Summary of Product Characteristics:Paracetamol Vir Pharma1 g tablets EFG

Read this entire leaflet carefully because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

• Keep this leaflet as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4
• You should consult your doctor if the fever worsens or persists after 3 days of treatment or the pain lasts for more than 5 days

Paracetamol is effective in reducing pain and fever.

It is indicated for the relief of occasional mild or moderate pain, such as headache, toothache, muscle pain (contractures) or back pain (lumbago) and in febrile states in adults and adolescents over 15 years old.

Consult a doctor if it worsens or does not improve after 3 days.

Do not takeParacetamol Vir Pharma:

• You are allergic (hypersensitive) to paracetamol or to any of the other components ofthis medication (listed in section 6).

Warnings and precautions

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

• If you have liver problems, including liver problems due to excessive alcohol consumption (3 or more alcoholic beverages per day);
• If you have kidney problems;
• If you have glucose-6-phosphate dehydrogenase deficiency;
• If you have anorexia, bulimia, cachexia, or chronic malnutrition;
• If you have dehydration or hypovolemia;
• If you are taking an antiepileptic medication, consult your doctor before taking this medication, as when used together, it reduces the efficacy and increases the hepatotoxicity of paracetamol, especially in high-dose treatments of paracetamol (see below in this section “Other medications and Paracetamol Vir Pharma”);
• If you have Gilbert's disease (also known as Meulengracht's disease);
• If you have heart problems, respiratory insufficiency, or anemia; in these situations, administration should be made under supervision and only for short periods;
• If you have asthma and are sensitive to acetylsalicylic acid;
• 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 severe disease called metabolic acidosis (a blood and fluid anomaly) 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 respiratory distress with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Paracetamol may cause severe skin reactions, such asacute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), and Toxic Epidermal Necrolysis (TEN), which can be fatal. Inform patients about the symptoms of severe skin reactions and discontinue use of the medication at the first sign of skin rash or any other sign of hypersensitivity.

Do not take more paracetamol than recommended in section 3 "How to take Paracetamol Vir Pharma".

Concomitant use of this medication with other medications containing paracetamol, such as cold and flu medications, should be avoided, as high doses may cause liver damage. Do not use more than one medication containing paracetamol without consulting your doctor.

If you experience an overdose, seek medical attention immediately (see "If you take more Paracetamol Vir Pharma than you should").

This medication should not be used for self-medication of high fever (over 39°C), prolonged fever, or recurrent fever, unless your doctor prescribes it, as these situations may require medical evaluation and treatment.

Administration of paracetamol doses higher than recommended involves a high risk of severe liver damage. Medications containing paracetamol should not be taken for more than a few days or at high doses, unless your doctor advises you to do so.

The prolonged use of analgesics or the use of high doses may cause headaches, which should not be treated with higher doses of the medication.

Interference with analytical tests.

If you are to undergo any analytical test (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 uric acid and glucose determinations.

Children and adolescents

This medication should not be used in children or adolescents under 15(and weighing less than 50 kg). Ask your pharmacist about the available presentations that allow for proper dosing of these patients.

Other medications and Paracetamol Vir Pharma

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

Antiepileptic medications (carbamazepine, phenytoin, phenobarbital, primidone, lamotrigine): The combination of paracetamol and antiepileptic medications may cause or worsen liver damage.

Lamotrigine: The effect of lamotrigine may be reduced.

Medications for high blood pressure and heart rhythm disorders (propranolol): The combination of paracetamol and propranolol may increase the action and/or toxicity.

Medications for gout:Probenecidcauses a reduction of almost 2 times in the excretion of paracetamol. Consider reducing the paracetamol dose when administering a concomitant treatment with probenecid.

Medications for tuberculosis (rifampicin, isoniazid):The combination of paracetamol andrifampicin or isoniazid may cause or worsen liver damage.

Salicylamide, a medication for fever and pain, may prolong the elimination half-life (t1/2) of paracetamol.

Medications to reduce cholesterol levels in the blood: cholestyraminereduces the absorption of paracetamol. To avoid this, paracetamol should be administered 1 hour before or 4 hours after the resin.

Medications to prevent nausea and vomiting (metoclopramide and domperidone):The simultaneous ingestion of medications that cause accelerated gastric emptying, such as metoclopramide and domperidone, increases the absorption and anticipates the onset of paracetamol action. However, it is not necessary to avoid concomitant use.

Medications to prevent blood clots (oral anticoagulants such as acenocoumarol, warfarin):Paracetamol may increase the effects of oral anticoagulants. Prolonged use of this medication in patients treated with oral anticoagulants should only be done under medical supervision. An increase in the effects of warfarin has been observed with high-dose, continuous paracetamol.

Diuretics (furosemide):The effects of diuretics may be reduced.

