Tapimio 50 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tapimio 50 mg prolonged-release tablets EFG

Tapentadol

Read all of this 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. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.

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

Contents of the leaflet

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

1. What Tapimio is and what it is used for

Tapentadol—the active substance in Tapimio—is a potent analgesic belonging to the opioid class.

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

2. What you need to know before starting Tapimio

Do not take Tapimio:

• if you are allergic to tapentadol or to any of the other ingredients of this medicine (listed in section 6),
• if you have asthma or your breathing is slow or shallow to dangerous levels (respiratory depression, hypercapnia),
• if you have intestinal paralysis,
• if you have consumed alcohol, sleeping pills, other analgesics, or other psychotropic medicines (medicines that affect mood and emotions) in high doses (see section "Other medicines and Tapimio").

Warnings and precautions

Talk to your doctor or pharmacist before starting this medicine:

• if your breathing is slow or shallow,
• if you have increased intracranial pressure or altered consciousness up to and including coma,
• if you have had a head injury or brain tumors,
• if you have liver or kidney disease (see section “How to take Tapimio”),
• if you have a disease of the pancreas or bile ducts, including pancreatitis,
• if you are taking medicines called mixed opioid agonist/antagonists (e.g.: pentazocine, nalbuphine) or partial agonists of µ-opioid receptors (e.g.: buprenorphine),
• if you are prone to epilepsy or seizures, or if you are taking other medicines with a known risk of increasing seizures, as the risk of such seizures may increase.

Tolerance, dependence, and addiction

This medicine contains tapentadol, which is an opioid. It may cause dependence and/or addiction.

This medicine contains tapentadol, which is an opioid medicine. Repeated use of opioid analgesics may reduce the effectiveness of the medicine (your body becomes accustomed to the medicine, known as tolerance). Repeated use of tapentadol may also lead to dependence and abuse, which could result in a potentially fatal overdose. The risk of adverse effects may increase with higher doses and longer duration of use.

Dependence or addiction may make you feel that you no longer have control over how much medicine you need to take or how often you need to take it.

The risk of becoming dependent or addicted varies from person to person. You may have a higher risk of becoming dependent or addicted to tapentadol if:

• you or a family member has a history of alcohol, prescription medicine, or illicit substance abuse or dependence (“addiction”),
• you are a smoker,
• 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.

If you notice any of the following signs while taking tapentadol, it could be a sign that you have become dependent or addicted:

• you need to take the medicine for longer than recommended by your doctor,
• you need to take higher doses than recommended,
• you may feel that you need to continue taking the medicine even when it does not help relieve pain,
• you are using the medicine for reasons other than prescribed, for example, “to calm down” or “to help you sleep”,
• you have made repeated but unsuccessful attempts to stop or control the use of the medicine,
• you feel unwell when you stop taking the medicine and feel better when you take it again (“withdrawal symptoms”).

If you notice any of these signs, speak with your doctor to discuss the most appropriate treatment strategy for your case, including when it is appropriate to stop taking the medicine and how to do so safely (see section 3 “If you stop taking Tapimio”).

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 blood oxygen levels). 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.

Other medicines and Tapimio

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

• 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 this medicine simultaneously with these medicines. Your doctor will advise whether this medicine is suitable for you.

• Concomitant use of tapentadol and sedative medicines such as benzodiazepines or related medicines (certain sleeping tablets or tranquilizers [e.g., barbiturates] or analgesics such as opioids, morphine, and codeine [also as a cough medicine]), antipsychotics, H1 antihistamines, or 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 together with sedative medicines, your dose and duration of concomitant treatment will be limited.

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 other sedative medicine, and strictly follow your doctor’s dosing recommendations.

It may be helpful to inform friends or family members so they are aware of the signs and symptoms mentioned above. Contact your doctor if you experience these symptoms.

