Paracetamol Aurovitas Spain 500 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Paracetamol Aurovitas Spain 500 mg tablets EFG

Read all of this 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 must not be given to other people, even if they have the same symptoms as you, because it could 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.

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 Aurovitas Spain contains the active substance paracetamol, which belongs to a group of medicines called analgesics.

Paracetamol is used to relieve pain and helps to reduce fever. The tablets can relieve mild to moderate pain (for example, headache or toothache) and/or feverish conditions.

This medicine can be used in adults and adolescents, but is not suitable for children under 10 years of age.

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

Do not take Paracetamol Aurovitas Spain

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

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine:

• if you have kidney or liver disease (including Gilbert's syndrome or acute hepatitis).
• if you have a deficiency of an enzyme called glucose-6-phosphate dehydrogenase.
• if you have haemolytic anaemia (abnormal breakdown of red blood cells).
• if you regularly consume large amounts of alcohol. Never take more than 2 g of paracetamol per day.
• if you are asthmatic and sensitive to acetylsalicylic acid.
• in case of dehydration or chronic malnutrition.

If you are being treated with any medication for epilepsy, consult your doctor before taking paracetamol, as concomitant use may reduce effectiveness and increase the risk of liver damage from paracetamol, especially with high-dose paracetamol treatment.

If you have high fever, signs of a secondary infection, or if symptoms persist for more than 3 days, consult your doctor or pharmacist.

Headache due to overuse of painkillers should not be treated by increasing the dose of analgesic. In such cases, use of analgesics should only be done after consulting a doctor.

Do not take more paracetamol 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 lead to liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.

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 in these situations 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.

Taking Paracetamol Aurovitas Spain with other medicines

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

Do not take Paracetamol Aurovitas Spain together with other medicines containing paracetamol.

If you are taking any of the following medicines, consult your doctor before taking paracetamol:

• Metoclopramide or domperidone (medicines used to treat nausea and vomiting).
• Colestyramine (used to lower cholesterol).
• Warfarin and other coumarin derivatives (medicines to make the blood less likely to clot), especially if you need to take paracetamol every day for a long period.
• Salicylamide (a medicine for pain).
• Probenecid (a medicine used to treat gout).
• Isoniazid or rifampicin (medicines used to treat tuberculosis).
• Lamotrigine or phenytoin (medicines used to treat epilepsy).
• Barbiturates or carbamazepine (medicines that cause relaxation and drowsiness).
• St. John's wort (a herbal remedy used to treat depression).
• Chloramphenicol (an antibiotic).
• Zidovudine (a medicine used to treat AIDS).
• Flucloxacillin (an antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) requiring urgent treatment (see section 2).

If you are due to have any laboratory tests (such as blood tests, urine tests, skin allergy tests, etc.), you must inform your doctor that you are taking this medicine, as it may alter the results of these tests.

Taking Paracetamol Aurovitas Spain with food, drinks and alcohol

Alcohol intake should be avoided while taking paracetamol.

Pregnancy, breastfeeding and fertility

Pregnancy

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

Paracetamol is excreted in breast milk, but in negligible amounts. Therapeutic doses of paracetamol may be taken during breastfeeding.

Fertility

No harmful effects on fertility are known with normal use of paracetamol.

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.

Driving and using machines

This medicine is not expected to affect your ability to drive or operate machinery.

3. How to take Paracetamol Aurovitas Spain

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The tablet may be divided into equal doses.

Recommended dose:

Adults, elderly patients, and adolescents aged 16 years or older (weighing more than 55 kg):

Take one or two 500 mg tablets up to 4 times a day. The maximum daily dose of paracetamol must not exceed 6 tablets (3 g).

Children and adolescents aged 10 to 15 years (weighing between 40 and 55 kg):

Take one 500 mg tablet up to 4 times a day. The daily dose of paracetamol must not exceed 4 tablets (2 g).

Not recommended for children under 10 years of age.

Doses should be spaced at least 4 hours apart, and no more than 4 doses should be taken within 24 hours.

The tablets should be swallowed whole with sufficient water.

