Tramadol/paracetamol ViatriS 37.5 mg/325 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Tramadol/Paracetamol Viatris 37.5 mg/325 mg

film-coated tablets EFG

Tramadol hydrochloride/Paracetamol

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. 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 this leaflet

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

1. What Tramadol/Paracetamol Viatris is and what it is used for

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

Tramadol/Paracetamol Viatris is used for the treatment of moderate to severe pain. Your doctor will prescribe this medicine if they consider it advisable to use a combination of tramadol hydrochloride and paracetamol.

Tramadol/Paracetamol Viatris should only be used in adults and adolescents aged 12 years or older.

2. What you need to know before taking Tramadol/Paracetamol Viatris

Do not take Tramadol/Paracetamol Viatris:

• If you are allergic to tramadol, paracetamol, or any of the other ingredients of this medicine (listed in section 6).
• In cases of acute alcohol intoxication.
• If you are taking sleeping pills, painkillers, or medicines that affect mood and emotions (psychotropic medicines).
• If you are also taking medicines known as monoamine oxidase inhibitors (MAOIs) or within two weeks after stopping such treatment. MAOIs are used to treat depression or Parkinson’s disease.
• If you have severe liver disorders.
• If you have epilepsy that is not adequately controlled with your current medication.

Warnings and precautions

Consult your doctor or pharmacist before taking 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 medicines”).
• If you have severe kidney problems. In this case, the use of Tramadol/Paracetamol Viatris is not recommended. In cases of moderate kidney impairment, 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 turn yellowish, which may indicate jaundice or bile duct problems.
• If you have serious breathing difficulties, such as asthma or severe lung problems.
• If you have recently suffered a head injury or severe headaches associated with vomiting (dizziness).
• If you have epilepsy or have previously experienced seizures or convulsions.
• If you have a decreased level of consciousness for unknown reasons.

During treatment with Tramadol/Paracetamol Viatris, inform your doctor immediately if:

You have serious illnesses such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients in these situations when paracetamol is used regularly over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulty with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

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

There is a slight risk that you may experience serotonin syndrome, which may occur after taking tramadol in combination with certain antidepressants or tramadol as monotherapy. Contact a doctor immediately if you develop any symptoms associated with this serious syndrome (see section 4 “Possible side effects”).

Tramadol should not be used as a substitution therapy in opioid-dependent patients, as it does not suppress morphine withdrawal symptoms.

Tramadol may cause seizures even at recommended doses. Therefore, patients with epilepsy controlled by medication or those prone 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 individuals in different ways. In some people, sufficient pain relief may not be achieved, while others may be more likely to experience serious adverse effects. If you notice any of the following adverse effects, you must stop taking this medicine and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, pinpoint pupils, malaise, constipation, loss of appetite.

Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure may be signs of adrenal insufficiency (low cortisol levels). If you experience these symptoms, contact your doctor, who will decide whether you need hormonal supplementation.

Sleep-related breathing disorders

Tramadol/paracetamol may cause sleep-related breathing 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 shortness of breath, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor. Your doctor may consider reducing the dose.

Tolerance, dependence, and addiction

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

Dependence or addiction may make you feel that you no longer control the amount of medicine you need to take or how often you 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 Tramadol/paracetamol if:

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

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

• You need to take the medicine for longer than advised by your doctor.
• You need to take more than the recommended dose.
• You use the medicine for reasons other than prescribed, e.g., “to feel calm” or “to sleep.”
• You have repeatedly tried and failed 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 effect).

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

Children and adolescents

Treatment with Tramadol/Paracetamol Viatris is not recommended in children under 12 years of age. Safety and efficacy have not been established in children.

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

Abuse

At therapeutic doses, tramadol may cause withdrawal symptoms.

Surgery

The use of tramadol with the anesthetics enflurane and nitrous oxide during general anesthesia may help the anesthetist recover the patient during surgery if needed. Until more information is available, tramadol use should be avoided during light anesthesia. Inform your doctor or dentist if you are to be anesthetized.

Use of Tramadol/Paracetamol Viatris with other medicines

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

Important: This medicine contains paracetamol and tramadol. Inform your doctor if you are taking any other medicine containing paracetamol or tramadol to avoid exceeding the maximum daily dose.

Concomitant use of Tramadol/Paracetamol Viatris with sedatives, such as benzodiazepines or related drugs, 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 Tramadol/Paracetamol Viatris together with sedatives, your doctor should limit the dose and duration of concomitant treatment.

Inform your doctor about all sedatives you are taking, and follow your doctor’s dosage recommendations carefully. It may be helpful to inform your friends or family so they are aware of the symptoms described above. Contact your doctor if you experience such symptoms.

Tramadol/Paracetamol Viatris must not be taken together with: MAO inhibitors (used in the treatment of depression or Parkinson’s disease), as there is a risk of serotonin syndrome. Symptoms of serotonin syndrome include diarrhea, increased heart rate, sweating, tremor, confusion, and even coma. If you have recently been treated with MAO inhibitors, a two-week interval must be observed before starting treatment with Tramadol/Paracetamol Viatris.

