Patient Information Leaflet: Package Insert

Tapentadol Teva 25 mg Extended-Release Tablets EFG

Read this 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Tapentadol Teva

3. How to take Tapentadol Teva

4. Possible side effects

5. Storage of Tapentadol Teva

6. Contents of the pack and additional information

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

Do not take Tapentadol Teva:

• if you are allergic to tapentadol or any of the other ingredients in 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) in high doses (see section "Other medications 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, even to the point of 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 pancreatitis or other pancreatic or biliary tract diseases,
• 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 that are 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, prescription medication abuse, or substance abuse ("addiction"),
• if you smoke,
• if you have ever had mood problems (depression, anxiety, or personality disorder) or have received treatment from a psychiatrist for other mental health conditions.

This medication contains tapentadol, which is 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 Teva. 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 abruptly.

Tapentadol Teva 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 breathing disorders

Tapentadol Teva 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, nocturnal awakenings due to difficulty breathing, difficulty maintaining sleep, or excessive daytime somnolence. If you or someone else observes these symptoms, contact your doctor. Your doctor may consider reducing the dose.

Other medications and Tapentadol Teva

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

• The risk of side 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 Teva simultaneously with these medications. Your doctor will tell you if Tapentadol Teva is suitable for you.

• The concomitant use of Tapentadol Teva and sedatives such as benzodiazepines or related medications (certain sleeping pills or tranquilizers, e.g., barbiturates) or analgesics such as opioids, morphine, and codeine (also for cough) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may put the patient's life at risk. Therefore, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes Tapentadol Teva along with sedatives, you should limit the dose and duration of concomitant treatment.

The concomitant use of opioids and medications 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, and follow your doctor's dosage recommendations exactly. It may be helpful to inform friends or family members about the symptoms mentioned above. Contact your doctor when you experience these symptoms.

• If you are taking a type of medication that affects serotonin levels (e.g., certain antidepressants), talk to your doctor before taking Tapentadol Teva, as there have been cases of "serotonin syndrome." Serotonin syndrome is a rare but potentially fatal condition. Symptoms may include involuntary 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 Teva 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 Teva may not be as effective if taken with one of these medications. Inform your doctor if you are currently being treated with one of these medications.

• The administration of Tapentadol Teva 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. Inform your doctor about all the medications you are taking.

• Tapentadol Teva should not be taken with monoamine oxidase inhibitors (MAOIs, medications for depression). Inform your doctor if you are taking MAOIs or have taken them in the last 14 days.

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. Food intake 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, as 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.

Tapentadol Teva is not recommended for use:

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

Driving and operating machinery

Tapentadol Teva may cause drowsiness, dizziness, and blurred vision and may affect your reactions. Be especially careful at the start of treatment, after changing the dose, and when taking it with alcohol or tranquilizers. Ask your doctor if you can drive or operate machinery during treatment with Tapentadol Teva.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will adjust the dose based on the intensity of your pain and your personal sensitivity to pain. Generally, you should take the minimum effective dose to relieve pain.

Adults

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

Do not recommend daily total doses exceeding 500 mg of tapentadol.

Your doctor may prescribe a dose or a different and more suitable dosing regimen if necessary. If you think 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, the elimination of tapentadol may be delayed and slower in certain patients in this age group. If this happens 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. In case of mild liver problems, no dose adjustment is necessary.

Patients with severe kidney problems should not take these tablets. In case of mild or moderate kidney problems, no dose adjustment is necessary.

Use in children and adolescents

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

How and when to take Tapentadol Teva

Tapentadol Teva should be taken orally.

Swallow the tablets whole with a sufficient amount of liquid.

Do not chew or crush them, as this could lead to an overdose, as the active ingredient will be released in your body too quickly.

You can take them on 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 may appear in the stool. This should not worry you, as the active ingredient of the tablet will have already been absorbed by the body, and what you see is only the empty coating.

Instructions for opening the blister pack

This medication is packaged in a pre-cut, child-resistant blister pack. You cannot push the tablet out of the blister pack. Please follow the following instructions for opening the blister pack:

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

1. Locate the non-sealed area where the pre-cut lines intersect.

1. Tear the non-sealed area to separate the sheet.

For how long should you take Tapentadol Teva

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

If you take more Tapentadol Teva than you should

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

• very small pupils,
• vomiting,
• low 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, call a doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forget to take Tapentadol Teva

If you forget to take a tablet, you are likely to feel pain again. Do not take a double dose to compensate for the missed doses, but continue taking the tablets as before.

If you interrupt treatment with Tapentadol Teva

If you interrupt or stop taking the treatment too soon, you are likely to feel pain again. If you want to interrupt the 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, tearful 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 tell you how to do it, which may involve a gradual reduction in dose.

If you have any other doubts 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 those that affect the entire body.
• Another serious side effect is breathing more slowly or more weakly than normal. This occurs mainly in elderly patients or in weakened patients.

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, depression, difficulty sleeping, nervousness, restlessness, attention disturbances,
• tremors, muscle tics,
• angina,
• 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, urticarial rash, 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,
• hives,
• urinary retention, frequent urination,
• sexual dysfunction,
• drug withdrawal syndrome (see section “If you stop treatment with Tapentadol Teva”), feeling unwell, irritability.

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

• drug dependence, thought disorder, seizures, feeling of impending syncope, coordination disturbances,
• respiratory depression to dangerous levels,
• gastrointestinal emptying disturbances,
• sensation of intoxication, sensation of relaxation.

Frequency not known(the 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 (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 on the blister after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and the

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

Composition of Tapentadol Teva

• The active ingredient is tapentadol.

Tapentadol Teva 25 mgextended-release tablets EFG

Each tablet contains tapentadol phosphate equivalent to 25 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), iron oxide red (E172), iron oxide yellow (E172), iron oxide black (E172).

Appearance of the product and content of the container

Tapentadol Teva 25 mg are extended-release tablets of light brown color, oblong biconvex (6 mm x 12 mm) with grooves on both sides.

The tablet can be divided into equal doses.

Tapentadol Teva 25 mg extended-release tablets are available in the following container sizes:

20x1, 30x1, 40x1, 50x1, 54x1, 60x1 or 100x1 extended-release tablets in pre-cut, single-dose safety blisters for children.

Only some container sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

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

28108 Alcobendas. Madrid (Spain).

Responsible manufacturer

Develco Pharma GmbH

Grienmatt 27

79650 Schopfheim

Germany

Last review date of this leaflet: September 2022

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es