TAPENTADOL KRKA 50 mg PROLONGED-RELEASE TABLETS

2. What you need to know before you take Tapentadol Krka

Do not take Tapentadol Krka

• 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 (elevated carbon dioxide levels in the blood)),
• if you do not have bowel movements that manifest as severe constipation and bloating that may be accompanied by abdominal pain or discomfort,
• if you have consumed alcohol, sleeping pills, other pain relievers, or medications that affect mood and emotions at high doses (see section "Other medicines and Tapentadol Krka").

Warnings and precautions

Consult your doctor or pharmacist before starting Tapentadol Krka if:

• your breathing is slow or too shallow,
• you have increased intracranial pressure or altered consciousness,
• you have had a head injury or brain tumors,
• you have liver or kidney disease (see section "How to take Tapentadol Krka"),
• you have a pancreatic disease such as pancreatitis or biliary tract disease,
• you are taking mixed opioid agonist/antagonist medications (e.g., pentazocine, nalbuphine) or partial agonists of the mu opioid receptor (e.g., buprenorphine),
• you are prone to epilepsy or convulsive seizures, or if you are taking other medications with a known risk of increasing seizures, as the risk of these seizures may increase,
• you have a tendency to abuse medications or if you are dependent on medications, as tapentadol can cause addiction. In this case, you should only take these tablets for short periods and under strict medical supervision.
• you or a family member have a history of substance abuse or dependence on prescription or illicit substances ("addiction").
• you smoke.
• you have ever had problems with your mood (depression, anxiety, or personality disorder) or have received psychiatric treatment for other mental illnesses.

This medication contains tapentadol, an opioid medication. Repeated use of opioid analgesics can reduce their effectiveness (you may become accustomed to them). It can also lead to dependence and abuse, which can develop into dependence on tapentadol. Its use (even at therapeutic doses) can cause physical dependence, which may lead to withdrawal symptoms and a recurrence of your problems if you stop taking this medication abruptly.

Sleep-related respiratory disorders

Tapentadol can cause sleep-related respiratory 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.

Children and adolescents

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

Other medicines and Tapentadol Krka

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Your doctor will inform you about which medications are safe to take with tapentadol.

• The risk of side effects increases if you are taking medications that can cause seizures (attacks), such as certain antidepressants or antipsychotics. The risk of seizures increases if you take tapentadol simultaneously with these medications. Your doctor will tell you if tapentadol is suitable for you.
• Concomitant use of tapentadol and sedative medications such as benzodiazepines or related medications (certain sleeping pills or tranquilizers (e.g., barbiturates) or pain relievers like opioids, morphine, and codeine (also as a cough medication), antipsychotics, antihistamines H1, alcohol) increases the risk of drowsiness, respiratory difficulties (respiratory depression), coma, and can be potentially fatal. Due to this, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes tapentadol with sedative medications, they will limit the dose and duration of concomitant treatment.
• 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 can be potentially fatal.
• Tell your doctor if you are taking gabapentin or pregabalin or any sedative medication you are taking and strictly follow your doctor's dosage recommendation. It may be helpful to inform your friends and family about the signs and symptoms mentioned above. Tell your doctor if you experience any of these symptoms.
• If you are taking a type of medication that affects serotonin levels (e.g., certain medications 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 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 additional information.
• It is possible that tapentadol may not have the same effectiveness if administered with other types of opioid medications (e.g., those containing pentazocine, nalbuphine, or buprenorphine). Tell your doctor if you are currently being treated with one of these medications.
• Administration of tapentadol with potent inhibitors or inducers (e.g., rifampicin, phenobarbital, St. John's Wort) of certain enzymes necessary for eliminating tapentadol from your body may affect the efficacy of tapentadol or cause adverse effects, especially when starting or stopping this other type of medication.
• Tapentadol should not be taken with MAO inhibitors (medications for treating depression). Tell your doctor if you are taking MAO inhibitors or if you have taken them in the last 14 days.

Keep your doctor informed about all the medications you are taking.

Taking Tapentadol Krka with alcohol

Do not consume alcohol while taking tapentadol, as some of its side effects, such as drowsiness, may increase.

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 medication.

Do not take this medication:

• if you are pregnant, unless your doctor has told you to, as prolonged use of tapentadol during pregnancy 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.
• if you become pregnant during treatment with this medication. Consult your doctor.
• during labor, as it may cause slow or shallow breathing (respiratory depression) in the newborn.

Driving and using machines

Do not drive or use tools or machines if you feel drowsy, dizzy, have blurred vision, or have a slow reaction while taking tapentadol.

Be particularly careful at the start of treatment, after a dose change, and when administering it concomitantly with alcohol or tranquilizers.

Ask your doctor if you can drive or use machines.

Tapentadol Krka contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medication.

3. How to take Tapentadol Krka

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

Your doctor will adjust the dose and time between doses of tapentadol based on the intensity of your pain and your needs. Generally, you should take the minimum effective dose to relieve pain.

Adults

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

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

Tapentadol should be taken twice a day, approximately every 12 hours.

Daily doses above 500 mg of tapentadol are not recommended.

How and when to take Tapentadol Krka

Tapentadol should be taken orally.

Always take the tablets whole with a glass of water. You can take them on an empty stomach (without food) or with meals. Do not chew, break, or crush them, as this could lead to an overdose because the active substance will be released rapidly in your body.

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.

