Package Insert: Information for the Patient

Paracetamol Vir 500 mg Film-Coated Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

2.What you need to know before starting to take Paracetamol Vir

3.How to take Paracetamol Vir

4.Possible adverse effects

5.Storage of Paracetamol Vir

6.Contents of the package and additional information

Paracetamol belongs to a group of medicines called analgesics and antipyretics.

This medicine is indicated for adults and children aged 10 years and above for the symptomatic relief of mild to moderate pain, and in febrile states.

Do not takeParacetamolVir

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

Do not take more medication than recommended in section 3.

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

Patients with asthma who are sensitive to acetylsalicylic acid shouldconsult with their doctor before taking this medication.

Consult your doctor or pharmacist before starting to take paracetamol.

• if you have any liver, kidney, heart, or lung disease, or have anemia (decrease in hemoglobin levels in the blood, due or not due to a decrease in red blood cells),
• ifyouhaveGilbert's syndrome,ifyouaredehydratedorhavechronic malnutrition
• when you are being treated with any medication for epilepsy, you should consult your doctor before taking this medication, as when used together, the efficacy is reduced and the hepatotoxicity of paracetamol is increased, especially in high-dose treatments with paracetamol.
• in chronic alcoholics, be careful not to take more than 2 g/24 hours of paracetamol.
• If you have severe diseases, such as severe renal insufficiency 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 (a blood and fluid anomaly) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. The symptoms of metabolic acidosis may include: severe respiratory distress 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 if the pain or fever worsen or other symptoms appear, you should consult your doctor and reevaluate the clinical situation.

Children and adolescents

This medication should not be administered to children under 10 years of age, or with a weight of less than 33 kg. Consult your doctor or pharmacist as there are presentations available with doses adapted to this group of patients.

Interference with analytical tests

If you are tohave any analytical test (including blood, urine, etc… tests) inform your doctor that you are taking this medication, as it may alter the results.

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

Other medications and ParacetamolVir

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Paracetamol may interact with the following medications:

• Medication to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin).
• Medications to treat epilepsy: antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medications to treat tuberculosis (isoniazid, rifampicin).
• Medications to treat depression and seizures: barbiturates (used as hypnotics, sedatives, and anticonvulsants).
• Medications to reduce blood cholesterol levels (colestiramine).
• Medications used to increase urine elimination (diuretics such as furosemide).
• Medications used to treat gout (probencid and sulfinpyrazone).
• Medications used to prevent nausea and vomiting: metoclopramide and domperidone.
• Medications used to treat high blood pressure and heart rhythm disorders (arhythmias): propranolol.
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomaly (denominated metabolic acidosis) that must receive urgent treatment.

Do not use with other analgesics (medications that reduce pain) without consulting your doctor.

Avoid simultaneous use of this medication with other medications that contain paracetamol, for example, medications for the flu and cold, as high doses may cause liver damage. Do not take more than one medication that contains paracetamol without consulting your doctor.

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

ParacetamolVirwith food, drinks, and alcohol

The taking of this medication with food does not affect the efficacy of the same.

Pregnancy, lactation, and fertility

Pregnancy

Consult your doctor or pharmacist before using any medication.

In case of need, 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 do not decrease or if you need to take the medication more frequently.

IMPORTANT FOR WOMEN

If you are pregnant or think you may be pregnant, consult your doctor before taking this medication. The consumption of medications during pregnancy can be dangerous for the embryo or fetus, and should be monitored by your doctor.

Lactation

Consult your doctor or pharmacist before using any medication.

Paracetamol passes into breast milk, so women in the lactation period should consult their doctor or pharmacist before taking this medication.

Driving and operating machinery

No effects have been described that modify the ability to drive and operate machinery.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication. This medication must 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 divided in half with water, milk, or fruit juice.

Adults and adolescents over 15 years old (and weight over 50 kg): the usual dose is 1 or 2 tablets, according to the intensity of the symptoms, 3 to 4 times a day. The doses should be spaced at least 4 hours apart. No more than 4 grams (8 tablets) should be taken in 24 hours.

It should be avoided to use high daily doses of paracetamol for prolonged periods of time as it increases the risk of suffering adverse effects such as liver damage.

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

Patients with kidney diseases: before taking this medication, they must consult their doctor. They should take a maximum of one tablet (500 mg of paracetamol) per dose.

Older patients: they should consult their doctor.

Use in children and adolescents

It is necessaryto respect the dosages defined according to weight. The child's age according to weight is given for information purposes only.

The recommended daily dose of paracetamol is approximately 60 mg/kg/day, which is divided into 4 or 6 doses per day, that is15 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 old): 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 old): 1 tablet per dose, every 4 hours,up to a maximum of 6 tablets per day.

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

If you take more ParacetamolThan you should

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

If an overdose has been taken, you should go to a medical center immediately, even if there are no symptoms, as they often do not appear until three days after the overdose, even in cases of severe intoxication.

The symptoms of an overdose may be: dizziness, vomiting, loss of appetite, yellowish discoloration of the skin and eyes (jaundice), and abdominal pain.

The treatment of an overdose is more effective if it is initiated within 4 hours of taking the medication.

Patients undergoing barbiturate treatment or those suffering from chronic alcoholism may be more susceptible to a paracetamol overdose.

If you forgot to take Paracetamol

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

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

This medication may produce the following adverse effects:

• Rare (may affect up to 1 in 1,000 patients): discomfort, low blood pressure, and increased levels of liver enzymes.
• Very rare (may affect up to 1 in 10,000 patients): allergic reactions (such as skin reactions), low blood sugar, blood abnormalities, and kidney and liver abnormalities. Rarely, severe skin reactions have been reported.
• Unknown frequency (cannot be estimated from available data): A serious disease that can make the blood more acidic (known as metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

No special storage conditions are required.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition ofParacetamolVir

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

Appearance of the product and contents of the packaging

Paracetamol Vir are white, oblong, scored tablets conditioned in PVC/Aluminum blisters in a cardboard box.They are presented in packs of 20 tablets.

Holder of the marketing authorization and responsible for manufacturing

Industria Química y Farmacéutica Vir, S.A.

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

28923. Alcorcón (Madrid)

Spain

Last review date of this leaflet: February 2025

Other sources of information

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/