears on the box and the blister pack after CAD/EXP. The expiration date is the last day of the month indicated.

This medicationdoes not require special conditions for conservation.

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and the

medicines that you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and the medicines that you no longer need. By doing so, you will help protect the environment.

Composition of Pagrentil Retard

• The active ingredient is tapentadol.

Pagrentil Retard 25 mg

Each prolonged-release tablet contains tapentadol phosphate equivalent to 25 mg of tapentadol.

PagrentilRetard 50 mg

Each prolonged-release tablet contains tapentadol phosphate equivalent to 50 mg of tapentadol.

PagrentilRetard 100 mg

Each prolonged-release tablet contains tapentadol phosphate equivalent to 100 mg of tapentadol.

PagrentilRetard 150 mg

Each prolonged-release tablet contains tapentadol phosphate equivalent to 150 mg of tapentadol.

PagrentilRetard 200 mg

Each prolonged-release tablet contains tapentadol phosphate equivalent to 200 mg of tapentadol.

PagrentilRetard 250 mg

Each prolonged-release tablet contains tapentadol phosphate equivalent to 250 mg of tapentadol.

• The other components are:

Tablet core:microcrystalline cellulose (E460), hypromellose (E464), anhydrous colloidal silica (E551), magnesium stearate.

Tablet coating:hypromellose (E464), glycerol (E422), talc (E553b), microcrystalline cellulose (E460), titanium dioxide (E171), red iron oxide (E172) (only for doses of 25, 100, 150, 200, and 250 mg), yellow iron oxide (E172) (only for doses of 25, 100, and 200 mg), black iron oxide (E172) (only for doses of 25, 100, 150, 200, and 250 mg).

Appearance of the product and contents of the package

Pagrentil Retard 25 mg are prolonged-release tablets that are oblong, biconvex (6 mm x 12 mm), brown in color, with scored lines on both faces.

The tablet can be divided into equal doses.

PagrentilRetard 50 mg are prolonged-release tablets that are oblong, biconvex (6 mm x 13 mm), white in color, with scored lines on both faces.

The tablet can be divided into equal doses.

PagrentilRetard 100 mg are prolonged-release tablets that are oblong, biconvex (7 mm x 14 mm), yellowish in color, with scored lines on both faces.

The tablet can be divided into equal doses.

PagrentilRetard 150 mg are prolonged-release tablets that are oblong, biconvex (7 mm x 15 mm), bright reddish in color, with scored lines on both faces.

The tablet can be divided into equal doses.

PagrentilRetard 200 mg are prolonged-release tablets that are oblong, biconvex (8 mm x 16 mm), yellow in color, with scored lines on both faces.

The tablet can be divided into equal doses.

PagrentilRetard 250 mg are prolonged-release tablets that are oblong, biconvex (9 mm x 18 mm), brownish red in color, with scored lines on both faces.

The tablet can be divided into equal doses.

PagrentilRetard is available in the following package sizes:

PagrentilRetard 25 mg

Unit dose, child-resistant blister packs of 20, 30, 40, 50, 54, 60, or 100 (clinical pack) prolonged-release tablets.

PagrentilRetard 50 - 250 mg

Unit dose, child-resistant blister packs of 20, 24, 30, 50, 54, 60, or 100 (clinical pack) prolonged-release tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Develco Pharma GmbH

Grienmatt 27

DE-79650 Schopfheim

Germany

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1,

DE-39179 Barleben

Germany

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:February 2023.

The detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)

http://www.aemps.gob.es/