YANTIL 50 mg FILM-COATED TABLETS

2. What you need to know before you take YANTIL 50 mg

Do not take YANTIL 50 mg:

• 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 (elevated carbon dioxide levels in the blood)],
• if you have a disease in which the intestine does not function properly (paralytic ileus),
• if you have consumed alcohol, sleeping pills, other analgesics, or other psychotropic medications (medicines that affect mood and emotions) at high doses (see section "Taking YANTIL 50 mg with other medicines").

Warnings and precautions

Consult your doctor or pharmacist before starting to take YANTIL 50 mg:

• if your breathing is slow or 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 YANTIL 50 mg”),
• if you have a disease of the pancreas (such as pancreatitis) or bile ducts,
• if you are taking medicines called mixed opioid agonist/antagonists (e.g., pentazocine, nalbuphine) or partial agonists of 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 can reduce their effectiveness (you may get used to it). It can also lead to dependence and abuse, which can result in a potentially fatal overdose. It is essential that you inform your doctor if you think you may have developed dependence on YANTIL 50 mg. Its use (even at therapeutic doses) can cause physical dependence, which may cause you to experience withdrawal effects and a recurrence of your problems if you stop taking this treatment suddenly.

YANTIL 50 mg can cause physical and psychological addiction. If you have a tendency to abuse medications or have drug dependence, you should only take these tablets for short periods under strict medical supervision.

Sleep-related respiratory disorders

YANTIL 50 mg may 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.

Taking YANTIL 50 mg with other medicines

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 YANTIL 50 mg simultaneously with these medicines. Your doctor will tell you if YANTIL 50 mg is suitable for you.

The concomitant use of YANTIL 50 mg 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, 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 YANTIL 50 mg with sedative medicines, they will limit the dose and duration of concomitant treatment.

The concomitant use of opioids and drugs 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 other sedative medicine, and follow your doctor's dosage recommendation to the letter. It may be helpful to inform your friends and family about the signs and symptoms indicated above. Tell your doctor if you experience any of 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 YANTIL 50 mg, as there have been cases of "serotonin syndrome". Serotonin syndrome is a rare but potentially fatal disorder. Symptoms can include involuntary rhythmic 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 you with more information.

The concomitant administration of YANTIL 50 mg with other types of medicines called mixed opioid agonist/antagonists (e.g., pentazocine, nalbuphine) or partial agonists of opioid μ receptors (e.g., buprenorphine) has not been studied. It is possible that YANTIL 50 mg may not have the same effectiveness if administered with one of these medicines. Tell your doctor if you are currently being treated with one of these medicines.

The administration of YANTIL 50 mg 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 effectiveness of tapentadol or may cause adverse effects, especially when starting or stopping this other type of medication. Keep your doctor informed about all the medicines you are taking.

YANTIL 50 mg should not be taken with MAO inhibitors (medicines for treating depression). Tell your doctor if you are taking MAO inhibitors or if you have taken them in the last 14 days.

Taking YANTIL 50 mg with food, drinks, and alcohol

Do not consume alcohol while taking YANTIL 50 mg, as some of its adverse effects, such as drowsiness, may increase. The intake of food 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, 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 childbirth, as it may cause slow or shallow breathing to dangerous levels (respiratory depression) in the newborn,
• during breastfeeding, as it may be excreted in breast milk.

Driving and using machines

Ask your doctor if you can drive or use machines during treatment with YANTIL. It is essential that before driving or using machines, you observe how this medicine affects you. Do not drive or use machines if you feel drowsy, dizzy, have blurred vision, or have difficulty concentrating. Be particularly careful at the start of treatment, after a dose change, and when administering it concomitantly with alcohol or tranquilizers.

YANTIL 50 mg contains lactose

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

YANTIL 50 mg contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, so it is essentially "sodium-free".

3. How to take YANTIL 50 mg

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

Your doctor will adjust the dose according to the intensity of your pain and your personal sensitivity to pain. You should generally take the minimum effective dose to relieve pain.

Adults

The usual starting dose is 50 mg every 4 to 6 hours.

Your doctor may prescribe a different dose or dosing regimen, which 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.

Daily doses above 700 mg of tapentadol on the first day of treatment and doses above 600 mg of tapentadol on subsequent days of treatment are not recommended.

