Paracetamol Viatris 650 mg tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Paracetamol Viatris 650 mg Tablets EFG
Read the entire leaflet carefully before you start taking this medicine, as 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 effects not listed in this leaflet. See section 4.
Leaflet Contents
- What Paracetamol Viatris is and what it is used for
- What you need to know before taking Paracetamol Viatris
- How to take Paracetamol Viatris
- Possible side effects
- How to store Paracetamol Viatris
- 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 feverish conditions in adults and children aged 6 years and older with a body weight above 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 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 (e.g. 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 exceed 2 grams of paracetamol in 24 hours.
- Patients with kidney, liver, heart or lung disease, or those with anaemia, should consult their doctor before taking this medicine.
- If you are being treated with medication for epilepsy, consult your doctor before taking this medicine, as when used together, the effectiveness may be reduced and the hepatotoxicity of paracetamol may be increased, especially with high-dose paracetamol treatment.
- 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 called metabolic acidosis (an abnormality 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 breathing difficulty with deep and rapid breathing, drowsiness, feeling unwell (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
Tell 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, as it may be necessary to adjust the dose of some of them or discontinue treatment:
-
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 due to have any laboratory tests (including blood, urine, etc.), inform your doctor that you are taking/using this medicine, as it may alter test results.
Taking Paracetamol Viatris with food and drink
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 time.
Contact your doctor if pain or fever does 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, so women who are breastfeeding 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 none or negligible.
3. How to take Paracetamol Viatris
Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Remember to take your medicine. This medicine is taken orally. Depending on your preference, the tablets may be swallowed whole or split 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 more than 50 kg: 1 tablet every 4–6 hours, up to a maximum of 6 tablets per day.
Children: It is necessary to follow dosage guidelines 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; that is, 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.
- Weighing between 21 and 25 kg (ages 6 to 10): Half a tablet per dose, every 6 hours, up to a maximum of 2 tablets per day.
- Weighing between 26 and 40 kg (ages 8 to 13): Half a tablet per dose, every 4 hours, up to a maximum of 3 tablets per day.
- Weighing between 41 and 50 kg (ages 12 to 15): 1 tablet per dose, every 6 hours, up to a maximum of 4 tablets per day.
Renal impairment:
In cases of moderate kidney problems, the usual dose is 500 mg every 6 hours.
In cases of severe kidney problems, the usual dose is 500 mg every 8 hours.
Hepatic impairment:
If you have liver problems, consult your doctor. Your doctor may decide to reduce your dose.
In cases of chronic alcoholism, the dose should not exceed 2 g per day.
Elderly patients: Should consult their doctor.
If you feel that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.
When doses lower than 650 mg of paracetamol per administration are required, other paracetamol formulations appropriate 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 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 if started within 4 hours of taking 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 center 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 missed 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 cause adverse effects, although not everyone experiences them.
Rare adverse effects (occurring in between 1 and 10 out of every 10,000 people) include: 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) include: 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 severe skin reactions have been reported.
Paracetamol may cause liver damage when taken at high doses or during prolonged treatment.
Adverse effects with 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 critically ill patients 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 can 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 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 which is stated on the packaging after CAD or EXP. The expiry date corresponds 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 Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Package contents and additional information
Composition of Paracetamol Viatris
The active substance is paracetamol. Each tablet contains 650 mg of paracetamol.
The other components are: pregelatinized maize starch, stearic acid (E-570), povidone (E-1201), crospovidone (E-1202), microcrystalline cellulose, and magnesium stearate of vegetable origin (E-470b).
Appearance of the medicinal product and contents of the pack
Paracetamol Viatris tablets are oblong, biconvex, scored, and white, packed 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 revision of this leaflet: February 2025
Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): https://www.aemps.gob.es/