PARACETAMOL VIR PHARMA 1 g EFFERVSCENT TABLETS

Introduction

Leaflet: Information for the user

Paracetamol Vir Pharma 1 g effervescent tablets EFG

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

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

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

Contents of the leaflet:

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

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

Paracetamol Vir Pharma belongs to the group of medications called analgesics and antipyretics.

This medication is used for the symptomatic treatment of mild or moderate pain and fever in adults and adolescents from 15 years old and weighing over 50 kg.

2. What you need to know before taking Paracetamol Vir Pharma

Do not take Paracetamol Vir Pharma

• if you are allergic (hypersensitive) to paracetamol or to 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. How to take Paracetamol Vir Pharma.
• Avoid taking this medication simultaneously with other medications that contain paracetamol without consulting your doctor.
• Chronic alcoholics should be cautious not to take more than 2g/24 hours of paracetamol.
• Patient with 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.
• Inform your doctor before taking this medication if you are an asthmatic patient sensitive to acetylsalicylic acid.
• Paracetamol may cause severe skin reactions, such as acute generalized exanthematous pustulosis(AGEP), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of severe skin reactions and should discontinue the use of the medication at the first symptom of skin rash or any other sign of hypersensitivity.
• 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 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. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling of discomfort (nausea) and vomiting.

Children and adolescents

Due to the dose of paracetamol, this medication should not be used in children or adolescents under 15 years old (and weighing less than 50 kg). Ask your pharmacist about the available presentations that allow for adequate dosing of these patients.

Interference with analytical tests

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

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

Other medications and Paracetamol Vir Pharma

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

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

• Medications to prevent blood clots: 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 blood: cholestyramine
• Medications used to increase urine elimination (diuretics such as furosemide)
• Medications used to treat gout: probenecid and sulfinpyrazone
• Medications used to prevent nausea and vomiting: metoclopramide, domperidone.
• Medications 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 anomaly (called metabolic acidosis) that requires urgent treatment.

Taking Paracetamol Vir Pharma with food, drinks, and alcohol

Taking paracetamol in patients who habitually consume alcohol (3 or more alcoholic beverages - beer, wine, liquor, ... - per day) may cause liver damage.

Taking it with food does not affect its efficacy.

Pregnancy and breastfeeding

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

If necessary, Paracetamol Vir Pharma 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. Contact your doctor or midwife if the pain or fever does not decrease or if you need to take the medication more frequently.

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 this medication on the ability to drive and use machines is zero or insignificant.

Paracetamol Vir Pharma contains sorbitol.

This medication contains sorbitol (E-420). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Patient on a low-sodium diet should note that this medication contains 657 mg (29 mmol) of sodium per tablet.

3. How to take Paracetamol Vir Pharma

Follow your doctor's instructions for administering this medication exactly. In case of doubt, consult your doctor again.

This medication is taken orally.

Dissolve the tablet in a glass of water and do not take it until the bubbling has stopped completely.

Always take the smallest effective dose.

The recommended dose is:

Adults and adolescents from 15 years old (and weighing over 50 kg):

1 tablet (1 g of paracetamol) every 6-8 hours, 3 or 4 times a day.

Do not exceed 1 gram of paracetamol per dose. Do not take more than 4g of paracetamol in 24 hours divided into 4 doses.

The minimum interval between one dose and the next should be between 4 and 6 hours.

Do not exceed the indicated dose.

Kidney problems: the dose of paracetamol should be reduced. Patients with severe or moderate kidney disease should not take this medication.

Liver problems: do not take more than 2 g of paracetamol in 24 hours. Take the amount of medication prescribed by your doctor with a minimum interval of 8 hours between each dose. Consult your doctor, as they may decide to reduce the dose.

Adults weighing less than 50 kg or in cases of chronic malnutrition, dehydration, or chronic alcoholism, the dose of paracetamol should not exceed 2 g in 24 hours.

Use in children and adolescents

Do not administer to children or adolescents under 16 years old.

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

Taking this medication is subject to the appearance of symptoms, pain, or fever. As they disappear, treatment should be discontinued.

