PARACETAMOL MABO 500 MG TABLETS

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Paracetamol MABO 500 mg tablets

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

This medicine can be purchased without a prescription. However, to obtain the best results, it must be used with care.

• Keep this leaflet as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If your symptoms worsen or if fever persists for more than 3 days or pain for more than 5 days, you should consult your doctor.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Paracetamol MABO is and what it is used for
2. What you need to know before taking Paracetamol MABO
3. How to take Paracetamol MABO
4. Possible side effects
5. How to store Paracetamol MABO
6. Contents of the pack and other information

1. What Paracetamol MABO is and what it is used for

Paracetamol is effective in reducing pain and fever.

It is indicated for the symptomatic relief of mild to moderate occasional pain, such as headache, dental pain, muscle pain (muscle spasms), or back pain (lumbago), as well as for feverish conditions in adults and children from 10 years of age (weighing more than 33 kg).

2. What you need to know before taking Paracetamol MABO

Do not take Paracetamol MABO

• If you are allergic (hypersensitive) 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 Paracetamol MABO.

• Do not take more medicine than the recommended dose stated in section 3, How to take Paracetamol MABO.
• The simultaneous use of this medicine with other medicines containing paracetamol, such as cold and flu remedies, should be avoided, as high doses may cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.
• Chronic alcoholics should take care not to exceed 2 g in 24 hours of paracetamol.
• Patients with kidney, liver, heart or lung disease, or patients with anaemia, should consult their doctor before taking this medicine.
• If you are being treated with medicines for epilepsy, consult your doctor before taking this medicine, because when used together, the effectiveness may be reduced and the hepatotoxicity of paracetamol may be increased, especially with high-dose paracetamol treatment.
• Asthmatic patients who are sensitive to acetylsalicylic acid should consult their doctor before taking this medicine.

During treatment with Paracetamol MABO, inform your doctor immediately if:

• You have serious illnesses 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.

Interference with diagnostic tests

If you are due to have any laboratory tests (including blood and urine tests, etc.), inform your doctor that you are taking/using this medicine, as it may alter test results.

Use of Paracetamol MABO with other medicines

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

In particular, if you are taking any of the following medicines, the dose of some of them may need to be adjusted or treatment interrupted:

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

Taking Paracetamol MABO with food, drinks and alcohol

Taking this medicine with food does not affect its efficacy.

Pregnancy and breastfeeding

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.

Paracetamol passes into breast milk; therefore, women who are breastfeeding should consult their doctor or pharmacist before taking this medicine.

Driving and operating machinery

The influence of paracetamol on the ability to drive or operate machinery is none or negligible.

Paracetamol MABO contains sodium

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

3. How to take Paracetamol MABO

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

Recommended dose:

Adults and adolescents over 15 years of age:

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

If necessary, 1 gram (2 tablets) may be taken every 8 hours, 3 times daily.

Do not exceed 3 g of paracetamol in 24 hours (6 tablets).

High daily doses of paracetamol should be avoided for prolonged periods, as this increases the risk of adverse effects such as liver damage.

Patients with liver disease: Before taking this medicine, you must consult your doctor.

You should take the amount of medicine prescribed by your doctor, with a minimum interval of 8 hours between each dose.

Do not exceed 2 grams of paracetamol in 24 hours, divided into several doses.

Patients with kidney disease: Before taking this medicine, you must consult your doctor.

Take a maximum of 500 milligrams per dose.

Depending on your condition, your doctor will advise whether you should take the medicine with a minimum interval of 6 or 8 hours.

Do not exceed 2 grams in 24 hours, divided into several doses, and in no case exceed 500 milligrams per dose.

Use in children and adolescents

Children: It is necessary to respect dosage regimens based on body weight. The age of the child in relation to weight is provided for informational purposes only.

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

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

This medicine is taken orally.

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

Always take the lowest effective dose.

This medicine should only be taken when pain or fever occurs. As these symptoms subside, treatment should be discontinued.

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.

If you take more Paracetamol MABO than you should

You should consult your doctor or pharmacist immediately.

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

If you have ingested an overdose, you must go immediately to a medical center even if you do not feel symptoms, as symptoms often do not appear until 3 days after the overdose, even in cases of severe poisoning.

Treatment for overdose is most effective if started within 4 hours of ingestion of the medicine.

Patients undergoing treatment with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, Paracetamol MABO may cause adverse effects, although not everyone experiences them.

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

Very rare adverse effects (may affect up to 1 in 10,000 people) are: kidney disorders, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, haemolytic anaemia), and hypoglycaemia (low blood sugar).

Very rare cases of serious skin reactions have been reported.

Paracetamol may damage the liver when taken at high doses or during prolonged treatment.

Frequency not known (cannot be estimated from available data): A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who are using paracetamol (see section 2).

Reporting of adverse effects

If you experience any type of adverse effect, consult 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Paracetamol MABO

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Paracetamol MABO

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

The other components (excipients) are: sodium saccharin, hydroxypropylcellulose, magnesium stearate, talc, sodium carboxymethyl starch from potato, silicon dioxide, orange flavour.

Nature of the product and pack contents

The tablets are round, white and scored.

The pack contains 10 or 20 tablets in aluminium/PVC blisters.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

MABO-FARMA S.A.

Calle 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 most recent revision of this leaflet: February 2025

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