Package Leaflet: Information for the User

Tramadol/Paracetamol Vir 37.5 mg/325 mg Film-Coated Tablets

Tramadol/paracetamol hydrochloride

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

• Keep this leaflet, as 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 give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet.

Tramadol/Paracetamol Vir is a combination of two analgesics: Tramadol and paracetamol, which act together to relieve pain.

It is indicated for symptomatic treatment of moderate to intense pain whenever your doctor believes that the combination of tramadol and paracetamol is necessary.

It should only be used by adults and children over 12 years old.

Do not take Tramadol/Paracetamol Vir if you:

• are allergic (hypersensitive) to tramadol, paracetamol, or any of the other components of this medication (listed in section 6).

-have acute alcohol intoxication, if you have taken any medication for insomnia, potent analgesics (opioids), or psychotropic drugs (drugs that can alter the level of consciousness).

-are taking monoamine oxidase inhibitors (MAOIs) (certain medications used to treat depression or Parkinson's disease), or if you have taken them in the last 14 days before treatment with Tramadol/Paracetamol Vir.

-have severe liver disease.

-have uncontrolled epilepsy.

Warnings and precautions

• If you are taking other medications that contain paracetamol or tramadol;
• If you have liver problems or liver disease, or if you notice that your eyes or skin turn yellow. This may be indicative of jaundice or problems with your bile ducts;
• If you have kidney problems;
• If you have severe respiratory difficulties, for example, asthma or severe lung problems;
• If you are epileptic or have had seizures;
• If you have recently had a head injury, severe headaches associated with vomiting;
• If you are dependent on any other medication used to relieve pain, for example, morphine;
• If you are taking other medications for pain relief that contain buprenorphine, nalbuphine, or pentazocine;
• If you are to be anesthetized. Inform your doctor or dentist that you are using Tramadol/Paracetamol Vir.
• Tramadol is metabolized in the liver by an enzyme. Some people have a variation of this enzyme, and this can affect each person differently. In some people, it may not be possible to achieve sufficient pain relief, while others may be more likely to experience severe adverse effects. If you notice any of the following adverse effects, stop taking this medication and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general discomfort, or vomiting, constipation, loss of appetite.
• If you suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Other medications and Tramadol/Paracetamol Vir).
• If you have severe diseases, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (a blood and fluid anomaly) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe respiratory difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

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 tolerant of it, known as tolerance). Repeated use of tramadol/paracetamol can also lead to dependence, abuse, and addiction, which can result in a potentially fatal overdose. The risk of these adverse effects may increase with a higher dose and longer duration of use.

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

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

• You or a family member has abused or been dependent on alcohol, prescription medications, or illegal drugs ("addiction").
• You are a smoker.
• You have had problems with your mood (depression, anxiety, or a 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 a longer period 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 stay calm" or "to sleep".
• You have repeatedly and unsuccessfully tried to stop or control the use of the medication.
• You feel unwell when you stop taking the medication, and you feel better when you start taking it again ("withdrawal symptoms").

If you observe 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 interrupt treatment with Tramadol/paracetamol Vir).

Respiratory problems related to sleep

Tramadol/Paracetamol Vir may cause respiratory problems 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 notices these symptoms, contact your doctor. Your doctor may consider reducing the dose.

Consult your doctor or pharmacist before starting to take Tramadol/Paracetamol Vir.

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 alone. Consult a doctor immediately if you experience any of the symptoms associated with this severe syndrome (see section 4 "Possible adverse effects").

If you experience or have experienced any of these problems while taking Tramadol/Paracetamol Vir, please inform your doctor. Your doctor will decide if you should continue taking this medication.

Children and adolescents

Use in children with respiratory problems

Tramadol is not recommended for use in children with respiratory problems, as the symptoms of tramadol toxicity can worsen in these children.

Taking Tramadol/Paracetamol Vir 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.

Youmust not takeTramadol/Paracetamol Virtogether with monoamine oxidase inhibitors (MAOIs) (see section ("Do not takeTramadol/Paracetamol Vir"))

Tramadol/Paracetamol Vir is contraindicated for use if you are being treated with:

• Carbamazepine (a medication normally used to treat epilepsy or some types of pain, such as severe facial pain called trigeminal neuralgia).
• Buprenorphine, nalbuphine, or pentazocine (opioid analgesic). Pain relief may be reduced.

The risk of adverse effects increases if you are also using:

• Triptans (for the treatment of migraines) or selective serotonin reuptake inhibitors, "SSRIs" (for the treatment of depression). If you experience confusion, agitation, fever, sweating, uncoordinated limb or eye movements, involuntary muscle contractions, or diarrhea, you should call your doctor.

