Paracetamol Viatris 1 g tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Paracetamol Viatris 1 g tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Paracetamol Viatris is and what it is used for

Paracetamol Viatris belongs to a group of medicines called analgesics and antipyretics.

This medicine is used for the symptomatic treatment of mild to moderate pain and fever in adults and adolescents over 15 years of age and with a body weight above 50 kg.

2. What you need to know before taking Paracetamol Viatris

Do not take Paracetamol Viatris:

• If you are allergic (hypersensitive) to paracetamol or to any of the other ingredients of this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking Paracetamol Viatris:

• Do not take more medicine than the recommended dose stated in section 3, How to take Paracetamol Viatris.
• The simultaneous 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.
• Chronic alcoholics should take care not to take more than 2 grams of paracetamol in 24 hours.
• Patients with kidney, liver, heart, or lung diseases, or those with anaemia, should consult their doctor before taking this medicine.
• If you are being treated with medicines for epilepsy, consult your doctor before taking this medicine, as the concomitant use may reduce the effectiveness and increase the hepatotoxicity of paracetamol, especially with high-dose paracetamol regimens.
• Asthmatic patients who are sensitive to acetylsalicylic acid should consult their doctor before taking this medicine.

During treatment with paracetamol, inform your doctor immediately 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 known as metabolic acidosis (an imbalance in blood and body fluids) has been reported in patients under these conditions 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 difficulty breathing with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

Children and adolescents

For children under 15 years of age, consult your doctor or pharmacist, as other formulations with doses appropriate for this patient group are available.

Other medicines and Paracetamol Viatris

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

In particular, if you are taking any of the following medicines, dose adjustments or discontinuation of treatment may be necessary:

• Medicines to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)

• Medicines to treat epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)

• Medicines to treat tuberculosis: (isoniazid, rifampicin)

• Medicines to treat depression and seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)

• Medicines to lower blood cholesterol levels: (cholestyramine)

• Medicines used to increase urine elimination (loop diuretics such as furosemide)

• Medicines used to treat gout (probenecid and sulfinpyrazone)

• Medicines used to prevent nausea and vomiting: Metoclopramide and domperidone

• Medicines used to treat high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias): Propranolol.

• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (called metabolic acidosis with high anion gap) that requires urgent treatment.

Interference with laboratory tests

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

Taking Paracetamol Viatris with food and drinks

Using paracetamol in patients who regularly consume alcohol (3 or more alcoholic drinks: beer, wine, spirits, etc., per day) may cause liver damage.

Taking this medicine with food does not affect its effectiveness.

Pregnancy and breastfeeding

Pregnancy

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

Paracetamol may be used during pregnancy if necessary. Use the lowest possible dose that relieves pain or fever, and use it for the shortest possible duration.

Contact your doctor if pain or fever do not improve, or if you need to take the medicine more frequently.

Breastfeeding

Consult your doctor or pharmacist before using any medicine.

Paracetamol passes into breast milk; therefore, women who are breastfeeding should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

The effect of paracetamol on the ability to drive and operate machinery is negligible or none.

3. How to take Paracetamol Viatris

Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine. This medicine is to be taken orally. Depending on your preference, the tablets can be swallowed whole or split in half with water, milk, or fruit juice.

The tablet may be divided into equal doses.

The recommended dose is:

Adults and adolescents over 15 years of age and weighing more than 50 kg: 1 tablet every 4–6 hours, up to a maximum of 4 tablets per day.

Renal impairment:

In case of moderate renal problems, the usual dose is half a tablet (500 mg paracetamol) every 6 hours.

In case of severe kidney problems, the usual dose is half a tablet (500 mg paracetamol) every 8 hours.

Hepatic impairment:

In case of liver problems, consult your doctor. Your doctor may decide to reduce your dose.

In chronic alcoholism, the dose should not exceed 2 g per day.

Elderly patients: should consult their doctor.

Use in children and adolescents

For children under 15 years of age and weighing less than 50 kg, consult your doctor or pharmacist, as other formulations may be available with doses appropriate for these patients.

If you feel the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

When doses lower than 1 g of paracetamol per dose are required, other paracetamol formulations suitable for the required dosage should be used.

If you take more Paracetamol Viatris than you should

If you have taken more paracetamol than you should:

You must consult your doctor or pharmacist immediately.

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

If you have ingested an overdose, you must go immediately to a medical centre 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 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.

In case of overdose or accidental ingestion, go immediately to a medical centre or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount ingested.

If you forget to take Paracetamol Viatris

Do not take a double dose to make up for forgotten doses. Simply take the missed dose as soon as you remember, then take the following doses at the recommended intervals (at least 4 hours apart).

4. Possible adverse effects

Like all medicines, this medicine can have adverse effects, although not everyone will experience them.

Rare adverse effects (occurring in between 1 and 10 out of every 10,000 people) are: malaise, low blood pressure (hypotension), and increased levels of transaminases in the blood.

Very rare adverse effects (occurring in fewer than 1 out of every 10,000 people) are: kidney disorders, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, haemolytic anaemia), and hypoglycaemia (low blood sugar). Very rare cases of serious skin reactions have also been reported.

Paracetamol may damage the liver when taken at high doses or during prolonged treatment.

Adverse effects with unknown frequency (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 use 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 through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Paracetamol Viatris

Keep this medicine 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 CAD or EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Paracetamol Viatris

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

The other components are: pregelatinized corn starch, stearic acid (E-570), povidone (E-1201), crospovidone (E-1202), microcrystalline cellulose, and vegetable magnesium stearate (E-470b).

Appearance of the medicine and contents of the pack

Paracetamol Viatris tablets are oblong, biconvex, scored, white tablets, packaged in blisters in packs of 20 and 40 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

Manufacturer

Toll Manufacturing Services, S.L.
C/ Aragoneses, 2.
28108 - Alcobendas (Madrid)
Spain

Or

Rovi Pharma Industrial Services, S.A.
Vía Complutense, 140
28805 - Alcalá de Henares (Madrid)
Spain

Or

Pharmaloop, S.L.
C/ Bolivia, 15, Polig. Industrial Azque
28806 - Alcalá de Henares (Madrid)
Spain

Or

Farmalider, S.A.
C/ Aragoneses, 2
28108 - Alcobendas (Madrid)
Spain

Date of the most recent review of this leaflet: February 2025

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/