Paracetamol Winadol 250 mg granules

Patient Information Leaflet

Introduction

Package leaflet: Information for the user

Paracetamol Winadol 250 mg granules

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

Follow exactly the instructions for administration of the medicine contained in this leaflet or those provided 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 adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if you get worse or do not improve after 3 days of fever or 5 days of pain.

Leaflet Contents

1. What Paracetamol Winadol is and what it is used for
2. What you need to know before taking Paracetamol Winadol
3. How to take Paracetamol Winadol
4. Possible side effects
5. How to store Paracetamol Winadol
6. Contents of the pack and other information

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

Paracetamol is effective in reducing pain and fever.

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

2. What you need to know before taking Paracetamol Winadol

Do not take Paracetamol Winadol

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

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine.

• Do not exceed the dose recommended in section 3. How to take Paracetamol Winadol.
• A dose higher than recommended does not increase pain relief but may cause liver damage. Symptoms of liver damage may appear only after several days. If you have taken more paracetamol than indicated in this leaflet, it is important to consult your doctor as soon as possible.
• Avoid using this medicine simultaneously with other medicines containing paracetamol, such as cold and flu remedies, as high doses may lead to liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.
• If you have kidney, liver, heart, or lung diseases, or if you have anaemia (reduced haemoglobin levels in the blood, with or without a reduction in red blood cells),
• If you suffer from chronic malnutrition or dehydration,
• If you are being treated with medicines for epilepsy, you should consult your doctor before taking this medicine, as concomitant use may reduce efficacy and increase the hepatotoxicity of paracetamol, especially when high doses of paracetamol are used.
• If you are an aspirin-sensitive asthmatic,
• Chronic alcoholics should take care not to exceed 2 g of paracetamol in 24 hours.

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

• You have serious conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients under these circumstances when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing 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 of age), as it does not allow for dosing below one sachet per dose (250 mg).

Other medicines and Paracetamol Winadol

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In particular, if you are taking medicines containing any of the following active substances, dose adjustment or discontinuation of treatment may be necessary:

• Ethanol (alcoholic drinks)
• Oral anticoagulants (acenocoumarol, warfarin)
• Anticonvulsants (phenytoin, phenobarbital, methylphenobarbital, primidone)
• Isoniazid
• Rifampicin
• Lamotrigine
• Metoclopramide and domperidone (used to prevent nausea and vomiting)
• Probenecid
• Propranolol (used to treat 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 abnormalities (called metabolic acidosis) requiring urgent treatment (see section 2).

Interference with laboratory tests:

If you are scheduled for any laboratory tests (including blood and urine tests), inform your doctor that you are taking this medicine, as it may alter the test results.

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

Use of Paracetamol Winadol with food, drinks and alcohol

Using paracetamol in patients who habitually consume alcohol (3 or more alcoholic drinks per day) may cause liver damage.

Taking this medicine with food does not affect its efficacy.

Pregnancy and breastfeeding

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; therefore, women who are breastfeeding should consult their doctor or pharmacist before using this medicine.

If necessary, paracetamol may be used during pregnancy. Use the lowest possible dose that relieves pain or fever and use it for the shortest possible duration. Contact your doctor if pain or fever do not improve 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 none or negligible.

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

• This medicine contains 11.81 mg of aspartame (E-951) per sachet. Aspartame is a source of phenylalanine, which may be harmful in individuals with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.
• This medicine contains 57.5 mg of sodium (a main component of table/cooking salt). This corresponds to 2.8% of the maximum daily sodium intake recommended for an adult.
• This medicine contains sucrose and traces of glucose (from potato maltodextrin). If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine. May cause dental caries.

3. How to take Paracetamol Winadol

Follow exactly the administration instructions provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Use in children

Children weighing 19 to 24 kg (approximately 5 to 7 years of age): the recommended dose is 1 sachet (250 mg 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, divided into 4 or 6 doses per day, i.e. 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.

It is essential to follow the dosage recommendations based on the child's weight, and therefore the appropriate dose must be selected. The approximate age corresponding to the weight is provided for informational purposes only.

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

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

This medicine is administered orally.

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

It may be taken with or without food.

If you take more Paracetamol Winadol than you should

Contact your doctor or pharmacist immediately.

In case of overdose, seek urgent medical attention even if there are no symptoms, as symptoms often do not appear until 3 days after the overdose has occurred, even in cases of severe poisoning.

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

Treatment for overdose is most effective when started within 4 hours of taking the medicine.

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

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 a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

Renal and urinary disorders

Rare (may affect up to 1 in 1,000 people): kidney disorders; cloudy urine

Skin and subcutaneous tissue disorders

Rare (may affect up to 1 in 1,000 people): allergic dermatitis (skin rash)

Hepatobiliary disorders

Rare (may affect up to 1 in 1,000 people): jaundice (yellowing of the skin)

Blood and lymphatic system disorders

Rare (may affect up to 1 in 1,000 people): blood disorders (agranulocytosis, leucopenia, neutropenia, thrombocytopenia, haemolytic anaemia)

Metabolism and nutrition disorders

Rare (may affect up to 1 in 1,000 people): hypoglycaemia (low blood sugar)

Paracetamol may cause liver damage when taken at high doses or during prolonged treatment.

Frequency not known (cannot be estimated from available data): A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who are using paracetamol (see section 2).

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed 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 via the Spanish Pharmacovigilance System for Human 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 expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point in the pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Paracetamol Winadol

The active substance 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 (composed of natural flavourings, flavouring substances identical to natural ones, maltodextrine, sucrose, aspartame (E-951) and potassium acesulfame (E-950)), mannitol (E-421), lemon flavour, amorphous silica, glycerol monostearate type 1, croscarmellose sodium, sodium carboxymethyl starch (potato starch type A), ethylcellulose, hydroxypropyl methylcellulose, polyethylene glycol 400.

Nature of the product and pack contents

White granules with a strong lemon odour, packed in single-dose sachets.

Packed in boxes of 10 and 20 sachets.

Only certain pack 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

Polígono Industrial Enchilagar del Rullo, 117

46191, Villamarchante, Valencia

Spain

Date of the most recent revision of this leaflet: March 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/