DIFENATIL INFANTIL 100 mg/mL ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Difenatil Infantil 100 mg/ml Oral Solution

Paracetamol

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse.

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

• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 3 days, in case of fever, or if pain persists in children for more than 3 days (2 days for throat pain).

Contents of the Package Leaflet

1. What Difenatil Infantil is and what it is used for
2. What you need to know before taking Difenatil Infantil
3. How to take Difenatil Infantil
4. Possible side effects
5. Storage of Difenatil Infantil
6. Contents of the pack and further information

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

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

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

You should consult a doctor if your condition worsens or does not improve after 3 days, in case of fever, or if pain persists in children for more than 3 days (2 days for throat pain).

2. What you need to know before taking Difenatil Infantil

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 at the same time.
• In patients with kidney, heart, or lung disease, and in patients with anemia (decrease in hemoglobin levels in the blood, due to or not due 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 if you suffer from chronic malnutrition or dehydration, consult your doctor, as you may need a reduction in the paracetamol dose.
• If you are an asthmatic sensitive to acetylsalicylic acid, consult your doctor before using this medication.
• Consumption of alcoholic beverages can cause paracetamol to produce liver damage.
• If the pain persists for more than 3 days in children (2 days for throat pain) or the fever for more than 3 days, or worsens, or other symptoms appear, treatment should be discontinued and a doctor consulted.

During treatment with Difenatil Infantil, inform your doctor immediately if:

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 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 of discomfort (nausea) and vomiting.

Children

It is recommended to consult a doctor before administering it to children under 3 years of age.

Other medications and Difenatil Infantil

Inform your doctor or pharmacist if you are using or 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, it may be necessary to modify the dose or interrupt treatment of 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 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 decrease 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).

Interference with analytical tests

If you are going to have 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 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 habitually consume alcohol (three or more alcoholic beverages per day) can 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 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.

Difenatil Infantil contains aspartame (E-951)

This medication contains 6 mg of aspartame per milliliter.

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

Difenatil Infantil contains azorubine (E-122)

It can cause allergic reactions.

Difenatil Infantil contains benzyl alcohol

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

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

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

Benzyl alcohol has been associated with the risk of serious side effects, including respiratory problems ("gasping syndrome") in children.

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

This medication should not be used for more than one week in children under 3 years of age unless indicated by your doctor or pharmacist.

Difenatil Infantil contains sodium

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

3. How to take Difenatil 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.

Remember to take your medication.

This medication is administered orally.

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

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

The recommended daily dose of paracetamol is approximately 60 mg/kg/day, divided into 4 or 6 daily doses, that is, 15 mg/kg every 6 hours, or 10 mg/kg every 4 hours.

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

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

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

For the 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 of paracetamol to be administered.

These doses can be repeated every 6 hours.

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

Administration of the preparation is subject to the appearance of painful or febrile symptoms. As these symptoms disappear, this medication should be suspended.

Instructions for the correct administration of the medication

1. Open the bottle following the instructions indicated on the cap (when opening for the first time, the seal will break).
2. Insert the oral syringe into the hole in the 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 Difenatil Infantil than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to take the package 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, since 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/kg of weight in children. Treatment of the overdose is more effective if started within 4 hours of ingestion of the medication.

In general, symptomatic treatment will be performed.

If you forget to take Difenatil 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 stop taking Difenatil 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 gets them.

Paracetamol side effects are generally 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): serious skin reactions, liver disorders (such as jaundice), low blood sugar, blood disorders (thrombocytopenia, agranulocytosis, leukopenia, neutropenia, hemolytic anemia), cloudy urine, and kidney disorders.

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 disease using paracetamol (see section 2).

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

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 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. Storage of Difenatil Infantil

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

This medication does not require special storage conditions.

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

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

Medications should not be thrown away in drains or trash. Deposit the packages and medications you no longer need in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you will help protect the environment.

6. Contents of the package and further information

Composition of Difenatil Infantil

• The active ingredient 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 package contents

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

Packages with 30 ml bottles:

Each package contains a transparent plastic (PET) bottle with a pressure adapter for inserting the dosing syringe and a child-resistant screw cap (HDPE), plus a 2 ml oral syringe graduated in ml.

Packages with 60 ml and 90 ml bottles:

Each package contains a transparent plastic (PET) bottle with a pressure adapter for inserting the dosing syringe and a child-resistant screw cap (HDPE), plus a 5 ml oral syringe graduated in ml.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 - 28760 Tres Cantos - Madrid (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) (http://www.aemps.gob.es/).