TAPENTADOL TEVA 200 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

Tapentadol Teva 200 mg Prolonged-Release Tablets EFG

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

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

Contents of the Package Leaflet

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

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

Tapentadol - the active substance in Tapentadol Teva - is a potent analgesic belonging to the class of opioids. Tapentadol Teva 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 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 too shallow (respiratory depression, hypercapnia)
• if you have intestinal paralysis
• if you have consumed alcohol, sleeping pills, other analgesics, or other psychotropic medicines (medicines that affect mood and emotions) at high doses (see section "Other medicines and Tapentadol Teva").

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Tapentadol Teva:

• if your breathing is slow or too shallow
• 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 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 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 a potentially life-threatening overdose. It is essential that you inform your doctor if you think you may have developed dependence on Tapentadol Teva. Its use (even at therapeutic doses) can lead to physical dependence, which may cause withdrawal symptoms and recurrence of your problems if you stop taking this treatment abruptly.

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

Sleep-related breathing disorders

Tapentadol Teva can 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, contact your doctor. Your doctor may consider a dose reduction.

Other medicines and Tapentadol Teva

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 seizures increases if you take Tapentadol Teva simultaneously with these medicines. Your doctor will tell you if Tapentadol Teva is suitable for you.

• Concomitant use of Tapentadol Teva and sedative medicines such as benzodiazepines or related medicines (certain sleeping pills or tranquilizers, e.g., barbiturates) or analgesics like opioids, morphine, and codeine (also as a cough medicine), antipsychotics, antihistamines H1, alcohol increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can put the patient's life at risk. Due to this, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes Tapentadol Teva with sedative medicines, you should limit the dose and duration of concomitant treatment.

The concomitant use of opioids and drugs used for the treatment of epilepsy, nerve pain, or anxiety (gabapentin and pregabalin) increases the risk of opioid overdose, respiratory depression, and can be potentially life-threatening. Inform 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 to be 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 Teva, as there have been cases of "serotonin syndrome". Serotonin syndrome is a rare but potentially life-threatening disorder. Symptoms can include involuntary muscle contractions, agitation, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, and body temperature above 38°C. Your doctor can provide you with more information.

• Concomitant administration of Tapentadol Teva 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 Teva 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.

• Administration of Tapentadol Teva 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 cause side effects, especially when starting or stopping this other type of medicine. Keep your doctor informed about all the medicines you are taking.

• Tapentadol Teva 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 Teva with food, drinks, and alcohol

Do not consume alcohol while taking Tapentadol Teva, as some of its side effects, such as drowsiness, may increase. Food intake does not affect the effect 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 told you to do so. If used during prolonged periods during pregnancy, tapentadol may cause withdrawal symptoms in the newborn, which can be life-threatening if not detected and treated by a doctor.
• during breastfeeding, as it may be excreted in breast milk.

Tapentadol Teva is not recommended:

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

Driving and using machines

Tapentadol Teva can cause drowsiness, dizziness, and blurred vision and may affect your reactions. Be particularly careful at the start of treatment, after a dose change, and when taken with alcohol or tranquilizers. Ask your doctor if you can drive or use machines during treatment with Tapentadol Teva.

3. How to take Tapentadol Teva

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

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

Adults

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

Daily doses above 500 mg of tapentadol are not recommended.

Your doctor may prescribe a different dose or dosing regimen, which is more suitable for you. If you think the effect of these tablets is too strong or too weak, talk to your doctor or pharmacist.

Elderly patients

In elderly patients (over 65 years of age), the dose does not usually need to be adjusted. However, the elimination of tapentadol 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 (liver and kidney failure)

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 cases of mild liver problems, no dose adjustment is necessary.

Patients with severe kidney problems should not take these tablets. In cases 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 below 18 years of age.

How and when to take Tapentadol Teva

Tapentadol Teva should be taken orally.

Always swallow the tablets whole with a sufficient amount of liquid.

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

You can take them 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 in the feces. This should not concern you, as the active substance 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 medicine is packaged in a child-resistant, single-dose, pre-cut blister pack. You cannot push the tablet through the blister pack. Note 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. Pull the non-sealed area to detach the foil

For how long to take Tapentadol Teva

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

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
• decreased blood pressure
• rapid heartbeat
• fainting, altered consciousness, or coma (deep loss of consciousness)
• seizures
• slow or too shallow breathing 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used. It is recommended to bring the packaging and the package leaflet of the medicine to the healthcare professional.

If you forget to take Tapentadol Teva

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, but continue taking the tablets as before.

If you stop taking Tapentadol Teva

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 abruptly.

Symptoms may include:

• restlessness, 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 stopping treatment, consult your doctor.

Do 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 on 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 may consist of wheezing (a kind of whistling when breathing), difficulty breathing, swelling of the eyelids, face, or lips, skin rash, or itching, especially those that affect the whole body.
• Another serious adverse effect is 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.

Other 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 twitches,
• hot flashes,
• shortness of breath,
• vomiting, diarrhea, indigestion,
• itching, increased sweating, skin rash,
• feeling of weakness, fatigue, feeling of change in body temperature, dryness of mucous membranes, water retention (edema).

Uncommon(may affect up to 1 in 100 people)

• allergic reaction to medicines (including swelling under the skin, urticarial hives, and in severe cases difficulty breathing, decreased blood pressure, collapse, or shock),
• weight loss,
• disorientation, confusion, excitability (agitation), altered perception, sleep disorders, euphoric mood, 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 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 treatment with Tapentadol Teva"), feeling of discomfort, irritability.

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

• drug dependence, altered thinking, epileptic seizures, feeling of being about to faint, altered coordination,
• slow or shallow breathing to dangerous levels (respiratory depression),
• altered gastric emptying,
• feeling of intoxication, feeling of relaxation.

Frequency not known(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 (with an impact 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 proven 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 that is not listed in this prospectus. You can also report them 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. Storage of Tapentadol Teva

Keep this medicine out of the sight and reach of children.

Do not use this medicine 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 medicine does not require special storage conditions.

Medicines should not be thrown away through drains or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, 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 Teva

• The active ingredient 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 Package Contents

Tapentadol Teva 200 mg are prolonged-release tablets of yellow color, oblong, and biconvex (8 mm x 16 mm) with score lines on both sides.

The tablet can be divided into equal doses.

Tapentadol Teva 200 mg prolonged-release tablets are available in the following package sizes:

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

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1ª planta.

28108 Alcobendas. Madrid (Spain).

Manufacturer

Develco Pharma GmbH

Grienmatt 27

79650 Schopfheim

Germany

Date of the Last Revision of this Prospectus: September 2022

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