PARACETAMOL VIR 500 mg FILM-COATED TABLETS

2. What you need to know before taking Paracetamol Vir

Do not takeParacetamolVir

If you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine.

Do not take more than the recommended dose in section 3.

To do this, check that you are not taking other medicines that contain paracetamol at the same time.

Asthmatic patients sensitive to acetylsalicylic acid should consult their doctor before taking this medicine.

Consult your doctor or pharmacist before taking paracetamol.

• if you have any liver, kidney, heart, or lung disease, or if you have anemia (reduced hemoglobin levels in the blood, due to or not due to a reduction in red blood cells),
• if you have Gilbert's syndrome (mild jaundice), if you are dehydrated or have chronic malnutrition
• when you are being treated with any medicine for epilepsy, you should consult your doctor before taking this medicine, as when used at the same time, the efficacy of paracetamol is reduced and its hepatotoxicity is increased, especially in high-dose paracetamol treatments.
• in chronic alcoholics, caution should be exercised not to take more than 2 g/24 hours of paracetamol.
• If you have severe diseases, such as severe renal 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 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.

If the pain persists for more than 5 days, the fever for more than 3 days, or the pain or fever worsens or other symptoms appear, you should consult your doctor and reassess the clinical situation.

Children and adolescents

Do not administer to children under 10 years of age or weighing less than 33 kg. Consult your doctor or pharmacist, as there are available presentations with doses that adapt to this group of patients.

Interference with laboratory tests

If you are going to have any laboratory tests (including blood, urine, etc.), inform your doctor that you are taking this medicine, as it may alter the results.

Paracetamol may alter the values of analytical determinations of uric acid and glucose.

Other medicines and ParacetamolVir

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

Paracetamol may interact with the following medicines:

• Medicines to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin).
• Medicines for treating epilepsy: antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medicines for treating tuberculosis (isoniazid, rifampicin).
• Medicines for treating depression and convulsions: barbiturates (used as hypnotics, sedatives, and anticonvulsants).
• Medicines to lower cholesterol levels in the blood (cholestyramine).
• Medicines used to increase urine elimination (loop diuretics such as furosemide).
• Medicines used to treat gout (probenecid and sulfinpyrazone).
• Medicines used to prevent nausea and vomiting: metoclopramide and domperidone.
• Medicines used to treat high blood pressure and heart rhythm disorders (arrhythmias): propranolol.
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment.

Do not use with other analgesics (pain-relieving medicines) without consulting your doctor.

Avoid taking this medicine with other medicines that contain paracetamol, such as medicines for colds and flu, as high doses can lead to liver damage. Do not take more than one medicine that contains paracetamol without consulting your doctor.

As a general rule for any medicine, it is recommended to systematically inform your doctor or pharmacist if you are being treated with another medicine. In the case of treatment with oral anticoagulants, it can be administered occasionally as the analgesic of choice.

TakingParacetamolVir with food, drinks, and alcohol

Taking this medicine with food does not affect its efficacy.

Pregnancy, breastfeeding, and fertility

Pregnancy

Consult your doctor or pharmacist before using any medicine.

If necessary, Paracetamol can be used during pregnancy. You should use the lowest possible dose that reduces pain or fever and use it for the shortest possible time. Consult your doctor if the pain or fever does not decrease or if you need to take the medicine more frequently.

IMPORTANT FOR WOMEN

If you are pregnant or think you may be pregnant, consult your doctor before taking this medicine. The use of medicines during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

Breastfeeding

Consult your doctor or pharmacist before using any medicine.

Paracetamol passes into breast milk, so breastfeeding women should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

No effects have been described that alter the ability to drive or operate machinery.

3. How to take Paracetamol Vir

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine. This medicine should be taken orally.

The tablets are scored, which allows the tablet to be divided into equal doses.

According to your preferences, the tablets can be taken directly or broken in half with water, milk, or fruit juice.

Adults and adolescents over 15 years of age (and weighing more than 50 kg): the usual dose is 1 or 2 tablets, depending on the intensity of the symptoms, 3 to 4 times a day. The doses should be spaced at least 4 hours apart. Do not take more than 4 g (8 tablets) in 24 hours.

High daily doses of paracetamol should be avoided during prolonged periods, as the risk of adverse effects such as liver damage increases.

Patient with liver disease: before taking this medicine, they must consult their doctor. They should take the amount of medicine prescribed by their doctor with a minimum interval between each dose of 8 hours. Do not take more than 2 grams (4 tablets) of paracetamol in 24 hours.

Patient with kidney disease: before taking this medicine, they must consult their doctor. Take a maximum of one tablet (500 mg of paracetamol) per dose.

Elderly patients: should consult their doctor.

Use in children and adolescents

It is necessary to respect the dosages defined according to weight. The age of the child according to weight is given for information purposes.

The recommended daily dose of paracetamol is approximately 60 mg/kg/day, divided into 4 or 6 daily doses, i.e., 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.

• Children between 33 kg and 42 kg in weight (from 10 to 12 years, approximately): 1 tablet per dose, every 6 hours, up to a maximum of 4 tablets per day.
• Children between 42 kg and 50 kg in weight (from 12 to 15 years, approximately): 1 tablet per dose, every 4 hours, up to a maximum of 6 tablets per day.

When doses lower than 500 mg of paracetamol per dose are required, other presentations of paracetamol that adapt to the required dosage should be used.

If you take more ParacetamolVir than you should

If you have taken more paracetamol than you should, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 915 620 420.

If you have taken an overdose, you should go to a medical center immediately, even if you do not have symptoms, as they often do not appear until three days after taking the overdose, even in cases of severe poisoning.

Symptoms of overdose may include: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

Treatment of overdose is most effective if started within 4 hours of taking the medicine.

Patient being treated with barbiturates or suffering from chronic alcoholism may be more susceptible to a paracetamol overdose.

If you forget to take ParacetamolVir

Do not take a double dose to make up for forgotten doses, simply take the forgotten dose when you remember, taking the next doses with the indicated interval between doses (at least 4 hours).

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

This medicine can cause the following side effects:

• Rare (may affect up to 1 in 1,000 patients): discomfort, low blood pressure, and increased liver enzyme levels.
• Very rare (may affect up to 1 in 10,000 patients): allergic reactions (such as skin reactions), low glucose levels, blood disorders, and liver or kidney disorders. Very rare cases of severe skin reactions have been reported.
• 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 side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Paracetamol Vir

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

No special storage conditions are required.

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition ofParacetamolVir

• The active ingredient is paracetamol. Each film-coated tablet contains 500 mg of paracetamol.
• The other ingredients (excipients) are: tablet core: pregelatinized corn starch and magnesium stearate. Coating: hypromellose, polyethylene glycol, propylene glycol, titanium dioxide, talc, isopropyl alcohol, and dichloromethane.

Appearance of the product and packaging contents

Paracetamol Vir are white, oblong, and scored film-coated tablets packaged in PVC/Aluminum blisters in a cardboard box. They are available in packs of 20 tablets.

Marketing authorization holder and manufacturer

Industria Química y Farmacéutica Vir, S.A.

C/Laguna 66-70. Polígono Industrial Urtinsa II.

1. Alcorcón (Madrid)

Spain

Date of the last revision of this package leaflet: February 2025

Other sources of information

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