Product Information for the User

Tapimio 100 mg Extended-Release Tablets EFG

Tapentadol

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

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What Tapimio is and what it is used for

2.What you need to know before taking Tapimio

3.How to take Tapimio

4.Possible side effects

5.Storage of Tapimio

6.Contents of the pack and additional information

Tapentadol - the active ingredient in Tapimio - is a potent analgesic that belongs to the class of opioids.

Tapimio is used for the treatment of severe chronic pain in adults, which can only be adequately treated with an opioid analgesic.

Do not take Tapimio:

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication:

• if your breathing is slow or shallow,

• if you have increased intracranial pressure or altered consciousness to even coma,
• if you have had a head trauma or brain tumors,
• if you have liver or kidney disease (see section “How to take Tapimio”),
• if you have pancreas disease or bile duct disease, including pancreatitis,
• if you are taking medications called mixed opioid agonist/antagonists (e.g. pentazocine, nalbuphine) or partial opioid agonists (e.g. buprenorphine),
• if you are prone to epilepsy or seizures, or if you are taking other medications known to increase the risk of seizures, as the risk of seizures may increase.
• if you or a family member has a history of alcohol abuse, prescription medication abuse, or illicit substance abuse (“addiction”).
• if you smoke,
• if you have ever had mood problems (depression, anxiety, or personality disorder) or have received treatment from a psychiatrist for other mental health conditions.

This medication contains tapentadol, which is an opioid medication. Repeated use of opioid analgesics may reduce the effectiveness of the medication (you may become accustomed to it). It may also lead to dependence and abuse, which may result in a potentially fatal overdose. It is essential to inform your doctor if you think you may have developed dependence on this medication. Your use (even at therapeutic doses) may cause physical dependence, which may lead to withdrawal symptoms and a recurrence of your problems if you stop taking this medication abruptly.

Tapentadol may produce physical and psychological addiction. If you have a tendency to abuse medications or have medication dependence, you should take these tablets only for short periods of time under strict medical supervision.

Respiratory disorders related to sleep

Tapentadol 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, nocturnal awakenings due to difficulty breathing, difficulty maintaining sleep, or excessive daytime somnolence. If you or someone else observes these symptoms, consult your doctor. Your doctor may consider reducing the dose.

Other medications and Tapimio

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

• The risk of side effects increases if you are taking medications that may cause seizures (e.g. certain antidepressants or antipsychotics). The risk of seizures increases if you take this medication simultaneously with these medications. Your doctor will tell you if this medication is suitable for you.

• The concomitant use of tapentadol and sedatives such as benzodiazepines or related medications (certain sleeping pills or tranquilizers [e.g. barbiturates] or painkillers like opioids, morphine, and codeine [also as a cough medication], antipsychotics, H1 antihistamines, alcohol),increases the risk of drowsiness, respiratory difficulties (respiratory depression), coma, and may 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 sedatives, you should limit the dose and duration of concomitant treatment.

The 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 may be potentially fatal.

Inform your doctor if you are taking gabapentin or pregabalin or any other sedative, and follow your doctor's dosage recommendations exactly.

It may be helpful to inform friends or family members about the symptoms mentioned above. Contact your doctor when you experience these symptoms.

• If you are taking a type of medication that affects serotonin levels (e.g. certain medications for depression), speak with your doctor before taking this medication, as there have been cases of "serotonin syndrome". Serotonin syndrome is a rare but potentially fatal condition. Symptoms may include involuntary muscle contractions, including those that control eye movement, agitation, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, and body temperature above 38°C. Your doctor may provide additional information.

• Tapentadol has not been studied in combination with other types of medications called mixed opioid agonist/antagonists (e.g. pentazocine, nalbuphine) or partial opioid agonists (e.g. buprenorphine). Tapentadol may not have the same effectiveness if taken with one of these medications. Inform your doctor if you are currently being treated with one of these medications.

• The administration of this medication 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 cause adverse effects, especially when starting or stopping this other type of medication. Inform your doctor about all medications you are taking.

• Tapentadol should not be taken with MAO inhibitors (medications for depression). Inform your doctor if you are taking MAO inhibitors or have taken them in the last 14 days.

Taking Tapimio with food, drinks, and alcohol

Do not consume alcohol while taking this medication, as some of its adverse effects, such as drowsiness, may increase. Food intake does not affect the effect of this medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Do not take this medication:

• if you are pregnant, unless your doctor has indicated it, as tapentadol may cause withdrawal symptoms in the newborn, which may put the newborn's life at risk if not detected and treated by a doctor.
• during breastfeeding, as it may be excreted in breast milk.

The use of tapentadol is not recommended:

• during delivery, as it may cause slow or shallow breathing in the newborn,

Driving and operating machinery

This medication may cause drowsiness, dizziness, and blurred vision and may affect your reactions.

This may occur especially when you start taking tapentadol, when your doctor changes your dose, or when you drink alcohol or take tranquilizers. Ask your doctor if you can drive or operate machinery.

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

Your doctor will adjust the dose based on the intensity of your pain and your personal sensitivity to pain. Generally, you should take the minimum effective dose to relieve pain.

Adults

The recommended starting dose is 50 mg taken twice a day, approximately every 12 hours. Do not recommend daily total doses exceeding 500 mg of tapentadol.

