Leaflet: information for the patient

XUMADOL 1 g tablets EFG

Paracetamol

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

- Keep this leaflet, as you may need to read it again.

• If you have any questions, consult yourdoctor or pharmacist.

- This medicine has been prescribedonlyfor you, and you must not give it to others even if they havethe same symptomsas you,as it may harm them.

- If you experience any side effects,consult your doctor or pharmacist,evenif they are not listed in this leaflet. See section 4.

Contents of this leaflet:

1.What Xumadol is and what it is used for

2.What you need to know before you start taking Xumadol.

3.How to take Xumadol

4.Possible side effects

5.Storage of Xumadol

6.Contents of the pack and additional information

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

This medicine is indicated for the symptomatic treatment of mild to moderate pain and febrile states in adults and adolescents over 15 years old.

You should consult your doctor if the pain worsens or does not improve within 5 days or the fever lasts more than 3 days.

Do not take Xumadol

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

Warnings and precautions

• Do not take more than the recommended dose as stated in section 3, How to take Xumadol. Check that you are not taking other medications that contain paracetamol at the same time (for example, cold and flu medications or other pain relievers).

Consult your doctor, pharmacist, or nurse before starting to take this medication.

Inform your doctor immediately during treatment with Xumadol:

• If you are an asthmatic patient sensitive to acetylsalicylic acid.
• If you have any liver, kidney, heart, or lung disease, or have anemia (a decrease in hemoglobin levels in the blood, due or not due to a decrease in red blood cells).
• If you have chronic malnutrition or are dehydrated.
• If you are being treated with an antiepileptic medication, as the combination of these medications can decrease the effectiveness and increase the hepatotoxicity of paracetamol, especially with high doses of paracetamol.
• When taking Xumadol, chronic alcoholics should not take more than 2 tablets of 1g 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 worsen or other symptoms appear, consult your doctor and reevaluate the clinical situation.
• If you have severe diseases, such as severe renal insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (a blood and fluid anomaly) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe respiratory distress with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Children and adolescents

This medication is not suitable for the recommended doses in children (under 12 years) and adolescents with a weight of less than 40 kg. Consult your doctor or pharmacist as there are other presentations with doses adapted to these patients.

Consult your doctor to use it in children under 15 years or in treatments lasting more than 10 days.

Interference with diagnostic tests:

Inform your doctor that you are taking paracetamol before any diagnostic test (blood, urine, etc.) as it may alter the results.

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

Use of Xumadol with other medications:

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

Paracetamol may interact with the following medications:

• Antibiotics (chloramphenicol)
• Anticoagulants (used to treat thromboembolic diseases)
• Antiepileptic medications (used to treat epilepsy)
• Contraceptives
• Diuretics (used to increase urine elimination)
• Isoniazid (used to treat tuberculosis)
• Lamotrigine (used to treat epilepsy)
• Probenecid (used to treat gout)
• Propranolol (used to treat hypertension, cardiac arrhythmias)
• Rifampicin (used to treat tuberculosis)
• Anticholinergic medications (used to relieve spasms or contractions of the stomach, intestines, and bladder)
• Zidovudine (used to treat HIV infections)
• Colestiramide (used to reduce cholesterol levels in the blood)
• Flucloxacillin (antibiotic), due to a severe risk of blood and fluid anomaly (metabolic acidosis) that requires urgent treatment (see section 2).

Do not use with other analgesics (pain relievers) without consulting your doctor.

As a general rule for any medication, it is recommended to inform your doctor or pharmacist if you are being treated with another medication. In the case of oral anticoagulants, paracetamol can be used occasionally as the preferred analgesic.

Taking Xumadol with food, drinks, and alcohol

The taking of this medication with food does not affect its efficacy.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

In case of need, Xumadol can be used during pregnancy. Use the lowest possible dose that reduces pain or fever and use it for the shortest possible time. Contact your doctor or midwife if the pain or fever do not decrease or if you need to take the medication more frequently.

Breastfeeding

Consult your doctor or pharmacist before using any medication.

