PARACETAMOL VIR 1 g EFFERVSCENT TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Paracetamol Vir 1 g effervescent tablets EFG

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

Follow the administration instructions for this medication as indicated in this package leaflet or as directed by your doctor or pharmacist.

? Keep this package leaflet, as you may need to read it again.

? If you have any doubts, consult your doctor or pharmacist.

? If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

• You should consult a doctor if your symptoms worsen or do not improve, if the fever persists for more than 3 days, or if the pain lasts for more than 5 days.

Contents of the package leaflet:

1. What is Paracetamol Vir and what is it used for
2. What you need to know before taking Paracetamol Vir
3. How to take Paracetamol Vir
4. Possible side effects
5. Storage of Paracetamol Vir
6. Package contents and additional information

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

Paracetamol is effective in reducing pain and fever.

It is indicated for the symptomatic relief of occasional mild or moderate pain, such as headache, toothache, muscle pain (cramps), or back pain (lumbago), and in febrile states.

Paracetamol Vir is indicated for adults.

2. What you need to know before taking Paracetamol Vir

Do not take Paracetamol Vir

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

Warnings and precautions

• Do not take more than the recommended dose of medication as indicated in section 3 "How to take Paracetamol Vir".
• Avoid taking this medication simultaneously with other medications that contain paracetamol, such as medications for fever and colds, as high doses can lead to liver damage. Do not use more than one medication that contains paracetamol without consulting your doctor.
• Chronic alcoholics should be cautious not to take more than 2 grams of paracetamol in 24 hours.
• Patient with kidney, liver, heart, or lung disease, and patients with anemia, should consult their doctor before taking this medication.
• When being treated with medication for epilepsy, consult your doctor before taking this medication, as the efficacy of paracetamol may be decreased and hepatotoxicity may be increased, especially with high doses of paracetamol.
• Asthmatic patients sensitive to acetylsalicylic acid should consult their doctor before taking this medication.
• If you have severe diseases, 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 disease called metabolic acidosis (an anomaly in 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. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Interference with analytical tests:

If you are going to undergo any analytical tests (including blood, urine, etc.), inform your doctor that you are taking this medication, as it may alter the results of these tests.

Children and adolescents

Do not use in children under 18 years of age.

Other medications and Paracetamol Vir:

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

In particular, if you are using any of the following medications, it may be necessary to modify the dose of one of them or interrupt treatment:

• Medications 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 convulsions: barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medications to lower cholesterol levels in the blood: (cholestyramine)
• Medications used to increase urine elimination (loop diuretics such as furosemide)
• Medications used to treat gout (probenecid and sulfinpyrazone)
• Medications used to prevent nausea and vomiting: metoclopramide and domperidone
• Medications 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.

Taking Paracetamol Vir with food, drinks, and alcohol

Taking this medication with food does not affect its absorption.

Taking paracetamol in patients who habitually consume alcohol (three or more alcoholic beverages per day: beer, wine, liquor) may damage the liver.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using this medication.

IMPORTANT FOR WOMEN

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before taking this medication. Taking medication 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 medication.

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

Driving and using machines

The influence of paracetamol on the ability to drive and use machines is negligible.

Paracetamol Vir contains sodium and sorbitol.

This medication contains 354.52 mg of sodium (main component of table salt) per tablet, which is equivalent to 17.73% of the maximum recommended sodium intake for an adult.

This medication contains 30 mg of sorbitol per tablet.

3. How to take Paracetamol Vir

Follow the administration instructions for this medication as indicated in this package leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults:

Take 1 tablet every 6-8 hours as needed. Do not take more than 3 grams (3 tablets) in 24 hours.

Patient with kidney disease: before taking this medication, you must consult your doctor.

Take a maximum of 500 milligrams per dose.

Due to the dose, 1 gram of paracetamol, the medication is not indicated for this group of patients.

Patient with liver disease: before taking this medication, you must consult your doctor.

Take the amount of medication prescribed by your doctor with a minimum interval of 8 hours between each dose. Do not take more than 2 tablets of paracetamol in 24 hours, divided into 2 doses.

