Patient Information

Tramadol/Paracetamol Viatris 37.5 mg/325 mg

Coated Tablets EFG

Tramadol Hydrochloride/Paracetamol

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you are unsure about anything, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do 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 Tramadol/Paracetamol Viatris is and what it is used for

2. What you need to know beforestartingtotake Tramadol/Paracetamol Viatris

3. How to take Tramadol/Paracetamol Viatris

4. Possible side effects

5. Storage of Tramadol/Paracetamol Viatris

6. Contents of the pack and additional information

Tramadol/Paracetamol Viatris is a combination of two analgesics, tramadol hydrochloride and paracetamol, which act together to relieve pain.

Tramadol/Paracetamol Viatris is used for the treatment of moderate or severe pain. Your doctor will prescribe this medication if they consider a combination of tramadol hydrochloride and paracetamol to be appropriate.

Tramadol/Paracetamol Viatris should only be used by adults and adolescents 12 years of age or older.

Do not take Tramadol/Paracetamol Viatris:

• If you are allergic to tramadol, paracetamol, or any of the other components of this medication (listed in section 6).
• In cases of acute alcohol intoxication.
• If you are taking sedatives, painkillers, or medications that affect mood and emotions (psychoactive medications).
• If you are taking monoamine oxidase inhibitors (MAOIs) or in the two weeks following the discontinuation of such treatment. MAOIs are used to treat depression or Parkinson's disease.
• If you have severe liver problems.
• If you have uncontrolled epilepsy with your current medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tramadol/Paracetamol Viatris:

• If you suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Use of Tramadol/Paracetamol Viatris with other medications").
• If you have severe kidney problems. In this case, the use of Tramadol/Paracetamol Viatris is not recommended. In cases of moderate kidney problems, it may be necessary to increase the interval between doses.
• If you have other liver problems or liver diseases, or if you notice that your eyes and skin may turn yellow, indicating jaundice or bile duct problems.
• If you have severe breathing difficulties, for example, asthma or severe lung problems.
• If you have recently suffered a head injury or have severe headaches associated with vomiting (dizziness).
• If you have epilepsy or have already had seizures or convulsions.
• If you have a decreased level of consciousness for unknown reasons.

In all the cases described above, this medication should only be used with caution.

There is a weak risk that you may experience a serotonin syndrome that can occur after taking tramadol in combination with certain antidepressants or tramadol monotherapy. Consult your doctor immediately if you experience any of the symptoms associated with this severe syndrome (see section 4 "Possible side effects").

Tramadol should not be taken as a substitute for opioid-dependent patients, as it does not suppress withdrawal symptoms from morphine.

Tramadol can cause seizures even with the recommended doses. Therefore, patients with controlled epilepsy or those susceptible to seizures or convulsions should not be treated with Tramadol/Paracetamol Viatris unless absolutely necessary.

Tramadol is metabolized in the liver by an enzyme. Some people have a variant of this enzyme; this can affect people in different ways. In some people, they may not get sufficient pain relief, while others may be more likely to experience severe side effects. If you detect any of the following side effects, stop taking this medication and consult your doctor immediately: slow or shallow breathing, confusion, drowsiness, small pupils, feeling unwell, constipation, loss of appetite.

Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. These may be indicators of adrenal insufficiency (low cortisol levels). If you experience these symptoms, contact your doctor, who will decide if you need to take hormone supplements.

Respiratory disturbances related to sleep

Tramadol/paracetamol may cause respiratory disturbances related to sleep, 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 lack of breath, difficulty maintaining sleep, or excessive daytime somnolence. If you or someone else observes these symptoms, contact your doctor. Your doctor may consider reducing the dose.

Tolerance, dependence, and addiction

This medication contains tramadol, which is an opioid medication. Repeated use of opioids can make the medication less effective (you become accustomed to it, known as tolerance). Repeated use of Tramadol/paracetamol tablets can also lead to dependence, abuse, and addiction, which can result in a potentially fatal overdose. The risk of these side effects may increase with higher doses and longer use.

