Paracetamol Mabogen 1 g tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Paracetamol Mabogen 1 g tablets EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Paracetamol is an analgesic medicine (reduces pain) and antipyretic (reduces fever).

This medicine is used for the symptomatic treatment of mild to moderate pain and fever in adults.

2. What you need to know before taking Paracetamol Mabogen

Do not take Paracetamol Mabogen:

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

Warnings and precautions:

Consult your doctor or pharmacist or nurse before taking Paracetamol.

• if you have liver problems, including liver problems due to excessive alcohol consumption (3 or more alcoholic drinks per day);
• if you have kidney problems;
• if you have glucose-6-phosphate dehydrogenase deficiency;
• if you have anorexia, bulimia, cachexia, or chronic malnutrition;
• if you are dehydrated or have hypovolemia;
• if you are taking a medicine for epilepsy, you should consult your doctor before taking this medicine, as its simultaneous use reduces the efficacy and increases the hepatotoxicity of paracetamol, especially with high-dose paracetamol treatments (see below in this section “Other medicines and Paracetamol”);
• if you have Gilbert's disease (also known as Meulengracht's disease);
• if you have heart problems, respiratory failure, or anemia; in these situations, administration should be under medical supervision and only for short periods;
• if you have asthma and are sensitive to acetylsalicylic acid;
• when used by patients on a sodium-free or low-sodium diet (see “Paracetamol Mabogen contains sodium”).

Paracetamol may cause serious skin reactions, such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the symptoms of serious skin reactions, and the use of the medicine must be discontinued at the first sign of a skin rash or any other symptom of hypersensitivity.

The recommended maximum dose must not exceed 4 g.

Concomitant 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 take more than one medicine containing paracetamol without consulting your doctor.

If you take an overdose, seek medical attention immediately (see "If you take more Paracetamol than you should").

Administration of paracetamol doses higher than recommended involves a risk of severe liver injury. Medicines containing paracetamol should not be taken for more than a few days or in high doses unless directed by your doctor.

Prolonged use of analgesics, or inappropriate use of high doses, may cause headache, which should not be treated with higher doses of the medicine.

During treatment with Paracetamol Mabogen, 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 if you 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, malaise (nausea), and vomiting.

Interference with laboratory tests

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

Paracetamol may alter the analytical values of uric acid and glucose determinations.

Children and adolescents

This medicine is not recommended for children (see section 3). This medicine is indicated only for adults and adolescents over 15 years of age and weighing more than 55 kg.

For children under 15 years of age or weighing less than 55 kg, consult your doctor or pharmacist, as other formulations with appropriate doses for these patients may be available.

Other medicines and Paracetamol

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, dose adjustments or discontinuation of treatment may be necessary:

Medicines for treating seizures (antiepileptics such as carbamazepine, phenytoin, phenobarbital, primidone, lamotrigine): the combination of paracetamol and antiepileptic medicines may cause or worsen liver damage.

Lamotrigine: The effect of lamotrigine may be reduced.

Medicines for treating high blood pressure and heart rhythm disorders (cardiac arrhythmias) (propranolol): the combination of paracetamol and propranolol may increase the action and/or toxicity.

Medicines for treating gout: Probenecid causes a reduction of almost 2-fold in the excretion of paracetamol. A reduction in the paracetamol dose should be considered when probenecid is administered concomitantly.

Medicines for treating tuberculosis (rifampicin, isoniazid): the combination of paracetamol and rifampicin or isoniazid may cause or worsen liver damage.

Salicylamide, a medicine for treating fever and pain, may prolong the elimination half-life (t1/2) of paracetamol.

Medicines to reduce cholesterol levels in the blood: cholestyramine reduces the absorption of paracetamol. To avoid this, paracetamol should be administered one hour before or four hours after the resin.

Medicines to prevent nausea and vomiting (metoclopramide and domperidone): simultaneous intake of medicines that accelerate gastric emptying, e.g. metoclopramide and domperidone, increases the absorption of paracetamol and advances the onset of its action. However, concomitant use does not need to be avoided.

Medicines to prevent blood clots (oral anticoagulants such as acenocoumarol, warfarin): paracetamol may increase the effects of oral anticoagulants. Prolonged use of this medicine in patients treated with oral anticoagulants should only be done under medical supervision. Potentiation of the effects of warfarin has been observed with continued high doses of paracetamol.

Medicines to increase urine production (loop diuretics such as furosemide): the effects of diuretics may be reduced.

Chloramphenicol, a medicine used to treat infections: the simultaneous administration of paracetamol and chloramphenicol may significantly delay the elimination of chloramphenicol, increasing its plasma concentrations and causing a higher risk of toxicity.

Zidovudine (AZT), a medicine used in viral diseases: concomitant administration of paracetamol and AZT may increase the incidence of neutropenia or worsen it (reduction in white blood cell count). Paracetamol should only be taken simultaneously with AZT if specifically recommended by your doctor.

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).

Concomitant use of substances that induce hepatic enzymes, such as barbiturates, carbamazepine, isoniazid, rifampicin, or ethanol, should be taken into account, as they may enhance the toxic effect of paracetamol.