Avoid using high daily doses of paracetamol for prolonged periods, as this increases the risk of suffering from side effects such as liver damage.

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 reevaluate the clinical situation.

If you take more Paracetamol Vir Pharma than you should

The first symptoms of paracetamol overdose in the first 24 hours may include pallor, nausea, vomiting, loss of appetite (anorexia), and stomach pain. If you or someone you know accidentally takes more doses than indicated (overdose), you should contact your doctor immediately, even if you feel well, as symptoms often do not appear until three days after taking the overdose, even in cases of severe poisoning.

Later, liver and kidney damage can develop. Severe overdoses can cause death.

In case of overdose or accidental ingestion, go to a medical center or call the Toxicology Information Service (telephone 91 5620420), indicating the medication and the amount ingested. Treatment of the overdose is more effective if started within 4 hours of taking the medication.

If you forget to take Paracetamol Vir Pharma

If you forget to take a dose, take another as soon as you remember, unless the time for the next dose is very close, in which case you should wait until then. The minimum time interval between two doses should be between 4 and 6 hours. Do not take a double dose to make up for forgotten doses.

If you have any other questions 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 experiences them.

You should stop taking Paracetamol Vir Pharma and consult your doctor if you experience any of the following symptoms: swelling of the face, tongue, or throat, difficulty swallowing, red and itchy inflammation of the skin, or difficulty breathing.

Rare (may affect up to 1 in 1,000 patients):

• platelet disorders (coagulation disorders), decreased blood cell formation, frequent infections due to poor functioning of white blood cells or decreased white blood cell count (leukopenia), abnormal destruction of red blood cells that can cause weakness or pallor (hemolytic anemia), decreased blood cell count (pancytopenia), decreased neutrophil count in blood (neutropenia).
• allergies (excluding swelling of the face, mouth, or hands)
• depression, confusion, hallucinations
• tremors, headache
• abnormal vision
• abnormal fluid accumulation under the skin (edema)
• abdominal pain, diarrhea, nausea, vomiting, bleeding (hemorrhage)
• abnormal liver function, liver failure, liver cell death (necrosis), jaundice
• dizziness, discomfort, fever, sedation, interaction with other medications
• overdose and poisoning

Very rare (may affect up to 1 in 10,000 patients):

• liver damage caused by chemicals (hepatotoxicity)
• low blood sugar levels (hypoglycemia)
• cloudy urine and kidney disorders
• allergic skin reaction (erythema multiforme)
• fluid accumulation in the larynx
• anaphylactic shock (severe allergic reaction)
• decreased red blood cell count (anemia)
• severe kidney impairment (renal failure)
• interstitial nephritis (kidney disorder)
• blood in the urine (hematuria)
• inability to urinate (anuria)
• stomach ulcers and bleeding (gastrointestinal effects)
• restlessness

Unknown (cannot be estimated from available data):

• decreased white blood cell count in blood that can cause severe infections (agranulocytosis),
• decreased platelet count that increases the risk of bleeding or bruising (thrombocytopenia),
• severe allergic reaction (hypersensitivity reaction that requires treatment interruption)
• liver damage
• exanthema

• Severe skin reactions have been reported in very rare cases (medications that induce Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP).
• A serious disease that can make the blood more acidic (called metabolic acidosis) 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 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 Pharma

Keep this medication out of sight and reach of children.

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

Aluminum strips: store below 25°C. Keep in the original packaging to protect it from light and moisture.

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

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Paracetamol Vir Pharma

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

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

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.

Appearance of Paracetamol Vir Pharma and package contents

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

Aluminum strips:

The effervescent tablets are packaged in laminated aluminum strips with LDPE. The strips are packaged in boxes and contain 20 tablets and 40 tablets.

Not all pack sizes may be marketed.

Not all pack sizes may be marketed.

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

Laboratorio Fundacio Dau

C/C, 14-14 Pol. Ind. Zona Francam Barcelona,

08040 Barcelona, Spain

Date of the last revision of this 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.gob.es/