Dependence or addiction can make you feel like you no longer control the amount of medication you need to take or how often you need to take it.

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

• You or a family member has ever abused or been dependent on alcohol, prescription medications, or illegal drugs ("addiction").
• You are a smoker.
• You have ever had mood problems (depression, anxiety, or personality disorder) or have been treated by a psychiatrist for other mental health conditions.

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

• You need to take the medication for longer than advised by your doctor.
• You need to take more than the recommended dose.
• You use the medication for reasons other than those prescribed, for example, "to feel calm" or "to sleep".
• You have repeatedly tried and failed to stop or control the use of the medication.
• When you stop taking the medication, you feel unwell, and you feel better when you take it again ("withdrawal effect").

If you notice any of these signs, talk to your doctor to determine the best course of treatment for you, including when it is appropriate to stop taking it and how to do it safely (see section 3, If you stop taking Tramadol/paracetamol).

Children and adolescents

Tramadol/Paracetamol Viatris is not recommended for children under 12 years old. The safety and efficacy have not been established in children.

Tramadol is not recommended for children with respiratory problems, as the symptoms of tramadol toxicity may be worse for these children.

Abuse

At therapeutic doses, tramadol can cause withdrawal symptoms.

Surgery

The use of tramadol with anesthetics such as enflurane and nitrous oxide during general anesthesia may help the anesthesiologist recover the patient during operations if necessary. Until more information is available, it is recommended to avoid the use of tramadol during light anesthesia. Inform your doctor or dentist if you are to be anesthetized.

Use of Tramadol/Paracetamol Viatris with other medications

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

Important: This medication contains paracetamol and tramadol. Inform your doctor if you are taking any other medication that contains paracetamol or tramadol so that you do not exceed the maximum daily dose.

The concomitant use of Tramadol/Paracetamol Viatris with sedatives, such as benzodiazepines or related drugs, increases the risk of somnolence, breathing difficulties (respiratory depression), coma, and may be potentially fatal. Therefore, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes Tramadol/Paracetamol Viatris together with sedatives, your doctor should limit the dose and duration of concomitant treatment.

Inform your doctor of all sedatives you are taking, and follow your doctor's dose recommendation carefully. It may be helpful to inform your friends or family members to be aware of the symptoms and signs described above. Contact your doctor if you experience these symptoms.

Tramadol/Paracetamol Viatris should not be taken with::

• Inhibitors of MAO (used to treat depression or Parkinson's disease), as there is a risk of developing a serotonin syndrome. Symptoms of serotonin syndrome include diarrhea, increased heart rate, sweating, tremors, confusion, and even coma. In cases of recent MAO treatment, a two-week waiting period should be observed before starting Tramadol/Paracetamol Viatris treatment.
• Carbamazepine (a medication used to treat epilepsy and certain types of pain such as trigeminal neuralgia). If you take these medications simultaneously, the effectiveness and duration of the tramadol effect will be reduced.
• Opioid analgesics (buprenorphine, nalbuphine, pentazocine). If you take these medications simultaneously, the analgesic effect of Tramadol/Paracetamol Viatris will be reduced, with a risk of withdrawal syndrome.

Inform your doctor or pharmacist if you are taking:

• Flucloxacillin (antibiotic), due to a severe risk of blood and fluid disorder (metabolic acidosis with high anion gap, which occurs when there is an increase in plasma blood acidity) that must be treated urgently and may occur particularly in cases of severe renal or hepatic insufficiency, sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), malnutrition, chronic alcoholism, and if you take the maximum daily dose of paracetamol, especially if you take the maximum daily dose of paracetamol for a prolonged period. Metabolic acidosis with high anion gap is a serious disease that requires urgent treatment.
• Gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain)

The risk of side effects increases:

