Xumadol 1 g tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

XUMADOL 1 g tablets EFG

Paracetamol

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, since 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 this leaflet:

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

1. What Xumadol is and what it is used for

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 conditions in adults and adolescents over 15 years of age.

You should consult your doctor if pain worsens or does not improve after 5 days, or if fever persists for more than 3 days.

2. What you need to know before starting to take Xumadol

Do not take Xumadol

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

Warnings and precautions

• Do not take more than the recommended dose stated in section 3. How to take Xumadol. To avoid overdose, check that you are not simultaneously taking other medicines containing paracetamol (for example, cold remedies or other pain or fever medications).

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

During treatment with Xumadol, inform your doctor immediately:

• If you are an asthmatic patient sensitive to acetylsalicylic acid.
• If you have any 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).
• If you suffer from chronic malnutrition or are dehydrated.
• If you are being treated with medications for epilepsy, as concomitant use may reduce efficacy and increase the hepatotoxic potential of paracetamol, especially with high-dose paracetamol regimens.
• In chronic alcoholics, caution should be taken not to exceed 2 tablets of 1 g 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, you should consult your doctor and re-evaluate your clinical condition.
• 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 imbalance 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 breathing difficulties with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

Children and adolescents

This medicine is not suitable for the recommended doses in children (under 12 years of age) and adolescents weighing less than 40 kg. Consult your doctor or pharmacist, as other formulations with appropriate doses are available for these patients.

You should consult your doctor before using this medicine in children under 15 years of age or for treatments lasting more than 10 days.

Interference with diagnostic tests:

If you are scheduled for any diagnostic tests (blood, urine, etc.), inform your doctor that you are taking paracetamol, as it may alter test results.

Paracetamol may interfere with analytical measurements of uric acid and glucose.

Use of Xumadol with other medicines:

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

Paracetamol may interact with the following medicines:

• Antibiotics (chloramphenicol)
• Anticoagulants (used to treat thromboembolic disorders)
• Antiepileptics (used to treat epileptic seizures)
• Oral 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)
• Anticholinergics (used to relieve spasms or contractions of the stomach, intestine, and bladder)
• Zidovudine (used to treat HIV infections)
• Colestyramine (used to lower blood cholesterol levels)
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormalities (known as metabolic acidosis) requiring urgent treatment (see section 2).

Do not use with other analgesics (medicines that relieve pain) 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 any other medication. In patients treated with oral anticoagulants, paracetamol may occasionally be used as the analgesic of choice.

Taking Xumadol with food, drinks, and alcohol

Taking this medicine with food does not affect its efficacy.

Pregnancy, breastfeeding, and fertility

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.

Xumadol may be used during pregnancy if necessary. Use the lowest possible dose that reduces pain or fever, and use it for the shortest duration possible. Contact your doctor or midwife if pain or fever does not decrease, or if you need to take the medicine more frequently

Breast-feeding

Consult your doctor or pharmacist before taking any medicine.

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.

3. How to take Xumadol

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Follow exactly the instructions for use of this medicine given 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 50 kg): half a tablet (500 mg paracetamol) or 1 tablet (1 g paracetamol) as needed, 3-4 times a day. Doses should be spaced at least 4 hours apart. Do not take more than 4 tablets (4 g of paracetamol) in 24 hours.
• Adolescents over 12 years of age (and weighing more than 43 kg): the usual dose is half a tablet (500 mg of paracetamol). Doses should be spaced at least 4 hours apart. Do not take more than 5 doses (2 and a half tablets) in 24 hours.
• Patients with liver disease: must consult their doctor before taking this medicine. They should take the amount of medicine prescribed by their doctor, with a minimum interval of 8 hours between doses. They must not take more than 2 grams of paracetamol in 24 hours, divided into 2 doses.
• Patients with kidney disease: must consult their doctor before taking this medicine. Take a maximum of 500 milligrams (half a tablet) per dose. Depending on their condition, their doctor will indicate whether the medicine should be taken with a minimum interval of 6 or 8 hours. They must not take more than 2 grams in 24 hours, divided into several doses, and must not exceed 500 milligrams per dose under any circumstances.
• Elderly patients: must consult their doctor.
• Use in children: do not use in children under 12 years of age.

Method of administration:

Remember to take your medicine. Xumadol is taken orally.

The tablet can be divided into equal doses. Depending on your preference, the tablets can be swallowed whole or split in half with water, milk, or fruit juice.

Consult your doctor or pharmacist if you have any doubts.

If pain worsens or does not improve within 5 days, or fever persists for more than 3 days, you should consult your doctor.

If you take more Xumadol than you should

If you have taken more Xumadol than you should, contact your doctor or the Toxicology Information Service immediately, telephone 915 620 420. If you have taken an overdose, you must go immediately to a medical center even if there are no symptoms, as symptoms often do not appear until three days after the overdose, even in cases of severe poisoning. Symptoms of overdose may include dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

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

Patients undergoing treatment with barbiturates or those suffering from chronic alcoholism may be more susceptible to paracetamol overdose.

If you forget to take Xumadol

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

If you stop treatment with Xumadol

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

4. Possible adverse effects

Like all medicines, Xumadol can cause adverse effects, although not everyone will experience them.

This medicine may cause the following adverse effects:

• Rare (may affect up to 1 in 1,000 people): malaise and drop in blood pressure.
• Very rare (may affect up to 1 in 10,000 people): allergic reactions (such as skin reactions), hypoglycemia, blood disorders, and liver and kidney disorders.

Very rare cases of serious adverse skin reactions have been reported.

• 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).

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 can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Xumadol

Keep out of the reach and sight of children.

This medicine does not require any special storage conditions.

Do not use Xumadol after the expiry date stated on the packaging (after EXP.). The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Xumadol

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

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

Appearance of the product and contents of the pack

Xumadol is presented as white, oblong, scored tablets for oral administration, available in packs of 20 and 40 tablets in aluminum-PVC-PVDC blisters.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

ITALFARMACO S.A.

Polígono Industrial Alcobendas

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

Manufacturer:

Noucor Health, S.A.

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

Date of the most recent review of this leaflet: December 2024

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