Tapentadol Teva 200 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Tapentadol Teva 200 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, ask 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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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 potent 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 taking Tapentadol Teva

Do not take Tapentadol Teva:

• 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 shallow to dangerous levels (respiratory depression, hypercapnia)
• if you have intestinal paralysis
• if you have consumed alcohol, sleeping pills, other painkillers, or other psychotropic medicines (medicines that affect mood and emotions) in high doses (see section "Other medicines and Tapentadol Teva").

Warnings and precautions

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

• if your breathing is slow or 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 Tapentadol Teva”),
• if you have a disease of the pancreas or biliary tract, 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 with a known risk of increasing 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 dependence or addiction varies from person to person. You may be at higher risk of becoming dependent or addicted to tapentadol 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 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 your medicine, even when it does not help 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 use of the medicine,
• 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, speak with your doctor to discuss the most appropriate treatment strategy in your case, including when it is appropriate to stop taking it 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, nighttime awakenings 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

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

• 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 painkillers 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, 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 follow your doctor’s dosing recommendations exactly. 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 concomitant 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 not have the same effectiveness 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 Tapentadol Teva 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 affect the efficacy of tapentadol or may cause adverse effects, especially when starting or stopping such medication. 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 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 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 increase. 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.
• during breastfeeding, as it may be excreted in breast milk.

The use of Tapentadol Teva is not recommended:

• during labour, 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 start of treatment, after a dose change, and when taken together with alcohol or tranquilizers. Ask your doctor whether you can drive or use machines during treatment with Tapentadol Teva.

3. How to take Tapentadol Teva

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

Before starting treatment and periodically during treatment, your doctor will discuss with you what to expect from the use of 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 taking 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 for pain relief should be used.

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 appropriate dose or dosing schedule 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), 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 dosing schedule.

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 dosing schedule. Dose adjustment is not necessary in patients with mild liver problems.

Patients with severe kidney problems must not take these tablets. Dose adjustment is not necessary in patients with 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 (before meals) 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 stool. 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 should you 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:

• extremely 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 you experience any of these effects, call a doctor immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 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 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 a missed dose; instead, continue taking the tablets as before.

If you stop taking Tapentadol Teva

If you stop or interrupt treatment too early, you may start to feel pain again. If you wish to discontinue 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 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 tells 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 experiences them.

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, rash or itching, especially if affecting the whole body.
• Another serious adverse effect is breathing more slowly or more weakly than normal. 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, somnolence, 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, urticarial rash, 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, depressed level of consciousness, memory impairment, mental deterioration,
• fainting, sedation, balance disorders, difficulty speaking, numbness, abnormal sensations in the skin (e.g., tingling, itching),
• visual disturbances,
• rapid heartbeat, slow heartbeat, palpitations, decreased 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 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 (with effects 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 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 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. Return any unused medicines and their packaging to your pharmacy’s SIGRE collection point. If you are unsure how to dispose of unused medicines or their packaging, ask your pharmacist. 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 200 mg prolonged-release tablets EFG

Each tablet contains tapentadol phosphate equivalent to 200 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), yellow iron oxide (E172), black iron oxide (E172).

Appearance of the product and contents of the pack

Tapentadol Teva 200 mg are prolonged-release tablets, yellow in colour, oblong biconvex (8 mm x 16 mm), with notches on both sides.

The tablet can be divided into equal doses.

Tapentadol Teva 200 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 safety precut unit-dose blisters.

Some pack sizes may not 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 200 mg Retardtabletten

Denmark: Tapentadol Teva

Italy: Tapentadolo Teva 200 mg, compresse a rilascio prolungato

Netherlands: Tapentadol retard Teva 200 mg, tabletten met verlengde afgifte

Portugal: Tapentadol Teva 200 mg comprimidos de libertação prolongada

Spain: Tapentadol Teva 200 mg comprimidos de liberación prolongada EFG

Sweden: Tapentadol Depot Teva

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 Medical Devices (AEMPS) http://www.aemps.gob.es