• If you are taking medications that can cause seizures (attacks), such as certain antidepressants or antipsychotics. The risk of having a seizure may increase if you take Tramadol/Paracetamol Viatris at the same time. Your doctor will inform you if Tramadol/Paracetamol Viatris is suitable for you.
• If you are taking certain antidepressants (selective serotonin reuptake inhibitors (SSRIs)) or triptans (used for migraines). Tramadol/Paracetamol Viatris may interact with these medications and may experience a serotonin syndrome (see section 4 "Possible side effects").
• Other opioid derivatives (including medications for cough and substitution treatments), barbiturates, and benzodiazepines (sedatives). If you take these medications simultaneously, the risk of respiratory depression may increase, which can be fatal in cases of overdose.
• Other central nervous system depressants, anxiolytics (used to reduce fear), hypnotics, sedative antidepressants, antihistamines (used to treat allergies), neuroléptics (used to treat psychosis), central-acting antihypertensive medications (used to reduce blood pressure), talidomide (a sedative), and baclofen (a muscle relaxant). These medications may exacerbate central depression. The effect on alertness may make driving vehicles and operating machinery hazardous.
• Warfarin or other anticoagulants, such as phenprocoumon (used to prevent blood clotting). The effectiveness of these medications may be altered, and bleeding may occur. Your doctor may need to regularly evaluate your prothrombin time. Any prolonged or unexpected bleeding should be immediately reported to your doctor.
• Other medications that, as known, inhibit the CYP3A4 liver enzyme, such as ketoconazole and erythromycin (medications used to treat infections).
• Metoclopramide or domperidone (medications used to treat nausea and vomiting/sensation of dizziness). It may increase the absorption of paracetamol if you take these medications simultaneously.
• Colestiramine (a medication used to reduce cholesterol in the blood), as it may reduce the absorption of Tramadol/Paracetamol Viatris.
• Ondansetron (used to treat nausea), as it may alter the effectiveness of Tramadol/Paracetamol Viatris.

Tramadol/Paracetamol Viatris with alcohol

You should not drink alcohol during treatment, as alcohol with Tramadol/Paracetamol Viatris may make you feel drowsy.

Pregnancy and breastfeeding

As Tramadol/Paracetamol Viatris contains tramadol, do not take this medication during pregnancy.

Tramadol may pass into breast milk. Therefore, do not take Tramadol/Paracetamol Viatris more than once during breastfeeding or, if you take Tramadol/Paracetamol Viatris more than once, stop breastfeeding.

Based on human experience, it is not suggested that tramadol affects male or female fertility. There are no available data on the combination of tramadol and paracetamol in fertility.

If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

This medication may cause drowsiness or dizziness, which may intensify with alcohol or other depressants that affect the central nervous system. If you feel drowsy or dizzy, do not drive or operate machinery.

Tramadol/Paracetamol Viatris contains sodium

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

Always follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Before starting treatment and regularly during it, your doctor will explain what you can expect from the use of Tramadol/paracetamol, when and for how long you should take it, when you should contact your doctor and when you should interrupt it (see also section 2).

The recommended dose is:

Adults and adolescents (12 years or older):

• Your doctor will adjust the dose individually based on the intensity of your pain and your response.
• The recommended dose is to start with 2 tablets unless your doctor has prescribed otherwise.
• If necessary and recommended by your doctor, you can take more tablets per day, but do not exceed the maximum daily dose of 8 tablets (equivalent to 300 mg of tramadol and 2,600 mg of paracetamol) and do not take other medications that contain paracetamol or tramadol hydrochloride to avoid overdose.
• The interval between 2 administrations should not be less than 6 hours.
• The dose should be adjusted based on the intensity of your pain and your individual pain sensitivity. In general, you should take the lowest dose that relieves your pain.

Older adults (75 years or older):

In older adults (75 years or older), the excretion of tramadol hydrochloride may be delayed. If this applies to you, your doctor may recommend prolonging the dosing interval.

Severe liver and/or kidney disease (insufficiency) and/or patients on dialysis:

Patients with severe liver and/or kidney insufficiency should not take Tramadol/Paracetamol Viatris. If your insufficiency is mild or moderate, your doctor may recommend prolonging the dosing interval.

Use in children under 12 years

Tramadol/Paracetamol Viatris is not recommended for use in children under 12 years.

