Paracetamol Vir Pharma 650 mg tablets EFG

Package leaflet: Information for the user

Introduction

Paracetamol Vir Pharma 650 mg tablets EFG

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

Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist.

This medicine is available without a prescription. However, to achieve the best results, it must be used carefully.

• 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 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 side 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 symptomatic relief of mild to moderate occasional pain, such as headache, dental pain, muscular pain (cramps), or back pain (lumbago), and for febrile conditions in adults and children over 9 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 to 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.

• 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, the efficacy of paracetamol is reduced and hepatotoxicity is increased, 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 suffer from 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 over a prolonged period 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 serious 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 serious skin reactions, and use of the medicine must 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".

Concomitant use of this medicine with other medicines containing paracetamol, such as 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 take an overdose, seek medical attention immediately (see "If you take more Paracetamol Vir Pharma than you should").

This medicine should not be used for self-treatment 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 carries a risk of severe liver damage. 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 analgesics, or inappropriate use of high doses, may cause headaches, which should not be treated with higher doses of the medicine.

Interference with laboratory tests.

If you are scheduled for any laboratory tests (including blood and urine tests), inform your doctor that you are taking this medicine, as it may alter test results.

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

Children and adolescents

This medicine should not be used in children under 9 years of age. 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 dose of paracetamol should be considered when probenecid is administered 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 of paracetamol and advances the onset of its action. However, concomitant use does not need to be avoided.

Medicines used to prevent blood clots (oral anticoagulants such as acenocoumarol, warfarin): paracetamol may enhance the effects of oral anticoagulants. Prolonged use of this medicine in patients treated with oral anticoagulants should only be done under medical supervision. Potentiation of warfarin's effects has been observed with continued high-dose 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: concomitant 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 or worsen neutropenia (reduction in white blood cell count). Paracetamol should only be taken simultaneously with AZT if specifically recommended by your doctor.

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 require 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 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; hence, 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:

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

For adults and underweight adolescents (weighing less than 50 kg), a daily dose of 2 g of paracetamol (3 tablets) is recommended.

Always take the lowest effective dose.

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

Avoid using high daily doses of paracetamol for prolonged periods, 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, discontinue treatment and consult your doctor.

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

Take only the amount prescribed by your doctor, with a minimum interval of 8 hours between doses.

Do not exceed 2 grams of paracetamol in 24 hours, divided into several doses.

Patients with kidney disease:

Consult your doctor before taking this medicine.

Take a maximum of 500 milligrams per dose.

Depending on your condition, your doctor will advise whether you should take the medicine at intervals of at least 6 or 8 hours.

Children:

It is essential to follow dosage recommendations based on body weight. The age range corresponding to each weight category is provided for informational purposes only. The recommended daily dose of paracetamol is approximately 60 mg/kg/day, divided into 4 or 6 doses per day (i.e., 15 mg/kg every 6 hours or 10 mg/kg every 4 hours).

• Weighing between 27 and 43 kg (approximately 9 to 12 years of age): Half a tablet every 4 hours, up to a maximum of 6 doses per day (3 tablets).

• Weighing between 43 and 50 kg (approximately 12 to 15 years of age): 1 tablet every 6 hours, up to a maximum of 4 doses per day (4 tablets).

This medicine must not be used in children weighing less than 27 kg (approximately 9 years of age), as the dosage of this formulation is not suitable for this patient group.

Do not use in children weighing more than 27 kg for longer than 3 days without reassessing the clinical condition.

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

If you take more Paracetamol Vir Pharma than you should:

You must 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 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 you have taken an overdose, go immediately to a medical center even if you do not have symptoms, as symptoms often do not appear until 3 days after the overdose, even in cases of severe poisoning.

Treatment for overdose is most effective when started within 4 hours of ingestion.

Patients undergoing treatment with barbiturates or chronic alcoholics may be more susceptible to the toxic effects 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 abnormalities 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 urinating, decreased amount of urine, and blood in the urine)

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

• A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who are taking paracetamol (see section 2).

Reporting of adverse effects

If you experience any 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 sight and reach 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 or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Paracetamol Vir Pharma:

The active substance is paracetamol. Each tablet contains 650 milligrams of paracetamol.

The other components (excipients) are sodium carboxymethyl starch 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 "PB" on the other side.

The tablet can be divided into equal doses.

Pack sizes are 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 most recent review 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 Medical Devices (AEMPS): http://www.aemps.gob.es/