XUMADOL 1 g TABLETS

Introduction

Package Leaflet: Information for the Patient

XUMADOL 1 g Tablets EFG

Paracetamol

Read this package leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not give it to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of this Package 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. Storage of Xumadol
6. Package Contents and Additional 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 or moderate pain and febrile states in adults and adolescents over 15 years of age.

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

2. What you need to know before taking Xumadol

Do not take Xumadol

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

Warnings and Precautions

• Do not take more than the recommended dose in section 3. How to take Xumadol. Check that you are not taking other medicines that contain paracetamol (e.g., cold medicines or other pain or fever medicines) at the same time.

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 (decreased hemoglobin level in the blood, due to or not due to a decrease in red blood cells).
• If you have chronic malnutrition or are dehydrated.
• If you are being treated with any medicine for epilepsy, as the efficacy of paracetamol may be decreased and hepatotoxicity may be increased when used at the same time, especially with high doses of paracetamol.
• In chronic alcoholics, caution should be exercised not to 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 worsens or other symptoms appear, you should consult your doctor and reassess 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 serious disease called metabolic acidosis (an anomaly in the 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. The symptoms of metabolic acidosis may include: severe respiratory distress with deep and rapid breathing, drowsiness, feeling of discomfort (nausea) and vomiting.

Children and Adolescents

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

You should consult your doctor to use it in children under 15 years or in treatments for more than 10 days.

Interference with Laboratory Tests:

If you are going to have any diagnostic tests (blood tests, urine tests, etc.), inform your doctor that you are taking paracetamol, as it may alter the results.

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

Use of Xumadol with other Medicines

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

Paracetamol may interact with the following medicines:

• Antibiotics (chloramphenicol)
• Anticoagulants (used to treat thromboembolic diseases)
• Antiepileptics (used to treat epileptic seizures)
• 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 stomach, intestine, and bladder spasms or contractions)
• Zidovudine (used to treat HIV infections)
• Colestyramine (used to decrease blood cholesterol levels)
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) 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 recommended to systematically inform your doctor or pharmacist if you are being treated with another medicine. In the case of treatment with oral anticoagulants, it can be administered occasionally 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

In case of necessity, Xumadol 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 or midwife if the pain or fever does not decrease or if you need to take the medicine more frequently

Breastfeeding

Consult your doctor or pharmacist before using any medicine.

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

Driving and Using Machines

The influence of paracetamol on the ability to drive and use machines is negligible or nonexistent.

3. How to Take Xumadol

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Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

• Adults and adolescents over 15 years (and weighing over 50 kg): as needed, half a tablet (500 mg of paracetamol) or 1 tablet (1 g of paracetamol) 3-4 times a day. The 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 (and weighing over 43 kg): the usual dose is half a tablet (500 mg of paracetamol). The doses should be spaced at least 4 hours apart. Do not administer more than 5 doses (2 and a half tablets) in 24 hours.
• Patients with liver disease: before taking this medicine, they must consult their doctor. They should take the amount of medicine prescribed by their doctor with a minimum interval between each dose of 8 hours. Do not take more than 2 grams of paracetamol in 24 hours, divided into 2 doses.
• Patients with kidney disease: before taking this medicine, they must consult their doctor. Take a maximum of 500 milligrams (half a tablet) per dose. Depending on their disease, their doctor will indicate whether they should take their medicine with a minimum interval of 6 or 8 hours. Do not take more than 2 grams in 24 hours, divided into several doses, never exceeding 500 milligrams per dose.
• Elderly patients: they should consult their doctor.
• Use in children: do not use in children under 12 years.

Method of administration:

Remember to take your medicine. Xumadol is taken orally.

The tablet can be divided into equal doses. According to your preferences, the tablets can be taken directly or broken 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 after 5 days or if the fever lasts for more than 3 days, you should 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 Toxicology Information Service, phone 915 620 420, immediately. If you have taken an overdose, you should go to a medical center immediately, even if you do not have symptoms, as they often do not appear until three days after taking the overdose, even in cases of severe poisoning. The symptoms of overdose may be: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

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

Patients being treated with barbiturates or suffering from chronic alcoholism may be more susceptible to a paracetamol overdose.

If you forget to take Xumadol

Do not take a double dose to make up for forgotten doses; simply take the forgotten dose when you remember, taking the following doses with the indicated separation between doses (at least 4 hours).

If you stop taking Xumadol

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

4. Possible Side Effects

Like all medicines, Xumadol can cause side effects, although not everybody gets them.

This medicine may cause the following side effects:

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

Very rare cases of serious skin reactions have been reported.

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

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website: https://www.notificaram.es. By reporting side 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 special storage conditions.

Do not use Xumadol after the expiration date stated on the package (after EXP.). The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packages and medicines you no longer need in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Xumadol Composition

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

The other ingredients are: pregelatinized corn starch, stearic acid, and povidone.

Appearance of the Product and Package Contents

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 packaged 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 Last Revision of this Package Leaflet: December 2024

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