ANTIDOL NIÑOS 325 MG GRANULES

Introduction

Leaflet: information for the user

Antidol CHILDREN 325 mg granule

Paracetamol

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

Follow the administration instructions of the medicine contained in this leaflet or as 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 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 it worsens or does not improve after 3 days with fever or 5 days with pain.

Contents of the leaflet

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

1. What is Antidol CHILDREN and what is it used for

Paracetamol is effective in reducing pain and fever.

This medicine is used in children between 25 and 43 kg (from 8 to 11 years old) for the symptomatic treatment of occasional mild or moderate pain, such as headaches, toothaches, muscle pain (cramps), and fever.

2. What you need to know before taking Antidol CHILDREN

Do not takeAntidol CHILDREN

• 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 Antidol CHILDREN. 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 important that you consult your doctor as soon as possible.
• The simultaneous use of this medicine with other medicines that contain paracetamol, such as flu and cold medicines, should be avoided, as high doses can lead to liver damage. Do not use more than one medicine that contains paracetamol without consulting your doctor.
• You should consult your doctor or pharmacist before starting to take this medicine.
• If you have kidney, liver, heart, or lung disease, and patients with anemia (decrease in hemoglobin levels 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 of paracetamol is decreased and its hepatotoxicity is increased, 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 g of paracetamol in 24 hours.
• 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 are also taking flucloxacillin (an antibiotic). A serious 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 of discomfort (nausea), and vomiting.

Children

Do not use in children with a weight below 25 kg (under 8 years old approximately) because it does not allow for dosing of doses lower than 1 sachet per intake (325 mg).

Other medicines and Antidol CHILDREN

Tell 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 ingredients, 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 and heart rhythm disorders
• Ion exchange resins (cholestyramine)

Tell your doctor or pharmacist if you are taking:

• Flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (called metabolic acidosis with high anion imbalance) that should be treated urgently (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 Antidol CHILDREN 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 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, 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 null or insignificant.

Antidol CHILDREN contains aspartame (E-951), sodium, and sucrose

• This medicine contains 15.35 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 73.6 mg of sodium (main component of table/cooking salt). This is equivalent to 3.68% of the maximum daily sodium intake recommended for an adult.

• This medicine contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Antidol CHILDREN

Follow these instructions unless your doctor has given you different instructions. Consult your doctor or pharmacist if you have doubts.

You should always take the smallest dose that is effective in relieving symptoms.

Taking this medicine is subject to the appearance of pain or fever. As they disappear, treatment should be suspended.

High daily doses of paracetamol should be avoided during prolonged periods, as the risk of adverse effects such as liver damage increases.

If the pain persists for more than 5 days, the fever for more than 3 days, or the pain or fever worsens or other symptoms appear, you should interrupt treatment and consult your doctor.

For throat pain, do not take the medicine for more than 2 consecutive days without consulting your doctor.

Use in children

Children between 25 and 43 kg (from 8 to 11 years old approximately): 1 sachet of 325 mg every 4-6 hours as needed. According to weight, children with a weight below 33 kg should not exceed 5 sachets in 24 hours, and those with a weight above 33 kg up to 6 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 informational 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 granule disperses immediately in saliva and is then swallowed.

It can be taken with or without food.

If you take more Antidol CHILDREN 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.

Symptoms of overdose 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 ingestion of the medicine.

Patients treated with barbiturates 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 Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount ingested.

If you forget to take Antidol CHILDREN

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

4. Possible side effects

Like all medicines, this medicine can have 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 1,000 people):kidney disorders; cloudy urine

Disorders of the skin and subcutaneous tissue

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

Very rare (may affect up to 1 in 10,000 people):Very rare cases of serious skin reactions have been reported.

Hepatobiliary disorders

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

Disorders of the blood and lymphatic system

Rare (may affect up to 1 in 1,000 people):blood disorders (agranulocytosis, leukopenia, neutropenia, thrombocytopenia, hemolytic anemia)

Disorders of metabolism and nutrition

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

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 using paracetamol (see section 2).

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

If you consider that any of the side effects you are experiencing 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 that does not appear in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website (www.notificaRAM).

5. Storage of Antidol CHILDREN

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 EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Antidol CHILDREN

The active ingredient is paracetamol. Each sachet contains 325 mg of paracetamol.

The other components are calcium carbonate, sodium hydrogen carbonate, anhydrous citric acid, anhydrous sodium citrate, aspartame (E-951), mask it (contains sucrose and aspartame (E-951)), mannitol (E-421), lemon flavor, amorphous silica, glycerol (E-422) type 1 diester, sodium croscarmellose, sodium carboxymethylcellulose (type A) (from potato), ethylcellulose, hydroxypropyl methylcellulose, and polyethylene glycol 400.

Appearance of the product and package contents

White granule 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

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Farmalider, S.A.

C/Aragoneses, 2

28108 Alcobendas, Madrid

Spain

or

Edefarm, S.L

Polígono Industrial Enchilagar del Rullo, 117

46191, Villamarchante, Valencia

Spain

Date of the last revision of this leaflet: March 2025

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