Paracetamol Vir 500 mg film-coated tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Package leaflet: Information for the patient
Paracetamol Vir 500 mg film-coated tablets EFG
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. Do not pass it on to other people, 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 the side effects are not listed in this leaflet. See section 4.
What is in this leaflet
- What Paracetamol Vir is and what it is used for
- What you need to know before taking Paracetamol Vir
- How to take Paracetamol Vir
- Possible side effects
- How to store Paracetamol Vir
- Contents of the pack and other information
1. What Paracetamol Vir is and what it is used for
Paracetamol belongs to a group of medicines called analgesics and antipyretics.
This medicine is indicated in adults and children from 10 years of age for the symptomatic relief of mild to moderate pain, and for feverish conditions.
2. What you need to know before taking Paracetamol Vir
Do not take Paracetamol Vir
If you are allergic to paracetamol or to 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 medicine than the recommended dose stated in section 3.
To ensure this, check that you are not simultaneously taking other medicines containing paracetamol.
Asthmatic patients who are 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, with or without a reduction in red blood cells),
- if you have Gilbert's syndrome (mild jaundice), if you are dehydrated or suffer from chronic malnutrition,
- if you are being treated with antiepileptic medicines, you should consult your doctor before taking this medicine, as concomitant use may reduce efficacy and increase the hepatotoxicity of paracetamol, especially with high-dose paracetamol regimens.
- in chronic alcoholics, caution should be taken not to exceed 2 g of paracetamol in 24 hours.
- if you have serious conditions such as severe renal insufficiency 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 known as metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients under these conditions when paracetamol is used at regular doses 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, general malaise (nausea), and vomiting.
If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, you should consult your doctor and reevaluate the clinical situation.
Children and adolescents
This medicine should not be administered to children under 10 years of age or weighing less than 33 kg. Consult your doctor or pharmacist, as there are formulations available with doses adapted for this patient group.
Interference with diagnostic tests
If you are due to undergo any laboratory tests (including blood and urine tests), inform your doctor that you are taking this medicine, as it may alter test results.
Paracetamol may alter the analytical values of uric acid and glucose measurements.
Other medicines and Paracetamol Vir
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Paracetamol may interact with the following medicines:
- Medicines used to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin).
- Medicines used to treat epilepsy: antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
- Medicines used to treat tuberculosis (isoniazid, rifampicin).
- Medicines used to treat depression and seizures: barbiturates (used as hypnotics, sedatives, and anticonvulsants).
- Medicines used to lower blood cholesterol levels (cholestyramine).
- Medicines used to increase urine elimination (loop diuretics such as furosemide).
- Medicines used in the treatment of gout (probenecid and sulfinpyrazone).
- Medicines used to prevent nausea and vomiting: metoclopramide and domperidone.
- Medicines used in the treatment of high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias): propranolol.
- Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) that requires urgent treatment.
Do not use with other analgesics (medicines that relieve pain) without consulting your doctor.
The simultaneous use of this medicine with other medicines containing paracetamol, such as cold and flu remedies, should be avoided, as high doses may lead to liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.
As a general rule for any medicine, it is advisable to systematically inform your doctor or pharmacist if you are taking any other medicine. In patients treated with oral anticoagulants, paracetamol may occasionally be used as the analgesic of choice.
Taking Paracetamol Vir with food, drinks and alcohol
The use of paracetamol in patients who habitually consume alcohol (three or more alcoholic drinks per day—beer, wine, liquor, etc.) may cause liver damage. |
Taking this medicine with food does not affect its effectiveness.
Pregnancy, lactation and fertility
Pregnancy
Consult your doctor or pharmacist before using any medicine.
Paracetamol may be used during pregnancy if necessary. Use the lowest dose that controls the pain or fever, and take it for the shortest possible time. Consult your doctor if pain or fever do not improve, or if you need to take the medicine more frequently.
IMPORTANT FOR WOMEN
If you are pregnant or think you might be pregnant, consult your doctor before taking this medicine. Taking medicines during pregnancy may be dangerous for the embryo or fetus, and should be monitored by your doctor.
Lactation
Consult your doctor or pharmacist before using any medicine.
Paracetamol passes into breast milk; therefore, women who are breastfeeding should consult their doctor or pharmacist before taking this medicine.
Driving and using machines
No effects on the ability to drive or operate machinery have been reported.
3. How to take Paracetamol Vir
Follow exactly the instructions for use of this medicine as given 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 them to be divided into equal doses.
Depending on your preference, the tablets may be taken directly or split 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 symptom intensity, 3 to 4 times daily. Doses should be spaced at least 4 hours apart. Do not exceed 4 g (8 tablets) in 24 hours.
Prolonged use of high daily doses of paracetamol should be avoided, as this increases the risk of adverse effects such as liver damage.
Patients with liver disease: Before taking this medicine, you must consult your doctor. You should take the amount prescribed by your doctor, with a minimum interval of 8 hours between doses. Do not exceed 2 grams (4 tablets) of paracetamol in 24 hours.
Patients with kidney disease: Before taking this medicine, you must consult your 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 follow the dosage regimens defined according to body weight. The child's age corresponding to weight is provided for informational purposes only.
The recommended daily dose of paracetamol is approximately 60 mg/kg/day, divided into 4 or 6 doses per day, i.e., 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.
- Children weighing between 33 kg and 42 kg (approximately 10 to 12 years of age): 1 tablet per dose, every 6 hours, up to a maximum of 4 tablets per day.
- Children weighing between 42 kg and 50 kg (approximately 12 to 15 years of age): 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 administration are required, other paracetamol formulations better suited to the required dosage should be used.
If you take more Paracetamol Vir than you should
If you have taken more paracetamol than you should, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 915 620 420.
If you have taken an overdose, you must go immediately to a medical center even if there are no symptoms, as symptoms often do not appear until three days after 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.
Patients undergoing treatment with barbiturates or those suffering from chronic alcoholism may be more susceptible to paracetamol overdose.
If you forget to take Paracetamol Vir
Do not take a double dose to make up for missed doses. Simply take the missed dose as soon as you remember, and take subsequent doses at the recommended intervals (at least 4 hours apart).
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 may cause adverse effects, although not everyone experiences them.
This medicine may cause the following adverse effects:
- Rare (may affect up to 1 in 1,000 patients): malaise, 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 blood sugar, blood disorders, and liver or kidney disorders. Very rare cases of severe skin reactions have been reported.
- Frequency not known (cannot be estimated from available data): A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who use 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 not listed in this leaflet. You may also report them directly through 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 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 must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Paracetamol Vir
- The active substance is paracetamol. Each film-coated tablet contains 500 mg of paracetamol.
- The other components (excipients) are: tablet core: pregelatinized maize starch and magnesium stearate. Coating: hypromellose, polyethylene glycol, propylene glycol, titanium dioxide, talc, isopropyl alcohol and dichloromethane.
Appearance of the product and contents of the pack
Paracetamol Vir are white, oblong, film-coated tablets, scored on one side, packed in PVC/aluminum blisters contained in cardboard boxes. 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.
28923 Alcorcón (Madrid)
Spain
Date of the most recent revision of this leaflet: February 2025
Other sources of information
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/