YANTIL 4 mg/ml ORAL SOLUTION

2. What you need to know before you take Yantil

Do not take Yantil:

• 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 to levels that are dangerous [respiratory depression; hypercapnia (higher than normal carbon dioxide levels in the blood)],
• if you have a disease in which the intestine does not work properly (paralytic ileus),
• if you have consumed alcohol, sleeping pills, other pain relievers, or other psychotropic medicines (medicines that affect mood and emotions) at high doses (see section "Taking Yantil with other medicines").

Warnings and precautions

Consult your doctor or pharmacist before starting to take Yantil:

• 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 Yantil”),
• if you have a disease of the pancreas (such as pancreatitis) or of the 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 may 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. 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 can cause physical and psychological dependence. If you have a tendency to abuse medicines or have drug dependence, you should only take this medicine for short periods under strict medical supervision.

Yantil has not been systematically evaluated in children and adolescents with obesity; therefore, pediatric patients with obesity should be closely monitored, and the maximum recommended dose for each age should not be exceeded.

Do not give this medicine to children under 2 years of age.

Sleep-related respiratory disorders

Yantil 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 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 simultaneously with these medicines. Your doctor will tell you if Yantil is suitable for you.

• Taking Yantil with sedative medicines such as benzodiazepines or related medicines (certain sleeping pills or tranquilizers [e.g., barbiturates] or pain relievers 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 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 with sedative medicines, the 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 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, as there have been cases of "serotonin syndrome". Serotonin syndrome is a rare but potentially life-threatening 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 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 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 this medicine with potent inhibitors or inducers (e.g., rifampicin, phenobarbital, St. John's Wort) of certain enzymes necessary to eliminate tapentadol from your body may affect the efficacy 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 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 with food, drinks, and alcohol

Do not consume alcohol while taking this medicine, as some of its side effects, such as drowsiness, may increase. Taking 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. If tapentadol is used for prolonged periods during pregnancy, it may cause withdrawal symptoms in the newborn, which can be life-threatening if not detected and treated by a doctor.

Yantil is not recommended:

• during labor because it may cause slow or shallow breathing to dangerous levels (respiratory depression) in the newborn,
• during breastfeeding, as tapentadol may be excreted in breast milk.

Driving and using machines

Ask your doctor if you can drive or use machines while being treated with tapentadol. 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 when starting treatment, after a dose change, and when taking it concomitantly with alcohol or tranquilizers.

Yantil contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose unit, which is essentially "sodium-free".

Yantil contains sodium benzoate

This medicine contains 59 mg of sodium benzoate per dose unit equivalent to 2.4 mg/ml.

Yantil contains propylene glycol

This medicine contains 48 mg of propylene glycol in 25 ml of solution (maximum dose unit), which is equivalent to 2 mg/ml.

3. How to take Yantil

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 level to pain. You should generally take the minimum effective dose to relieve pain.

Adults

The recommended dose is 50 mg of tapentadol (12.5 ml of oral solution), 75 mg of tapentadol (18.75 ml of oral solution), or 100 mg of tapentadol (25 ml of oral solution) every 4 or 6 hours.

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

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

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 (hepatic and renal insufficiency)

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

Use in children and adolescents

Yantil should only be administered to children in the hospital.

The dose of Yantil for children and adolescents from 2 to 18 years is 1.25 mg/kg every 4 hours. Your doctor or nurse will administer the correct dose.

Always wait 4 hours before giving the next dose. The dose can be reduced as the acute pain decreases.

How and when to take Yantil

This medicine should be taken orally.

You can take the oral solution on an empty stomach or with food.

The pack contains a dosing syringe with an adapter that must be used to extract the exact amount (volume) from the bottle that corresponds to the prescribed dose of tapentadol.

Instructions for opening the bottle and using the dosing syringe

The bottle has a child-resistant screw cap. To remove the cap, press it down and turn it counterclockwise (Fig. 1). Remove the cap and peel off the security seal from the top of the bottle. If the security seal is damaged, do not use this medicine and consult your pharmacist.

Fig. 1

Place the bottle on a firm and flat surface. Open the plastic bag containing the dosing syringe and the adapter by the perforated end and remove the dosing syringe (A) and the adapter (B) both included in the same bag. Insert the dosing syringe into the adapter and place it firmly on the neck of the bottle (Fig. 2).

