PARACETAMOL MABO 650 mg TABLETS

2. What you need to know before taking Paracetamol MABO

Do not take Paracetamol MABO:

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

Be careful with Paracetamol MABO

• Do not take more medicine than recommended in section 3. How to take Paracetamol MABO
• Avoid taking this medicine simultaneously with other medicines that contain paracetamol, such as flu and cold medicines, as high doses can cause liver damage. Do not use more than one medicine that contains paracetamol without consulting your doctor.
• In patients with asthma who are sensitive to acetylsalicylic acid, consult your doctor before taking this medicine.
• If you have liver, kidney, heart, or lung disease, or if you have anemia (reduced hemoglobin levels in the blood, with or without a reduction in red blood cells), you should consult your doctor before taking this medicine.
• When being treated with any medicine for epilepsy, consult your doctor before taking this medicine, as the efficacy of paracetamol may be reduced and hepatotoxicity increased, especially with high doses of paracetamol.

• In chronic alcoholics, take no more than 2 grams of paracetamol in 24 hours.
• 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, consult your doctor and reevaluate the clinical situation.

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

• You have severe illnesses, such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you have malnutrition, chronic alcoholism, or are taking flucloxacillin (an antibiotic). A severe 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. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

• In children and adolescents under 15 years old, consult your doctor or pharmacist, as there are other presentations with doses suitable for this group of patients.

Other medicines and Paracetamol MABO

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine.

Paracetamol may interact with the following medicines:

• Medicines to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin)
• Medicines for treating epilepsy: antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medicines for treating tuberculosis: (isoniazid, rifampicin)
• Medicines for treating 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 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 must be treated urgently (see section 2).

Do not use with other analgesics (pain-relieving medicines) without consulting your doctor.

As a general rule for any medicine, it is recommended to systematically inform your doctor or pharmacist if you are being treated with another medicine. In the case of treatment with oral anticoagulants, it can be administered occasionally as the analgesic of choice.

Interference with analytical tests

If you are going to have any analytical tests (including blood tests, urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter the results of these tests.

Taking Paracetamol MABO with food, drinks, and alcohol

The use of paracetamol in patients who habitually consume alcohol (3 or more alcoholic beverages: beer, wine, liquor, etc. per day) may cause liver damage.

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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

If necessary, this medicine can be used during pregnancy. You should use the lowest possible dose that reduces the 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.

Small amounts of paracetamol may appear in breast milk; therefore, it is recommended that you consult your doctor or pharmacist before taking this medicine.

Driving and using machines

The influence of this medicine on the ability to drive and use machines is zero or insignificant.

Paracetamol MABO contains sodium

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

3. How to take Paracetamol MABO

Follow these instructions unless your doctor has given you different instructions. Remember to take your medicine. Paracetamol should be taken orally.

The normal dose is:

Adults and adolescents over 15 years old:

The usual dose is 1 tablet (650 mg of paracetamol) every 4-6 hours. The doses should be spaced at least 4 hours apart. Do not take more than 3 grams (4 tablets) in 24 hours.

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

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 the treatment and consult your doctor.

Patient with liver disease:

Before taking this medicine, they must consult their doctor.

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

Do not take more than 3 tablets of 650 mg of paracetamol in 24 hours.

Patient with kidney disease: before taking this medicine, they must consult their doctor. Take a maximum of 500 mg per dose.

Due to the dose, 650 mg of paracetamol, it is not indicated for this group of patients.

Elderly patients: should consult their doctor.

Use in children and adolescents: do not use in children and adolescents under 15 years old.

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

When lower doses of 650 mg of paracetamol per dose are required, other presentations of paracetamol that adapt to the required dosage should be used.

If you take more Paracetamol MABO than 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 taken an overdose, go to a medical center immediately, even if you do not notice symptoms, as they often do not appear until 3 days after taking the overdose, even in cases of severe poisoning.

Treatment of overdose is more effective if started within 4 hours of taking the overdose of the medicine.

Patient being 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 medicine and the amount taken.

If you forget to take Paracetamol MABO

Do not take a double dose to make up for forgotten doses; simply take the forgotten dose when you remember, taking the next doses with the indicated interval between doses (at least 4 hours).

4. Possible side effects

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

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

Very rare side effects, may affect up to 1 in 10,000 people: kidney disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leukopenia, neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar). Very rare cases of severe skin reactions have been reported.

Frequency not known (cannot be estimated from the 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).

Paracetamol may damage the liver when taken in high doses or for prolonged treatments.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Paracetamol MABO

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

This medicine does not require special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information Composition of Paracetamol MABO

Each tablet contains 650 milligrams of paracetamol as the active ingredient.

The other components (excipients) are potato starch glycolate (Type A), purified water, pregelatinized corn starch, povidone K30 (E1201), stearic acid (E570), and crospovidone (E1202).

Appearance of the product and package contents

Paracetamol MABO is presented in oral tablets.

The tablets are oblong, biconvex, white, with a score line on one side and marked with PB on the other side. The tablet can be divided into two equal halves.

The packaging is 20 tablets, packaged in PVC/PVDC/Aluminum blisters.

Marketing authorization holder:

MABO-FARMA S.A.

Vía de los Poblados, 3, Edificio 6

28033 Madrid,

Spain.

Manufacturer:

Galenicum Health, S.L.U.

Sant Gabriel, 50

Esplugues de Llobregat, 08950,

Barcelona –

Spain

or

SAG Manufacturing S.L.U

Crta. N-I, Km 36

28750 San Agustin de Guadalix,

Madrid –

Spain

Date of the last revision of this leaflet: February 2025

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