Elderly patients

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

YANTIL 50 mg is not indicated in children and adolescents under 18 years of age.

How and when to take YANTIL 50 mg

YANTIL 50 mg should be taken orally.

Take the tablets with a sufficient amount of liquid. You can take them on an empty stomach or with food.

How long to take YANTIL 50 mg

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

If you take more YANTIL 50 mg than you should

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

• pupils very reduced, vomiting, decreased blood pressure, rapid heartbeat, fainting, altered consciousness or coma (deep loss of consciousness), epileptic seizures, slow or shallow breathing to dangerous levels or respiratory arrest.

If any of these things happen to you, 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 take the package and the package leaflet of the medicine to the healthcare professional.

If you forget to take YANTIL 50 mg

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 YANTIL 50 mg

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 adverse 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 suddenly.

The symptoms can be:

• 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Important side effects or symptoms to look out for and what to do if you are affected by them:

This medicine can cause allergic reactions. The symptoms can include wheezing (a kind of whistling when breathing), difficulty breathing, swelling of the eyelids, face, or lips, skin rash, or itching, especially if they affect the whole body.

Another serious side effect is breathing more slowly or more weakly than normal. This occurs mainly in elderly or debilitated patients.

If you experience any of these important symptoms, consult your doctor immediately.

Side effects that may occur:

Very common(may affect more than 1 in 10 people): nausea, vomiting, dizziness, drowsiness, headache.

Common(may affect up to 1 in 10 people): decreased appetite, anxiety, confusion, hallucinations, difficulty sleeping, sleep disturbances, tremors, hot flashes, constipation, diarrhea, indigestion, dry mouth, itching, increased sweating, skin rash, muscle cramps, feeling of weakness, fatigue, feeling of changed body temperature.

Uncommon(may affect up to 1 in 100 people): depression, disorientation, excitability (agitation), nervousness, restlessness, euphoric mood, attention disturbances, memory impairment, feeling of being about to faint, sedation, difficulty controlling movements, difficulty speaking, numbness, abnormal sensations in the skin (e.g., tingling, itching), muscle twitches, vision disturbances, rapid heartbeat, palpitations, decreased blood pressure, slow or shallow breathing to dangerous levels (respiratory depression), decreased oxygen levels in the blood, shortness of breath, abdominal discomfort, rash, feeling of heaviness, urinary retention, frequent urination, drug withdrawal syndrome (see section “If you stop taking YANTIL 50 mg”), fluid retention in the tissues (edema), feeling of malaise, feeling of intoxication, irritability, feeling of relaxation.

Rare(may affect up to 1 in 1,000 people): drug allergy (including swelling under the skin, hives, and in severe cases difficulty breathing, decreased blood pressure, collapse, or shock), altered thinking, epileptic seizures, decreased level of consciousness, altered coordination, slow heartbeat, altered gastric emptying.

Frequency not known(frequency cannot be estimated from the available data): delirium.

In general, the possibility of having suicidal thoughts and behaviors increases in patients with chronic pain. Additionally, some medicines 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 shown that it increases this risk.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of YANTIL 50 mg

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. 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 via wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE Point. 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 YANTIL 50 mg

The activeingredient is tapentadol.

Each tablet contains 50 mg of tapentadol (as 58.24 mg of tapentadol hydrochloride).

The othercomponents are:

Tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, povidone, magnesium stearate. Tablet coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol, talc.

Appearance of the product and package contents

Coated tablets, round, white, 7 mm in diameter, with the Grünenthal logo embossed on one side and "H6" on the other.

YANTIL coated tablets are packaged in blisters and supplied in packages of 5, 10, 10x1, 14, 14x1, 20, 20x1, 24, 28, 28x1, 30, 30x1, 40, 50, 50x1, 54, 56, 56x1, 60, 60x1, 90, 90x1, 100, and 100x1 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Grünenthal Pharma, S.A.

Doctor Zamenhof, 36 – 28027 Madrid, Spain

Manufacturer:

Grünenthal GmbH

Zieglerstrasse, 6 – D-52078 Aachen, Germany

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Germany: Tapentadol Libra-Pharm Akutschmerz

Austria, Portugal, Sweden, and the United Kingdom (Northern Ireland): Ationdo

Spain: YANTIL

Italy: Tapentadolo Grünenthal

Date of the last revision of this prospectus: November 2023

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/