Inform your doctor if this medicine is taken together with medicines that delay gastric emptying (e.g. propantheline) or that accelerate gastric emptying (e.g. metoclopramide and domperidone).

Use of Paracetamol with food, drinks and alcohol:

Alcohol should not be consumed during treatment with paracetamol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist.

If necessary, paracetamol 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 does not improve or if you need to take the medicine more frequently.

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

Driving and using machines

This medicine does not affect the ability to drive or operate machinery. However, during treatment with paracetamol, mild drowsiness and dizziness may occur as side effects.

Paracetamol Mabogen contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per dose unit; this is essentially “sodium-free”.

3. How to take Paracetamol Mabogen

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

Recommended dose:

• Adults and adolescents over 15 years of age (and weighing more than 55 kg): the recommended dose is 1 tablet or half tablet (1 g – 500 mg of paracetamol) every 6 or 8 hours. If necessary, administration may be repeated after an interval of at least 4 hours.

Generally, it is not necessary to exceed 3 g of paracetamol per day, i.e., 3 tablets per day. However, for more intense pain, the maximum dose may be increased to 4 g per day (4 tablets).

There must always be a minimum interval of 4 hours between doses.

Administration after meals may delay the onset of action.

Frequency of administration

Regular dosing prevents fluctuations in pain or temperature.

Liver disease

Consult your doctor before taking this medicine.

Patients with moderate to severe renal impairment must not take this medicine.

Kidney disease

Consult your doctor. Patients with moderate to severe impairment must not take this medicine.

Hepatic impairment

You must take the amount prescribed by your doctor at a minimum interval of 8 hours.

Do not take more than 2 g of paracetamol (2 tablets) every 24 hours.

In chronic alcoholics, no more than 2 g/day of paracetamol should be administered.

Elderly patients

No dose adjustment is necessary.

Use in children and adolescents

This medicine must not be administered to children or adolescents under 15 years of age weighing less than 55 kg.

For children weighing more than 33 kg between 13 and 15 years of age, 500 mg of paracetamol (half a tablet) may be administered 4 times daily with a large glass of water. Doses should be spaced at least 4 hours apart.

Maximum daily dose: 2 g/day.

Other formulations are available that do not require manipulation of the tablet.

Children (under 13 years). Use in these patients is not recommended.

Method of administration:

Paracetamol Mabogen is to be taken orally.

The tablet may be divided into equal doses.

Depending on your preference, the tablets may be swallowed whole or split in half, taken with a glass of liquid, preferably water.

Consult your doctor or pharmacist if you have any doubts.

When doses lower than 1 g of paracetamol per administration are required, it is recommended to use other available formulations of paracetamol that are better suited to the required dosing.

If you take more Paracetamol Mabogen than you should:

Contact your doctor or pharmacist immediately, even if you feel well. Symptoms of severe liver damage may be delayed by 1 to 2 days. Proper management of paracetamol overdose requires immediate treatment. Despite the absence of early symptoms, patients should be taken to hospital for immediate treatment. Symptoms of overdose include nausea, vomiting, anorexia, pallor, malaise, diaphoresis, and abdominal pain, which generally appear within the first 24 hours.

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 Mabogen:

If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Remember to leave at least four hours between doses. Do not take a double dose to make up for missed doses.

If you stop taking Paracetamol Mabogen

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

The following adverse effects have been reported in patients treated with paracetamol:

Rare: (may affect up to 1 in 1,000 people)

• Low blood pressure (hypotension).
• Increased liver enzymes.
• Malaise.

Very rare: (may affect up to 1 in 10,000 people)

• Blood disorders may occur, including changes in blood cell counts (such as abnormally low levels of certain blood components which may cause, for example, bleeding from the nose or gums) and bleeding.
• Allergic reactions (symptoms such as edema, shortness of breath, sweating, nausea, sudden drop in blood pressure).
• Decreased blood sugar levels.
• Jaundice (yellowing of the skin), liver failure.
• Skin reactions such as allergic dermatitis, urticaria, itching, skin rash.
• Changes in urination (difficulty or pain when urinating, decreased amount of urine, blood in the urine).

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).

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if these adverse reactions are not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Paracetamol Mabogen

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 refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point in your pharmacy. Ask your pharmacist how to properly 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 Mabogen:

The active substance is paracetamol.

The other components (excipients) are stearic acid, povidone, sodium carboxymethyl starch (type A) from potato, and pregelatinized corn starch.

Appearance of the medicine and contents of the pack:

Paracetamol Mabogen 1 g is presented as tablets for oral administration.

The tablets are white or almost white, capsule-shaped, marked on one side with “10” and “00” on each side of the score line, and on the other side with “PA” and “RA” on each side of the score line.

The packs contain 20 or 40 tablets, packed in opaque PVC/Al blisters and transparent PVC/Al blisters. The tablet can be divided into equal doses.

Marketing Authorization Holder:

MABO-FARMA S.A.

Calle Vía de los Poblados, 3, Edificio 6

28033 Madrid,

Spain.

Manufacturer:

Medis International a.s.

Prumyslova 961/16, Bolatice

747 23, Czech Republic

or

Qualimetrix, S.A.

579 Mesogeion Avenue,

15343, Agia Paraskevi,

Athens, Greece

This leaflet was approved in: February 2025

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