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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tramadol/Paracetamol Vir 37.5 mg/325 mg film-coated tablets EFG

Tramadol hydrochloride/paracetamol

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Contents of the leaflet

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

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

Tramadol/Paracetamol Vir is a combination of two analgesics: 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 the 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 taking Tramadol/Paracetamol Vir

Do not take Tramadol/Paracetamol Vir if you:

• are allergic (hypersensitive: skin rash, facial swelling, wheezing or difficulty breathing) to tramadol, paracetamol, or any of the other ingredients of this medicine (listed in section 6).

• are experiencing acute alcohol intoxication, have taken medications for insomnia, strong painkillers (opioids), or psychotropic drugs (medications that may alter consciousness levels).

• are taking or have taken monoamine oxidase inhibitors (MAOIs) (certain medications used to treat depression or Parkinson's disease) within the last 14 days prior to treatment with Tramadol/Paracetamol Vir.

• have severe liver disease.

• have epilepsy that is not controlled by treatment.

Warnings and precautions

• If you are taking other medications containing paracetamol or tramadol;
• If you have liver problems or liver disease, or if you notice your eyes or skin turning yellow. This may indicate jaundice or problems with your bile ducts;
• If you have kidney problems;
• If you have severe breathing difficulties, for example asthma or serious lung conditions;
• If you have epilepsy or have had seizures;
• If you have recently suffered head trauma, severe headaches associated with vomiting;
• If you are dependent on any other medication used for pain relief, such as morphine;
• If you are taking other pain medications containing buprenorphine, nalbuphine, or pentazocine;
• If you are going 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, which may affect individuals differently. 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, stop taking this medicine immediately and consult a doctor: 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 medicines and Tramadol/Paracetamol Vir").
• 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 under these conditions when paracetamol is used regularly over a prolonged period or when paracetamol is taken with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulty with deep and rapid breathing, drowsiness, nausea, and vomiting.

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids may cause the medicine to become less effective (you may become accustomed to it, known as tolerance). Repeated use of tramadol/paracetamol may also lead to dependence, abuse, and addiction, which could result in a 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 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 a family member has abused or been dependent on alcohol, prescription medicines, or illegal drugs ("addiction").
• You are a smoker.
• You have ever had mood disorders (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 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 those prescribed, for example, "to stay 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 effects").

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

Sleep-related breathing disorders

Tramadol/Paracetamol Vir 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 breathlessness, 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.

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

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

If you develop or have previously experienced any of these problems while taking Tramadol/Paracetamol Vir, please inform your doctor. They will decide whether you should continue taking this medicine.

Children and adolescents

Use in children with respiratory problems

The use of tramadol is not recommended in children with respiratory problems, as symptoms of tramadol toxicity may worsen in these children.

Taking Tramadol/Paracetamol Vir with other medicines

Inform 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, so that you do not exceed the maximum daily dose.

You must not take Tramadol/Paracetamol Vir together 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 medicine usually used to treat epilepsy or certain types of pain, such as severe facial pain attacks known as trigeminal neuralgia).
• Buprenorphine, nalbuphine, or pentazocine (opioid analgesics). Pain relief may be reduced.

The risk of adverse effects increases if you also use:

• Triptans (for migraine treatment) or selective serotonin reuptake inhibitors (SSRIs) (for depression treatment). If you experience confusion, agitation, fever, sweating, uncoordinated limb or eye movements, uncontrollable muscle contractions, or diarrhea, contact your doctor immediately.
• Sedatives, sleeping pills, other analgesics such as morphine and codeine (also when used for cough treatment), baclofen (muscle relaxant), certain blood pressure-lowering medicines, antidepressants, or allergy medications. You may feel drowsy or dizzy. If this occurs, consult your doctor.
• Antidepressants, anesthetics, neuroleptics (medicines affecting mood), or bupropion (a medicine used to help quit smoking). The risk of seizures may increase. Your doctor will advise whether Tramadol/Paracetamol Vir is suitable for you.
• Gabapentin or pregabalin (used to treat epilepsy or nerve-related pain [neuropathic pain]).
• Warfarin or phenprocoumon (medicines used to prevent blood clots). The effectiveness of these medicines may be altered, increasing the risk of bleeding. Inform your doctor immediately if you experience prolonged or unexpected bleeding.
• Flucloxacillin (an antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis with high anion gap imbalance) requiring urgent treatment.

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

• Metoclopramide, domperidone, or ondansetron (medicines used to treat nausea and vomiting);
• Colestyramine (a medicine that lowers blood cholesterol);
• Ketoconazole and erythromycin (medicines used to treat infections).

The risk of adverse effects increases:

• If you are taking medicines that may trigger or facilitate seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Tramadol/Paracetamol simultaneously with these medicines. Your doctor will advise whether Tramadol/Paracetamol is suitable for you.
  • • If you are taking antidepressants, Tramadol/Paracetamol may interact with these medicines and you may experience serotonin syndrome (see section 4 "Possible side effects").

Your doctor will know which medicines 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 signs of adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide whether you need hormonal supplements.

