PARACETAMOL VIATRIS 650 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Paracetamol Viatris 650 mg Tablets EFG

Read this package leaflet carefully before starting to take this medicine, as it contains important information for you.

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

Contents of the Package 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. Storage of Paracetamol Viatris
6. Package Contents and Additional Information

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

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

This medicine is used for the symptomatic treatment of mild to moderate pain and febrile states in adults and children over 6 years of age and with a body weight of over 21 kg.

2. What you need to know before taking Paracetamol Viatris

Do not take Paracetamol Viatris:

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

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Paracetamol Viatris:

• Do not take more than the recommended dose in section 3. How to take Paracetamol Viatris.
• Avoid taking this medicine simultaneously with other medicines that contain paracetamol, such as flu and cold medicines, as high doses can cause liver damage. Do not use more than one medicine that contains paracetamol without consulting your doctor.
• Chronic alcoholics should be cautious not to take more than 2 grams per day of paracetamol.
• Patient with kidney, liver, heart, or lung disease, and patients with anemia, should consult their doctor before taking this medicine.
• When being treated with any medicine for epilepsy, consult your doctor before taking this medicine, as the efficacy of paracetamol may be decreased and hepatotoxicity may be increased, especially with high doses of paracetamol.
• Asthmatic patients sensitive to acetylsalicylic acid should consult their doctor before taking this medicine.

During treatment with paracetamol, inform your doctor immediately if:

If you have severe diseases, such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), 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.

Children and Adolescents

In children under 15 years of age, consult your doctor or pharmacist, as there are other presentations with doses that are suitable for this group of patients.

Other Medicines and Paracetamol Viatris

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine, including those obtained without a prescription.

In particular, if you are using any of the following medicines, it may be necessary to modify the dose of some of them or interrupt treatment:

• Medicine 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 convulsions: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medicines to lower cholesterol levels in the blood: (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 and heart rhythm disorders (arrhythmias): Propranolol.

• Flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (called metabolic acidosis with high anion imbalance) that must be treated urgently.

Interference with Analytical Tests

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

Taking Paracetamol Viatris with Food and Drinks

Using paracetamol in patients who habitually consume alcohol (3 or more alcoholic beverages: beer, wine, liquor, ... per day) may cause liver damage.

Taking this medicine with food does not affect its efficacy.

Pregnancy and Breastfeeding

Pregnancy

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 if the pain or fever does not decrease 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, so breastfeeding women should consult their doctor or pharmacist before taking this medicine.

Driving and Using Machines

The influence of paracetamol on the ability to drive and use machines is zero or insignificant.

3. How to Take Paracetamol Viatris

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

Remember to take your medicine. This medicine should be taken orally. According to your preferences, the tablets can be taken directly or broken in half with water, milk, or fruit juice.

The tablet can be divided into equal doses.

The recommended dose is:

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

Children: it is necessary to respect the dosages defined according to weight. The age of the child according to weight is given for information purposes only.

The recommended daily dose of paracetamol is approximately 60 mg/kg/day, divided into 4 or 6 daily doses, i.e., 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.

• Between 21 and 25 kg of weight (from 6 to 10 years): half a tablet per dose, every 6 hours, up to a maximum of 2 tablets per day.
• Between 26 and 40 kg of weight (from 8 to 13 years): half a tablet per dose, every 4 hours, up to a maximum of 3 tablets per day.
• Between 41 and 50 kg of weight (from 12 to 15 years): 1 tablet per dose, every 6 hours, up to a maximum of 4 tablets per day.

Kidney Problems:

In case of moderate kidney problems, the usual dose is 500 mg every 6 hours.

In case of severe kidney problems, the usual dose is 500 mg every 8 hours.

Liver Problems:

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

In case of chronic alcoholism, the dose should not exceed 2 grams per day.

Elderly Patients: should consult their doctor.

If you think the action of this medicine is too strong or too weak, tell your doctor or pharmacist.

When lower doses of paracetamol are required (less than 650 mg per dose), other presentations of paracetamol should be used that adapt to the required dosage.

If You Take More Paracetamol Viatris Than You Should

If you have taken more paracetamol than you should:

Consult your doctor or pharmacist immediately.

The symptoms of overdose may be: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), abdominal pain, and pancreatitis (inflammation of the pancreas).

If you have ingested an overdose, go to a medical center immediately, even if you do not notice symptoms, as they often do not appear until 3 days after ingestion, even in cases of severe poisoning.

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

Patient taking barbiturates or chronic alcoholics may be more susceptible to paracetamol toxicity.

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

If You Forget to Take Paracetamol Viatris

Do not take a double dose to make up for forgotten doses, simply take the forgotten dose when you remember, taking the next doses with the indicated interval between doses (at least 4 hours).

4. Possible Side Effects

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

Rare Side Effectsthat may occur (between 1 and 10 in every 10,000 people) are: discomfort, low blood pressure (hypotension), and increased levels of transaminases in the blood.

Very Rare Side Effectsthat may occur (in less than 1 in every 10,000 people) are: kidney disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar). Very rare cases of severe skin reactions have been reported.

Paracetamol may damage the liver when taken in high doses or for prolonged periods.

Side Effects with Unknown Frequency(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 Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package 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 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 special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Paracetamol Viatris

The active ingredient is paracetamol. Each tablet contains 650 mg of paracetamol.

The other ingredients 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 Product and Package Contents

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

Only certain package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturer

Toll Manufacturing Services, S.L.

C/ Aragoneses, 2.

28108 - Alcobendas (Madrid)

Spain

O

Rovi Pharma Industrial Services, S.A.

Vía Complutense, 140

28805 - Alcalá de Henares (Madrid)

Spain

O

Pharmaloop, S.L.

C/ Bolivia, 15, Polig. Industrial Azque

28806 - Alcalá de Henares (Madrid)

Spain

O

Farmalider, S.A.

C/ Aragoneses, 2

28108 - Alcobendas (Madrid)

Spain

Date of Last Revision of this Package Leaflet:February 2025

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