PARACETAMOL AUROVITAS SPAIN 500 mg TABLETS

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

Do not takeParacetamol Aurovitas Spain

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication:

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

If you have a high fever, signs of a secondary infection, or if 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.

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

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 organ damage), or if you suffer from 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. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Taking Paracetamol Aurovitas Spain with other medications

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

Do not take Paracetamol Aurovitas Spain with other medications that contain paracetamol.

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

• Metoclopramide or domperidone (medications used to treat nausea and vomiting).
• Colestyramine (used to lower cholesterol).
• Warfarin and other coumarin derivatives (medications that make blood more liquid), especially if you need to take paracetamol every day for a long period.
• Salicylamide (a medication for pain).
• Probenecid (a medication used to treat gout).
• Isoniazid or rifampicin (medications used to treat tuberculosis).
• Lamotrigine or phenytoin (medications used to treat epilepsy).
• Barbiturates or carbamazepines (medications that produce relaxation and sleep).
• St. John's Wort (a medication used to treat depression).
• Chloramphenicol (an antibiotic).
• Zidovudine (a medication 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.), 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

When taking paracetamol, 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 medication more frequently.

Breastfeeding

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

Fertility

No harmful effects on fertility are known with the 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 medication.

Driving and using machines

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

Paracetamol Aurovitas Spain contains sodium

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

3. How to take Paracetamol Aurovitas Spain

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. If in doubt, 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 one or two 500 mg tablets up to 4 times a day. The maximum daily dose of paracetamol should not exceed 6 tablets (3 g).

Children and adolescents from 10 to 15 years (with a weight between 40 and 55 kg):

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

Not recommended for children under 10 years.

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

Tablets should be swallowed whole with sufficient water.

• This medication is not suitable for children under 10 years.
• At least 4 hours should pass between doses.
• 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, 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 failure, 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 medication 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 medical attention immediately, even if you feel well, due to the risk of severe late liver damage. 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 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. If you forget to take a dose, simply take your normal dose when the next one is due.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience 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, and cytoblast disorders (disorders of blood-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 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 medications.
• Overdose and intoxication.

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

• Pancytopenia (reduction of blood cell count).
• Allergic reactions that require treatment interruption, 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 medications.
• Hematuria (blood in the urine).
• Anuria (inability to urinate).

Frequency not known(frequency 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).
• Acute generalized exanthematous pustulosis (drug rash characterized by numerous small, sterile pustules, mainly non-follicular).
• Severe skin rash or peeling.
• Stevens-Johnson syndrome (potentially life-threatening skin disorder).
• Redness of the skin, blisters, or rash due to paracetamol ingestion.

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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: 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 this medication out of the sight and reach of children.

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

No special storage conditions are required.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Paracetamol Aurovitas Spain

• The active ingredient is paracetamol. Each tablet contains 500 mg 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 package contents

White or off-white, round, uncoated tablets with the marks "A" and "8" 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, 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 medication is authorized in the member states of the European Economic Area under the following names:

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/).