Tramadol/Paracetamol Viatris should not be taken together with:

• Carbamazepine (a medicine used to treat epilepsy and certain types of pain, such as acute facial pain known as trigeminal neuralgia). If taken simultaneously, the effectiveness and duration of tramadol’s effect may be reduced.
• Opioid-type analgesics (buprenorphine, nalbuphine, pentazocine). If taken simultaneously, the analgesic effect of Tramadol/Paracetamol Viatris may be reduced, with a risk of withdrawal syndrome.

Inform your doctor or pharmacist if you are taking:

• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) requiring urgent treatment (see section 2).
• Gabapentin or pregabalin for treating epilepsy or nerve-related pain (neuropathic pain).

The risk of adverse effects increases:

• If you are taking medicines that may cause seizures (fits), 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 advise you whether Tramadol/Paracetamol Viatris is suitable for you.
• If you are taking certain antidepressants (selective serotonin reuptake inhibitors (SSRIs)) or triptans (used for migraine). Tramadol/Paracetamol Viatris may interact with these medicines, and you may experience serotonin syndrome (see section 4 “Possible side effects”).
• Other opioid derivatives (including cough medicines and substitution treatments), barbiturates, and benzodiazepines (sedatives). If taken simultaneously, the risk of respiratory depression may increase, which could be fatal in case of overdose.
• Other central nervous system depressants, anxiolytics (used to reduce fear), hypnotics, sedating antidepressants, sedating antihistamines (used to treat allergies), neuroleptics (used to treat psychosis), centrally acting antihypertensives (used to reduce blood pressure), thalidomide (a sedative), and baclofen (a muscle relaxant). These medicines may worsen central depression. The effect on alertness may make driving and operating machinery dangerous.
• Warfarin or other anticoagulants, for example, phenprocoumon (used to prevent blood clots). The effectiveness of these medicines may be altered, leading to bleeding. Your doctor may need to monitor your prothrombin time regularly. Any prolonged or unexpected bleeding should be reported to your doctor immediately.
• Other medicines known to inhibit the liver enzyme “CYP3A4”, such as ketoconazole and erythromycin (medicines used against infections).
• Metoclopramide or domperidone (medicines used to treat nausea and vomiting/dizziness). These may increase the absorption of paracetamol if taken simultaneously.
• Colestyramine (a medicine used to lower blood cholesterol), as it may reduce the absorption of Tramadol/Paracetamol Viatris.
• If you have taken ondansetron (used to treat nausea), the effectiveness of Tramadol/Paracetamol Viatris may be altered.

Taking Tramadol/Paracetamol Viatris with alcohol

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

Pregnancy and breastfeeding

Since Tramadol/Paracetamol Viatris contains tramadol, do not take this medicine during pregnancy.

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

Based on human experience, tramadol is not thought to affect fertility in men or women. There are no data available on the combination of tramadol and paracetamol regarding fertility.

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.

Driving and using machines

This medicine may cause drowsiness or dizziness, which may be intensified by alcohol or other depressants affecting the central nervous system. If you feel drowsy or dizzy, you should not drive or operate machinery.

Tramadol/Paracetamol Viatris contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially “sodium-free”.

3. How to take Tramadol/Paracetamol Viatris

Always follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, your doctor will explain to you what to 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 stop taking it (see also section 2).

Recommended dose:

Adults and adolescents (12 years of age or older):

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

Elderly patients (over 75 years of age):

In elderly patients (over 75 years of age), elimination of tramadol hydrochloride may be delayed. If this applies to you, your doctor may recommend extending the dosing interval.

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

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

Use in children under 12 years of age

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

Method of administration

• Take the tablets by mouth.
• Swallow the tablets whole, with a sufficient amount of liquid (for example, a 200 ml glass of water). The tablets must not be split or chewed.
• Tramadol/Paracetamol Viatris may be taken with or without food.

Duration of treatment

Do not take this medicine for longer than strictly necessary.

If repeated or prolonged treatment with this medicine is required (due to the nature or severity of the illness), caution should be exercised and regular monitoring should be carried out to assess whether continued treatment is necessary. Whenever possible, treatment breaks should be introduced during long-term therapy.

If you think the effect of Tramadol/Paracetamol Viatris is too strong (for example, you feel very drowsy or have difficulty breathing) or too weak (for example, 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, contact your doctor or the nearest emergency department immediately, even if you feel well, due to the risk of delayed severe liver damage.
• In case of overdose, you may experience nausea (feeling of dizziness), miosis (pupil constriction), vomiting (feeling of dizziness), anorexia (loss of appetite), severe circulatory failure (cardiovascular collapse), disturbances of consciousness, including coma, seizures, respiratory depression which may lead to respiratory arrest, and pale skin.
• Liver damage may occur 12 to 48 hours after ingestion. In severe poisoning, liver failure may lead to severe brain disease (encephalopathy), coma, and death. Severe kidney failure with tubular necrosis (cell destruction) may also develop, even in the absence of severe liver damage. Cardiac arrhythmias (irregular heartbeat) and pancreatitis (inflammation of the pancreas) have also been observed.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Tramadol/Paracetamol Viatris

If you forget to take this medicine, you may skip the missed dose and continue treatment as normal, or you may take the missed tablet, but you must wait 6 hours until the next dose.

