Tapentadol Teva 50 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Tapentadol Teva 50 mg prolonged-release tablets EFG

Read the entire 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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Tapentadol Teva is and what it is used for

Tapentadol—the active substance in Tapentadol Teva—is a strong analgesic belonging to the opioid class. Tapentadol Teva is used for the treatment of severe chronic pain in adults, which can only be adequately managed with an opioid analgesic.

2. What you need to know before starting to take Tapentadol Teva

Do not take Tapentadol Teva:

• if you are allergic to tapentadol or to any of the other ingredients 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)
• if you have paralytic ileus (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 "Other medicines and Tapentadol Teva").

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Tapentadol Teva:

• if your breathing is slow or shallow,
• if you have increased intracranial pressure or impaired 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 Tapentadol Teva”),
• 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 µ-opioid receptor agonists (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. It may cause dependence and/or 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 tapentadol may also lead to dependence, abuse, and addiction, which may result in 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 be at higher risk of becoming dependent or addicted to tapentadol if:

• you or a family member has 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 tapentadol, 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 may feel that you need to keep taking the medicine even when it is not helping relieve 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 medicine use,
• you feel unwell when you stop taking the medicine and feel better when you start taking it again (“withdrawal symptoms”).

If you notice any of these signs, talk to your doctor to discuss the most appropriate treatment strategy for you, including when it is appropriate to stop taking the medicine and how to do so safely (see section 3 “If you stop treatment with tapentadol”).

Sleep-related breathing disorders

Tapentadol Teva may cause sleep-related breathing disorders, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels). Symptoms may include breathing pauses during sleep, waking up at night due to difficulty breathing, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor. Your doctor may consider reducing the dose.

Other medicines and Tapentadol Teva

Tell 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 Tapentadol Teva at the same time as these medicines. Your doctor will tell you whether Tapentadol Teva is suitable for you.

• The concomitant use of Tapentadol Teva 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, alcohol) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be life-threatening. Because of this, concomitant use should only be considered when no other treatment options are possible. However, if your doctor prescribes Tapentadol Teva together with sedative medicines, the dose and duration of concomitant treatment should be limited.

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 friends or family members so they are aware of the signs and symptoms mentioned above. Contact your doctor if you experience these symptoms.

• If you are taking a type of medicine that affects serotonin levels (e.g., certain medicines to treat depression), talk to your doctor before taking Tapentadol Teva, as cases of "serotonin syndrome" have been reported. Serotonin syndrome is a rare but potentially life-threatening condition. Symptoms may include rhythmic involuntary muscle contractions, including muscles controlling eye movement, agitation, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, and body temperature above 38°C. Your doctor can provide further information.

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

• Taking Tapentadol Teva together with strong inhibitors or inducers (e.g., rifampicin, phenobarbital, St. John’s wort) of certain enzymes needed to eliminate tapentadol from your body may affect the efficacy of tapentadol or may cause adverse effects, especially when starting or stopping these other medicines. Keep your doctor informed about all medicines you are taking.

• Tapentadol Teva 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 tapentadol together with the following medicines that have anticholinergic effects, the risk of side effects may increase:

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

Taking Tapentadol Teva with food, drinks, and alcohol

Do not consume alcohol while taking Tapentadol Teva, 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 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 instructed you to do so. If used for prolonged periods during pregnancy, tapentadol may cause withdrawal symptoms in the newborn, which may be life-threatening if not detected and treated by a doctor.
• while breastfeeding, as it may be excreted in breast milk.

The use of Tapentadol Teva is not recommended:

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

Driving and using machines

Tapentadol Teva may cause drowsiness, dizziness, and blurred vision and may affect your reactions. Exercise particular caution at the beginning of treatment, after a dose change, and when taken together with alcohol or tranquilizers. Ask your doctor whether you can drive or operate machinery while being treated with Tapentadol Teva.

3. How to take Tapentadol Teva

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 tapentadol, 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 treatment with tapentadol”).

Your doctor will adjust the dose according to the intensity of your pain and your individual sensitivity to pain. Generally, the lowest effective dose should be used to relieve pain.

Adults

The recommended dose is 50 mg twice daily, approximately every 12 hours.

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

Your doctor may prescribe a different and 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.

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 individuals within 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 liver 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 liver problems.

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

Use in children and adolescents

Tapentadol Teva is not indicated for use in children and adolescents under 18 years of age.

How and when to take Tapentadol Teva

Tapentadol Teva should be taken orally.

