Label: information for the user

Antidol NIÑOS 325 mg granulated

Paracetamol

Read this label carefully before taking this medicine, as it contains important information for you.

Follow exactly the administration instructions contained in this label or those given by your doctor or pharmacist.

• Keep this label, as you may need to refer to 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 label. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 3 days with fever or 5 days with pain.

Paracetamol is effective in reducing pain and fever.

This medication is usedin children between 25 and 43 kg (8 to 11 years)for the symptomatic treatment of occasional mild or moderate pains, such as headaches, dental pain, muscle pains (cramps) and fever.

Do not takeAntidol NIÑOS

• 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 the section 3. How to take Antidol NIÑOS. 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 that contain paracetamol, for example, medications for the flu and cold, as high doses may cause liver damage. Do not use more than one medication that contains paracetamol without consulting your doctor.
• Consult your doctor or pharmacist before starting to take this medication.
• If you suffer from kidney, liver, heart, or lung diseases, or patients with anemia (decrease in hemoglobin levels in the blood, due or not 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, the efficacy is reduced and the hepatotoxicity of paracetamol is increased, especially in treatments with high doses of paracetamol.
• If you are an asthmatic sensitive to acetylsalicylic acid.
• Chronic alcoholics should be careful not to take more than2 gin 24 hours of paracetamol.
• If you have severe diseases, such as severe renal insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have chronic malnutrition, 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 with a weight of less than 25 kg (approximately under 8 years old) as it does not allow for dosing of doses less than 1 tablet per dose (325 mg).

Other medications and Antidol NIÑOS

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 that contain in their composition some of the following active principles, as it may be necessary to reducethe dose of some of them or the interruption of 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 (hypertension) and heart rhythm alterations (arrhythmias)
• Ion exchange resins (colestiramine)

Inform your doctor or pharmacist if you are taking:

• Flucloxacillin (antibiotic), due to a severe risk of blood and fluid imbalance (denominated metabolic acidosis with high anionic imbalance) that must be treated urgently (see section 2).

Interference with analytical tests:

If you are to undergo any analytical test (including blood, urine, etc) inform your doctor that you are taking this medication, as it may alter the result of said tests. Paracetamol may alter the values of uric acid and glucose determinations.

Use of Antidol NIÑOS 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.

The taking of this medication with food does not affect the efficacy of the same.

Pregnancy and lactation

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

Paracetamol is excreted with 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.

Antidol NIÑOS contains aspartame (E-951), sodium, and saccharose

• This medication contains 15.35 mg of aspartame (E-951) in each sachet. Aspartame contains a source of phenylalanine that may be harmful in the case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates due to the body's inability to eliminate it correctly.
• This medication contains 73.6 mg of sodium (main component of table salt/cooking salt). This is equivalent to 3.68% of the maximum daily sodium intake recommended for an adult.

• This medication contains saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

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

You should always take the smallest effective dose to relieve symptoms.

The use of this medication is subject to the appearance of pain or fever. As these symptoms disappear, treatment should be discontinued.

You should avoid taking high daily doses of paracetamol for prolonged periods of time, as this increases the risk of adverse effects such as liver damage.

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

For sore throat, you should not take the medication for more than 2 consecutive days without consulting a doctor.

Use in children

Children between 25 and 43 kg (approximately 8 to 11 years old): 1 tablet of 325 mg every 4-6 hours as needed.According to weight, children with a weight below 33 kg should not exceed 5 tablets in 24 hours, and those with a weight above 33 kg up to 6 tablets in 24 hours.

The recommended daily dose of paracetamol in children is 60 mg/kg/day, which is divided into 4 or 6 doses per day, i.e. 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.

You must respect the defined dosages based on the child's weight, and therefore, choose the appropriate dosage. The approximate age based on weight is given for information purposes 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 your doctor prescribes this medication, you should wait at least 8 hours between doses.

This medication is administered orally.

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

You can take it with or without food.

If you take more Antidol NIÑOS 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 do not have 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 Antidol NIÑOS

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

Like all medications, this medicationmay have adverse effects, although not all people may 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 1,000 people):kidney disorders; cloudy urine

Dermatological 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):Severe skin reactions have been rarely reported.

Hepatobiliary Disorders

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

Haematological and Lymphatic System Disorders

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

Metabolic and Nutritional Disorders

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

Unknown frequency (cannot be estimated from available data):a serious condition that can make the blood more acidic (designated as metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

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

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).

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.

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

Composition of Antidol NIÑOS

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 aroma, amorphous silica, glycerol (E-422) diestearate type 1, sodium croscarmellose, sodium carboxymethylcellulose (type A) (from potato), ethylcellulose, hydroxypropyl methylcellulose, and polyethylene glycol 400.

Appearance of the product and content of the packaging

White granulated product with a lemon scent, packaged in single-dose sachets.

Packed in boxes of 10 and 20 sachets.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization

Cinfa Laboratories, S.A.

Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) – Spain

Responsible for manufacturing

Farmalider, S.A.

Aragoneses, 2

28108 Alcobendas, Madrid

Spain

or

Edefarm, S.L

Enchilagar del Rullo Industrial Estate, 117

46191, Villamarchante, Valencia

Spain

Last review date of this leaflet: March 2025

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