PARACETAMOL AUROVITAS SPAIN 1 g TABLETS

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

Do not takeParacetamol Aurovitas Spain

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

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine:

If you are being treated with any medication for epilepsy, you should consult your doctor before taking paracetamol, as the efficacy may be decreased and the risk of liver damage from paracetamol may be increased, especially with high doses of paracetamol.

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

Headache caused by analgesic abuse should not be treated by increasing the dose of analgesic. In these cases, the use of analgesics should 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 should be avoided, e.g., medicines for colds and flu, 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:

If you have severe illnesses, such as severe renal insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (an anomaly in the 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 unwell (nausea) and vomiting.

TakingParacetamolAurovitasSpainwith other medicines

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

Do not take Paracetamol Aurovitas Spain with other medicines that contain 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 that make the blood more fluid), 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 carbamazepines (medicines that produce relaxation and sleep).
• St. John's Wort (a medicine used to treat depression).
• Chloramphenicol (an antibiotic).
• Zidovudine (a medicine used to treat AIDS).
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

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

TakingParacetamolAurovitasSpainwith food, drinks, and alcohol

When taking paracetamol, you should avoid consuming alcohol.

Pregnancy, breastfeeding, and fertility

Pregnancy

Paracetamol can be used during pregnancy if necessary. You should use the lowest possible dose that reduces pain or fever and use it for the shortest possible time. Contact your doctor if the pain or fever does not decrease or if you need to take the medicine more frequently.

Breastfeeding

Paracetamol is eliminated in breast milk but in insignificant amounts. Therapeutic doses of paracetamol can be administered during breastfeeding.

Fertility

No harmful effects on fertility have been observed with the normal use of paracetamol.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

This medicine is not expected to affect your ability to drive or use machines.

Paracetamol Aurovitas Spain contains sodium

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

3. How to take Paracetamol Aurovitas Spain

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The tablet can be divided into equal doses.

The recommended dose is:

Adults, elderly, and adolescents over 16 years (with a weight over 55 kg):

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

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

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

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

The tablets should be swallowed whole with sufficient water.

This medicine is not suitable for children under 10 years of age.

• Between two doses, at least 4 hours must pass.
• Do not use in combination with other preparations containing paracetamol.
• Do not exceed the indicated dose.
• The tablet is scored to facilitate breaking and use in children.
• 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 stop treatment and consult your doctor.

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

• Adults with a weight under 50 kg.
• Mild to moderate liver insufficiency, Gilbert's syndrome (non-hemolytic familial jaundice).
• Dehydration.
• Chronic malnutrition.

Follow these instructions unless your doctor has indicated otherwise.

If you think the action of this medicine is too strong or too weak, tell your doctor or pharmacist.

Method of administration

Swallow the tablet with a glass of water.

If you take moreParacetamolAurovitasSpainthan you should

In case of overdose, seek medical attention immediately, even if you feel well, due to the risk of severe late liver damage. The symptoms of paracetamol overdose are nausea, vomiting, and decreased appetite. Loss of consciousness usually does not occur.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to takeParacetamolAurovitasSpain

Do not take a double dose to make up for forgotten doses. If you forget to take a dose, simply take your normal dose when the next one is due.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible side effects are listed below and classified as:

Rare side 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 cytoblast disorders (disorders of blood cell-forming cells in the bone marrow).
• Allergic reactions.
• Depression, confusion, hallucinations.
• Tremors, headache.
• Visual disturbances.
• 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), liver cell death (necrosis).
• 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 side effects(may affect up to 1 in 10,000 people)

• Pancytopenia (reduction of 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 chemicals).
• 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 disease that can make the blood more acidic (called metabolic acidosis) in patients with severe illness using paracetamol (see section 2).
• Acute generalized exanthematous pustulosis (a drug rash characterized by numerous small, sterile pustules, mainly non-follicular).
• Severe skin rash or peeling.
• Stevens-Johnson syndrome (a potentially life-threatening skin disorder).
• Redness of the skin, blisters, or rash due to paracetamol ingestion.

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side 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 which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. Ask your pharmacist how to dispose of containers and medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition ofParacetamol Aurovitas Spain

• The active substance is paracetamol. Each tablet contains 1 g of paracetamol.
• The other ingredients are: pregelatinized corn starch, anhydrous colloidal silica, low viscosity hydroxypropylcellulose, sodium carboxymethylcellulose (Type A) potato, talc, magnesium stearate.

Appearance of the product and pack contents

White or off-white, oval, uncoated tablets with the marks "A" and "9" on either side of the score line on one face and smooth on the other.

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

Not all 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet: January 2025

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