Paracetamol Aurovitas Spain 650 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Paracetamol Aurovitas Spain 650 mg tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

This medicine can be purchased 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 more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve, if fever persists for more than 3 days or pain for more than 5 days.
• If you consider any of the side effects you experience to be severe, or if you notice any adverse effects not mentioned in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

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

1. What Paracetamol Aurovitas Spain is and what it is used for

Paracetamol is effective in reducing pain and fever.

This medicine is indicated for the symptomatic relief of mild to moderate occasional pain, such as headache, dental pain, muscle pain (cramps), or back pain (lumbago), and in febrile conditions.

Paracetamol is indicated for adults and adolescents over 14 years of age.

2. What you need to know before taking Paracetamol Aurovitas Spain

Do not take Paracetamol Aurovitas Spain

• If you are allergic (hypersensitive) to paracetamol or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Do not take more medicine than recommended in section 3. How to take Paracetamol Aurovitas Spain.

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.

In chronic alcoholics, caution should be taken not to exceed 2 g/day of paracetamol.

If you have liver, kidney, heart or lung disease, or if you have anaemia, you should consult your doctor before taking this medicine.

If you are being treated with any medicine for epilepsy, you should consult your doctor before taking this medicine, as the simultaneous use may reduce efficacy and increase the hepatotoxicity of paracetamol, especially with high-dose paracetamol regimens.

In asthmatic patients sensitive to acetylsalicylic acid, you should consult your 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 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.

Other medicines and Paracetamol Aurovitas Spain

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

Paracetamol may interact with the following medicines:

• Medicines to prevent blood clots: oral anticoagulants (used to treat thromboembolic disorders such as acenocoumarol, warfarin).
• Medicines to treat epilepsy: antiepileptics (lamotrigine, phenytoin and 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 disturbances (called metabolic acidosis with high anion gap) that must be urgently treated (see section 2).

Do not use with other analgesics (medicines that relieve pain) without consulting your doctor.

As a general rule for any medicine, it is advisable to systematically inform your doctor or pharmacist if you are taking any other medicine. In patients taking oral anticoagulants, paracetamol may occasionally be used as the analgesic of choice.

Interference with laboratory tests

If you are to undergo any laboratory tests (including blood, urine, etc.), inform your doctor that you are taking this medicine, as it may alter the results of such tests.

Taking Paracetamol Aurovitas Spain with food, drinks and alcohol

It is recommended not to consume alcohol during treatment with paracetamol due to the increased risk of liver damage. The use of paracetamol in patients who habitually consume alcohol (three or more alcoholic drinks per day – beer, wine, spirits, etc.) may cause liver damage.

Taking this medicine with food does not affect its efficacy.

Use in children:

Do not use in adolescents under 14 years of age.

Pregnancy

Consult your doctor or pharmacist before using any medicine.

If you are pregnant or think you may be pregnant, consult your doctor before taking this medicine. Taking medicines during pregnancy may be harmful to the embryo or fetus and should be monitored by your doctor.

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 do not improve or if you need to take the medicine more frequently.

Breast-feeding

Consult your doctor or pharmacist before using any medicine.

Small amounts of paracetamol may appear in breast milk; therefore, it is recommended that you consult your doctor or pharmacist before taking this medicine.

Driving and using machines

No effects affecting the ability to drive or operate machinery have been reported.

Paracetamol Aurovitas Spain contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; hence, it is essentially “sodium-free”.

3. How to take Paracetamol Aurovitas Spain

Follow exactly the instructions provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

• Adults and adolescents over 14 years of age (weight 64–65 kg): take 1 tablet every 4–6 hours as needed. Do not take more than 3 g (4 tablets) in 24 hours.
• 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 3 tablets in 24 hours, divided into 3 doses.
• Patients with kidney disease: must consult their doctor before taking this medicine. Maximum dose per intake should be 500 milligrams. Due to the dosage (650 milligrams of paracetamol), this medicine is not recommended for this patient group.

This medicine should be taken orally.

Depending on your preference, the tablets can be swallowed whole or split in half with a glass of liquid, preferably water. Consult your doctor or pharmacist if you have any doubts.

The tablets are scored, which allows them to be split in half. The score line is provided solely to facilitate splitting if you have difficulty swallowing the tablet whole.

Always use the lowest effective dose.

High daily doses of paracetamol should be avoided over prolonged periods, as this increases the risk of adverse effects such as liver damage.

This medicine should only be administered when pain or fever is present. As symptoms subside, treatment should be discontinued.

If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, you must stop treatment and consult your doctor.

If you take more Paracetamol Aurovitas Spain than you should

If you have taken more paracetamol than recommended, contact 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 an overdose has occurred, seek immediate medical attention even if no symptoms are present, as symptoms often do not appear until three days after the overdose, even in cases of severe poisoning.

Treatment for overdose is most effective if initiated within 4 hours of taking the medicine.

Patients undergoing treatment with barbiturates or those suffering from chronic alcoholism may be more susceptible to 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 Aurovitas Spain

Do not take a double dose to make up for a missed dose. Simply take the missed dose as soon as you remember, and 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 will experience them.

Paracetamol may cause the following adverse effects:

• Rare (between 1 and 10 in 10,000 people): malaise, increased levels of liver transaminase enzymes in the blood, and low blood pressure (hypotension).
• Very rare (less than 1 in 10,000 people): 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 damage the liver when taken at high doses or during prolonged treatment.
• 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 serious 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 can also report them directly via the Spanish Pharmacovigilance System for Human Medicines Website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Paracetamol Aurovitas Spain

Keep out of the sight and reach of children.

No special storage conditions are required.

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 must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Paracetamol Aurovitas Spain 650 mg tablets EFG

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

The other components are: pregelatinized starch (from corn), stearic acid, povidone, crospovidone, microcrystalline cellulose and vegetable magnesium stearate.

Appearance of the medicine and contents of the pack

Paracetamol Aurovitas Spain 650 mg tablets are oblong, white tablets, scored on one side.

They are available in packs of 20 and 40 tablets, packed in aluminum-PVC-PVDC blisters.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

Toll Manufacturing Services S.L

C/ Aragoneses, 2.

28108 Alcobendas (Madrid)

Spain

Or

Pharmaloop, S.L.

C/ Bolivia, No 15, Pol. Ind Azque,

Alcalá de Henares, 28806 Madrid

Spain

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

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