TAPENTADOL RETARD ZENTIVA 50 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Tapentadol Retard Zentiva 25 mg Prolonged-Release Tablets EFG

Tapentadol Retard Zentiva 50 mg Prolonged-Release Tablets EFG

Tapentadol Retard Zentiva 100 mg Prolonged-Release Tablets EFG

Tapentadol Retard Zentiva 150 mg Prolonged-Release Tablets EFG

Tapentadol Retard Zentiva 200 mg Prolonged-Release Tablets EFG

Tapentadol Retard Zentiva 250 mg Prolonged-Release Tablets EFG

Read the entire package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package 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. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is Tapentadol Retard Zentiva and what is it used for
2. What you need to know before you take Tapentadol Retard Zentiva
3. How to take Tapentadol Retard Zentiva
4. Possible side effects

5 Storage of Tapentadol Retard Zentiva

1. Contents of the pack and other information

1. What is Tapentadol Retard Zentiva and what is it used for

What is Tapentadol Retard Zentiva

Tapentadol - the active substance of Tapentadol Retard Zentiva - is a potent analgesic belonging to the class of opioids. Tapentadol is used for the treatment of severe chronic pain in adults that can only be adequately managed with an opioid analgesic.

2. What you need to know before you take Tapentadol Retard Zentiva

Do not take Tapentadol Retard Zentiva

• 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 (respiratory depression; hypercapnia),
• if you have intestinal paralysis,
• if you have acute poisoning with alcohol, sleeping pills, pain relievers or other psychoactive medicines (medicines that affect mood and emotions) (see "Other medicines and Tapentadol Retard Zentiva").

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine:

• if you have slow or shallow breathing,
• 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 "How to take Tapentadol Retard Zentiva"),
• if you have a disease of the pancreas or bile ducts, including pancreatitis,
• 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 abuse or dependence on alcohol, prescription drugs, 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 tolerance to the medicine (you may get used to it). It can also lead to dependence and abuse, which can result in potentially life-threatening overdose. It is important that you inform your doctor if you think you may have developed dependence on tapentadol. Its use (even at therapeutic doses) can cause physical dependence, which may cause you to experience withdrawal symptoms and recurrence of your problems if you stop taking this treatment suddenly.

Tapentadol can cause physical and psychological addiction. If you have a tendency to abuse medicines or have drug dependence, you should only take these tablets for short periods of time under strict medical supervision.

Sleep-Related Breathing Disorders

Tapentadol may 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.

Other medicines and Tapentadol Retard Zentiva

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 (attacks), such as certain antidepressants or antipsychotics. The risk of having a seizure may increase if you take tapentadol at the same time as these medicines. Your doctor will tell you if tapentadol is suitable for you.

• Concomitant use of tapentadol and sedative medicines, such as benzodiazepines or other related medicines (certain sleep aids or tranquilizers, e.g. barbiturates) or pain relievers like opioids, morphine, and codeine (also as cough medicines), antipsychotics, antihistamines H1, alcohol, increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and can put the patient's life at risk. Due to this, concomitant use with these medicines should only be considered when other treatment options are not possible.

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

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 can be potentially 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 friends or family members so they are aware of the signs and symptoms mentioned above. Contact your doctor when you experience 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 tapentadol, 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 tapentadol 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. It is possible that tapentadol may not have the same efficacy if administered with one of these medicines. Inform your doctor if you are currently being treated with one of these medicines.

• The administration of tapentadol together with 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 may cause adverse effects, especially when starting or stopping this other type of medication. Keep your doctor informed about all the medicines you are taking.

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

Taking Tapentadol Retard Zentiva with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan 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 told you to do so. If tapentadol is used for prolonged periods during pregnancy, it may cause withdrawal symptoms in the newborn, which can be life-threatening to the newborn if not detected and treated by a doctor,

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

Tapentadol is not recommended:

• during labor, as it may cause slow or shallow breathing (respiratory depression) in the newborn.

Driving and using machines

Tapentadol may cause drowsiness, dizziness, blurred vision, and may affect your reactions. This may occur especially when you start taking tapentadol, when your doctor changes your dose, or when you drink alcohol or take tranquilizers. Ask your doctor if you can drive or use machines.

3. How to take Tapentadol Retard Zentiva

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

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

Adults

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

Total daily doses of tapentadol above 500 mg are not recommended.

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

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 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 below 18 years of age.

How and when to take Tapentadol Retard Zentiva

Tapentadol should be taken orally.

Always take the tablets whole with a sufficient amount of liquid. Do not chew or crush them, as this may lead to an overdose, as the medicine will be released too quickly in your body. You can take the tablets on an empty stomach or with food.

The tablet can be divided into equal doses.

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

Instructions for opening the blister pack

This medicine is packaged in a child-resistant unit dose blister pack. You cannot push the tablets through the blister pack. Note the following instructions for opening the blister pack:

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

1. In this way, you can access an unsealed area located where the perforation lines cross.
2. Pull the unsealed section to remove the seal from the cover.

