Tapentadol Krka 150 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tapentadol Krka 50 mg prolonged-release tablets EFG

Tapentadol Krka 100 mg prolonged-release tablets EFG

Tapentadol Krka 150 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. 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 may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Leaflet contents

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

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

Tapentadol—the active substance in Tapentadol Krka—is a potent analgesic belonging to the opioid class. Tapentadol 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 taking 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 shallow to dangerous levels (respiratory depression, hypercapnia (higher than normal levels of carbon dioxide in the blood)),
• if you have no bowel movements, manifested by severe constipation and bloating, which may be accompanied by abdominal pain or discomfort,
• if you have consumed alcohol, sleeping pills, other analgesics, or medicines that affect mood and emotions at high doses (see section "Other medicines and Tapentadol Krka").

Warnings and precautions

Talk to your doctor or pharmacist before taking Tapentadol Krka if:

• your breathing is slow or 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 disease of the pancreas such as inflammation of the pancreas (pancreatitis) or of the bile ducts (biliary tract disease),
• you are taking medicines called mixed opioid agonist/antagonists (e.g., pentazocine, nalbuphine) or partial agonists of µ-opioid receptors (e.g., buprenorphine),
• 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 seizures may increase,
• you have a tendency to abuse medicines or if you are dependent on medicines, as tapentadol may cause addiction. In this case, you should only take these tablets for short periods and under strict medical supervision.
• you or a family member has a history of alcohol, prescription medicine, or illicit substance abuse or dependence (“addiction”).
• you smoke.
• 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.

This medicine contains tapentadol, an opioid medicine. Repeated use of opioid analgesics may reduce the effectiveness of the medicine (you may become tolerant to it). It may also lead to dependence and abuse, possibly resulting in dependence on tapentadol. Its use (even at therapeutic doses) may cause physical dependence, which could lead to withdrawal symptoms and a return of your problems if you suddenly stop this pharmacological treatment.

Sleep-related breathing disorders

Tapentadol may cause sleep-related breathing disorders such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low levels of oxygen 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 notices 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 need to take any other medicine. Your doctor will inform you which medicines are safe to take with tapentadol.

• 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 at the same time as these medicines. Your doctor will tell you whether tapentadol is suitable for you.
• The concomitant use of tapentadol and sedative medicines such as benzodiazepines or related medicines (certain sleeping pills 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, breathing difficulties (respiratory depression), coma, and may be potentially fatal. For this reason, concomitant use should only be considered when no other treatment options are possible. However, if your doctor prescribes tapentadol with sedative medicines, your 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 sedative medicine you are taking, and strictly follow your doctor’s dosing recommendations. It may be helpful to inform your friends and family about the signs and symptoms mentioned above. Inform your doctor if you experience any of these symptoms.
• If you are taking a medicine that affects serotonin levels (e.g., certain medicines to treat depression), talk to your doctor before taking tapentadol, as cases of "serotonin syndrome" have occurred. Serotonin syndrome is a rare but potentially life-threatening condition. Symptoms may include involuntary rhythmic muscle contractions, including muscles controlling eye movement, agitation, excessive sweating, tremors, exaggerated reflexes, increased muscle tone, and body temperature above 38°C. Your doctor can provide further information.
• Tapentadol may be less effective if taken together with other types of opioid medicines (e.g., those containing pentazocine, nalbuphine, or buprenorphine). Inform your doctor if you are currently being treated with any of these medicines.
• Taking tapentadol 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 such medication.
• Tapentadol 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.

Keep your doctor informed about all medicines you are taking.

Taking Tapentadol Krka with alcohol

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

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 specifically instructed you to. 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.
• if you become pregnant while being treated with this medicine. Consult your doctor.
• during childbirth, as it may cause slow or shallow breathing to dangerous levels (respiratory depression) in the newborn.

Driving and using machines

Do not drive or operate tools or machinery if you feel drowsy, dizzy, have blurred vision, or have slow reaction times while taking tapentadol.

Take special care at the beginning of treatment, after a dose change, and when taking it together with alcohol or tranquilizers.

Ask your doctor whether you can drive or use machines.

Tapentadol Krka contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Tapentadol Krka

Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will adjust the dose and dosing interval of tapentadol according to the intensity of your pain and your individual needs. Generally, the lowest effective dose required to relieve pain should be used.

Adults

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

Your doctor may prescribe a different or more appropriate dose and dosing schedule 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 daily, approximately every 12 hours.

Daily total doses exceeding 500 mg of tapentadol are not recommended.

How and when to take Tapentadol Krka

Tapentadol should be taken orally.

