PARACETAMOL AUROVITAS SPAIN 650 mg TABLETS

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 any of the other components of this medication (listed in section 6).

Warnings and precautions

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

The simultaneous use of this medication with other medications containing paracetamol, such as flu and cold medications, should be avoided, as high doses can lead to liver damage. Do not use more than one medication containing paracetamol without consulting your doctor.

When being treated with any medication for epilepsy, consult your doctor before taking this medication, as the efficacy of paracetamol may be decreased and hepatotoxicity increased, especially with high doses of paracetamol.

In patients with asthma who are sensitive to acetylsalicylic acid, consult your doctor before taking this medication.

If you have liver, kidney, heart, or lung disease, or have anemia, you should consult your doctor before taking this medication.

In chronic alcoholics, it is recommended not to take more than 2 g/day of paracetamol.

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.

Other medications and Paracetamol Aurovitas Spain

Tell your doctor or pharmacist if you are using or have recently used or may need to use any other medication.

Paracetamol may interact with the following medications:

• Oral anticoagulants (used to treat thromboembolic diseases such as acenocoumarol, warfarin).
• Antiepileptics (used to treat epileptic seizures): lamotrigine, phenytoin, and other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine.
• Diuretics such as those in the furosemide group (used to increase urine elimination).
• Isoniazid (used to treat tuberculosis).
• Barbiturates, used as hypnotics, sedatives, and anticonvulsants (used to treat depression and seizures).
• Lamotrigine (used to treat epilepsy).
• Probenecid, sulfinpyrazone (used to treat gout).
• Metoclopramide and domperidone (used to prevent nausea and vomiting).
• Propranolol (used to treat hypertension, cardiac arrhythmias).
• Rifampicin (used to treat tuberculosis).
• Colestyramine (used to decrease blood cholesterol levels).
• 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 (see section 2).

Do not use with other analgesics (pain-relieving medications) without consulting your doctor.

As a general rule for any medication, it is recommended to systematically inform your doctor or pharmacist if you are being treated with another medication. In the case of treatment with oral anticoagulants, it can be administered occasionally as the analgesic of choice.

Interference with analytical tests

If you are going to have any analytical tests (including blood, urine, etc.), inform your doctor that you are taking this medication, as it may alter the results of these 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 beverages per day - beer, wine, liquor...) may cause liver damage.

Taking this medication 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 medication.

If you are pregnant or think you may be pregnant, consult your doctor before taking this medication. The use of medications during pregnancy can be dangerous for the embryo or fetus and should be monitored by your doctor.

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 or midwife if the pain or fever does not decrease or if you need to take the medication more frequently.

Breastfeeding

Consult your doctor or pharmacist before using any medication.

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

Driving and using machines

No effects have been described that modify the ability to drive and operate machines.

Paracetamol Aurovitas Spain contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; that is, it is essentially "sodium-free".

3. How to take Paracetamol Aurovitas Spain

Follow the instructions of this medication indicated by your doctor or pharmacist exactly. In case of 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: before taking this medication, they must consult their doctor. They should take the amount of medication prescribed by their doctor with a minimum interval of 8 hours between each dose. They should not take more than 3 tablets in 24 hours, divided into 3 doses.
• Patients with kidney disease: before taking this medication, they must consult their doctor. Take a maximum of 500 milligrams per dose. Due to the dose, 650 milligrams of paracetamol, the medication is not indicated for this group of patients.

This medication should be taken orally.

According to your preferences, the tablets can be swallowed directly or broken in half with a glass of liquid, preferably water. Consult your doctor or pharmacist if you have doubts.

Always use the lowest effective dose.

The use of high daily doses of paracetamol for prolonged periods of time should be avoided, as it increases the risk of suffering from side effects such as liver damage.

The administration of this medication is subject to the appearance of pain or fever. As they disappear, treatment should be discontinued.

If the pain persists for more than 5 days, the fever for more than 3 days, or the pain or fever worsens or other symptoms appear, you should interrupt treatment and consult your doctor.

If you take more Paracetamol Aurovitas Spain than you should

If you have taken more paracetamol than you should, consult your doctor or pharmacist immediately.

If you have taken an overdose, you should go to a medical center immediately, even if you do not have symptoms, as they often do not appear until three days after taking the overdose, even in cases of severe poisoning.

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

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

Patients being treated with barbiturates or suffering from chronic alcoholism may be more susceptible to a paracetamol overdose.

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

If you forget to take Paracetamol Aurovitas Spain

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Paracetamol may cause the following side effects:

• Rare (between 1 and 10 out of 10,000 people): discomfort, increased levels of liver transaminase enzymes in the blood, and low blood pressure (hypotension).
• Very rare (less than 1 in 10,000 people): kidney disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leukopenia, neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar). Very rare cases of severe skin reactions have been reported. Paracetamol can damage the liver when taken in high doses or for prolonged periods.
• Frequency not known (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 type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use Website www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Paracetamol Aurovitas Spain

Keep out of sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date shown on the packaging after "CAD". The expiration date is the last day of the month indicated.

Medications should not be thrown away in drains or trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Paracetamol Aurovitas Spain 650 mg tablets EFG

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

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

Appearance of the product and package contents

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

They are available in packages of 20 and 40 tablets, packaged 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, N° 15, Pol. Ind Azque,

Alcalá de Henares, 28806 Madrid

Spain

Date of the last revision of this leaflet:January 2025

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