• This medicine is not suitable for children under 10 years of age.
• At least 4 hours must elapse between doses.
• Do not use in combination with other products containing paracetamol.
• Do not exceed the recommended dose.
• The tablet is scored to allow splitting and ease of use in children.
• If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, discontinue treatment and consult your doctor.

In the following situations, the maximum daily dose must not exceed 60 mg/kg/day (up to 2 g/day):

• Adults weighing less than 50 kg.
• Mild to moderate hepatic impairment, Gilbert's syndrome (familial non-hemolytic jaundice).
• Dehydration.
• Chronic malnutrition.

Follow these instructions unless your doctor has advised you otherwise.

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

Method of administration

Swallow the tablet with a glass of water.

If you take more Paracetamol Aurovitas Spain than you should

In case of overdose, seek immediate medical help, even if you feel well, due to the risk of delayed severe liver damage. Symptoms of paracetamol overdose include nausea, vomiting, and loss of appetite. Loss of consciousness generally does not occur.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 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 missed doses. If you forget to take a dose, simply take your next dose at the scheduled time.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

The possible adverse effects are listed below and are classified as follows:

Rare adverse effects (may affect up to 1 in 1,000 people)

• Various blood disorders including agranulocytosis, thrombocytopenia, thrombocytopenic purpura, hemolytic anemia, leukopenia, platelet disorders (coagulation disorders), and cytopoietic disorders (disorders of blood-forming cells in the bone marrow).
• Allergic reactions.
• Depression, confusion, hallucinations.
• Tremor, headache.
• Vision disorders.
• Edema (abnormal accumulation of fluid under the skin).
• Abdominal pain, stomach or intestinal bleeding, diarrhea, nausea, vomiting.
• Abnormal liver function, liver failure, jaundice (with symptoms such as yellowing of the skin and eyes), hepatic necrosis (death of liver cells).
• Skin rash, itching, sweating, urticaria, red spots on the skin, angioedema with symptoms such as swelling of the face, lips, throat, or tongue.
• Dizziness, malaise, fever, sedation, interaction with other medicines.
• Overdose and intoxication.

Very rare adverse effects (may affect up to 1 in 10,000 people)

• Pancytopenia (reduction in the number of blood cells).
• Allergic reactions requiring discontinuation of treatment, including angioedema, difficulty breathing, sweating, nausea, hypotension, shock, and anaphylaxis.
• Low blood sugar levels.
• Hepatotoxicity (liver damage caused by chemical substances).
• Cloudy urine and kidney disorders.
• Bronchospasm (difficulty breathing) in patients sensitive to acetylsalicylic acid and other anti-inflammatory medicines.
• Hematuria (blood in the urine).
• Anuria (inability to urinate).

Frequency not known (frequency cannot be estimated from the available data)

• A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in severely ill patients using paracetamol (see section 2).
• Generalized exanthematous pustulosis (a drug eruption characterized by numerous small, sterile, mainly non-follicular pustules).
• Severe skin rash or skin peeling.
• Stevens-Johnson syndrome (a serious, potentially life-threatening skin disorder).
• Skin redness, blisters, or rash due to taking paracetamol.

Once you stop taking the medicine, these adverse effects should disappear. If any of them worsen, consult your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: 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 this medicine out of the sight and reach of children.

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

No special storage conditions are required.

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

6. Contents of the container and other information

Composition of Paracetamol Aurovitas Spain

• The active substance is paracetamol. Each tablet contains 500 mg of paracetamol.
• The other components are: pregelatinized starch (corn starch), povidone (K-30), stearic acid 50.

Appearance of the product and contents of the container

Uncoated white or almost white tablets, round, approximately 12 mm in diameter, marked “PARACETAMOL” on one side and with a score line on the other. The tablet can be divided into equal doses.

Paracetamol Aurovitas Spain is available in blister packs containing 16, 20, 30, 40 and 100 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.
Avda. de Burgos, 16-D
28036 Madrid
Spain

Manufacturer:

APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta

Or

Generis Farmacêutica, S.A.
Rua João de Deus, 19
Amadora, 2700-487
Portugal

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: April 2026

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