Always swallow the tablets whole with sufficient liquid.

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

You may take the tablets on an empty stomach or with food.

The tablet may be divided into equal doses.

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

Instructions for opening the blister pack

This medicine is packaged in a child-resistant, single-dose safety blister with pre-cut lines. The tablet cannot be pushed out through the blister. Please follow these instructions for opening the blister:

1. Cut one dose along the pre-cut lines of the blister.

1. Locate the unsealed area where the pre-cut lines intersect.

1. Pull the unsealed area to peel off the foil.

How long to take Tapentadol Teva

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

If you take more Tapentadol Teva than you should

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

• very small pupils,
• vomiting,
• low blood pressure,
• rapid heartbeat,
• fainting, altered consciousness, or coma (deep loss of consciousness),
• epileptic seizures,

slow or shallow breathing up to dangerous levels or respiratory arrest, which may lead to death. If any of these effects occur, call a doctor immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, stating the medicine and the amount taken. It is recommended to bring the medicine packaging and the patient leaflet to the healthcare professional.

If you forget to take Tapentadol Teva

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

If you stop treatment with Tapentadol Teva

If you stop or discontinue treatment too early, you may start to feel pain again. 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 abruptly.

Symptoms may include:

• restlessness, watery eyes, runny nose, yawning, sweating, chills, muscle aches, and dilated pupils,
• irritability, anxiety, back pain, joint pain, weakness, abdominal cramps, difficulty sleeping, nausea, loss of appetite, vomiting, diarrhea, 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 stop this medicine abruptly, unless your doctor specifically instructs you to do so. If your doctor wants you to stop taking these tablets, they will advise 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.

Important adverse effects or symptoms to be aware of, and what to do if you experience them:

• This medicine may cause allergic reactions. Symptoms may include wheezing (a whistling sound while breathing), difficulty breathing, swelling of the eyelids, face or lips, skin rash or itching, particularly 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.

Other possible adverse effects:

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, low mood, difficulty sleeping, nervousness, restlessness, attention disturbances,
• tremors, muscle tics,
• hot flushes,
• shortness of breath,
• vomiting, diarrhoea, indigestion,
• itching, increased sweating, skin rashes,
• feeling of weakness, fatigue, sensation of change in body temperature, dryness of mucous membranes, fluid accumulation in tissues (oedema).

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, drop in 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, difficulty speaking, numbness, abnormal skin sensations (e.g. tingling, itching),
• visual disturbances,
• rapid heartbeat, slow heartbeat, palpitations, drop in blood pressure,
• abdominal discomfort,
• rash,
• delayed urination, frequent urination,
• sexual dysfunction,
• drug withdrawal syndrome (see section “If you stop taking Tapentadol Teva”), feeling unwell, irritability.

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

• drug dependence, altered thinking, epileptic seizures, feeling faint, impaired coordination,
• slow or shallow breathing to dangerous levels (respiratory depression),
• delayed gastric emptying,
• sensation of drunkenness, sensation of relaxation.

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

• delirium.

In general, the likelihood of having suicidal thoughts and behaviours 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 adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 Tapentadol Teva

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 after EXP. 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 collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tapentadol Teva

• The active substance is tapentadol.

Tapentadol Teva 50 mg prolonged-release tablets EFG

Each tablet contains tapentadol phosphate equivalent to 50 mg of tapentadol.

• The other components are:

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

Tablet coating: hypromellose (E464), glycerol (E422), talc (E553b), microcrystalline cellulose (E460), titanium dioxide (E171).

Nature of the product and contents of the container

Tapentadol Teva 50 mg are prolonged-release tablets, white in colour, oblong biconvex (6 mm x 13 mm) with notches on both sides.

The tablet can be divided into equal doses.

Tapentadol Teva 50 mg prolonged-release tablets are available in the following pack sizes:

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1st floor.

28108 Alcobendas, Madrid (Spain).

Manufacturer

Develco Pharma GmbH

Grienmatt 27

79650 Schopfheim

Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Germany: Tapentadol AbZ 50 mg Retardtabletten

Denmark: Tapentadol Teva

Italy: Tapentadolo Teva 50 mg, compresse a rilascio prolungato

Netherlands: Tapentadol retard Teva 50 mg, tabletten met verlengde afgifte

Portugal: Tapentadol Teva 50 mg comprimidos de libertação prolongada

Spain: Tapentadol Teva 50 mg comprimidos de liberación prolongada EFG

Sweden: Tapentadol Depot Teva

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

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