Paracetamol Vir 1 g film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Paracetamol Vir 1 g 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, 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 other people, 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 effects not listed in this leaflet. See section 4.
Contents of the 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 adolescents from the age of 15 years for the symptomatic relief of mild to moderate pain, and for febrile 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 components of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to take this medicine.
Do not take more medicine than the recommended dose stated in section 3. To avoid overdose, 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 starting to take paracetamol:
- if you have 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 medications for epilepsy, as you should consult your doctor before taking this medicine, since concomitant use may reduce efficacy and increase the hepatotoxicity of paracetamol, especially with high-dose paracetamol regimens,
- in chronic alcoholics, caution is required not to exceed 2 g of paracetamol in 24 hours,
- if you have serious conditions 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 at regular doses for prolonged periods or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, 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
In children and adolescents under 15 years of age, consult your doctor or pharmacist, as other formulations with doses appropriate for this patient group may be available.
Interference with laboratory tests
If you are scheduled 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 to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin).
- Medicines for epilepsy: antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
- Medicines for tuberculosis: (isoniazid, rifampicin).
- Medicines for depression and seizures: barbiturates (used as hypnotics, sedatives, and anticonvulsants).
- Medicines to lower blood cholesterol levels: (cholestyramine).
- Medicines used to increase urine output (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 to treat high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias): propranolol.
- Flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (called metabolic acidosis) requiring 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 cause liver damage. Do not take 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 treatment. In patients taking 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, breastfeeding 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 pain or fever, and use 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 must be monitored by your doctor.
Breastfeeding
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 use of machinery
No effects affecting 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 is taken orally.
The tablets are scored, which allows them to be divided into equal doses.
Depending on your preference, the tablets may be taken whole or split in half, with water, milk, or fruit juice.
Adults and adolescents over 15 years of age: The usual dose is 1 tablet (1 g of paracetamol) 3 to 4 times daily. Doses should be spaced at least 4 hours apart. Do not take more than 4 tablets (4 g) in 24 hours.
The 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 take more than 2 grams (2 tablets) of paracetamol in 24 hours, divided into 2 doses.
Patients with kidney disease: Before taking this medicine, you must consult your doctor.
Take a maximum of half a tablet (500 milligrams of paracetamol) per dose.
Elderly patients: You should consult your doctor.
Use in children and adolescents
Do not use in children or adolescents under 15 years of age.
When doses lower than 1 g of paracetamol per dose are required, other paracetamol formulations adapted 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 an overdose has occurred, 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 then take the following 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 can cause adverse effects, although not everyone will experience them.
This medicine may cause the following adverse effects:
- Rare (may affect up to 1 in 1,000 patients): malaise, hypotension, and increased liver enzyme levels.
- Very rare (may affect up to 1 in 10,000 patients): allergic reactions (such as skin reactions), hypoglycemia, blood disorders, and liver and 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 via the Spanish Pharmacovigilance System for Human Medicinal Products: 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 at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. 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 1 g of paracetamol.
- The other components (excipients) are: 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 contents of the pack
Paracetamol Vir are white, oblong, film-coated tablets, scored on one side, packed in PVC/aluminum blisters within cardboard boxes. Available in packs of 20 or 40 tablets.
Only certain pack sizes may be marketed.
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 medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/