• If you are taking a type of medicine that affects serotonin levels (e.g., certain medicines to treat depression), talk to your doctor before taking this medicine, as cases of "serotonin syndrome" have been reported. Serotonin syndrome is a rare but potentially life-threatening condition. Symptoms may include rhythmic, involuntary muscle contractions, including those controlling eye movement, agitation, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, and body temperature above 38°C. Your doctor can provide further information.

• The concomitant administration of tapentadol with other types of medicines known as mixed agonists/antagonists of µ-opioid receptors (e.g., pentazocine, nalbuphine) or partial µ-opioid agonists (e.g., buprenorphine) has not been studied. Tapentadol may not be as effective if administered together with one of these medicines. Inform your doctor if you are currently being treated with any of these medicines.

• Administration of this medicine together with strong inhibitors or inducers (e.g., rifampicin, phenobarbital, St. John’s wort) of certain enzymes required to eliminate tapentadol from your body may affect the efficacy of tapentadol or may cause adverse effects, especially when starting or stopping such medication. Keep your doctor informed about all medicines you are taking.

• 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.

• If you use tapentadol together with the following medicines that have anticholinergic effects, the risk of side effects may increase:

• medicines to treat depression,

• medicines used to treat allergies, dizziness, or nausea (antihistamines or antiemetics),

• medicines to treat psychiatric disorders (antipsychotics or neuroleptics),

• muscle relaxants,

• medicines to treat Parkinson’s disease.

Taking Tapimio with food, drinks, and alcohol

Do not consume alcohol while taking this medicine, as some of its adverse effects, such as drowsiness, may be increased. Taking food does not affect the action 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 instructed you to do so. If used for prolonged periods during pregnancy, tapentadol may cause withdrawal symptoms in the newborn, which could be life-threatening 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 childbirth, as it may cause slow or shallow breathing to dangerous levels (respiratory depression) in the newborn.

Driving and using machines

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

This may occur especially when you first start taking tapentadol, when your doctor changes your dose, or when you drink alcohol or take tranquilizers. Ask your doctor whether you can drive or use machines.

3. How to take Tapimio

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Before starting treatment and periodically during treatment, your doctor will discuss with you what to expect from the use of tapentadol, when and for how long you should take it, when to contact your doctor, and when you should stop taking it (see also “If you stop taking Tapimio”).

Your doctor will adjust the dose according to the intensity of your pain and your individual sensitivity to pain. Generally, the lowest effective dose should be used to relieve pain.

Adults

The recommended starting dose is 50 mg taken twice daily, approximately every 12 hours. Total daily doses exceeding 500 mg of tapentadol are not recommended.

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

Elderly patients

In elderly patients (over 65 years of age), dose adjustment is usually not required. However, elimination of tapentadol may be delayed and slower in certain patients in this age group. If this applies to you, your doctor may prescribe a different dosing regimen.

Liver and kidney disease (hepatic and renal impairment)

Patients with severe liver problems must not take these tablets. If you have moderate liver problems, your doctor will prescribe a different dosing regimen. Dose adjustment is not necessary in patients with mild liver problems.

Patients with severe kidney problems must not take these tablets. Dose adjustment is not necessary in patients with mild or moderate kidney problems.

Use in children and adolescents

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

How and when to take Tapentadol

Tapentadol should be taken by mouth.

Always swallow the tablet with sufficient liquid. Do not chew or crush the tablets, as this could lead to overdose because the active ingredient would be released too quickly into your body.

You may take the tablets on an empty stomach or with food.

The tablet may be divided into equal doses.

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

Instructions for opening the blister pack

This medicine is packaged in a child-resistant, single-dose perforated blister pack.

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

1. Tear off a single dose along the perforation line of the blister.

1. This will expose an unsealed area located at the intersection of the perforation lines.

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

How long to take Tapentadol

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

If you take more Tapentadol than you should

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

• very small pupils,
• vomiting,
• low blood pressure,
• rapid heartbeat,
• fainting, altered consciousness, or coma (deep loss of consciousness),
• epileptic seizures,
• slow or shallow breathing, potentially reaching dangerous levels or respiratory arrest, which may lead to death.