-Sedatives, sleeping pills, other pain relievers such as morphine and codeine (also when used to treat cough), baclofen (muscle relaxant), some medications to lower blood pressure, antidepressants, or medications for allergy treatment. You may feel drowsy or dizzy. If this occurs, consult your doctor.

- Antidepressants, anesthetics, neuroleptics (medications that affect mood) or bupropion (medication used as a smoking cessation aid). The risk of having a seizure may increase. Your doctor will tell you if Tramadol/Paracetamol Vir is suitable for you.

- Gabapentin or pregabalin for treating epilepsy or pain due to nerve problems (neuropathic pain).

- Warfarin or phenprocoumon (medication used to prevent blood clots). The effectiveness of these medications may be altered, with a risk of bleeding. Inform your doctor immediately of any prolonged or unexpected bleeding.

-flucloxacillin (antibiotic), due to a severe risk ofblood and fluid anomaly (calledmetabolic acidosis with high anion gap) that requires urgent treatment.

The effectiveness of Tramadol/Paracetamol Vir may be altered if you are also using:

- Metoclopramide, domperidone, or ondansetron (medications for nausea and vomiting),

- Cholestyramine (medication that reduces cholesterol in the blood),

- Ketoconazole and erythromycin (medications used to treat infections).

The risk of adverse effects increases,

- If you are taking medications that facilitate or may cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Tramadol/Paracetamol simultaneously with these medications. Your doctor will tell you if Tramadol/Paracetamol is suitable for you.

• - If you are taking antidepressants, Tramadol/Paracetamol may interact with these medications and may experiencea serotonin syndrome (see section 4 “possible adverse effects”)

Your doctor will know which medications are safe to use with Tramadol/Paracetamol Vir

Talk to your doctor or pharmacist if you experience:

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 have these symptoms, contact your doctor, who will decide if you need to take hormone supplements.

Taking Tramadol/Paracetamol Vir with food and drinks

Tramadol/Paracetamol Virmay make you feel drowsy. Alcohol may make you feel more drowsy, so it is recommended not to drink alcohol while takingTramadol/Paracetamol Vir.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Due to the fact that Tramadol/Paracetamol Vir 37.5 mg/325 mg tablets contain tramadol, it is not recommended to use this medication during pregnancy.

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

Lactation

Tramadol is excreted in breast milk. Therefore, you should not take tramadol/paracetamol more than once during lactation, or if you take tramadol/paracetamol more than once, you should interrupt breastfeeding.

Driving and operating machines

Ask your doctor if you can drive or operate machines during treatment with Tramadol/Paracetamol Vir 37.5 mg/325 mg tablets. It is essential to observe how this medication affects you before driving or operating machines. Do not drive or operate machines if you feel drowsy, dizzy, have blurred vision, or double vision, or have difficulty concentrating. Be especially careful at the start of treatment, after increasing the dose, after changing the formulation, and/or taking it concurrently with other medications.

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 stop it (see also section 2).

Follow exactly the administration instructions of this medication indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

You should take Tramadol/Paracetamol Vir for the shortest time possible. The dose should be adjusted to the intensity of the pain and your individual sensitivity. Normally, the lowest dose possible that produces pain relief should be used.

Use in children

This medication is not recommended for use in children under 12 years old.

Use in adults

Unless your doctor prescribes something different, the usual starting dose for adults and adolescents over 12 years old is 2 tablets.

If necessary, you can increase the dose, as recommended by your doctor. The shortest interval between doses should be at least 6 hours.

Do not take more than 8 tablets of Tramadol/Paracetamol Vir per day.

Do not take Tramadol/Paracetamol Vir more frequently than your doctor has indicated. Your doctor may increase the interval between doses.

- If you are over 75 years old.

- If you have kidney problems.

- If you have liver problems.

Older patients

In elderly patients (over 75 years old), the elimination of tramadol may be slow. If this is your case, your doctor may recommend prolonging the dosing intervals.

Patients with liver or kidney insufficiency/patients on dialysis

If you have a severe liver or kidney disease, treatment with Tramadol/Paracetamol is not recommended. If you have moderate liver or kidney problems, your doctor may prolong the dosing intervals.

Administration form

Tramadol/Paracetamol Vir is presented in the form of tablets for oral administration. The tablets should be swallowed whole with sufficient liquid. They should not be broken or crushed. If you estimate that the effect of Tramadol/Paracetamol Vir is too strong (e.g., you feel very drowsy or have difficulty breathing) or too weak (e.g., you do not have adequate pain relief), inform your doctor.

If you take more Tramadol/Paracetamol Vir than you should

If you have taken more Tramadol/Paracetamol Vir than you should, although you feel well, consult your doctor immediately, as there is a risk of severe liver damage that will only become apparent later.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone 91 562 04 20.

