Paracetamol Vir Pharma 1 g tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Paracetamol Vir Pharma 1 g tablets EFG

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

Follow exactly the instructions for use of this medicine as described in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these adverse effects are not listed in this leaflet. See section 4.
• You should consult your doctor if your condition worsens or if fever persists beyond 3 days of treatment, or if pain persists beyond 5 days.

Leaflet contents:

1. What Paracetamol Vir Pharma is and what it is used for.
2. What you need to know before taking Paracetamol Vir Pharma.
3. How to take Paracetamol Vir Pharma.
4. Possible adverse effects.
5. How to store Paracetamol Vir Pharma.
6. Contents of the pack and other information.

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

Paracetamol is effective in reducing pain and fever.

It is indicated for the relief of mild to moderate occasional pain, such as headache, dental pain, muscle pain (contractures), or back pain (lumbago), and for feverish conditions in adults and adolescents over 15 years of age.

You should consult a doctor if symptoms worsen or do not improve after 3 days.

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 any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

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

• if you have liver problems, including liver problems due to excessive alcohol consumption (3 or more alcoholic drinks per day);
• if you have kidney problems;
• if you have glucose-6-phosphate dehydrogenase deficiency;
• if you suffer from anorexia, bulimia, cachexia, or chronic malnutrition;
• if you are dehydrated or have hypovolemia;
• if you are taking a medicine to treat epilepsy, you should consult your doctor before taking this medicine, as when used together, it decreases the efficacy and increases the hepatotoxicity of paracetamol, especially with high-dose paracetamol treatments (see below in this section "Other medicines and Paracetamol Vir Pharma");
• if you have Gilbert's disease (also known as Meulengracht's disease);
• if you have heart problems, respiratory failure, or anemia; in these situations, administration should be under medical supervision and only for short periods;
• if you have asthma and are sensitive to acetylsalicylic acid;
• if you have serious conditions 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 condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients in these situations when paracetamol is used at regular doses for prolonged periods or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulty 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 medicine should be discontinued at the first sign of a skin rash or any other symptom of hypersensitivity.

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

Concurrent use of this medicine with other medicines containing paracetamol, for example, cold and flu remedies, should be avoided, as high doses may cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.

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

This medicine should also not be used for self-medication of high fever (over 39°C), fever lasting more than 3 days, or recurrent fever, unless prescribed by your doctor, as these conditions may require medical evaluation and treatment.

Taking doses of paracetamol higher than recommended involves a serious risk of severe liver injury. Medicines containing paracetamol should not be taken for more than a few days or in high doses unless directed by your doctor.

Prolonged use of painkillers, or inappropriate use of high doses, may cause headache, which should not be treated with higher doses of the medicine.

Interference with laboratory tests.

If you are due to have any laboratory tests (including blood or urine tests), inform your doctor that you are taking this medicine, as it may alter the results.

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

Children and adolescents

This medicine should not be used in children or adolescents under 15 years of age (and weighing less than 50 kg). Ask your pharmacist about available formulations that allow appropriate dosing for these patients.

Other medicines and Paracetamol Vir Pharma

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

Medicines used 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 be reduced.

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

Medicines used to treat gout: Probenecid causes a nearly two-fold reduction in the excretion of paracetamol. A reduction in the paracetamol dose should be considered when probenecid is used concomitantly.

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

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

Medicines used to lower blood cholesterol levels: cholestyramine reduces the absorption of paracetamol. To avoid this, paracetamol should be administered one hour before or four hours after the resin.

Medicines used to prevent nausea and vomiting (metoclopramide and domperidone): simultaneous intake of medicines that accelerate gastric emptying, e.g., metoclopramide and domperidone, increases the absorption and advances the onset of action of paracetamol. However, it is not necessary to avoid concomitant use.

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

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

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

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

Inform your doctor if this medicine is taken together with medicines that delay gastric emptying (e.g., propantheline) or that accelerate gastric emptying (e.g., metoclopramide and domperidone).

Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormalities (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, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

If necessary, paracetamol may be used during pregnancy. Use the lowest possible dose that relieves pain or fever and use it for the shortest possible time. Contact your doctor or midwife if pain or fever does not improve or if you need to take the medicine more frequently.

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

Driving and using machines

This medicine does not affect the ability to drive or operate machinery. However, during treatment with paracetamol, mild drowsiness and dizziness may occur as side effects.

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

3. How to take Paracetamol Vir Pharma

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

This medicine is taken orally.

The recommended dose is:

Adults and adolescents aged 15 years and older, weighing more than 50 kg:

1 tablet (1 g of paracetamol) every 6–8 hours, up to 3 times a day. Do not exceed 3 g (3 tablets) of paracetamol in 24 hours.

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

Always use the lowest effective dose.

This medicine should only be taken when pain or fever occurs. Treatment should be discontinued as symptoms subside.

Prolonged use of high daily doses of paracetamol should be avoided, 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 new symptoms appear, treatment must be stopped and a doctor should be consulted.

Patients with liver disease: must consult their doctor before taking this medicine.

They should take the amount prescribed by their doctor, with a minimum interval of 8 hours between doses.

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

Patients with kidney disease: This medicine does not follow the recommended dosing for these patients.

If you take more Paracetamol Vir Pharma than you should

Contact 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), stating the name of the medicine and the amount ingested.

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

If an overdose has been ingested, immediate medical attention must be sought even if no symptoms are present, as symptoms often do not appear until 3 days after the overdose, even in cases of severe poisoning.

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will 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
• malaise

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

• blood changes may occur, including changes in blood cell counts (such as abnormally low levels of certain blood components which may cause, for example, bleeding from the nose or gums) and bleeding
• allergic reactions (symptoms such as edema, shortness of breath, sweating, nausea, sudden drop in blood pressure)
• decreased blood sugar
• jaundice (yellowing of the skin), liver failure
• skin reactions such as allergic dermatitis, urticaria, itching, skin rash
• changes in urination (difficulty or pain when passing urine, decreased amount of urine, blood in the urine)

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

• A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who are 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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Additional information

Composition of Paracetamol Vir Pharma:

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

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

Appearance of the product and contents of the pack

Paracetamol Vir Pharma is presented as tablets for oral administration.

The tablets are oblong, biconvex, white in colour, with a score line on one side and marked "PC" on the other side.

The tablet can be divided into equal doses.

Pack sizes of 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 most recent revision of this leaflet: February 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/