Paracetamol Farmamabo 1000 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

ParacetamolfarmaMABO 1,000 mg tablets EFG

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

Follow exactly the instructions for use provided in this leaflet or those given by your doctor, pharmacist, or nurse.

This medicine is available without a prescription. However, to achieve the best results, it should be used carefully.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult your doctor if your condition worsens or if fever persists for more than 3 days of treatment, or if pain lasts for more than 5 days.

Contents of the leaflet

1. What Paracetamol farmaMABO is and what it is used for.
2. What you need to know before taking Paracetamol farmaMABO.
3. How to take Paracetamol farmaMABO.
4. Possible side effects.
5. How to store Paracetamol farmaMABO.

Contents of the pack and additional information.

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

Paracetamol belongs to a group of medicines called analgesics and antipyretics.

Paracetamol is used to treat moderate pain and feverish conditions in adults and adolescents aged 16 years and older (or with a body weight above 50 kg).

You should consult your doctor if your condition worsens or if fever persists beyond 3 days of treatment, or pain beyond 5 days.

2. What you need to know before taking Paracetamol farmaMABO

Do not take Paracetamol farmaMABO:

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

Warnings and precautions

• Do not take more medicine than the recommended dose stated in section 3, "How to take Paracetamol farmaMABO".

• The simultaneous use of this medicine with other medicines containing paracetamol (e.g. 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.

  • If you are an asthmatic patient sensitive to acetylsalicylic acid, consult your doctor before taking this medicine.
  • If you have kidney, liver, heart or lung disease, or suffer from anaemia (reduced haemoglobin levels in the blood, with or without a reduction in red blood cells), consult your doctor before taking this medicine.
  • If you are being treated with medicines for epilepsy, consult your doctor before taking this medicine, as concomitant use may reduce efficacy and increase the hepatotoxicity of paracetamol, especially with high-dose paracetamol regimens.

• Chronic alcoholics should take care not to exceed 2 grams of paracetamol in 24 hours.

  • If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, consult your doctor and re-evaluate your clinical condition.
  • For adolescents under 16 years of age, consult your doctor or pharmacist, as other formulations with doses adapted to this patient group are available.

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

• You have serious conditions 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 known as metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients under these conditions 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, malaise (nausea), and vomiting.

Other medicines and Paracetamol farmaMABO

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

Paracetamol may interact with the following medicines:

• Medicines to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)
• Medicines for epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medicines for tuberculosis: (isoniazid, rifampicin)
• Medicines for 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 in the treatment of 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).

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

As a general rule for any medicine, it is advisable to systematically inform your doctor or pharmacist if you are taking another medicine. In patients taking oral anticoagulants, paracetamol may occasionally be used as the analgesic of choice.

Interference with laboratory tests

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

Taking Paracetamol farmaMABO with food, drinks and alcohol

The use of paracetamol in patients who habitually consume alcohol (3 or more alcoholic drinks: beer, wine, spirits, 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

If necessary, this medicine may be used during pregnancy. Use the lowest possible dose that relieves pain or fever, and use it for the shortest possible time. Contact your doctor if pain or fever do not improve or if you need to take the medicine more frequently.

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

Driving and using machines

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

Paracetamol farmaMABO contains sodium

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

3. How to take Paracetamol farmaMABO

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

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

Recommended dosage:

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

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

The prolonged use of high daily doses of paracetamol should be avoided, as this increases the risk of adverse effects such as liver damage.

If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, you must stop treatment and consult your doctor.

Patients with liver disease: must consult their doctor before taking this medicine. They should take the amount prescribed by their doctor, with a minimum interval of 8 hours between doses.

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

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

Due to the dosage (1,000 mg paracetamol), this product is not indicated for this patient group.

Elderly patients: must consult their doctor.

Use in children and adolescents: Do not use in children and adolescents under 16 years of age.

If you feel that the effect of paracetamol is too strong or too weak, inform your doctor or pharmacist. When lower doses than 1,000 mg of paracetamol per dose are required, other paracetamol formulations adapted to the required dosage should be used.

If you take more Paracetamol farmaMABO than you should

You must 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 have 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 taking 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.

If you forget to take Paracetamol farmaMABO

Do not take a double dose to make up for missed doses. Simply take the missed dose when you remember, then take the following doses at the recommended intervals (at least 4 hours apart).

4. Possible adverse effects

Like all medicines, this medicine can have adverse effects, although not everyone experiences them.

Rare adverse effects (occurring in between 1 and 10 out of 10,000 people) are: malaise, drop in blood pressure (hypotension), and increased levels of transaminases in the blood.

Very rare adverse effects (occurring in fewer than 1 out of 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 severe 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 critically ill patients 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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Paracetamol farmaMABO

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

This medicine does not require any special storage conditions.

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

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

6. Contents of the pack and other information

Composition of Paracetamol farmaMABO

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

The other components (excipients) are sodium starch glycolate from potato (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 pack

Paracetamol farmaMABO is presented as oral tablets.

The tablets are oblong, biconvex, white in colour, with a score on one side and marked "PC" on the other side. The tablet can be divided into equal halves.

Packaged in packs of 10 tablets, presented in PVC/PVDC/Aluminium 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 most recent review of this leaflet: February 2025

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