Fig. 2

To fill the dosing syringe, turn the bottle upside down. While keeping the dosing syringe in place, gently pull the plunger (C) down to the line that corresponds to the dose prescribed by your doctor (see the section "How to take Yantil"). Do not removethe dosing syringe yet! (Fig. 3).

Fig. 3

Turn the bottle back to its original positionand then carefully remove the dosing syringe from the bottle. Once the dosing syringe is removed, carefully check that you have withdrawn the correct amount of solution. The adapter (B) that was previously attached to the dosing syringe should now remain in the bottle (Fig. 4).

Fig. 4

To take the medicine, put the dosing syringe in your mouth and gently press the plunger. Press the plunger all the way down to ensure you take the entire solution. If you prefer, you can dilute the medicine in a glass of water or a non-alcoholic drink before taking it, in which case you must take the entire glass to ensure you take the correct dose of the medicine (Fig. 5).

Fig. 5

Leave the adapter in the bottle, close the bottle tightly, and store it in an upright position. Rinse the dosing syringe with water after each use and let it dry. The next time you take the medicine, place the dosing syringe in the adapter that will be on the neck of the bottle and follow the instructions mentioned above.

How long to take Yantil

Do not take this medicine for longer than your doctor has told you. In children, the treatment duration should not exceed 3 days.

If you take more Yantil than you should

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

• pupils very small, vomiting, decrease in 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 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 leaflet of the medicine to the healthcare professional.

If you forget to take Yantil

If you forget to take this medicine, you will probably feel pain again. Do not take a double dose to make up for forgotten doses, but continue taking this medicine as before.

If you stop taking Yantil

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 this medicine for a long time may feel unwell if they stop taking it suddenly.

The symptoms may be:

• restlessness, tearful eyes, runny nose, yawning, sweating, chills, muscle pain, and dilated pupils,
• irritability, anxiety, back pain, joint pain, weakness, abdominal cramps, sleep disturbances, 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.

You should not stop taking this medicine abruptly, unless your doctor tells you to do so. If your doctor wants you to stop taking this medicine, they will tell you how to do it, which 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 may 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 if they affect the whole body.

Another serious adverse effect is feeling drowsy and breathing more slowly or more weakly than normal. It occurs mostly in elderly patients or weakened patients.

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

Adverse 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 rashes, muscle cramps, feeling of weakness, fatigue, feeling of change in 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 skin sensations (e.g., tingling, itching), muscle twitches, vision changes, rapid heartbeats, 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, delayed urination, frequent urination, drug withdrawal syndrome (see section "If you stop treatment with Yantil"), water retention in tissues (edema), feeling of discomfort, feeling of intoxication, irritability, feeling of relaxation.

Rare(may affect up to 1 in 1,000 people): allergic reaction to medicines (including swelling under the skin, urticarial habon, and in severe cases difficulty breathing, decreased blood pressure, collapse, or shock), altered thinking, epileptic seizures, decreased level of consciousness, altered coordination, slow heartbeats, 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.

No additional adverse effects have been observed in children and adolescents.

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 does not appear 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. Conservation of Yantil

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the box and on the bottle after CAD. The expiration date is the last day of the month indicated.

Before the first opening: this medicine does not require special storage conditions.

The solution should not be used six weeks after the first opening of the bottle.

Store in a vertical position after the first opening.

Medicines should not be thrown away through the sewers or in the trash. Deposit the containers 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 containers and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition ofYantil

The active ingredientis tapentadol.

1 ml of oral solution contains 4 mg of tapentadol (in the form of hydrochloride).

The othercomponents are:

Sodium benzoate (E211)

Citric acid monohydrate

Sucralose (E955)

Raspberry flavor, contains propylene glycol (E1520)

Purified water

Appearance of the Product and Package Contents

Yantil is a clear and colorless oral solution.

The oral solution is supplied in plastic bottles containing 100 milliliters of solution and includes a 5 ml dosing syringe graduated in 0.1 ml fractions and an adapter attached to the dosing syringe.

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 under the following names:

Germany: Tapentadol Libra-Pharm

Spain: Yantil

Date of the last revision of this prospectus: October 2024

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/