Cloranfenicol, an antibiotic medication:The simultaneous administration of paracetamol and cloranfenicol may significantly delay the excretion of cloranfenicol, increasing its plasma concentrations and causing a higher risk of toxicity.

Zidovudine (AZT), a medication used in viral diseases:The concomitant administration of paracetamol and AZT may increase the incidence of neutropenia or worsen it (reduction of white blood cell count). Paracetamol should only be taken simultaneously with AZT if your doctor recommends it.

Concomitant use of substances that induce liver enzymes, such asbarbiturates, carbamazepine, isoniazid, rifampicin, or ethanol, should be taken into account, as they may potentiate the toxic effect of paracetamol.

Inform your doctor if this medication is taken with medications that delay gastric emptying (e.g. propantelina) or that accelerate gastric emptying (e.g. metoclopramide and domperidone).

Flucloxacillin (antibiotic), due to a severe risk ofblood and fluid anomaly (denominatedmetabolic acidosis) that mustreceive urgent treatment.

Paracetamol Vir Pharma and alcohol

Do not take alcohol during treatment with paracetamol.

Pregnancy, lactation, and fertility

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

Paracetamol may be used during pregnancy if necessary. Use the lowest possible dose that reduces pain or fever and use it for the shortest possible time. Contact your doctor or midwife if pain or fever do not decrease or if you need to take the medication more frequently.

Paracetamol passes intobreast milk.Therapeutic doses of paracetamol may be administered during lactation.

Driving and operating machinery

This medication does not affect the ability to drive or operate machinery. However, during treatment with paracetamol, you may experience mild drowsiness and dizziness.

This medication contains less than 1 mmol of sodium (23 mg) per coated tablet; it is essentially “sodium-free”.

Follow these instructions unless your doctor has given you different instructions. Consult your doctor or pharmacist if you have any doubts.

This medication is taken orally.

The recommended dose is:

Adults and adolescents 15 years of age and older and weighing more than 50 kg:

1 tablet (1 g of paracetamol) every 6-8 hours, 3 times a day. Do not take more than 3 g (3 tablets) of paracetamol in 24 hours.

It is recommended for adults and adolescents with low weight (less than 50 kg) a daily dose of 2 g of paracetamol (2 tablets).

Always take the lowest effective dose.

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

It is recommended to avoid the use of high daily doses of paracetamol for prolonged periods of time as this increases the risk of adverse effects such as liver damage.

If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or other symptoms appear, treatment should be interrupted and your doctor consulted.

Patients with liver disease: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 of paracetamol in 24 hours, divided into several doses.

Patients with kidney disease:This medication does not follow the recommended dosage for these patients.

If you take more Paracetamol Vir Pharmathan you should

You should consult your doctor or pharmacist immediately.

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

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

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

The treatment of overdose is more effective if initiated within 4 hours of medication ingestion.

Patients undergoing treatment with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

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

The following adverse effects have been reported in patients treated with paracetamol:

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

• Low blood pressure (hypotension)
• Increased liver enzymes
• Discomfort

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

• May cause changes in the blood, including changes in blood cell counts (such as abnormally low levels of certain blood elements that may cause, for example, bleeding through the nose or gums) and bleeding
• Allergic reactions (symptoms such as swelling, shortness of breath, sweating, nausea, sudden drop in blood pressure)
• Decreased blood sugar
• Jaundice (yellow discoloration of the skin), liver insufficiency
• Skin reactions such as allergic dermatitis, urticaria, itching, skin rash.
• Changes in urination (difficult or painful urination, decreased urine output and blood in the urine)

Unknown frequency (cannot be estimated from available data):

• A serious disease that can make the blood more acidic (designated as metabolic acidosis) in patients with severe disease using 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 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 on the safety of this medication.

Keep out of reach and sight of children.

This medication does not require special storage conditions.

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 trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Paracetamol Vir Pharma:

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

The other components (excipients) are: sodium carboxymethylcellulose type A (from potato), purified water, pregelatinized cornstarch, povidone K30 (E1201), vegetable stearic acid, and crospovidone (E1202).

Appearance of the product and contents of the package

Paracetamol Vir Pharmais presented in tablets for oral administration.

The tablets are oblong, biconvex, white in color, with a notch on one face and marked with PC on the other face.

The tablet can be divided into equal doses.

The packages are of 10 tablets.

Holder of the marketing authorization:

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/Laguna 66-70. Industrial Park URTINSA II

28923 – Alcorcón (Madrid)

Spain

Responsible for manufacturing

SAG Manufacturing S.L.U

Crta.N-I, Km 36,

San Agustín de Guadalix,

28750 Madrid

Spain

or

Galenicum Health, S.L.

Avda. Cornellá 144, 7º-1ª, Edificio Lekla

Esplugues de Llobregat

08950 Barcelona

Spain

Last review date of this leaflet: February 2025

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/