PARACETAMOL VIR PHARMA 1 g TABLETS

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

Do not takeParacetamol Vir Pharma:

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

Warnings and precautions

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

Other medicines 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 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.

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 medicine 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 medicine with other medicines that contain paracetamol, such as flu and cold medicines, should be avoided, as high doses can cause liver damage. Do not use more than one medicine that contains paracetamol without consulting your doctor.

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

This medicine 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.

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

Prolonged use of pain relievers or inadequate use of high doses can cause headaches, which should not be treated with higher doses of the medicine.

Interference with analytical tests.

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

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

Children and adolescents

This medicine should not be used in children or adolescents under 15 (and weight under 50 kg). Ask your pharmacist about the available presentations that allow for adequate dosing of these patients.

Other medicines and Paracetamol Vir Pharma

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

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

Lamotrigine: The effect of lamotrigine may decrease.

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

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

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

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

Medicines 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.

Medicines to prevent nausea and vomiting (metoclopramide and domperidone): the simultaneous ingestion of medicines that cause gastric emptying acceleration, e.g., metoclopramide and domperidone, increase the absorption and anticipate the onset of action of paracetamol. However, it is not necessary to avoid concomitant use.

Medicines to prevent blood clots (oral anticoagulants such as acenocoumarol, warfarin): paracetamol may increase the effects of oral anticoagulants. The prolonged use of this medicine in patients treated with oral anticoagulants should only be done under medical supervision. The potentiation of the effects of warfarin has been observed with continued high doses of paracetamol.

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

Chloramphenicol, a medicine to treat infections: the simultaneous administration of paracetamol and chloramphenicol may significantly delay the elimination of chloramphenicol, increasing its plasma concentrations and causing a greater risk of toxicity.

Zidovudine (AZT), a medicine 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.

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

Inform your doctor if this medicine is taken with medicines that delay gastric emptying (e.g., propanteline) or 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 medicine.

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 medicine more frequently.

Paracetamol passes into breast milk. Therapeutic doses of paracetamol can be administered during breastfeeding.

Driving and using machines

This medicine 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 medicine contains less than 1 mmol of sodium (23 mg) per coated tablet; i.e., 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 medicine is taken orally.

The recommended dose is:

Adults and adolescents from 15 years and weighing over 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.

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

Always take the lowest effective dose.

The intake of this medicine 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 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 discontinue treatment and consult your doctor.

Patient with liver disease: before taking this medicine, they must consult their doctor.

They should take the amount of medicine 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.

Patient with kidney disease: This medicine does not adjust to the recommended dose for these patients.

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 Toxicological Information Service (telephone 91 562 04 20), indicating the medicine 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, as they often do not manifest until 3 days after ingestion, even in cases of severe poisoning.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

The following side 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 amount of urine, and blood in the urine)

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

• A severe disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Reporting of side effects

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

5. Storage of Paracetamol Vir Pharma

Keep out of the reach and sight of children.

This medicine does not require special storage conditions.

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

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines that you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Further information

Composition of Paracetamol Vir Pharma:

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

Paracetamol Vir Pharma is presented in oral tablets.

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

The tablet can be divided into equal doses.

The packaging is for 10 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 medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/