TRAMADOL/PARACETAMOL VIR 37.5 mg/325 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

Tramadol/Paracetamol Hydrochloride

Read all of 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 have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the Package Leaflet

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

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

Tramadol/Paracetamol Vir is a combination of two pain relievers: Tramadol and Paracetamol, which work together to relieve pain.

It is indicated for the symptomatic treatment of moderate to severe pain, when your doctor considers that a combination of tramadol and paracetamol is necessary.

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

2. What you need to know before you take Tramadol/Paracetamol Vir

Do not take Tramadol/Paracetamol Vir if you:

• are allergic (hypersensitive) to tramadol, paracetamol, or any of the other ingredients of this medicine (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 breathing difficulties, for example, asthma or severe lung problems
• If you are epileptic or have had seizures.
• If you have recently suffered a head injury, severe headaches associated with vomiting.
• If you are dependent on any other medication used for pain relief, for example, morphine;
• If you are taking other medications for pain relief that contain buprenorphine, nalbuphine, or pentazocine;
• If you are going to be anesthetized. Tell your doctor or dentist that you are using Tramadol/Paracetamol Vir.
• Tramadol is transformed in the liver by an enzyme. Some people have a variation of this enzyme, and this can affect each person differently. In some people, sufficient pain relief may not be achieved, while others are more likely to suffer serious side effects. If you notice any of the following side effects, you should stop taking this medication and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general malaise, 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 illnesses, 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 if you are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (an anomaly in the blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties 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 get used to it, which is 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 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 varies from person to person. You may have a higher risk of becoming dependent or addicted to tramadol/paracetamol if:

• You or someone in your family has abused or been dependent on alcohol, prescription medications, or illegal drugs ("addiction").
• You are a smoker.
• You have ever had problems with your mood (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 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 calm down" 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 symptoms").

If you observe any of these signs, talk to your doctor so that they can indicate the best course of treatment for you, including when it is appropriate to stop taking it and how to do so safely (see section 3, if you interrupt treatment with Tramadol/Paracetamol Vir).

Respiratory Disorders Related to Sleep

Tramadol/Paracetamol Vir may cause sleep-related respiratory disorders, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen level in the blood). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to lack of breath, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, contact your doctor. Your doctor may consider reducing the dose.

Talk to 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 present any of the symptoms related to this serious syndrome (see section 4 "Possible side effects").

If you have or have had any of these problems while taking Tramadol/Paracetamol Vir, please inform your doctor. They 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

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

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.

You must not takeTramadol/Paracetamol Vir with monoamine oxidase inhibitors (MAOIs) (see section "Do not take Tramadol/Paracetamol Vir")

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

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

The risk of side effects increases if you are also taking:

• 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, or diarrhea, you should call your doctor.

• Sedatives, sleeping pills, other analgesics such as morphine and codeine (also when used to treat cough), baclofen (muscle relaxant), certain medications to lower blood pressure, antidepressants, or medications for the treatment of allergies. You may feel drowsy or dizzy. If this happens, consult your doctor.
• Antidepressants, anesthetics, neuroleptics (medications that affect mood), or bupropion (a medication used as an aid to quit smoking). The risk of having a seizure may increase. Your doctor will tell you if Tramadol/Paracetamol Vir is suitable for you.
• Gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain).
• Warfarin or phenprocoumon (a medication used to prevent blood clots). The effectiveness of these medications may be altered, and there is a risk of bleeding. You should inform your doctor immediately of any prolonged or unexpected bleeding.
• Flucloxacillin (an antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis with high anion gap) that requires urgent treatment.

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

• Metoclopramide, domperidone, or ondansetron (medications for the treatment of nausea and vomiting),
• Cholestyramine (a medication that lowers cholesterol in the blood),
• Ketoconazole and erythromycin (medications used against infections).

The risk of side effects increases,

• If you are taking medications that can 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 you may experience a serotonin syndrome (see section 4 "Possible side 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 hormonal supplements.

