PARACETAMOL FARMAMABO 1000 mg TABLETS

2. What you need to know before starting to take Paracetamol farmaMABO

Do not take ParacetamolfarmaMABO:

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

Warnings and precautions

• Do not take more medication than recommended in section 3. How to take Paracetamol farmaMABO.
• 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.
• In patients with asthma who are sensitive to acetylsalicylic acid, consult your doctor before taking this medication.
• If you have kidney, liver, heart, or lung disease, or if you have anemia (decreased hemoglobin levels in the blood, due to or not due to a decrease in red blood cells), consult your 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 may be increased, especially with high doses of paracetamol.

• In chronic alcoholics, do not take 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 if the pain or fever worsens or other symptoms appear, consult your doctor and reassess the clinical situation.
• In adolescents under 16 years old, consult your doctor or pharmacist, as there are other formulations with doses suitable for this group of patients.

During treatment with Paracetamol farmaMABO, 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 damage to organs), or if you have malnutrition, chronic alcoholism, or are 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 respiratory distress with deep and rapid breathing, drowsiness, feeling of discomfort (nausea) and vomiting.

Other medications and Paracetamol farmaMABO

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Paracetamol may interact with the following medications:

• Medication to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin).
• Medications for treating epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medications for treating tuberculosis: (isoniazid, rifampicin).
• Medications for treating depression and convulsions: Barbiturates (used as hypnotics, sedatives, and anticonvulsants).
• Medications for lowering cholesterol levels in the blood: (cholestyramine).
• Medications used to increase urine elimination (loop diuretics such as furosemide).
• Medications used for treating gout (probenecid and sulfinpyrazone).
• Medications used to prevent nausea and vomiting: Metoclopramide and domperidone.
• Medications used for treating 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 medications) without consulting your doctor.

As a general rule for any medication, it is recommended to systematically inform your doctor or pharmacist if you are being treated with another medication. 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/using this medication, as it may alter the results of these tests.

Taking Paracetamol farmaMABO with food, beverages, and alcohol

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

Taking this medication with food does not affect its efficacy.

Pregnancy and lactation

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.

If necessary, this medication can be used during pregnancy. 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.

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

Driving and using machines

The influence of paracetamol on the ability to drive and use machines is nil or insignificant.

Paracetamol farmaMABO contains sodium

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

3. How to take Paracetamol farmaMABO

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Remember to take your medication. Paracetamol should be taken orally.

The recommended dose is:

Adults and adolescents over 16 years old: the usual dose is 1 tablet (1,000 mg of paracetamol) 3 times a day. The doses should be spaced at least 4 hours apart.

Do not take more than 3 grams (3 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 if the pain or fever worsens or other symptoms appear, you should stop treatment and consult your doctor.

Patient with liver disease: before taking this medication, they must consult their doctor. They should take the amount of medication prescribed by their doctor with a minimum interval of 8 hours between each dose.

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

Patient with kidney disease: before taking this medication, they must consult their doctor. They should take a maximum of 500 mg per dose.

Due to the dose, 1,000 mg of paracetamol, it is not indicated for this group of patients.

Elderly patients: they should consult their doctor.

Use in children and adolescents: do not use in children and adolescents under 16 years old.

If the effect of paracetamol is too strong or too weak, inform your doctor or pharmacist. When lower doses of paracetamol are required (less than 1,000 mg per dose), other formulations of paracetamol should be used that are suitable for the required dosage.

If you take more Paracetamol farmaMABO 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 appear until 3 days after ingestion, even in cases of severe poisoning. Treatment of overdose is more effective if started within 4 hours after ingestion of the medication.

Patient taking 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.

If you forget to take Paracetamol farmaMABO

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 (at least 4 hours).

4. Possible adverse effects

Like all medications, this medication can have adverse effects, although not everyone will experience them.

Rare adverse effects that may occur (between 1 and 10 in every 10,000 people) are: discomfort, low blood pressure (hypotension), and increased levels of transaminases in the blood.

Very rare adverse effects that may occur (in less than 1 in every 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 may damage the liver when taken in high doses or for prolonged treatments.

Frequency not known (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).

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 package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Paracetamol farmaMABO

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

This medication does not require special storage conditions.

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

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

6. Contents of the packaging and additional information

Composition of Paracetamol farmaMABO

The active ingredient is paracetamol. Each tablet contains 1,000 mg of paracetamol.

The other components (excipients) are potato starch glycolate (Type A), purified water, pregelatinized corn starch, povidone K30 (E-1201), stearic acid (E-570), and crospovidone (E-1202).

Appearance of the product and contents of the packaging

Paracetamol farmaMABO is presented in oral tablets.

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

In packaging of 10 tablets, packaged in PVC/PVDC/Aluminum blisters.

Marketing authorization holder

MABO-FARMA S.A.

Calle Vía de los Poblados, 3, Edificio 6

28033 Madrid,

Spain.

Manufacturer

Galenicum Health, S.L.U.

Sant Gabriel, 50 Esplugues de Llobregat, 08950,

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 package leaflet: February 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/