PARACETAMOL VIR PHARMA 650 mg TABLETS

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

Do not take Paracetamol Vir Pharma if:

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

Warnings and precautions

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

Other medications and Paracetamol Vir Pharma");
• If you have severe diseases, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (an anomaly in the 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 unwell (nausea), and vomiting.

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 symptoms of severe skin reactions and the use of the medication should be discontinued at the first symptom of skin rash or any other symptom of hypersensitivity.

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

The simultaneous use of this medication with other medications that contain paracetamol, such as medications for flu and colds, should be avoided, as high doses can cause liver damage. Do not use more than one medication that contains paracetamol without consulting your doctor.

If you suffer 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), fever that lasts more than 3 days, or recurrent fever, unless your doctor prescribes it, as these situations may require medical evaluation and treatment.

The administration of paracetamol doses higher than recommended implies a very serious risk of liver injury. Medications that contain paracetamol should not be taken for more than a few days or in high doses, unless your doctor indicates it.

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

Interference with analytical tests.

If you are going to have any analytical tests (including blood tests, urine tests, 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 glucose.

Children and adolescents

This medication should not be used in children under 9 years old. Ask your pharmacist about the available presentations that allow for adequate dosing of these patients.

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.

Medications to treat seizures (antiepileptics such as carbamazepine, phenytoin, phenobarbital, primidone, lamotrigine): the combination of paracetamol and antiepileptic medications may cause or worsen liver damage.

Lamotrigine: The effect of lamotrigine may decrease.

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

Medications to treat gout: Probenecid causes a reduction of almost 2 times in the excretion of paracetamol. The reduction of the paracetamol dose should be considered when concomitant treatment with probenecid is administered.

Medications to treat tuberculosis (rifampicin, isoniazid): the combination of paracetamol and rifampicin or isoniazid may cause or worsen liver damage.

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

Medications to reduce cholesterol levels in the blood: colestyramine reduces 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 gastric emptying acceleration, e.g., metoclopramide and domperidone, increases the absorption and anticipates the onset of the action of paracetamol. 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. The prolonged use of this medication in patients treated with oral anticoagulants should only be done under medical supervision. The potentiation of the effects of warfarin with continued high doses of paracetamol has been observed.

Medications to increase urine production (loop diuretics such as furosemide): the effects of diuretics may be reduced.

Chloramphenicol, a medication to treat infections: the simultaneous administration of paracetamol and chloramphenicol may significantly delay the elimination of chloramphenicol, 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 the white blood cell count). Paracetamol should only be taken simultaneously with AZT if your doctor recommends it.

The concomitant use of substances that induce hepatic enzymes, such as barbiturics, 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., propanteline) or that accelerate gastric emptying (e.g., metoclopramide and domperidone).

Flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment.

Taking Paracetamol Vir Pharma with alcohol

Alcohol should not be consumed during treatment with paracetamol.

Pregnancy, breastfeeding, and fertility

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 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. Therapeutic doses of paracetamol can be administered during breastfeeding.

Driving and using machines

This medication does not affect the ability to drive or use machines. However, during treatment with paracetamol, you may observe mild drowsiness and dizziness as side effects.

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

3. How to take Paracetamol Vir Pharma

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

This medication is taken orally.

The recommended dose is:

Adults:

Take half to 1 tablet (325 mg to 650 mg of paracetamol) every 4-6 hours, 3 times a day. Do not take more than 3 g (4 tablets) in 24 hours.

In adults and adolescents of low weight (less than 50 kg), a daily dose of 2 g of paracetamol (3 tablets) is recommended.

Always take the lowest effective dose.

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

The use of high daily doses of paracetamol for prolonged periods should be avoided, as it increases the risk of suffering adverse 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 interrupt treatment and consult your doctor.

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 intake.

They should not take more than 2 grams of paracetamol in 24 hours, divided into several intakes.

Patients with kidney disease:

Before taking this medication, they must consult their doctor.

Take a maximum of 500 milligrams per intake.

According to their disease, their doctor will indicate whether they should take their medication with a minimum interval of 6 or 8 hours.

Children:

It is necessary to respect the dosages defined according to weight.The child's age in relation to weight is given for information purposes. The recommended daily dose of paracetamol is approximately 60 mg/kg/day, which is divided into 4 or 6 daily intakes, i.e., 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.

• Between 27 and 43 kg of weight (from 9 to 12 years): one intake of half a tablet, every 4 hours, up to a maximum of 6 intakes per day (3 tablets).

• Between 43 and 50 kg of weight (from 12 to 15 years): one intake of one tablet, every 6 hours, up to a maximum of 4 intakes per day (4 tablets).

This medication should not be used in children weighing less than 27 kg (approximately 9 years old) because the dose of this presentation does not adapt to this group of patients.

Do not use in children weighing over 27 kg for more than 3 days without evaluating the clinical situation.

Whole, split, or crushed tablets should be taken with the help of a glass of liquid, preferably water.

If you take more Paracetamol Vir Pharma than 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 Toxicology Information Service (telephone 91 562 04 20), indicating the medication and the amount ingested.

The symptoms of overdose may be: dizziness, vomiting, loss of appetite, yellowing 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, since they often do not manifest until 3 days after ingestion, even in cases of severe poisoning.

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

Patients treated with barbiturics or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

4. Possible adverse effects

Like all medications, this medication can produce adverse effects, although not all people suffer from 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)
• increase in liver enzymes
• discomfort

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

• changes in blood, including changes in blood cell counts (such as abnormally low levels of certain blood elements that can cause, for example, bleeding through the nose or gums) and bleeding
• allergic reactions (symptoms such as edema, shortness of breath, sweating, nausea, sudden drop in blood pressure)
• decrease in blood sugar
• jaundice (yellowing of the skin), liver failure
• 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)

Frequency not known (cannot be estimated from available data):

• A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using 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 leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Paracetamol Vir Pharma

Keep out of sight and reach 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 thrown away through the sewers or in the trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Paracetamol Vir Pharma:

The active ingredient is paracetamol. Each film-coated tablet contains 650 milligrams of paracetamol.

The other components (excipients) are sodium carboxymethyl starch type A (potato), purified water, pregelatinized corn starch, povidone K30 (E1201), vegetable stearic acid, and crospovidone (E1202).

Appearance of the product and package contents:

Paracetamol Vir Pharma is presented in film-coated tablets for oral administration.

The tablets are oblong, biconvex, white, with a score line on one face and marked with PB on the other face.

The tablet can be divided into equal doses.

The boxes are of 12 and 20 tablets.

Marketing authorization holder:

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/Laguna 66-70. Polígono Industria URTINSA II

28923 – Alcorcón (Madrid)

Spain

Manufacturer

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

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/