Paracetamol Aurovitas Spain 1 g tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Paracetamol Aurovitas Spain 1 g tablets EFG

Read the entire 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 you should not give it 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.

Contents of the leaflet

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 febrile 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 hemolytic anemia (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 when used together, the effectiveness may be reduced and the risk of liver damage from paracetamol may increase, especially with high-dose paracetamol treatments.

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 analgesic overuse should not be treated by increasing the analgesic dose. In such cases, analgesics should only be used 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, feeling unwell (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 thin the blood), 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 medicine 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 disorder (called metabolic acidosis) requiring urgent treatment (see section 2).

If you are scheduled to undergo any laboratory tests (such as blood tests, urine tests, skin allergy tests, etc.), 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 when taking paracetamol.

Pregnancy, breastfeeding and fertility

Pregnancy

Paracetamol may be used during pregnancy if necessary. Use the lowest effective dose needed to relieve pain or fever, and use it for the shortest possible duration. Contact your doctor if pain or fever does not subside 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 used 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 are planning 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 can be divided into equal doses.

Recommended dose:

Adults, elderly, and adolescents aged 16 years or older (with body weight over 55 kg):

Take half or one 1 g tablet up to 4 times daily.

The maximum daily dose of paracetamol must not exceed 3 tablets (3 g).

Paracetamol 1 g is not considered suitable for children under 16 years of age. Other doses/formulations more appropriate for this age group are available.

Doses must be spaced at least 4 hours apart, and no more than 4 doses should be administered 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 preparations containing paracetamol.
• Do not exceed the recommended dose.
• The tablet is scored to allow splitting and facilitate 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 with body weight below 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 think that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

Administration method

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 Poison Information Service at 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 forgotten doses. If you miss 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, haemolytic anaemia, leucopenia, platelet disorders (coagulation disorders), and cytoplast disorders (disorders of blood-forming cells in the bone marrow).
• Allergic reactions.
• Depression, confusion, hallucinations.
• Tremor, headache.
• Vision disorders.
• Oedema (abnormal accumulation of fluid under the skin).
• Abdominal pain, stomach or intestinal bleeding, diarrhoea, 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, general malaise, fever, sedation, interaction with other medicines.
• Overdose and poisoning.

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, breathing difficulty, 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.
• Haematuria (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).
• Generalised exanthematous pustulosis (drug eruption characterised by numerous small, sterile pustules, mainly non-follicular).
• Severe skin rash or skin peeling.
• Stevens-Johnson syndrome (a serious, potentially life-threatening skin disorder).
• Skin redness, blisters, or rash due to intake of paracetamol.

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

Reporting of adverse effects

If you experience any adverse effect, talk to 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: 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 unused containers and medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines 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 1 g of paracetamol.
• The other components are: pregelatinized starch (corn starch), povidone (K-30), stearic acid 50.

Appearance of the medicinal product and contents of the container

Uncoated white or almost white tablets, oblong in shape, approximately 19 x 9.75 mm, with a score line on both sides. The tablet can be divided into equal doses.

Paracetamol Aurovitas Spain is available in blister packs containing 16, 18, 20, 30, 40 and 100 tablets.

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