PARACETAMOL WINADOL 250 MG GRANULES

Introduction

Leaflet: information for the user

Paracetamol Winadol 250 mg granules

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

Follow the administration instructions for the medicine contained in this leaflet or as indicated by your doctor or pharmacist exactly.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 3 days with fever or 5 days with pain.

Contents of the leaflet

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

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

Paracetamol is effective in reducing pain and fever.

This medicine is used in children between 19 and 24 kg (from 5 to 7 years old) for the symptomatic treatment of occasional mild or moderate pain, such as headache, toothache or muscle pain, and fever.

2. What you need to know before taking Paracetamol Winadol

Do not takeParacetamol Winadol

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

Warnings and precautions

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

• Do not take more than the recommended dose in section 3. How to take Paracetamol Winadol.
• A higher dose than indicated does not increase pain relief but can damage the liver. Symptoms of liver damage occur for the first time after a few days. If you have taken more paracetamol than indicated in this leaflet, it is essential that you consult your doctor as soon as possible.
• You should avoid taking this medicine simultaneously with other medicines that contain paracetamol, such as flu and cold medicines, as high doses can lead to liver damage. Do not use more than one medicine that contains paracetamol without consulting your doctor.
• If you have kidney, liver, heart, or lung disease, and patients with 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 dehydration,
• If you are being treated with any medicine for epilepsy, you should consult your doctor before taking this medicine, as when used at the same time, the efficacy is decreased and the hepatotoxicity of paracetamol is potentiated, especially in high-dose paracetamol treatments.
• If you are an asthmatic sensitive to acetylsalicylic acid
• Chronic alcoholics should be cautious not to take more than 2 grams in 24 hours of paracetamol

During treatment with Paracetamol Winadol, inform your doctor immediately if:

• If you have severe diseases, such as severe renal failure 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 (an anomaly in 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. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Children

Do not use in children with a weight of less than 19 kg (less than 5 years old) because it does not allow for dosing of doses less than 1 sachet per intake (250 mg).

Other medicines and Paracetamol Winadol

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicine.

In particular, if you are using medicines that contain in their composition some of the following active principles, as it may be necessary to reduce the dose of some of them or interrupt treatment:

• Ethyl alcohol
• Oral anticoagulants (acenocoumarol, warfarin)
• Anticonvulsants (phenytoin, phenobarbital, methylphenobarbital, primidone)
• Isoniazid
• Rifampicin
• Lamotrigine
• Metoclopramide and domperidone (used to prevent nausea and vomiting)
• Probenecid
• Propranolol used in the treatment of high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias)
• Ion exchange resins (cholestyramine)
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

Interference with analytical tests:

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

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

Use of Paracetamol Winadol with food, drinks, and alcohol

The use of paracetamol in patients who habitually consume alcohol (3 or more alcoholic beverages per day) may cause liver damage.

Taking this medicine with food does not affect its efficacy.

Pregnancy and lactation

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.

Paracetamol is excreted in breast milk, so breastfeeding women should consult their doctor or pharmacist before using this medicine.

In case of need, paracetamol 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 if the pain or fever does not decrease or if you need to take the medicine more frequently.

Driving and using machines

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

Paracetamol Winadol contains aspartame (E-951), sodium, sucrose, and glucose traces.

• This medicine contains 11.81 mg of aspartame (E-951) in each sachet. Aspartame contains a source of phenylalanine that can be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it correctly.
• This medicine contains 57.5 mg of sodium (main component of table salt/cooking salt). This is equivalent to 2.8% of the maximum daily sodium intake recommended for an adult.

• This medicine contains sucrose and glucose traces (from potato maltodextrin). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine. It can cause cavities.

3. How to take Paracetamol Winadol

Follow the administration instructions for the medicine contained in this leaflet or as indicated by your doctor or pharmacist exactly. In case of doubt, ask your doctor or pharmacist.

Use in children

Children between 19 and 24 kg (from 5 to 7 years old): the recommended dose is 1 sachet (250 mg of paracetamol) every 4-6 hours as needed, not exceeding 5 sachets in 24 hours.

The recommended daily dose of paracetamol in children is 60 mg/kg/day, divided into 4 or 6 daily doses, i.e., 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.

It is necessary to respect the posologies defined according to the child's weight and therefore choose the appropriate dosage. The approximate age based on weight is given for information purposes.

Due to the dose, this medicine is not suitable for use in adults. Consult your pharmacist for more information.

Patient with liver or kidney disease:should consult their doctor before taking this medicine. If your doctor prescribes this medicine, you should wait at least 8 hours between two doses.

This medicine is administered orally.

Open the sachet and pour the contents directly into the mouth. The granules disperse immediately in saliva and then swallow.

It can be taken with or without food.

If you take more Paracetamol Winadol than you should

You should consult your doctor or pharmacist immediately.

If you have taken an overdose, go quickly to a medical center, even if you have no symptoms, as they often do not appear until 3 days after ingestion, even in cases of severe poisoning.

Overdose symptoms may include: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

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

Patients treated with barbiturates or chronic alcoholics may be more susceptible to paracetamol toxicity.

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 Winadol

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

The following side effects have been reported according to the frequencies detailed below:

Renal and urinary disorders

Rare (may affect up to 1 in 1000 people)):kidney disorders; cloudy urine

Disorders of the skin and subcutaneous tissue

Rare (may affect up to 1 in 1000 people)):allergic dermatitis (skin rash)

Hepatobiliary disorders

Rare (may affect up to 1 in 1000 people)):jaundice (yellowing of the skin)

Disorders of the blood and lymphatic system

Rare (may affect up to 1 in 1000 people)):blood alterations (agranulocytosis, leukopenia, neutropenia, thrombocytopenia, hemolytic anemia)

Metabolic and nutritional disorders

Rare (may affect up to 1 in 1000 people)):hypoglycemia (low blood sugar)

Paracetamol can damage the liver when taken in high doses or in prolonged treatments.

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

If you consider that any of the side effects you suffer from is serious, or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines (www.notificaRAM.es).

5. Storage of Paracetamol Winadol

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

No special storage conditions are required.

Do not use this medicine 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 thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need in the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Paracetamol Winadol

The active ingredient is paracetamol. Each sachet contains 250 mg of paracetamol.

The other components are calcium carbonate, sodium hydrogen carbonate, anhydrous citric acid, anhydrous sodium citrate, aspartame (E-951), mask it (compound of natural flavorings, flavorings identical to natural ones, maltodextrin, sucrose, aspartame (E-951), and acesulfame potassium (E-950)), mannitol (E-421), lemon flavor, amorphous silica, glycerol distearate type 1, sodium croscarmellose, sodium carboxymethylcellulose (potato starch type A), ethylcellulose, hydroxypropyl methylcellulose, polyethylene glycol 400.

Appearance of the product and package contents

White granules with a marked lemon odor, packaged in single-dose sachets.

Packaged in boxes of 10 and 20 sachets.

Only some package sizes may be marketed.

Marketing authorization holder

Farmalider, S.A.

C/La Granja, 1

28108 Alcobendas, Madrid

Manufacturer

Farmalider, S.A.

C/Aragoneses, 2

28108 Alcobendas, Madrid

or

Edefarm, S.L.

Enchilagar del Rullo Industrial Estate, 117

46191, Villamarchante, Valencia

Spain

Date of the last revision of this leaflet: March 2025

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/