For how long to take Tapentadol Krka

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

Elderly patients

In elderly patients (over 65 years of age), the dose does not usually need to be adjusted. However, your doctor may prescribe a different dosing regimen.

Liver or kidney impairment

Patients with severe liver or kidney problems should not take this medication.

If you have moderate liver problems, your doctor will prescribe a different dosing regimen.

In cases of mild liver or mild to moderate kidney problems, no dose adjustment is necessary.

Use in children and adolescents

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

If you take more Tapentadol Krka than you should

Taking too much tapentadol can be life-threatening.

You should seek immediate medical attention in case of an overdose, even if you feel well.

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

• very small pupils
• feeling sick (vomiting)
• low blood pressure
• rapid heartbeat
• altered consciousness, fainting, or deep loss of consciousness (coma)
• seizures
• slow or shallow breathing or respiratory arrest

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 medication and the amount used. It is recommended to bring the packaging and the leaflet of the medication to the healthcare professional.

If you forget to take Tapentadol Krka

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 Krka

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. However, 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, irritability, anxiety, weakness, or discomfort (nausea), loss of appetite, feeling sick (vomiting), diarrhea,
• tearful eyes, runny nose, increased pupil size (dilated pupils),
• difficulty sleeping, yawning,
• sweating, chills,
• muscle or joint pain, back pain, abdominal cramps,
• increased blood pressure, respiratory rate, or heart rate.

If you experience any of these symptoms after stopping treatment with this medication, consult your doctor.

Do 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. This may involve gradually reducing the dose.

If you have any further questions about the use of this medication, 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, including swelling under the skin, hives, and, in severe cases, difficulty breathing, low blood pressure, collapse, or shock (uncommon). The symptoms may consist of wheezing, difficulty breathing, inflammation of the eyelids, face, or lips, skin rash, or itching, which can affect the whole body.
• Another serious adverse effect consists of breathing more slowly or more weakly than normal (rare). 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):

• feeling sick (nausea)
• constipation
• dizziness, drowsiness, headache

Common(may affect up to 1 in 10 people):

• decreased appetite, anxiety, feeling sick (vomiting), diarrhea, indigestion
• difficulty sleeping, fatigue or exhaustion, feeling of weakness, tremors, muscle twitches, shortness of breath
• depression of mood, nervousness, restlessness, attention disorders
• hot flashes, increased sweating, feeling of change in body temperature, dryness of mucous membranes such as nasal passages, mouth, lips, eyelids, ears, genitals, and anus
• itching, skin rashes
• water retention in tissues (edema)

Uncommon(may affect up to 1 in 100 people):

• weight loss
• loss of sense of time, place, or identity (disorientation), confusion, excitability (agitation), altered perception, abnormal dreams, memory impairment, mental deterioration
• euphoric mood, decreased level of consciousness, fainting, sedation, balance disorders, speech difficulties, numbness
• abnormal sensations in the skin (e.g., tingling, itching), skin reactions (hives)
• vision changes
• rapid heartbeats, slow heartbeats, palpitations, decreased blood pressure
• abdominal discomfort, delayed urination, frequent urination
• sexual dysfunction
• drug withdrawal syndrome (see section "If you stop treatment with Tapentadol Krka")
• 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, feeling of intoxication, feeling of relaxation
• altered gastric emptying

Frequency not known:

• 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, 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 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. Storage of Tapentadol Krka

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date stated on the box 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 wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in 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 Krka

• The active ingredient is tapentadol.

Tapentadol Krka 50 mg prolonged-release tablets EFG

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

Tapentadol Krka 100 mg prolonged-release tablets EFG

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

Tapentadol Krka 150 mg prolonged-release tablets EFG

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

• The other components (excipients) are:
• hypromellose, microcrystalline cellulose, anhydrous colloidal silica, and magnesium stearate in the tablet core.
• hypromellose, lactose monohydrate, titanium dioxide (E171), macrogol, triacetin, yellow iron oxide (E172) (only for 100 mg, 150 mg), red iron oxide (E172) (only for 150 mg) in the tablet coating. See section 2: "Tapentadol Krka contains lactose".

Appearance of the Product and Package Contents

Tapentadol Krka 50 mg prolonged-release tablets EFG: Prolonged-release tablets, white or almost white, oval, biconvex, film-coated, with the mark T1 on one side. Tablet dimensions: approximately 16 mm x 8.5 mm.

Tapentadol Krka 100 mg prolonged-release tablets EFG: Prolonged-release tablets, pale yellow-brown, oval, biconvex, film-coated, with the mark T2 on one side. Tablet dimensions: approximately 16 mm x 8.5 mm.

Tapentadol Krka 150 mg prolonged-release tablets EFG: Prolonged-release tablets, pale pink, oval, biconvex, film-coated, with the mark T3 on one side. Tablet dimensions: approximately 16 mm x 8.5 mm.

Tapentadol Krka prolonged-release tablets are available in packages of 20 (only for 50 mg), 30, 60 (2 x 30), or 100 prolonged-release tablets in a high-density polyethylene (HDPE) bottle with a polypropylene (PP) closure that is child-resistant and tamper-evident.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

KRKA, d.d., Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Manufacturer:

KRKA, d.d., Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

or

TAD Pharma GmbH

Heinz-Lohmann-Straße 5

27472 Cuxhaven

Germany

You can request more information about this medicine by contacting the local representative of the Marketing Authorization Holder:

KRKA Farmacéutica, S.L., C/Anabel Segura 10, 28108 Alcobendas, 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:February 2023

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/)