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

Older patients

In older patients (over 65 years old), it is usually not necessary to adjust the dose. However, the elimination of tapentadol may be delayed and slower in certain patients in this age group. If this happens 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 these tablets. If you have moderate liver problems, your doctor will prescribe a different dosing regimen. In the case of mild liver problems, no dose adjustment is necessary.

Patients with severe kidney problems should not take these tablets. In the case of mild or 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.

How and when to take Tapentadol

Tapentadol should be taken orally.

Always swallow the tablet with sufficient liquid. Do not chew or crush it, as this could lead to an overdose, as the active ingredient will be released in your body too quickly.

You can take the tablets with an empty stomach or with meals.

The tablet can be divided into equal doses.

The coating of the tablet may not be fully digested and may appear, apparently unchanged, in the feces. This should not worry you, as the active ingredient 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 medication is packaged in perforated, child-resistant blister packs.

You cannot push the tablets through the blister pack. Please follow the following instructions for opening the blister pack:

1. Rip a single dose along the perforation line of the blister pack.

2.This will allow access to an uncovered area located at the point where the perforation lines intersect.

1. Pull the uncovered section to remove the seal from the cover.

For how long should Tapentadol be taken

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

If you take more Tapentadol than you should

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

• very small pupils,
• vomiting,
• low blood pressure,
• rapid heart rate,
• syncope, altered consciousness or coma (deep loss of consciousness),
• seizures,
• slow or shallow breathing to dangerous levels or respiratory arrest.

If you experience any of these effects, you should call your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forget to take Tapimio

If you forget to take a tablet, it is likely that you will feel pain again. Do not take a double dose to compensate for the missed doses, but continue taking the tablets as before.

If you interrupt treatment with Tapimio

If you interrupt or stop treatment too soon, it is likely that you will feel pain again. If you want to interrupt treatment, consult your doctor before doing so.

Generally, patients do not experience any adverse effects after interrupting 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 may 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 interrupting treatment, consult your doctor.

You should not stop taking this medication abruptly, unless your doctor tells you to do so. If your doctor wants you to stop taking these tablets, they will indicate how to do it, which may involve a gradual reduction in dose.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Important side effects or symptoms to be aware of and what to do if you are affected by them:

• This medicine may cause allergic reactions. Symptoms may include wheezing (a whistling sound when breathing), difficulty breathing, inflammation of the eyelids, face, or lips, skin rash or itching, especially if it affects the entire body.
• Another serious side effect is breathing more slowly or more shallowly than normal. This occurs mainly in elderly patients or in weakened 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, constipation,
• dizziness, somnolence, headache.

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

• decreased appetite, anxiety,depression of mood,difficulty sleeping,nervousness, restlessness, alterations in attention,
• shakiness,muscle tics,
• palpitations,
• shortness of breath,
• vomiting,diarrhea, poor digestion,
• itching, increased sweating, skin rashes,
• sensation of weakness, fatigue, sensation of change in body temperature, dryness of mucous membranes, accumulation of water in tissues (edema).

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

• allergic reaction to medication (including hives, urticarial rash, and in severe cases difficulty breathing, decreased blood pressure, collapse, or shock),
• weight loss,
• disorientation, confusion, excitability (agitation), alterations in perception, sleep, mood, and level of consciousness, memory deterioration, mental deterioration,
• syncope, sedation, balance disorders, difficulty speaking, numbness, abnormal sensations in the skin (e.g., tingling, itching),
• vision changes,
• rapid heartbeats, slow heartbeats, palpitations, decreased blood pressure,
• abdominal discomfort,
• hives,
• delayed urination, frequent urination,
• sexual dysfunction,
• drug withdrawal syndrome (see section “If you stop taking Tapimio”), feeling unwell, irritability.

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

• drug dependence, thought disorder, seizures, feeling of impending syncope, coordination disorders,
• slow or shallow breathing to dangerous levels (respiratory depression),
• gastrointestinal emptying disorders,
• sensation of intoxication, sensation of relaxation.

Unknown frequency(frequency cannot be estimated with 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 (affecting neurotransmitters in the brain) may increase this risk, especially at the beginning of treatment. Although tapentadol also affects neurotransmitters, through experience in patients, it has not been proven to increase this risk.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

Medications should not be thrown down the drain or in the trash.Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Tapimio

The active principle is tapentadol.

Each prolonged-release tablet contains tapentadol phosphate equivalent to 100 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 (E 171); iron oxide red (E172); iron oxide yellow (E172); iron oxide black (E172).

Appearance of the product and contents of the package

Prolonged-release tablets, biconvex, oblong, yellowish (7 mm x 14 mm), with a groove on both faces.

The tablet can be divided into equal doses.

Tapimio 100 mg is packaged in a pre-cut single-dose blister, child-resistant, in packages of 20, 24, 30, 50, 54, 60, or 100 prolonged-release tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Responsible manufacturer:

Develco Pharma GmbH

Grienmatt 27

79650 Schopfheim

Germany

Neuraxpharm Arzneimittel GmgH

Elisabeth-Serbert-Strasse 23

40764 Langenfeld

Germany

This medicine is authorized in the member states of the European Economic Area with the following names:

GermanyTapentadol neuraxpharm 100 mg Retardtabletten

IrelandTapimio 100 mg prolonged-release tablets

SpainTapimio 100 mg prolonged-release tablets EFG

SwedenTapimio Depot 100 mg depot tablets

Last review date of this leaflet: September 2022

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