Antidol Niños 325 mg granules
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Antidol NIÑOS 325 mg granules
Paracetamol
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Follow exactly the instructions for administration provided in this leaflet or as directed 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 must consult a doctor if you worsen or do not improve after 3 days of fever or 5 days of pain.
Contents of the leaflet
- What Antidol NIÑOS is and what it is used for
- What you need to know before taking Antidol NIÑOS
- How to take Antidol NIÑOS
- Possible adverse effects
- How to store Antidol NIÑOS
- Contents of the pack and other information
1. What Antidol NIÑOS is and what it is used for
Paracetamol is effective in reducing pain and fever.
This medicine is used in children weighing between 25 and 43 kg (aged 8 to 11 years) for the symptomatic treatment of mild to moderate occasional pain, such as headaches, toothaches, muscular pain (muscle strains), and fever.
2. What you need to know before taking Antidol NIÑOS
Do not take Antidol NIÑOS
- If you are allergic to paracetamol or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before taking this medicine.
- Do not exceed the recommended dose stated in section 3, How to take Antidol NIÑOS. Taking more than the recommended dose does not increase pain relief but may cause liver damage. Symptoms of liver damage may not appear until several days after ingestion. If you have taken more paracetamol than indicated in this leaflet, it is important that you 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.
- Consult your doctor or pharmacist before starting this medicine.
- If you suffer from kidney, liver, heart, or lung disease, or if you have anemia (reduced hemoglobin levels in the blood, with or without a reduction in red blood cells).
- If you have chronic malnutrition or dehydration.
- If you are being treated with medication for epilepsy, consult your doctor before taking this medicine, as concomitant use may reduce efficacy and increase the hepatotoxicity of paracetamol, especially with high-dose paracetamol regimens.
- If you are an aspirin-sensitive asthmatic.
- Chronic alcoholics should take care not to exceed 2 g of paracetamol in 24 hours.
- 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 known as 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 breathing difficulties with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.
Children
Do not use in children weighing less than 25 kg (approximately under 8 years of age) because it does not allow for dosing below 1 sachet per dose (325 mg).
Other medicines and Antidol NIÑOS
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
In particular, inform them if you are taking medicines containing any of the following active substances, as it may be necessary to reduce the dose or discontinue 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 to treat high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias))
- Ion-exchange resins (cholestyramine)
Also inform your doctor or pharmacist if you are taking:
- Flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (called metabolic acidosis with high anion gap) that requires 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 test results. Paracetamol may affect analytical measurements of uric acid and glucose levels.
Use of Antidol NIÑOS 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 effectiveness.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 can be used during pregnancy. Use the lowest possible dose that relieves pain or fever, and use it for the shortest possible time. Contact your doctor if pain or fever does not improve or if you need to take the medicine more frequently.
Driving and using machines
The effect of paracetamol on the ability to drive and operate machinery is none or negligible.
Antidol NIÑOS contains aspartame (E-951), sodium, and saccharose
- This medicine contains 15.35 mg of aspartame (E-951) per sachet. Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.
- This medicine contains 73.6 mg of sodium (a main component of table/cooking salt). This corresponds to 3.68% of the maximum daily sodium intake recommended for an adult.
- This medicine contains saccharose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.
3. How to take Antidol CHILDREN
Follow these instructions unless your doctor has given you different ones. Consult your doctor or pharmacist if you have any doubts.
Always take the lowest effective dose to relieve symptoms.
This medicine should only be taken when pain or fever occurs. As these symptoms subside, treatment should be discontinued.
High daily doses of paracetamol should be avoided over prolonged periods, as this increases the risk of adverse effects such as liver damage.
If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, you must stop treatment and consult your doctor.
For sore throat, do not take this medicine for more than 2 consecutive days without consulting your doctor.
Use in children
Children between 25 and 43 kg (approximately 8 to 11 years of age): 1 sachet of 325 mg every 4–6 hours as needed. Depending on weight, children weighing less than 33 kg should not exceed 5 sachets in 24 hours, and those weighing more than 33 kg should not exceed 6 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; that is, 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.
It is essential to follow the dosages based on the child's weight, and therefore, the appropriate dosage must be selected. The approximate age according to 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 granules 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 Antidol CHILDREN than you should
Contact your doctor or pharmacist immediately.
If an overdose has occurred, go quickly to a medical center even if there are no symptoms, as symptoms often do not appear until 3 days after the overdose, 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 if started within 4 hours after taking the medicine.
Patients undergoing treatment 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), stating the medicine and the amount ingested.
If you forget to take Antidol CHILDREN
Do not take a double dose to make up for missed doses.
4. Possible adverse effects
Like all medicines, this medicine can have 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)
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)
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)
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 seriously ill patients using paracetamol (see section 2).
Paracetamol can cause liver damage when taken in high doses or during prolonged treatment.
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 may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products (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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. Ask your pharmacist how to dispose of containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Antidol NIÑOS
The active substance 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 flavour, amorphous silica, glycerol (E-422), diesterate type 1, sodium croscarmellose, sodium carboxymethyl starch (type A) (from potato), ethylcellulose, hydroxypropyl methylcellulose and polyethylene glycol 400.
Appearance of the medicine and contents of the pack
White granules with a strong lemon odour, packed in single-dose sachets.
Packed in boxes of 10 and 20 sachets.
Only some pack sizes may be commercially available.
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 most recent revision of this leaflet: March 2025
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/