Paracetamol Vir is for oral administration. Place the tablet in a glass of water. Let it dissolve completely and drink the solution immediately after.

Do not divide the 1-gram tablet to obtain equal parts with half the dose. Effervescent paracetamol tablets with a lower dose are available.

Do not exceed the recommended dose.

The cap contains a desiccant. Do not ingest.

Always use the lowest effective dose.

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

The administration of this medication is subject to the appearance of pain or fever. As these disappear, treatment should be discontinued.

If the pain persists for more than 5 days, the fever for more than 3 days, or the pain or fever worsen, or other symptoms appear, you should interrupt treatment and consult your doctor.

Use in children and adolescents:Do not use this medication in children or adolescents under 18 years of age.

If you take more Paracetamol Vir than you should:

You should consult your doctor or pharmacist immediately.

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

If you have ingested an overdose, you should go to a medical center immediately, even if you do not notice symptoms, as they often do not appear until 3 days after ingestion, even in cases of severe poisoning.

Treatment of overdose is more effective if started within 4 hours of ingestion of the medication.

Patient taking barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

In case of overdose or accidental ingestion, go to a medical center immediately or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medication and the amount ingested.

If you forget to take Paracetamol Vir

Do not take a double dose to make up for forgotten doses. Simply take the forgotten dose as soon as you remember, taking the next doses with the indicated interval between them.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Rare side effects that may occur (between 1 and 10 per 10,000 people) are: discomfort, low blood pressure (hypotension), and increased levels of transaminases in the blood.

Very rare side effects that may occur (in less than 1 per 10,000 people) are: kidney disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar). Very rare cases of severe skin reactions have been reported.

Paracetamol may damage the liver when taken in high doses or for prolonged periods.

Frequency not known (cannot be estimated from available data): A serious disease called metabolic acidosis (an anomaly in blood and fluids) in patients with severe disease using paracetamol (see section 2).

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Paracetamol Vir

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

Do not use this medication after the expiration date indicated on the box after EXP.

The expiration date is the last day of the month indicated.

Do not use the tablets after one month from the date of first opening.

Polypropylene tube: store below 25°C. Keep the polypropylene tube tightly closed. Store in the original packaging to protect it from light and moisture.

Do not use the tablets if you notice visible signs of deterioration, such as black or brown spots on the tablets, swelling, or discoloration of the tablets.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

6. Package contents and additional information

Composition of Paracetamol Vir

The active ingredient is paracetamol. Each tablet contains 1 gram of paracetamol.

The other ingredients are: citric acid, sorbitol (E420), sodium bicarbonate, anhydrous sodium carbonate, povidone K 25 (E1201), simethicone emulsion 30%, sodium docusate, sodium saccharin, macrogol 6000, monosodium glycine carbonate, sodium benzoate, and lemon flavor.

The simethicone emulsion 30% contains:

Water, polydimethylsiloxane, polyethylene glycol stearate, polyethylene glycol, glycerides, C14-C18 (mono-/di-), polyethylene glycol distearate, polyethylene glycol palmitate, and octamethylcyclotetrasiloxane.

The lemon flavor contains:

Corn maltodextrin, gum arabic (E414), and alpha-tocopherol (E307)

Appearance of the product and package contents

Paracetamol Vir are white or almost white, round, flat, effervescent tablets with beveled edges and smooth on both sides.

Polypropylene tubes:

The effervescent tablets are packaged in smooth, white, opaque polypropylene tubes with a tamper-evident polyethylene cap containing a desiccant. Each tube contains 10 tablets. The tubes are packaged in boxes containing 10 tablets (one tube with 10 tablets).

PRECAUTION:The cap contains a desiccant. Do not ingest.

Marketing authorization holder

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR S.A.

C/Laguna 66-70. Polígono Industria URTINSA II.

28923-Alcorcón (Madrid)

Spain

Manufacturer

Accord Healthcare Limited

319, Pinner Road,

North Harrow,

Middlesex HA1 4HF,

United Kingdom

LABORATORI FUNDACIÓ DAU

C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona,

08040 Barcelona, Spain

Date of last revision of this package leaflet:February 2025

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