Always swallow the tablets whole with a glass of water. You may take them on an empty stomach or with food. Do not chew, break, or crush the tablets, as this could lead to overdose due to rapid release of the active substance into your body.

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

How long to take Tapentadol Krka

Do not take the tablets for longer than prescribed by your doctor.

Elderly patients

In elderly patients (over 65 years of age), dose adjustment is usually not necessary. However, your doctor may prescribe a different dosing schedule.

Hepatic or renal impairment

Patients with severe liver or kidney problems must not take this medicine.

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

In cases of mild liver impairment or mild to moderate kidney impairment, dose adjustment is not necessary.

Use in children and adolescents

Tapentadol is not indicated for use 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.

Seek immediate medical attention in case of overdose, even if you feel well.

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

• extremely small pupils
• feeling sick (vomiting)
• low blood pressure
• rapid heartbeat
• altered consciousness, fainting, or deep unconsciousness (coma)
• epileptic seizures
• slow or shallow breathing, potentially reaching dangerous levels or respiratory arrest

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 medication and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to take Tapentadol Krka

If you forget to take a tablet, you may experience a return of pain. Do not take a double dose to make up for the missed dose; instead, continue taking the tablets as previously scheduled.

If you stop taking Tapentadol Krka

If you stop or discontinue treatment too early, you may experience a return of pain. If you wish to stop treatment, consult your doctor first.

Generally, patients do not experience any adverse effects after stopping treatment. However, in rare cases, individuals who have taken the tablets for a prolonged period may feel unwell if they stop abruptly.

Symptoms may include:

• restlessness, irritability, anxiety, weakness or malaise (nausea), loss of appetite, feeling sick (vomiting), diarrhea,
• watery eyes, runny nose, enlarged pupils (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 medicine, consult your doctor.

You should not stop this medicine abruptly, unless your doctor instructs you to do so. If your doctor wants you to stop taking these tablets, they will advise you on how to do so. This 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 including swelling under the skin, hives, and, in severe cases, difficulty breathing, drop in blood pressure, collapse, or shock (uncommon). Symptoms may include wheezing, difficulty breathing, swelling of the eyelids, face or lips, skin rash or itching, which may affect the entire body.
• Another serious adverse effect is breathing slower or more weakly than normal (rare). 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):

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

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

• loss of appetite, anxiety, feeling sick (vomiting), diarrhoea, indigestion
• difficulty sleeping, tiredness or exhaustion (fatigue), feeling weak, tremors, muscle tics, shortness of breath
• low mood, nervousness, restlessness, attention disturbances
• hot flushes, increased sweating, sensation of change in body temperature, dryness of mucous membranes such as nasal passages, mouth, lips, eyelids, ears, genitals and anus
• itching, skin rashes
• fluid accumulation in tissues (oedema)

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

• weight loss
• reduced awareness of time, place or identity (disorientation), confusion, excitability (agitation), disturbances in perception, abnormal dreams, memory impairment, mental deterioration
• euphoric mood, reduced level of consciousness, fainting, sedation, balance disorders, difficulty speaking, numbness
• abnormal skin sensations (e.g., tingling, itching), skin reactions (urticaria)
• visual disturbances
• rapid heartbeat, slow heartbeat, 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 unwell, irritability

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

• drug dependence
• altered thinking, epileptic seizures, feeling faint, impaired coordination, sensation of drunkenness, sensation of relaxation
• delayed gastric emptying

Frequency not known:

• 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, talk to 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 Krka

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

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date is 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 containers to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tapentadol Krka

• The active substance is tapentadol.

Tapentadol Krka 50 mg prolonged-release tablets EFG

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

Tapentadol Krka 100 mg prolonged-release tablets EFG

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

Tapentadol Krka 150 mg prolonged-release tablets EFG

Each prolonged-release tablet contains tapentadol hydrochloride 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".

Nature of the product and contents of the pack

Tapentadol Krka 50 mg prolonged-release tablets EFG: Prolonged-release tablets, white or almost white, oval, biconvex, film-coated, marked with 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 yellowish-brown in colour, oval, biconvex, film-coated, marked with 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 in colour, oval, biconvex, film-coated, marked with T3 on one side. Tablet dimensions: approximately 16 mm x 8.5 mm.

Tapentadol Krka prolonged-release tablets are available in packs 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) child-resistant and tamper-proof closure.

Only certain pack 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

KRKA Farmacéutica, S.L., C/Anabel Segura 10, 28108 Alcobendas, Madrid, Spain

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

Date of the most recent review of this leaflet: February 2023

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