PARACETAMOL MABO 500 mg tablets

2. What you need to know before taking Paracetamol MABO

Do not take Paracetamol MABO

• If you are allergic (hypersensitive) 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 Paracetamol MABO.

• Do not take more medication than recommended in section 3. How to take Paracetamol MABO.
• Avoid simultaneous use of this medication with other medications that contain paracetamol, such as medications for flu and colds, as high doses can lead to liver damage. Do not use more than one medication that contains paracetamol without consulting your doctor.
• Chronic alcoholics should be cautious not to take more than 2 g/24 hours of paracetamol.
• Patient with kidney, liver, heart, or lung disease, and patients with anemia, should consult their doctor before taking this medication.
• When being treated with 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.
• Asthmatic patients sensitive to acetylsalicylic acid should consult their doctor before taking this medication.

During treatment with Paracetamol Mabo, inform your doctor immediately 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 serious 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.

Interference with laboratory tests

If you are going to have any laboratory tests (including blood, urine, etc.), inform your doctor that you are taking this medication, as it may alter the results.

Use of Paracetamol MABO with other medications

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

In particular, if you are using any of the following medications, it may be necessary to modify the dose of some of them or interrupt treatment:

• Medications to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin).
• Medications to treat epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medications to treat tuberculosis: (isoniazid, rifampicin).
• Medications to treat depression and convulsions: Barbiturates (used as hypnotics, sedatives, and anticonvulsants).
• Medications to lower cholesterol levels in the blood: (cholestyramine).
• Medications used to increase urine elimination (loop diuretics such as furosemide).
• Medications used to treat gout (probenecid and sulfinpyrazone).
• Medications used to prevent nausea and vomiting: Metoclopramide and domperidone.
• Medications used to treat high blood pressure and heart rhythm disorders (arrhythmias): Propranolol.
• Flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (metabolic acidosis with high anion gap) that should be treated urgently (see section 2).

Taking Paracetamol MABO with food, drinks, and alcohol

Taking this medication with food does not affect its efficacy.

Pregnancy and breastfeeding

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.

Paracetamol passes into breast milk, so breastfeeding women should consult their doctor or pharmacist before taking this medication.

Driving and using machines

The influence of paracetamol on the ability to drive and use machines is negligible or non-existent.

Paracetamol MABO 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 MABO

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults and adolescents over 15 years:

Take 1 tablet (500 mg of paracetamol) every 4-6 hours as needed.

If necessary, you can take 1 gram (2 tablets) every 8 hours, 3 times a day.

Do not take more than 3 grams of paracetamol in 24 hours (6 tablets).

Avoid using high daily doses of paracetamol for prolonged periods, as this increases the risk of adverse effects such as liver damage.

Patient with liver disease: before taking this medication, they must consult their doctor.

They should take the prescribed amount of medication with a minimum interval of 8 hours between each dose.

They should not take more than 2 grams of paracetamol in 24 hours, divided into several doses.

Patient with kidney disease: before taking this medication, they must consult their doctor.

Take a maximum of 500 milligrams per dose.

Depending on their disease, their doctor will indicate whether they should take their medication with a minimum interval of 6 or 8 hours.

They should not take more than 2 grams in 24 hours, divided into several doses, not exceeding 500 milligrams per dose in any case.

Use in children and adolescents

Children: It is necessary to respect the dosages defined according to weight. The age of the child according to weight is given for information purposes.

The recommended daily dose of paracetamol is approximately 60 mg/kg/day, divided into 4 or 6 daily doses, i.e., 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.

• Children between 33 and 40 kg in weight (from 10 to 12 years): 1 tablet per dose according to weight/age, every 6 hours, up to a maximum of 4 tablets per day.
• Between 41 and 50 kg in weight (from 12 to 15 years): 1 tablet per dose, every 6 or 4 hours, up to a maximum of 5 tablets per day.

This medication is taken orally.

The tablets should be taken with a glass of liquid, preferably water.

Always take the lowest effective dose.

Taking this medication is subject to the appearance of pain or fever. As these disappear, treatment should be suspended.

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

If you take more Paracetamol MABO than you should

You should consult your doctor or pharmacist immediately.

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

If you have ingested an overdose, you should go to a medical center immediately, even if you do not notice symptoms, as they often do not manifest until 3 days after ingestion, even in cases of severe poisoning.

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

Patient treated with barbiturates or chronic alcoholics may be more susceptible to the toxicity of 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.

4. Possible side effects

Like all medications, Paracetamol MABO can cause side effects, although not everyone will experience them.

Rare side effects that may affect up to 1 in 1,000 people are: discomfort, low blood pressure (hypotension), and increased levels of transaminases in the blood.

Very rare side effects that may affect up to 1 in 10,000 people are: kidney disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, 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 treatments.

Frequency not known (cannot be estimated from available data): A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Reporting of side effects

If you experience any side effects, 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 Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Paracetamol MABO

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

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

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

6. Contents of the pack and further information

Composition of Paracetamol MABO

The active ingredient is paracetamol. Each tablet contains 500 mg of paracetamol.

The other components (excipients) are: sodium saccharin, hydroxypropylcellulose, magnesium stearate, talc, sodium starch glycolate, silicon dioxide, and orange flavor.

Appearance of the product and pack contents

The tablets are round, white, and scored.

The packaging contains 10 or 20 tablets in aluminum/PVC blisters.

Marketing authorization holder and manufacturer

Marketing authorization holder

MABO-FARMA S.A.

Vía de los Poblados, 3, Edificio 6

28033 Madrid,

Spain.

Manufacturer

LABORATORIOS ALCALA FARMA S.L.

Avda. de Madrid, 82

28802 ALCALÁ DE HENARES (Madrid)

Date of the last revision of this leaflet: February 2025

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