Small amounts of paracetamol may appear in breast milk, so it is recommended to consult your doctor or pharmacist before taking this medication.

Driving and operating machinery

The influence of paracetamol on the ability to drive and operate machinery is negligible or insignificant.

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Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

• Adults and adolescents over 15 years (and weight over 50 kg): as needed, half tablet (500 mg of paracetamol) or 1 tablet (1 g of paracetamol) 3-4 times a day. Doses should be spaced at least 4 hours apart. No more than 4 tablets (4 g of paracetamol) should be taken in 24 hours.
• Adolescents over 12 years (and weight over 43 kg): the usual dose is half tablet (500 mg of paracetamol). Doses should be spaced at least 4 hours apart. No more than 5 doses (2 and a half tablets) should be administered in 24 hours.
• Patients with liver diseases:before taking this medication, they must consult their doctor. They should take the prescribed amount of medication with a minimum interval of 8 hours between each dose. They should not take more than 2 grams of paracetamol in 24 hours, divided into 2 doses.
• Patients with kidney diseases:before taking this medication, they must consult their doctor.Take a maximum of 500 milligrams (half tablet) per dose. According to their disease, their doctor will indicate if they should take their medication with a minimum interval of 6 or 8 hours. They should not take more than 2 grams in 24 hours, divided into several doses, not exceeding 500 milligrams per dose in any case.
• Older patients: they must consult their doctor.
• Use in children: do not use in children under 12 years.

Administration form:

Remember to take your medication. Xumadol is taken orally.

The tablet can be divided into equal doses.According to your preferences, the tablets can be taken directly or split in half with water, milk, or fruit juice.

Consult your doctor or pharmacist if you have any doubts.

If the pain worsens or does not improve within 5 days or the fever lasts more than 3 days, you must consult your doctor.

If you take more Xumadol than you should

If you have taken Xumadol more than you should, consult your doctor or the Toxicological Information Service immediately, phone 915 620 420.If you have taken an overdose, you must go to a medical center immediately, even if you do not have symptoms, as they often do not appear until three days after the overdose, even in cases of severe intoxication. The symptoms of an overdose may be: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

The treatment of an overdose is more effective if it is initiated within 4 hours of taking the medication.

Patients undergoing barbiturate treatment or those with chronic alcoholism may be more susceptible to a paracetamol overdose.

If you forgot to takeXumadol

Do not take a double dose to compensate for the missed doses, simply take the missed dose when you remember, taking the next doses with the indicated interval (at least 4 hours).

If you interrupt the treatment with Xumadol

If you have any other doubts about the use of thismedication, ask your doctororpharmacist.

Like all medications, Xumadol may produce adverse effects, although not all people may experience them.

This medication may produce the following adverse effects:

• Rare (may affect up to 1 in 1,000 people): discomfort and blood pressure decrease.
• Very rare (may affect up to 1 in 10,000 people): allergic reactions (such as skin reactions), blood sugar decrease, blood alterations, and liver and kidney alterations.

Severe skin reactions have been reported very rarely.

• Frequency not known (cannot be estimated from available data): A serious disease that can make the blood more acidic (designated as metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of reach and sight of children.

This medication does not require special conditions for conservation.

Do not use Xumadol after the expiration date that appears on the packaging (after CAD.). The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy.Ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Xumadol

The active ingredient is paracetamol. Each tablet contains 1 g of paracetamol.

The other components are: maize pregelatinized starch, stearic acid and povidone.

Appearance of the product and contents of the packaging

Xumadol is presented in the form of oblong tablets, white in color and scored on one of their faces for oral administration, in packs of 20 and 40 tablets conditioned in aluminum-PVC-PVDC blister.

Holder of the marketing authorization and manufacturer responsible:

Holder of the marketing authorization:

ITALFARMACO S.A.

Polígono Industrial Alcobendas

C/ San Rafael 3, 28108-Alcobendas (Madrid)

Manufacturer responsible:

Noucor Health, S.A.

Avenida Camí Reial 51-57 – 08184 – Palau-solità i Plegamans (Barcelona)

Date of the last review of this leaflet: December 2024

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/