Do not take a double dose to make up for missed doses.

If you stop taking Tramadol/Paracetamol Viatris

You must not stop taking this medicine suddenly, unless your doctor tells you to. If you wish to stop taking the medicine, you should first discuss it with your doctor, especially if you have been taking it for a long time. Your doctor will advise you on when and how to stop taking it, which may involve gradually reducing the dose to reduce the likelihood of experiencing unnecessary adverse effects (withdrawal symptoms).

Generally, there will be no adverse effects when stopping treatment with Tramadol/Paracetamol Viatris. However, rarely, people who have been taking tramadol for some time may feel unwell if they stop treatment suddenly.

If therapy is no longer needed, treatment should be discontinued by gradually reducing the dose to avoid withdrawal symptoms.

People may:

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

Very few people may also experience:

• Panic attacks.
• Hallucinations, unusual perceptions such as itching, tingling, and numbness.
• Ringing in the ears.

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

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 can cause adverse effects, although not everyone will experience them.

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

Uncommon (may affect up to 1 in 100 people)

• Blood in the stools (faeces may be black and look like tar or bright red in colour).
• Difficulty or pain when urinating.

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

• Sudden signs of allergic reactions such as rash, itching or hives on the skin, swelling of the face, lips, tongue and other body parts, shortness of breath, wheezing or difficulty breathing, low blood pressure.
• Seizures (fits).
• Shallow or slow breathing.
• Severe confusion, which may be associated with hallucinations (seeing, feeling or hearing things that are not real), increased or decreased activity, and sleep disturbances (delirium).

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

• Cases of serious skin reactions have been reported.

Frequency not known (cannot be estimated from the available data)

• Serotonin syndrome, which may present with changes in mental status (e.g., agitation, hallucinations, coma), and other effects such as fever, increased heart rate, unstable blood pressure, involuntary muscle contractions, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea) (see section 2 “What you need to know before taking Tramadol/Paracetamol Viatris”).
• Changes in the effect of warfarin (used to prevent blood clots), including prolonged prothrombin time (which leads to reduced blood clotting).
• Changes in blood cell levels (seen in blood tests) with frequent infections (fever, severe chills, sore throat or mouth ulcers).

Other adverse effects include:

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

• Dizziness, drowsiness.
• Feeling of dizziness.

Common (may affect up to 1 in 10 people)

• Confusion, mood disturbance, anxiety, restlessness, euphoria, sleep disorders.
• Headache, agitation.
• Vomiting (feeling of nausea), constipation, dry mouth, diarrhoea, stomach pain, indigestion, stomach discomfort, flatulence.
• Sweating, itching.

Uncommon (may affect up to 1 in 100 people)

• Depression, hallucinations (seeing, feeling or hearing things that are not real), nightmares, memory loss.
• Involuntary muscle contractions, tingling or numbness, ringing in the ears.
• High blood pressure, palpitations, fast or irregular heartbeat.
• Disturbances in the heart's electrical 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 flushes, chest pain.

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

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

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

• Medication abuse.

Frequency not known (cannot be estimated from the available data)

• Decreased blood sugar (glucose) levels, causing sweating, weakness, hunger, dizziness, tremor, headache, flushing or pallor, numbness, rapid and strong heartbeat.

In addition, the following adverse effects have been reported by people using medicines 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 the available data)

• Dizziness when standing up from a lying or sitting position, slow heart rate, changes in blood cell levels (seen in blood tests) with increased tendency to bleed or bruise more easily than normal.
• A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who are using paracetamol (see section 2).
• Mood disturbances, changes in activity, and altered perception.
• Worsening of pre-existing asthma.
• Hiccups.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 Tramadol/Paracetamol Viatris

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

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

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

This medicine requires no special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. Ask your pharmacist how to properly 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 Tramadol/Paracetamol Viatris

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

Tablet core:

Pregelatinized corn starch, corn starch, sodium carboxymethyl potato starch (potato starch), microcrystalline cellulose, magnesium stearate.

Film coating:

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

Appearance of the medicine and contents of the pack

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer

MEDIS INTERNATIONAL a.s.
Výrobní závod Bolatice
Prúmyslová 961/16
747 23 Bolatice
Czech Republic

Or

McDermott Laboratories Ltd. T/A Gerard Laboratories T/A Mylan Dublin
35/36 Baldoyle Industrial Estate
Grange Road, Dublin 13
Ireland

Or

Martin Dow
Goualle Le Puy, Champ de Lachaud
19250 Meymac
France

Or

Mylan Hungary Kft.
Mylan utca 1.
Komarom, 2900
Hungary

For further information about this medicine, please contact 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 under the following names:

Slovakia: Tramylpa 37.5 mg/325 mg
Spain: Tramadol/Paracetamol Viatris 37.5 mg/325 mg film-coated tablets EFG
Portugal: Tramadol + Paracetamol Mylan 37.5 mg + 325 mg film-coated tablets
Czech Republic: Tramylpa 37.5 mg/325 mg potahované tablety

Date of the most recent revision of this leaflet: January 2025

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