Administration form

• Take the tablets orally.
• Swallow the tablets whole with a sufficient amount of liquid (e.g., a 200 ml glass of water). Do not break or chew the tablets.
• Tramadol/Paracetamol Viatris can be taken with or without food.

Treatment duration

Do not take this medication for longer than strictly necessary.

If repeated or prolonged treatment with this medication is required (due to the nature or severity of the disease), caution should be exercised and regular checks should be made to evaluate whether continued treatment is necessary. If possible, pauses in treatment should be introduced during long-term treatment.

If you believe the effect of Tramadol/Paracetamol Viatris is too strong (e.g., you feel very drowsy or have difficulty breathing) or too weak (e.g., inadequate pain relief), contact your doctor.

If you take more Tramadol/Paracetamol Viatris than you should

• If you have taken more tablets than you should, consult your doctor or the nearest emergency service immediately, even if you feel well, due to the risk of delayed severe liver damage.
• In case of overdose, you may experience nausea (sensation of dizziness), miosis (pupil constriction), vomiting (sensation of dizziness), anorexia (loss of appetite), abdominal pain, severe circulatory failure (cardiovascular collapse), cognitive disorders, including coma, seizures, respiratory depression that can cause respiratory arrest, and pale skin.
• 12 to 48 hours after ingestion, liver damage may appear. In severe intoxication, liver failure may lead to severe brain disease (encephalopathy), coma, and death. Severe renal failure with tubular necrosis (cell destruction) may also occur in the absence of severe liver damage. Cardiac arrhythmias (irregular heart rate) and pancreatitis (pancreas inflammation) have also been observed.

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 administered.

If you forget to take Tramadol/Paracetamol Viatris

If you forget to take this medication, you can skip the missed dose and continue with the treatment as normal, or you can take the missed tablet, but you will have to wait 6 hours for the next dose.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Tramadol/Paracetamol Viatris

You should not stop taking this medication abruptly, unless your doctor tells you to. If you want to stop taking the medication, you should talk to your doctor first, especially if you have been taking it for a long time. Your doctor will inform you about the time and way to stop taking it, which may involve gradually reducing the dose to reduce the risk of unnecessary adverse effects (withdrawal symptoms).

Generally, there will be no adverse effects when treatment with Tramadol/Paracetamol Viatris is interrupted. However, in rare cases, people who have been taking tramadol for a while may feel unwell if they stop treatment abruptly.

If therapy is no longer necessary, you should interrupt treatment by gradually reducing the dose to avoid withdrawal symptoms.

People may:

• Feel agitated, anxious, nervous, or shaky.
• Be hyperactive.
• Have difficulty breathing.
• Have stomach or intestinal discomfort.

Very few people may also experience:

• Panic attacks.
• Alucinations, unusual perceptions such as itching, tingling, and numbness.
• Tinnitus (ringing in the ears).

If you experience any of these symptoms after interrupting treatment with Tramadol/Paracetamol Viatris, consult your doctor.

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

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

If you think you may be experiencing any of the following side effects, stop taking this medicine and contact your doctor or go immediately to the nearest hospital. You may need medical attention if you experience these side effects:

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

• Blood in the stool (the stool may be black and have a tar-like appearance or be a deep red color).
• Difficulty or pain when urinating.

Very rare(may affect up to 1 in 10,000 people)

• Severe skin reactions have been reported.

Frequency not known(cannot be estimated from available data)

• Serotonin syndrome, which may manifest as changes in mental state (e.g., agitation, hallucinations, coma), and other effects, such as fever, rapid heart rate, unstable blood pressure, involuntary muscle contractions, muscle rigidity, loss of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) (see section 2 “What you need to know before starting to take Tramadol/Paracetamol Viatris”).
• Alterations in the effect of warfarin (used to prevent blood clotting), including prolongation of prothrombin time (which reduces blood clotting).
• Changes in blood cell levels (seen in a blood test) with frequent infections (fever, intense chills, sore throat, or mouth ulcers).

Other side effects include:

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

• Dizziness, somnolence.
• Sensation of spinning.

