Leaflet: information for the user

Difenatil Infantil 100 mg/ml oral solution

Paracetamol

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

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

• Keep this leaflet, as you may need to read it again.

• For advice on any side effects, consult your pharmacist.
• For advice on 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).

Paracetamol, the active ingredient of Difenatil Infantil, belongs to a group of medicines called analgesics and antipyretics.

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

Consult a doctor if it worsens or does not improve after 3 days, in case of fever or if the pain persists in children for more than 3 days (2 days for sore throat).

Do not take Difenatil Infantil

• If you are allergic to paracetamol or any of the other components of this medication (listed in section 6).
• If you have phenylketonuria (a hereditary disease diagnosed at birth).

Warnings and precautions

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

• Do not exceed the recommended dose in section 3 “How to take Difenatil Infantil”. Check that you are not using other medications that contain paracetamol simultaneously.
• In patients with kidney, heart, or lung diseases and in patients with anemia (decrease in hemoglobin levels in the blood, due or not to a decrease in red blood cells), consult your doctor before taking the medication.
• If you have liver problems (including Gilbert's syndrome) or kidney problems or suffer from chronic malnutrition or dehydration, consult your doctor as you may require a reduction in the paracetamol dose.
• If you are an asthmatic sensitive to acetylsalicylic acid, consult your doctor before using this medication.
• Consuming alcoholic beverages may cause paracetamol to damage the liver.
• If the pain persists for more than 3 days in children (2 days for sore throat) or fever for more than 3 days, or worsens or other symptoms appear, treatment should be interrupted and the doctor consulted.

Inform your doctor immediately during treatment with Difenatil Infantil 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 distress with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Children

It is recommended to consult your doctor before administering it to children under 3 years old.

Other medications and Difenatil Infantil

Inform your doctor or pharmacist if you are using or 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 ingredients, as you may need to modify the dose or interrupt treatment for any of them:

• Antibiotics (chloramphenicol, flucloxacillin). In the case of flucloxacillin, due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).Oral anticoagulants (acenocoumarol, warfarin).
• Oral contraceptives and hormone 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.
• 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).

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.

Taking Difenatil Infantil with food, drinks, and alcohol

This medication can be 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, breastfeeding, and fertility

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

In case of need, this medication 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 or midwife if pain or fever do not decrease or if you need to take the medication more frequently.

Paracetamol passes into breast milk, so women breastfeeding should 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.

Difenatil Infantil contains aspartame (E-951)

This medication contains 6 mg of aspartame per milliliter.

Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it correctly.

Difenatil Infantil contains azorubine (E-122)

It may cause allergic reactions.

Difenatil Infantil contains benzyl alcohol

This medication contains 0.000016 mg of benzyl alcohol per milliliter of solution. Benzyl alcohol may cause allergic reactions.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney problems. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Benzyl alcohol has been linked to the risk of severe adverse effects that include respiratory problems ("breathing syndrome") in children.

Do not administer this medication to your newborn (up to 4 weeks old) unless your doctor has recommended it.

This medication should not be used for more than a week in children under 3 years old unless your doctor or pharmacist has advised it.

Difenatil Infantil contains sodium

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

Follow exactly the administration instructions of the medication contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication.

This medication is administered orally.

It is intended for use in children between 3 and 32 kg (approximately 0 to 10 years old).

The dose of Difenatil Infantil depends on the child's weight. The approximate age is given 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.

Inchildren under 2-3 years, it is recommended to dose the oral solution with the oral syringe included in the 30 ml containers.

Inchildren 3 years or older, it is recommended to dose the oral solution with the oral syringe included in the 60 ml and 90 ml containers.

The dosing of the solution is done in milliliters (ml) using the oral syringe included in the 30 ml, 60 ml, and 90 ml containers.

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 of paracetamol to be administered.

These doses can be repeated every 6 hours.

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

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

Instructions for the correct administration of the medication

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 hole in the perforated cap.
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 tightly after each administration.

If you take more Difenatil Infantil than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the container and the medication leaflet to the healthcare professional.

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

A paracetamol overdose is considered to be the ingestion of a single dose of more than 6 g in adults and more than 100 mg/kg of body weight in children. The treatment of overdose is more effective if initiated within 4 hours of medication ingestion.

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 forget to take Difenatil 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 treatment with Difenatil 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.

Paracetamol adverse reactions are generally rare or very rare.

Rare (may affect up to 1 in 1,000 people): discomfort, elevated 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.

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).

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

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 not listed 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.

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

This medication does not require special storage conditions.

Once the container is opened, it should not be used after 12 months.

Do not use this medication after the expiration date shown on the container after CAD. The expiration date is the last day of the month indicated.

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

Composition of Difenatil Infantil

• The active principle is paracetamol. Each milliliter of solution contains 100 mg of paracetamol.
• The other components (excipients) are macrogol, glycerol, sodium saccharin, aspartame (E-951), raspberry flavor (contains benzyl alcohol), azorubine (E-122) and purified water.

Appearance of the product and contents of the packaging

Red and transparent oral solution with raspberry odor. It is presented in bottles containing 30 ml, 60 ml or 90 ml of oral solution.

Bottles with 30 ml:

Each package contains a transparent plastic (PET) bottle with a pressure adapter of plastic (LDPE) to insert the dosing syringe and a safety cap with a plastic (HDPE) thread, child-resistant, plus a 2 ml oral dosing syringe graduated in ml.

Bottles with 60 ml and 90 ml:

Each package contains a transparent plastic (PET) bottle with a pressure adapter of plastic (LDPE) to insert the dosing syringe and a safety cap with a plastic (HDPE) thread, child-resistant, plus a 5 ml oral dosing syringe graduated in ml.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6 - 28760 Tres Cantos - Madrid (SPAIN)

Date of the last review of this leaflet:February 2025

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