XUMADOL 1 g EFFERVESCENT GRANULES

Introduction

Prospective: Information for the User

Xumadol1 gEffervescent Granulate EFG

Paracetamol

Read the entire prospectus carefully before starting to take this medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.

• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

Contents of the Prospectus:

1. What Xumadol is and what it is used for.
2. What you need to know before starting to take Xumadol.
3. How to take Xumadol.
4. Possible adverse effects.
5. Storage of Xumadol.
6. Package contents and additional information.

1. What Xumadol is and what it is used for

• Xumadol belongs to the group of medications called analgesics (pain-relieving medications) and antipyretics (fever-reducing medications): anilines.
• This medication is used for the relief of moderate-intensity pain and fever.

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

Do not take Xumadol

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

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Xumadol.

During treatment with Xumadol, inform your doctor immediately:

• If you have kidney disease, the interval between two doses should be at least 8 hours.
• If you have heart or lung disease, or if you have anemia (reduced hemoglobin in the blood, due to or not due to a reduction in red blood cells), you should consult your doctor before taking this medication.
• In chronic alcoholics, it is recommended to take no more than 2 g/day of paracetamol.
• Cautious use is recommended in patients with asthma who are sensitive to acetylsalicylic acid (aspirin).
• Do not take more than the recommended dose in section 3. How to take Xumadol.
• 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 if you 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:

In children and adolescents under 15 years of age, consult your doctor or pharmacist, as there are other presentations with doses that are suitable for this group of patients.

Interference with Analytical Tests:

If you are going to undergo any analytical tests (including blood, urine, etc.), inform your doctor that you are taking this medication, as it may alter the results of these tests.

Use of Xumadol with Other Medications

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

Paracetamol may interact with the following medications:

• Antibiotics (chloramphenicol)
• Oral 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)

and

• Zidovudine (used to treat HIV infections).
• Colestyramine (used to reduce blood cholesterol levels).
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomalies (called metabolic acidosis) that requires urgent treatment (see section 2).

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

Taking Xumadol with Food, Drinks, and Alcohol

Pregnancy and Breastfeeding

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

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 medication more frequently

Paracetamol passes into breast milk, so breastfeeding women should consult their doctor or pharmacist before using this medication.

Driving and Using Machines

The influence of paracetamol on the ability to drive and use machines is nil or insignificant.

Xumadolcontains aspartame. This medication contains 15 mg of aspartame in each sachet, equivalent to 9.38 mg/g. Aspartame contains a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it correctly.

Xumadolcontains sodium. This medication contains 91.34 mg of sodium (main component of table salt/cooking salt) in each sachet. This is equivalent to 5% of the maximum recommended daily sodium intake for an adult.

3. How to Take Xumadol

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

This medication is administered orally, dissolving the contents of the sachet in a glass of water. Do not take until the effervescence has completely stopped.

The recommended dose is:

• Adults and adolescents over 15 years: 1 sachet every 4-6 hours, not exceeding 4 grams (4 sachets) of paracetamol in 24 hours.
• Elderly patients should consult their doctor, as they may recommend a dose reduction.
• In case of severe kidney failure, the interval between two doses will be at least 8 hours.

Always take the lowest possible dose required to relieve symptoms.

The intake of this medication is subject to the appearance of painful or febrile symptoms. As these symptoms disappear, the medication should be discontinued.

If the symptoms worsen or do not improve after 5 days, you should consult your doctor.

If you take more Xumadol than you should

You should consult your doctor or pharmacist immediately. In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you have ingested an overdose, you should go quickly to a medical center, even if you do not have symptoms, since they often do not appear until 3 days after ingestion of 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 after ingestion of the medication.

Patients undergoing treatment with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

If you forget to take Xumadol

Do not take a double dose to make up for forgotten doses.

If you interrupt treatment with Xumadol

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

4. Possible Adverse Effects

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

This medication can cause the following adverse effects:

• Rare (may affect up to 1 in 1,000 patients): discomfort, increased liver transaminase levels, and low blood pressure.
• Very rare (may affect up to 1 in 10,000 patients): skin rashes, low blood sugar, blood disorders, jaundice (yellowing of the skin), kidney disorders, cloudy urine.

Very rare cases of severe skin reactions have been reported.

• Frequency not known (cannot be estimated from available data): A serious disease that can make the blood more acidic (called 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 not listed in this prospectus. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Xumadol

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

Store in the original packaging.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medications at the SIGRE collection point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofXumadol

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

The other components (excipients) are: aspartame (E-951), sodium saccharin, povidone, anhydrous sodium carbonate, sodium bicarbonate, anhydrous citric acid, anhydrous monosodium citrate, and lemon flavor.

Appearance of the Product and Package Contents

Xumadol 1 g is a white granulate that, when in contact with water, produces effervescence with a lemon odor and flavor.

It is available in packages containing 20 or 40 sachets.

Marketing Authorization Holder and Manufacturer:

Italfarmaco, S.A.

San Rafael, 3

28108 - Alcobendas (Madrid)

Spain Tel.: 916572323

Date of the Last Revision of this Prospectus:December 2024

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