Package Leaflet: Information for the User

Paracetamol Winadol 250 mg Granule

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

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

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any 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 your fever worsens or does not improve after 3 days or if your pain does not improve after 5 days.

Paracetamol is effective in reducing pain and fever.

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

Do not takeParacetamol Winadol

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

Warnings and precautions

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

• 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 may damage the liver. Liver damage symptoms occur for the first time after a few days. If you have taken more paracetamol than indicated in this leaflet, it is essential to consult your doctor as soon as possible.
• Avoid using this medication with other medications containing paracetamol, for example, cold and flu medications, as high doses may cause liver damage. Do not use more than one medication containing paracetamol without consulting your doctor.
• If you have kidney, liver, heart, or lung diseases, or patients with anemia (decreased hemoglobin levels in the blood, due or not due to a decrease in red blood cells),
• If you have chronic malnutrition or dehydration,
• If you are being treated with any medication for epilepsy, consult your doctor before taking this medication, as when used together, it decreases the effectiveness and increases the hepatotoxicity of paracetamol, especially in high-dose treatments.
• If you are an asthmatic sensitive to acetylsalicylic acid
• Chronic alcoholics should be cautious not to take more than2 gin 24 hours of paracetamol

Inform your doctor immediately during treatment with Paracetamol Winadol if:

• You have severe diseases, such as severe kidney failure 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 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. Metabolic acidosis symptoms may include: severe respiratory difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Children

Do not use in children weighing less than 19 kg (approximately under 5 years old) as it does not allow for dosing of doses less than 1 tablet per dose (250 mg).

Other medications and Paracetamol Winadol

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

Particularly, if you are using medications containing some of the following active ingredients, as it may be necessary to reduce the dose of some of them or interrupt treatment:

• Alcohol ethyl
• 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 (arrhythmias)
• Ion exchange resins (colestiramine)
• Flucloxacillin (antibiotic), due to a severe risk of blood and fluid anomaly (denominated metabolic acidosis) that must receive urgent treatment (see section 2).

Interference with analytical tests:

Inform your doctor if you are to undergo any analytical test (including blood and urine tests, etc.) as it may alter the results of these tests.

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

Use of Paracetamol Winadol with food, drinks, and alcohol

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

Taking this medication with food does not affect its efficacy.

Pregnancy and lactation

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

Paracetamol is excreted in breast milk, so women in the lactation period should consult their doctor or pharmacist before using this medication.

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

Driving and operating machinery

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

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

• This medication contains 11.81 mg of aspartame (E-951) in each sachet. Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates due to the body's inability to eliminate it correctly.
• This medication 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 medication contains sucrose and traces of glucose (from potato starch maltodextrin). If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication. It may cause tooth decay.

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

Use in children

Children between 19 and 24 kg (approximately 5 to 7 years old) : the recommended dose is 1 sachet (250 mg of paracetamol) every 4-6 hours as needed, without exceeding 5 sachets in 24 hours.

The recommended daily dose of paracetamol in children is 60 mg/kg/day, which is 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 dosages defined according to the child's weight, and therefore, choose the appropriate dosage. The approximate age according to weight is given for information only.

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

Patients with liver or kidney disease: should consult their doctor before taking this medication. If their doctor prescribes this medication, they should wait at least 8 hours between doses.

This medication is administered orally.

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

It can be taken both with food and without it.

If you take more Paracetamol Winadol than you should

You should consult your doctor or pharmacist immediately.

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

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 chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicological Information Service (phone 91 562 04 20), indicating the medication and the amount ingested.

If you forgot to take Paracetamol Winadol

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

Like all medications, this medicationmay produce adverse effects, although not all people will experience them.

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

Renal and Urinary Tract Disorders

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

Skin and Subcutaneous Tissue Disorders

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 (yellow discoloration of the skin)

Blood and Lymphatic System Disorders

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

Metabolism and Nutrition Disorders

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

Paracetamol may damage the liver when taken in high doses or prolonged treatment.

Unknown frequency (cannot be estimated from available data):A severe disease that may cause the blood to become more acidic (designated metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

If you consider that any of the adverse effects you experience are severe, or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

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 through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use (www.notificaRAM.es).

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

No special storage conditions are required.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

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 (comprising natural flavorings, identical natural flavorings, maltodextrin, sucrose, aspartame (E-951) and potassium acesulfame (E-950)), mannitol (E-421), lemon aroma, amorphous silica, glyceryl distearate type 1, sodium croscarmellose, sodium carboxymethylcellulose (potato starch type A), ethylcellulose, hydroxypropyl methylcellulose, polyethylene glycol 400.

Appearance of the product and content of the packaging

White granule with a lemon-scented odor, packaged in single-dose sachets.

Packed in boxes of 10 and 20 sachets.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization

Farmalider, S.A.

C/La Granja, 1

28108 Alcobendas, Madrid

Responsible for manufacturing

Farmalider, S.A.

C/Aragoneses, 2

28108 Alcobendas, Madrid

or

Edefarm, S.L

Polígono Industrial Enchilagar del Rullo, 117

46191, Villamarchante, Valencia

Spain

Last review date of this leaflet: March 2025

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