Taking Tramadol/Paracetamol Vir with Food and Drinks

Tramadol/Paracetamol Vir may make you feel drowsy. Alcohol may make you feel more drowsy, so it is recommended not to drink alcohol while taking Tramadol/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, the use of this medication is not recommended during pregnancy.

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

Breastfeeding

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

Driving and Using Machines

Ask your doctor if you can drive or use machines during treatment with Tramadol/Paracetamol Vir 37.5 mg/325 mg tablets. It is important that before driving or using machines, you observe how this medication affects you. Do not drive or use machines if you feel drowsy, dizzy, have blurred vision, or see double, or have difficulty concentrating. Be especially careful at the start of treatment, after a dose increase, after a change in formulation, and/or when administering it in combination with other medications.

3. How to Take Tramadol/Paracetamol Vir

Before starting treatment and regularly during treatment, 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 taking it (see also section 2).

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

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

Use in Children

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

Use in Adults

Unless your doctor prescribes otherwise, the normal starting dose for adults and adolescents over 12 years of age is 2 tablets.

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

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

Do not take Tramadol/Paracetamol Vir more frequently than indicated by your doctor. 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.

Elderly 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 Hepatic or Renal Insufficiency/Patients on Dialysis

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

Method of Administration

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 chewed.

If you think 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), tell your doctor.

If you take more Tramadol/Paracetamol Vir than you should

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

In case of overdose or accidental ingestion, contact the Toxicology Information Service, telephone 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 return. Do not take a double dose to make up for the missed doses; simply continue taking the tablets as usual.

If you stop taking Tramadol/Paracetamol Vir

Do 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 taking it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary side effects (withdrawal symptoms).

4. Possible Adverse Effects

Like all medicines, this medicine may cause adverse effects, although not all people suffer from them.

Very frequent: more than 1 in 10 people treated;

• nausea.
• dizziness, drowsiness.

Frequent: 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 of being "high" all the time),

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

• tachycardia, hypertension, cardiac rhythm and frequency disorders
• difficulty or pain when urinating
• skin reactions (e.g., rashes, hives)
• tingling sensation, numbness, or pinching sensation in the limbs, ringing in the ears, 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;

• seizures, difficulties in carrying out coordinated movements.
• Addiction
• Blurred vision

Frequency not known: Hiccup

Undetermined frequency (cannot be estimated from the available data)

Serotonin syndrome, which can manifest through 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 stiffness, 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 rare cases of severe skin reactions have been reported

The following adverse effects recognized have been reported by people who have taken medicines that contained only tramadol or only paracetamol. However, if you experience any of these symptoms while taking Tramadol/Paracetamol Vir, you should tell your doctor:

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

• In rare cases, skin rashes, being indicative of allergic reactions that can manifest through the 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. You should not take this medicine again.
• In rare cases, using a medicine like tramadol can create dependence, 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 trembly. They may be hyperactive, have difficulty sleeping, and have digestive and intestinal disorders. Very few people may also have panic attacks, hallucinations, unusual perceptions such as itching, tingling, and numbness, and ringing in the ears (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 a low platelet count, which can result in nosebleeds or bleeding gums. The use of Tramadol/Paracetamol Vir with anticoagulants (e.g., phenprocoumon, warfarin) may increase the risk of bleeding. You should inform your doctor immediately about any prolonged or unexpected bleeding.

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

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 that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Tramadol/Paracetamol Vir

Keep this medicine in a safe and protected place, where other people cannot access it. It can cause serious harm and be fatal for people who have not been prescribed it.

It does not require special storage conditions.

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

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

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition ofTramadol/Paracetamol Vir

• The active ingredients 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:

Pregelatinized corn starch, sodium carboxymethylcellulose (Type A) of potato, microcrystalline cellulose (Avicel PH 102), magnesium stearate, magnesium stearate.

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

Appearance of the Product and Package Contents

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 packages of 20, 60, and 100 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder andManufacturer:

Industria Química y Farmacéutica VIR, S.A.

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

28923 Alcorcón (Madrid)

Spain

Date of the Last Revision of this Prospectus: February 2025

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