If this occurs, call a doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the medicine’s packaging and leaflet to the healthcare professional.

If you forget to take Tapimio

If you forget to take a tablet, you may feel pain again. Do not take a double dose to make up for a missed dose; instead, continue taking the tablets as before.

If you stop taking Tapimio

If you stop or discontinue treatment too early, you may feel pain again. If you wish to stop treatment, consult your doctor first.

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

Symptoms may include:

• restlessness, watery 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, diarrhoea, and increases in blood pressure, respiratory rate, or heart rate.

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

You must not stop taking 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, 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 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. Symptoms may include wheezing (a whistling sound when breathing), difficulty breathing, swelling of the eyelids, face or lips, skin rash or itching, especially if affecting the whole body.
• Another serious adverse effect is abnormally slow or weak breathing. This occurs mostly in elderly or weakened patients.

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

Adverse effects that may occur:

Very common (may affect more than 1 in 10 people):

• nausea, constipation,
• dizziness, drowsiness, headache.

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

• loss of appetite, anxiety, depressed mood, difficulty sleeping, nervousness, restlessness, attention disturbances,
• tremors, muscle tics,
• hot flushes,
• shortness of breath,
• vomiting, diarrhea, indigestion,
• itching, increased sweating, skin rashes,
• feeling of weakness, fatigue, sensation of change in body temperature, dryness of mucous membranes, fluid accumulation in tissues (edema).

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

• allergic reaction to medicines (including swelling under the skin, hives, and in severe cases difficulty breathing, low blood pressure, collapse or shock),
• weight loss,
• disorientation, confusion, excitability (agitation), disturbances in perception, sleep disturbances, euphoric mood, decreased level of consciousness, memory impairment, mental deterioration,
• fainting, sedation, balance disorders, speech difficulties, numbness, abnormal skin sensations (e.g., tingling, itching),
• visual disturbances,
• fast heartbeat, slow heartbeat, palpitations, low blood pressure,
• abdominal discomfort,
• rash,
• 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 disturbance, epileptic seizures, feeling faint, impaired coordination,
• slow or shallow breathing to dangerous levels (respiratory depression),
• delayed gastric emptying,
• feeling of drunkenness, sensation of relaxation.

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

• delirium.

In general, the likelihood of having suicidal thoughts and behaviors 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 type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 Tapimio

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

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date is the last day of the month indicated.

Store this medicine in a safe and secure place, where others cannot access it. It may cause serious harm or be fatal to individuals who take it accidentally or intentionally when it has not been prescribed for them.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tapimio

The active substance is tapentadol.

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

The other components are:

Tablet core: microcrystalline cellulose (E460); hypromellose (E464); anhydrous colloidal silica (E551); magnesium stearate.

Tablet film coating: hypromellose (E464); glycerol (E422); talc (E553b); microcrystalline cellulose (E460); titanium dioxide (E171).

Appearance of the product and contents of the pack

Prolonged-release tablets, biconvex, oblong, white in colour (6 mm x 13 mm), with a score line on both sides.

The tablet can be divided into equal doses.

Tapimio 50 mg is packaged in unit-dose, child-resistant, pre-perforated blisters, in pack sizes of 20, 24, 30, 50, 54, 60 or 100 prolonged-release tablets.

Only certain pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Manufacturer:

Develco Pharma GmbH

Grienmatt 27

79650 Schopfheim

Germany

Neuraxpharm Arzneimittel GmbH

Elisabeth-Serbert-Strasse 23

40764 Langenfeld

Germany

This medicinal product is authorised in the European Economic Area member states under the following names:

Germany Tapentadol neuraxpharm 50 mg Retardtabletten

Spain Tapimio 50 mg prolonged-release tablets EFG

Sweden Tapimio Depot 50 mg depottabletter

Date of the most recent review of this leaflet: October 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/