Common(may affect up to 1 in 10 people)

• Confusion, alteration of mood, anxiety, nervousness, euphoria, sleep disturbances.
• Headache, agitation.
• Nausea (sensation of spinning), constipation, dry mouth, diarrhea, stomach pain, indigestion, stomach discomfort, gas.
• Sweating, itching.

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

• Depression, hallucinations (seeing, feeling, or hearing things that are not there), nightmares, memory loss.
• Involuntary muscle contractions, numbness or tingling, ringing in the ears.
• High blood pressure, palpitations, rapid or irregular heart rate.
• Abnormal heart rhythm (arrhythmia).
• Difficulty breathing.
• Difficulty swallowing.
• Elevated levels of transaminase (a liver enzyme).
• Skin reactions (e.g., rash, urticaria).
• Albumin (a protein) in the urine (albuminuria).
• Chills, hot flashes, chest pain.

Very rare(may affect up to 1 in 10,000 people)

• Pharmacological dependence.
• Loss of coordination.
• Speech disorders.
• Blurred vision, pupil constriction or dilation.
• Transient loss of consciousness (syncope)/collapse.

Frequency not known(cannot be estimated from available data)

• Abuse of medications.

Other side effects reported by people using medications containing only tramadol or only paracetamol:

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

• Changes in appetite, muscle weakness.

Frequency not known(cannot be estimated from available data)

• Sensation of spinning when standing up from a lying or sitting position, slow heart rate,changes in blood cell levels (seen in blood tests) with bleeding or bruising more easily than normal.
• The ingestion of paracetamol alone or with theantibiotic flucloxacillin may induce an anomaly in the blood and fluids (metabolic acidosis with high anion gap) when there is an increase in plasma blood acidity.
• Alterations in mood, alteration in activity, and alteration in perception.
• Exacerbation of existing asthma.
• Hiccup.

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 leaflet. You can also report them directly through the Spanish System for the 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.

Keepthis medicationout of the sight and reach of children.

Store this medication in a safe and protected place, where other people cannot access it. It can cause serious harm and be fatal to individuals when not prescribed.

Do not use this medication after the expiration date that appears on the blister pack and on the box 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 disposed of through drains or trash. Deposit the containers and medications you no longer need at the SIGRE collection pointat the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Composition of Tramadol/Paracetamol Viatris

• The active ingredients are:hydrochloride of tramadol and paracetamol. A film-coated tablet contains 37.5 mg of hydrochloride of tramadol and 325 mg of paracetamol.
• The other components are:

Core of the film-coated tablet:

pregelatinized cornstarch, cornstarch, sodium carboxymethylstarch of potato (potato starch), microcrystalline cellulose, magnesium stearate.

Film coating::

hypromellose (E-464), titanium dioxide (E-171), triacetin, yellow iron oxide (E-172).

Appearance of the product and contents of the package

Your medicine is presented as a film-coated tablet, light yellow and elongated.

The PVC/PVdC/Al or PVC/Al blisters contain 2, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100 film-coated tablets.

Only some package sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing

MEDIS INTERNATIONAL a.s.

Výrobní závod Bolatice

Prúmyslová 961/16

747 23 Bolatice

Republic of Czech

O

McDermott Laboratories Ltd. T/A Gerard Laboratories T/A Mylan Dublin

35/36 Baldoyle Industrial Estate

Grange Road, Dublin 13

Ireland

O

Martin Dow

Goualle Le Puy, Champ de Lachaud

19250 Meymac

France

O

Mylan Hungary Kft.

Mylan utca 1.

Komarom, 2900

Hungary

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine has been authorized in the EEA member states with the following names:

SlovakiaTramylpa 37.5 mg/325 mg

SpainTramadol/Paracetamol Viatris 37.5 mg/325 mg film-coated tablets EFG

PortugalTramadol + Paracetamol Mylan 37.5 mg + 325 mg film-coated tablets

Republic of CzechTramylpa 37.5 mg/325 mg coated tablets

Last review date of this leaflet:May2024

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