If you forget to take Tramadol/Paracetamol Vir

If you forget to take a dose of Tramadol/Paracetamol Vir, it is likely that the pain will recur. Do not take a double dose to compensate for the missed doses, simply continue taking the tablets as usual.

If you interrupt treatment with Tramadol/Paracetamol Vir

You should not stop taking this medication suddenly unless your doctor tells you to. If you want to stop taking your medication, talk to your doctor first, especially if you have been taking it for a long time. Your doctor will inform you when and how to stop it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary adverse effects (withdrawal symptoms).

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

Very common: more than 1 in 10 people treated;

- nausea.

- dizziness, drowsiness.

Common: less than 1 in 10, but more than 1 in 100 people treated;

- vomiting, digestive problems (constipation, flatulence, diarrhea), stomach pain, dry mouth.

- itching, increased sweating.

- headache, agitation

- confusion, sleep disorders, mood changes (anxiety, nervousness, euphoria, feeling "high" all the time),

Uncommon: less than 1 in 100, but more than 1 in 1,000 people treated;

- tachycardia, hypertension, cardiac rhythm and frequency disorders

- difficulty or pain urinating

- skin reactions (e.g. rashes, urticaria)

- numbness, tingling, or pins and needles sensation in the extremities, ear noises, involuntary muscle spasms.

- depression, nightmares, hallucinations, (hearing, seeing or perceiving something that does not exist in reality), memory loss

- difficulty swallowing, blood in the stool

- chills, hot flashes, chest pain

- difficulty breathing.

Rare: less than 1 in 1,000, but more than 1 in 10,000 people treated;

- convulsions, difficulties with coordinated movements.

- Addiction

- Blurred vision

Frequency not known: Hiccups

Frequency unknown (cannot be estimated from available data)

Serotonin syndrome, which can manifest as changes in mental state (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, diarrhea) (see section 2 "what you need to know before taking Tramadol/Paracetamol").

Very rarely, severe skin reactions have been reported

The following adverse reactions recognized have been reported by people who have taken medications containing only tramadol or only paracetamol. However, if you experience any of those symptoms while taking Tramadol/Paracetamol Vir, please tell your doctor:

Dizziness when standing up after lying down or sitting, low heart rate, fainting, changes in appetite, muscle weakness, slower or weaker breathing, mood changes, activity changes, perception changes, worsening of asthma.

• In rare cases, skin eruptions, indicative of allergic reactions that may manifest as sudden swelling of the face and neck, shortness of breath, or a drop in blood pressure and dizziness. If this happens to you, stop treatment and consult your doctor immediately. Do not take this medicine again.
• In rare cases, using a medicine like tramadol, may make you dependent, making it difficult to stop taking it. In rare cases, people who have been taking tramadol for some time may feel unwell if they stop treatment abruptly. They may feel agitated, anxious, nervous, or shaky. They may be hyperactive, have difficulty sleeping, and experience gastrointestinal and intestinal disorders. Very few people may also experience panic attacks, hallucinations, unusual perceptions such as itching, numbness, and tingling, and ear noises (tinnitus). If you experience any of these symptoms after stopping treatment with Tramadol/Paracetamol Vir, please consult your doctor. In exceptional cases, blood tests may reveal certain abnormalities, such as low platelet count, which may result in nasal or gum bleeding. The use of Tramadol/Paracetamol Vir with anticoagulants (e.g. phenprocoumon, warfarin) may increase the risk of bleeding. Please inform your doctor immediately about any prolonged or unexpected bleeding.

Frequency not known (cannot be estimated from available data):A serious disease that can make the blood more acidic (designated metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

Reporting of adverse reactions

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

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

No special storage conditions are required.

Keep this medication out of sight and reach of children.

Do not use this medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Tramadol/Paracetamol Vir

• The active principles are tramadol hydrochloride and paracetamol.

Each film-coated tablet contains 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol.

• The other components are:

Core of the tablet:

Maize pregelatinized starch, sodium carboxymethyl starch (Type A) from potato, microcrystalline cellulose (Avicel PH 102), magnesium stearate, magnesium stearate.

Coating: OPADRY yellow YS-15B82958 (hypromellose, polyethylene glycol, titanium dioxide (E171), iron oxide yellow (E172), polysorbate 80).

Appearance of the product and contents of the packaging

Tramadol/Paracetamol Vir 37.5/325 mg film-coated tablets, EFG, are presented in the form of pale yellow tablets packaged in blisters.

Tramadol/Paracetamol Vir is presented in packaging of 20, 60, and 100 tablets.

Only some packaging sizes may be commercially marketed.

Holder of the marketing authorization and Responsible for Manufacturing:

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70. Pol. Ind. Urtinsa II

28923 Alcorcón (Madrid)

Spain

Last review date of this leaflet: February 2025

“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.es/”