Taking Tramadol/Paracetamol Vir with food and drinks

Tramadol/Paracetamol Vir may make you feel drowsy. Alcohol may increase drowsiness; therefore, it is recommended not to drink alcohol while taking Tramadol/Paracetamol Vir.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Because Tramadol/Paracetamol Vir 37.5 mg/325 mg tablets contain tramadol, the use of this medicine during pregnancy is not recommended.

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.

Breastfeeding

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

Driving and using machines

Ask your doctor if you can drive or operate machinery while being treated with Tramadol/Paracetamol Vir 37.5 mg/325 mg tablets. It is important to observe how this medicine affects you before driving or operating machinery. Do not drive or operate machinery if you feel sleepy, dizzy, have blurred or double vision, or have difficulty concentrating. Exercise particular caution at the beginning of treatment, after a dose increase, after changing formulations, and/or when taking it together with other medicines.

3. How to take Tramadol/Paracetamol Vir

Before starting treatment and regularly during treatment, your doctor will explain to you what to expect from using 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).

Always follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist.

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

Use in children

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

Use in adults

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

If necessary, the dose may be increased as advised by your doctor. The shortest interval between doses must 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 prescribed by your doctor. Your doctor may increase the interval between doses.

• If you are over 75 years of age.
• If you have kidney problems.
• If you have liver problems.

Elderly patients

In elderly patients (over 75 years of age), elimination of tramadol may be slower. If this applies to you, your doctor may recommend prolonging the dosing intervals.

Patients with hepatic or renal impairment/patients on dialysis

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

Method of administration

Tramadol/Paracetamol Vir is supplied as tablets for oral administration. The tablets should be swallowed whole with sufficient liquid. They must not be broken or chewed. If you feel 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 get 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 prescribed, even if you feel well, contact your doctor immediately, as there is a risk of serious liver damage which may only become apparent later.

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 91 562 04 20.

If you forget to take Tramadol/Paracetamol Vir

If you forget to take a dose of Tramadol/Paracetamol Vir, your pain may return. Do not take a double dose to make up for the missed dose; simply continue taking the tablets as usual.

If you stop taking Tramadol/Paracetamol Vir

You should not stop taking this medicine suddenly unless instructed by your doctor. If you wish to stop taking the medicine, especially if you have been taking it for a long time, speak to your doctor first. Your doctor will advise you when and how to stop treatment, which may involve gradually reducing the dose to minimize the risk of unnecessary adverse effects (withdrawal symptoms).

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences 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 "on a high" all the time).

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

• Tachycardia, hypertension, disturbances in heart rhythm and heart rate.
• Difficulty or pain when urinating.
• Skin reactions (e.g., rashes, urticaria).
• Tingling sensation, numbness, or prickling sensations 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 stools.
• Chills, hot flushes, chest pain.
• Difficulty breathing.

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

• Seizures, difficulty performing coordinated movements.
• Addiction.
• Blurred vision.

Frequency not known: Hiccups.

Frequency not determined (cannot be estimated from 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, diarrhea) (see section 2, "What you need to know before taking Tramadol/Paracetamol").

Very rare cases of serious skin reactions have been reported.

The following recognized adverse effects have been reported in individuals taking medicines containing tramadol alone or paracetamol alone. However, if you experience any of these symptoms while taking Tramadol/Paracetamol Vir, you must inform your doctor:

Feeling dizzy upon standing up after lying down or sitting, slow 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 may occur, indicating allergic reactions that may present as sudden swelling of the face and neck, shortness of breath, or drop in blood pressure and dizziness. If this happens, stop treatment immediately and consult your doctor. You must not take this medicine again.
• In rare cases, using a medicine such as tramadol may lead to dependence, making it difficult to stop taking it. Rarely, people who have been taking tramadol for some time may feel unwell if treatment is stopped abruptly. They may feel agitated, anxious, nervous, or shaky. They may become hyperactive, have difficulty sleeping, and experience digestive and intestinal disturbances. Very few people may also experience 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, for example, low platelet count, which may result in nosebleeds or bleeding gums. The use of Tramadol/Paracetamol Vir together with anticoagulants (e.g., fenprocumone, warfarin) may increase the risk of bleeding. You must inform your doctor immediately about any prolonged or unexpected bleeding.

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

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tramadol/Paracetamol Vir

Keep this medicine in a safe and secure place, out of reach of other people. It may cause serious harm or be fatal to individuals for whom it has not been prescribed.

No special storage conditions are required.

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

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tramadol/Paracetamol Vir

• The active substances 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:

Tablet core:

Pregelatinized maize starch, sodium carboxymethyl starch (potato origin, Type A), 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 contents of the pack

Tramadol/Paracetamol Vir 37.5/325 mg film-coated tablets EFG, are presented as pale yellow tablets packed in blisters.

Tramadol/Paracetamol Vir is available in packs containing 20, 60 and 100 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Industria Química y Farmacéutica VIR, S.A.

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

28923 Alcorcón (Madrid)

Spain

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

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