PARACETAMOL WINADOL 100 mg/ml ORAL SOLUTION

Introduction

Leaflet: information for the user

Paracetamol Winadol 100 mg/ml oral solution EFG

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

• Follow the administration instructions for the medication contained in this leaflet or as indicated by your doctor, pharmacist, or nurse. 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, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 3 days, in case of fever, or if pain persists in children for more than 3 days (2 days for throat 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 Conservation of Paracetamol Winadol

1. Package contents and additional information

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

Paracetamol Winadol belongs to a group of medications called analgesics and antipyretics.

This medication is used in febrile states and for the relief of mild or moderate pain in children between 3 and 32 kg in weight (approximately from 0 to 10 years).

2. What you need to know before taking Paracetamol Winadol

Do not takeParacetamol Winadol:

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

Warnings and precautions

• Do not exceed the recommended dose in section 3.

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

• In patients with liver, kidney, heart, or lung disease, and in patients with anemia (decrease in hemoglobin levels in the blood, due to or not due to a decrease in red blood cells), consult your doctor before taking the medication.
• In children with chronic malnutrition or dehydration, as it may increase liver toxicity.
• Consumption of alcoholic beverages may cause paracetamol to damage the liver.

If the pain or fever persists for more than 3 days (2 days for throat pain), or worsens, or other symptoms appear, treatment should be discontinued and a doctor consulted. Avoid prolonged treatments.

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 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 breathing difficulties with deep and rapid breathing, drowsiness, feeling of discomfort (nausea) and vomiting.

Children

You should consult a doctor before administering the medication to children under 2 years of age.

Other medications andParacetamol Winadol

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication. In particular, if you are using medications that contain any of the following active ingredients, as it may be necessary to modify the dose or discontinue treatment of either of them:

• Antibiotics (chloramphenicol)
• Oral anticoagulants (acenocoumarol, warfarin)
• Oral contraceptives and estrogen treatments
• Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Antituberculars (isoniazid, rifampicin)
• Barbiturates (used as sleep inducers, sedatives, and anticonvulsants)
• Activated charcoal, used for diarrhea or gas treatment
• Colestyramine (used to decrease blood cholesterol levels)
• Medications used to treat gout (probenecid and sulfinpyrazone)
• Medications used to relieve stomach, intestine, and bladder spasms or contractions (anticholinergics)
• Metoclopramide and domperidone (used to prevent nausea and vomiting)
• Propranolol used in the treatment of high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias)
• Zidovudine (used in the treatment of patients infected with the human immunodeficiency virus, which causes AIDS).
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that must be treated urgently (see section 2)

Interference with analytical tests:

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

Taking Paracetamol Winadol with food, drinks, and alcohol

This medication can be administered diluted with water, milk, or fruit juice. The use of paracetamol in patients who regularly consume alcohol (three or more alcoholic beverages per day) may damage the liver.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medication. In women, although there are no controlled studies, no teratogenic effects have been found. However, as a general rule, its use is not recommended during the first trimester of pregnancy. If necessary, Paracetamol Winadol 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 medication more frequently. Paracetamol passes into breast milk, so breastfeeding women should consult their doctor before using this medication.

Driving and using machines

No effects have been described that modify the ability to drive and use machines.

This medication contains propylene glycol (E-1520), azorubine, sodium, and glucose traces.

This medication contains 8.87 mg of propylene glycol (E-1520) per ml. If the baby is less than 4 weeks old, consult your doctor or pharmacist, especially if the baby has been given other medications that contain propylene glycol or alcohol.

This medication may cause allergic reactions because it contains azorubine. It can cause asthma, especially in patients allergic to acetylsalicylic acid.

This medication contains less than 23 mg of sodium (1 mmol) per ml; this is essentially "sodium-free".

This medication contains glucose (traces). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication. It may cause cavities.

3. How to take Paracetamol Winadol

Follow the administration instructions for the medication contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

This medication is administered orally.

It is intended for short-term use in children between 3 and 32 kg (approximately from 0 to 10 years).

