ANTIDOL INFANTIL 100 mg/mL ORAL SOLUTION

2. What you need to know before taking Antidol Infantil

Do not take Antidol Infantil

• If you are allergic (hypersensitive) to paracetamol or 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 disease, and in patients with anemia (reduced hemoglobin levels in the blood, due to or not due to a reduction in red blood cells), consult your doctor before taking the medication.
• In children with chronic malnutrition or dehydration, as it may increase liver toxicity.
• 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 throat pain), or worsens, or other symptoms appear, treatment should be discontinued and a doctor consulted. Avoid prolonged treatments.
• If you have severe illnesses, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (an anomaly in the 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. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Children

Your doctor must be consulted before administering the medication to children under 2 years of age.

Other Medications and Antidol Infantil

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

• Antibiotics (chloramphenicol).
• Oral anticoagulants (acenocoumarol, warfarin).
• Oral contraceptives and estrogen treatments.
• 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.
• Colestyramine (used to lower blood cholesterol levels).
• Medications used to treat gout (probenecid and sulfinpyrazone).
• Medications used to relieve stomach, intestine, and bladder spasms or contractions (anticholinergics).
• Metoclopramide and domperidone (used to prevent nausea and vomiting).
• Propranolol used in the treatment of high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias).
• Zidovudine (used in the treatment of patients infected with the human immunodeficiency virus, the cause of AIDS).
• Flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (called metabolic acidosis with high anion imbalance) that must be treated urgently (see section 2).

Interference with Analytical Tests

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

Taking Antidol Infantil with Food, Drinks, and Alcohol

This medication can be administered diluted with water, milk, or fruit juice. The use of paracetamol in patients who habitually consume alcohol (three or more alcoholic beverages per day) may damage the liver.

Pregnancy, Breastfeeding, and Fertility

Consult your doctor or pharmacist before using any medication. In women, although there are no controlled studies, no teratogenic effects have been found. However, as a general rule, its use is not recommended during the first trimester of pregnancy. If necessary, Antidol Infantil 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 medication more frequently. Paracetamol passes into breast milk, so breastfeeding women should consult their doctor before using this medication.

Driving and Using Machines

No effects have been described that modify the ability to drive and use 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 less than 4 weeks old, consult your doctor or pharmacist, especially if the baby has been given other medications that contain 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".

3. How to Take Antidol Infantil

Follow the administration instructions for the medication contained in this package leaflet or as 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).

Use in Children

In children under 2 years of age, the dose must always be established by a doctor.

The dose of paracetamol 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, divided into 4 or 6 daily doses, i.e., 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.

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

For administration of 15 mg/kg every 6 hours, the schedule is as follows:

For a direct calculation, you can also multiply the child's weight in kg by 0.15; the result is the ml to be administered of the medication.

These doses can be repeated every 6 hours.

If the desired effects are not achieved 3-4 hours after administration, the dose can be advanced every 4 hours, in which case 10 mg/kg will be administered.

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

Instructions for the Correct Administration of the Medication

1. Open the bottle by following the instructions on the cap (on the first opening, the seal will break).

2. Insert the oral syringe, pressing on the hole in the perforated cap.

3. Invert the bottle and withdraw the necessary dose.

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

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

Close the bottle well after each administration.

If You Take More Antidol Infantil Than You Should

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

If you have ingested an overdose, you should go quickly to a medical center, 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 overdose may be: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

Paracetamol overdose 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 body weight in children. Treatment of the overdose is more effective if started within 4 hours of ingestion of the medication.

In the event that 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 Forget to Take Antidol Infantil

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

If You Interrupt Treatment with Antidol Infantil

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Paracetamol's adverse reactions are, in general, rare or very rare.

Rare (may affect up to 1 in 1,000 people): discomfort, increased liver transaminase levels, and low blood pressure.

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

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

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 illness who use paracetamol (see section 2).

Reporting of Side Effects

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

5. Conservation of Antidol Infantil

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the bottle after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions. The validity period after opening is 12 months.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the Packaging and Additional Information

Composition of Antidol Infantil

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

Appearance of the Product and Contents of the Packaging

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

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

Only some packaging sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturers

Edefarm, S.L.

Polígono Industrial Enchilagar del Rullo, 117,

Villamarchante, 46191 Valencia

Spain

or

Farmalider, S.A.

C/ Aragoneses, 2

28108 Alcobendas – Madrid

Spain

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Date of the Last Revision of this Package Leaflet:February 2025

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.es/