Leaflet: information for the user

Antidol Infantil 100 mg/ml oral solution

paracetamol

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

• Follow exactly the administration instructions for the medicine contained in this leaflet or those 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 any 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 condition worsens or does not improve after 3 days, in the case of fever or if the pain persists in children for more than 3 days (2 days for sore throat).

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

2.What you need to knowbeforestarting totake Antidol Infantil

3.How to take Antidol Infantil

4.Possible side effects

5Storage of Antidol Infantil

6.Contents of the pack and additional information

Antidol Infantil belongs to a group of medications called analgesics and antipyretics.

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

Do not take Antidol Infantil

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

Warnings and precautions

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

• Do not exceed the recommended dose in section 3.
• In patients with liver, kidney, heart, or lung diseases and in patients with anemia (decrease in hemoglobin levels in the blood, due or not due to a decrease in red blood cells), consult your doctor before taking the medication.
• In children with chronic malnutrition, or dehydrated, as it may increase liver toxicity.
• The 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 sore throat), or worsens or other symptoms appear, discontinue treatment and consult your doctor. Avoid prolonged treatments.
• 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 suffer from malnutrition, chronic 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. Symptoms of metabolic acidosis may include: severe respiratory difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Children

You must consult your doctor before administering the medication to children under 2 years old.

Other medications and Antidol Infantil

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

• Antibiotics (chloramphenicol).
• Oral anticoagulants (acenocoumarol, warfarin).
• Oral contraceptives and hormone replacement therapy.
• 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.
• Colestiramine (used to reduce blood cholesterol levels).
• Medications used to treat gout (probencid and sulfinpyrazone).
• Medications used to relieve spasms or contractions of the stomach, intestines, and bladder (anticholinergics).
• Metoclopramide and domperidone (used to prevent nausea and vomiting).
• Propranolol used to treat high blood pressure (hypertension) and cardiac arrhythmias.
• Zidovudine (used to treat patients infected with the human immunodeficiency virus, causing AIDS).
• Flucloxacillin (antibiotic), due to a severe risk of blood and fluid imbalance (called metabolic acidosis with high anion gap) that must be treated urgently (see section 2).

Interference with analytical tests

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

Administration of Antidol Infantil with food, drinks, and alcohol

This medication may 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, lactation, and fertility

Consult your doctor or pharmacist before using any medication. In women, although there are no controlled studies, no teratogenic effects have been evidenced. However, as a general rule, it is not recommended to use this medication during the first trimester of pregnancy, in case of need, Antidol Infantil may 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. Paracetamol passes into breast milk, so women in the lactation period must consult their doctor before using this medication.

Driving and operating machines

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

Antidol Infantil contains propylene glycol (E-1520), azorubine (E-122), and sodium.

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

This medication may cause allergic reactions because it contains azorubine (E-122).

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

Follow exactly the medication administration instructions contained in this leaflet or those 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 0 to 10 years old).

Use in children

In children under 2 years, the dose must always be established by your doctor.

The paracetamol dose depends on the child's weight, the approximate age is for informational purposes only. The recommended daily dose of paracetamol is approximately 60 mg/kg/day, which is divided into 4 or 6 daily doses, that is15 mg/kg every 6 hours or 10 mg/kg every 4 hours.

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

For the administration of15 mg/kg every 6 hours, the schedule is as follows:

To make a direct calculation, the child's weight in kg can also be multiplied by 0.15; the result is the ml to administer 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.

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

Instructions for correct medication administration

1.- Open the bottle following the instructions indicated on the cap (in the first opening the seal will break).

2.- Insert the oral syringe, pressing on the cap's perforation.

3.- Invert the bottle and remove the necessary dose.

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

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

Close the bottle well after each administration.

If taking more Antidol Infantil than prescribed

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

If you have ingested an overdose, you must go to a medical center immediately, even if there are no 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 can be: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

An overdose of paracetamol 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. The treatment of an overdose is more effective if it is initiated within 4 hours of ingestion of the medication.

In cases where the patient is being treated with barbiturates or suffers from chronic alcoholism, they may be more susceptible to a paracetamol overdose.

Generally, symptomatic treatment will be performed.

If you forgot to take Antidol Infantil

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

If you interrupt the treatment with Antidol Infantil

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The adverse reactions of paracetamol are generally rare or very rare.

Rare (may affect up to 1 in 1,000 people): discomfort, elevated levels of liver transaminases, and decreased blood pressure.

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

Very rarely, it may damage the liver at high doses or prolonged treatment. Very rarely, severe skin reactions have been reported.

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

Reporting Adverse Effects

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

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthecontainerafter CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions. The shelf life once opened is 12 months.

Medicines should not be thrown down the drains or in the trash.Dispose of the containers and medicines you no longer need at the SIGREpoint of the pharmacy.In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need.By doing so, you will help protect the environment.

Composition of Antidol Infantil

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

Appearance of the product and content of the container

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

Containers containing a colorless plastic (PET) bottle of 30, 60 and 90 mlwith a safety screw cap, plus a 5 ml oral syringe, graduated in fractions of 0.1 ml.

Only some container sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) – Spain

Responsible manufacturers

Edefarm, S.L.

Enchilagar del Rullo Industrial Estate, 117,

Villamarchante, 46191 Valencia

Spain

or

Farmalider, S.A.

Aragoneses Street, 2

28108 Alcobendas – Madrid

Spain

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) – Spain

Last review date of thisleaflet:February 2025

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