Use in children

In children under 2 years of age, the dose should always be established by a doctor.

The dose of paracetamol depends on the child's weight; the approximate age is given for information purposes. The recommended daily dose of paracetamol is approximately 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.

The dosing of the solution is done in milliliters (ml) (100 mg/ml) using the 5 ml oral syringe included in the package.

For administration of 15 mg/kg every 6 hours, the schedule is as follows:

For a direct calculation, you can also multiply the child's weight in kg by 0.15; the result is the ml to be administered of the medication.

These doses can be repeated every 6 hours.

If the desired effects are not obtained 3-4 hours after administration, the dose can be advanced every 4 hours, in which case 10 mg/kg will be administered.

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

Instructions for the correct administration of the medication

1. Open the bottle by following the instructions on the cap (on the first opening, the seal will break).

2. Insert the oral syringe, pressing on the hole in the perforated cap.

3. Invert the bottle and withdraw the necessary dose.

4. Administer directly or dilute with water, milk, or fruit juice.

5. The oral syringe should be washed with water after each dose.

Close the bottle well after each administration.

If you take more Paracetamol Winadol than you should

If you have taken more paracetamol than you should, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount used. It is recommended to take the package and the leaflet of the medication to the healthcare professional.

If you have ingested an overdose, you should go quickly to a medical center, even if there are no 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.

Paracetamol overdose is considered to be the ingestion of a single dose of more than 6 g in adults and more than 100 mg per kg of weight in children. Treatment of the overdose is more effective if started within 4 hours of ingestion of the medication.

In the event that the patient is being treated with barbiturates or has chronic alcoholism, they may be more susceptible to a paracetamol overdose.

In general, symptomatic treatment will be performed.

If you forget to takeParacetamol Winadol

Do not take a double dose to make up for forgotten doses. If you have forgotten a dose, take another as soon as possible and continue with the usual schedule. However, if the time of the next dose is very close, skip the forgotten dose and take the next dose at the usual time.

If you interrupt treatment with Paracetamol Winadol

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

Paracetamol side effects are generally rare or very rare

Rare (may affect up to 1 in 1,000 people): discomfort, increased liver transaminase levels, and low blood pressure.

Very rare (may affect up to 1 in 10,000 people): severe skin reactions, liver disorders (such as jaundice), low glucose, blood disorders (thrombocytopenia, agranulocytosis, leucopenia, neutropenia, hemolytic anemia), cloudy urine, and kidney disorders.

Very rarely, it can damage the liver at high doses or prolonged treatments. Very rare cases of severe skin reactions have been reported.

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 who use paracetamol (see section 2).

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that is not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Paracetamol Winadol

Keep this medication out of sight and reach of children.

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

No special storage conditions are required. The validity period after opening is 12 months.

Medications should not be thrown away in drains or trash. Deposit the packages and medications you no longer need in the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition ofParacetamol Winadol

• The active ingredient is paracetamol. Each ml of solution contains 100 mg of paracetamol.
• The other components (excipients) are macrogol 400, glycerol (E-422), sodium saccharin, strawberry flavor, raspberry flavor (contains propylene glycol (E-1520)), taste masker (contains potato maltodextrin), azorubine (E-122), and purified water.

Appearance of the product and package contents

Transparent red solution, free of suspended particles, and with a characteristic strawberry/raspberry odor.

Packages containing a 30, 60, and 90 ml colorless PET plastic bottle with a safety screw cap, plus a 5 ml oral syringe with 0.1 ml graduations:

It is possible that only some package sizes are marketed

Marketing authorization holder and manufacturer

Marketing authorization holder

Nutra Essential OTC, S.L.

C/ La Granja, 1, 3rd floor

1. Alcobendas (Madrid)

Spain

Manufacturers

Edefarm, S.L.

Polígono Industrial Enchilagar del Rullo, 117,

Villamarchante, 46191 Valencia

Spain

Farmalider, S.A.

C/ Aragoneses, 2

28108 Alcobendas – Madrid

Spain

Date of the last revision of thisleaflet:February 2025

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