How long to take Tapentadol Retard Zentiva

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

If you take more Tapentadol Retard Zentiva than you should

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

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

If this happens, 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 medicine and the amount used. It is recommended to take the medicine package and package leaflet to the healthcare professional.

If you forget to take Tapentadol Retard Zentiva

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, simply continue taking the tablets as before.

If you stop taking Tapentadol Retard Zentiva

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, chills, muscle pain, and dilated pupils,

? irritability, anxiety, back pain, joint pain, weakness, abdominal cramps, sleep disturbances, 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. You should 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 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 all people suffer from them.

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

• This medicine may cause allergic reactions. The symptoms can be wheezing, difficulty breathing, swelling of the eyelids, face or lips, skin rash or itching, especially if they affect the whole body.
• Another serious adverse effect consists of breathing more slowly or more weakly than normal. It occurs mostly in elderly patients or in 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 of mood, difficulty sleeping, nervousness, restlessness, attention disorders,
• tremors, muscle spasms,
• flushing,
• 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 (e.g., tingling, itching),
• vision disorders,
• rapid heartbeats, slow heartbeats, palpitations, decreased blood pressure,
• abdominal discomfort,
• hives,
• delayed urination, frequent urination,
• sexual dysfunction,
• withdrawal syndrome (see section "If you stop treatment with Tapentadol retard Zentiva"), 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),
• gastric emptying disorders,
• feeling of intoxication, feeling of relaxation.

Frequency not known(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, the data from the use of tapentadol in humans do not provide evidence of an increased 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 is not listed in this prospectus. You can also report it 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. Conservation of Tapentadol retard Zentiva

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging and on the blister after CAD. 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 sewers or in the trash. Deposit the packaging and medicines you no longer need in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Tapentadol retard Zentiva

• The active ingredient is tapentadol.

Tapentadol retard Zentiva 25 mg prolonged-release tablets EFG

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

Tapentadol retard Zentiva 50 mg prolonged-release tablets EFG

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

Tapentadol retard Zentiva 100 mg prolonged-release tablets EFG

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

Tapentadol retard Zentiva 150 mg prolonged-release tablets EFG

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

Tapentadol retard Zentiva 200 mg prolonged-release tablets EFG

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

Tapentadol retard Zentiva 250 mg prolonged-release tablets EFG

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

• The other components (excipients) are:

Core of the tablet: microcrystalline cellulose (E460); hypromellose (E464); anhydrous colloidal silica (E551); magnesium stearate.

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

Appearance of the product and package contents

Tapentadol retard Zentiva 25 mg prolonged-release tablets EFG

are brown, oblong, biconvex, prolonged-release tablets (6 mm x 12 mm) with scoring on both sides.

The tablet can be divided into equal doses.

Tapentadol retard Zentiva 50 mg prolonged-release tablets EFG

are white, oblong, biconvex, prolonged-release tablets (6 mm x 13 mm) with scoring on both sides.

The tablet can be divided into equal doses.

Tapentadol retard Zentiva 100 mg prolonged-release tablets EFG

are yellowish, oblong, biconvex, prolonged-release tablets (7 mm x 14 mm) with scoring on both sides.

The tablet can be divided into equal doses.

Tapentadol retard Zentiva 150 mg prolonged-release tablets EFG

are bright reddish, oblong, biconvex, prolonged-release tablets (7 mm x 15 mm) with scoring on both sides.

The tablet can be divided into equal doses.

Tapentadol retard Zentiva 200 mg prolonged-release tablets EFG

are yellow, oblong, biconvex, prolonged-release tablets (8 mm x 16 mm) with scoring on both sides.

The tablet can be divided into equal doses.

Tapentadol retard Zentiva 250 mg prolonged-release tablets EFG

are brown-red, oblong, biconvex, prolonged-release tablets (9 mm x 18 mm) with scoring on both sides.

The tablet can be divided into equal doses.

Tapentadol retard Zentiva is available in packages of:

Tapentadol retard Zentiva 25 mg prolonged-release tablets EFG

20x1, 30x1, 40x1, 50x1, 54x1, 60x1, or 100x1 prolonged-release tablets in child-resistant unit dose blisters.

Tapentadol retard Zentiva 50 mg, 100 mg, 150 mg, 200 mg, 250 mg prolonged-release tablets EFG

20x1, 24x1, 30x1, 50x1, 54x1, 60x1, or 100x1 prolonged-release tablets in child-resistant unit dose blisters.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Zentiva, k.s.

U kabelovny 130,

Dolní Mecholupy,

102 37 Prague 10,

Czech Republic

Manufacturer

Develco Pharma GmbH

Grienmatt 27

Farhnau

79650 Schopfheim

Baden-Wuerttemberg

Germany

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3, Planta 1.

28224 Pozuelo de Alarcón, Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this prospectus:September 2022

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