Difenatil Infantil 100 mg/ml oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Difenatil Infantil 100 mg/ml oral solution

Paracetamol

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

Follow exactly the instructions for administration provided in this leaflet or those given 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 adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects 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 case of fever, or if pain in children persists beyond 3 days (2 days for sore throat).

Contents of the 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. How to store Difenatil Infantil
6. Contents of the pack and other information

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

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

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

You should consult a doctor if symptoms worsen or do not improve after 3 days in case of fever, or if pain persists for more than 3 days (2 days in the case of sore throat).

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 ingredients of this medicine (listed in section 6).
• If you have phenylketonuria (an inherited condition diagnosed at birth).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking this medicine.

• Do not exceed the recommended dose stated in section 3 “How to take Difenatil Infantil”. Check that you are not simultaneously using other medicines containing paracetamol.
• If you have kidney, heart, or lung disease, or if you have anemia (reduced hemoglobin levels in the blood, with or without a decrease in red blood cells), consult your doctor before taking this medicine.
• If you have liver (including Gilbert's syndrome) or kidney problems, or suffer from chronic malnutrition or dehydration, consult your doctor, as you may require a reduced dose of paracetamol.
• If you are an aspirin-sensitive asthmatic, consult your doctor before using this medicine.
• Drinking alcohol may increase the risk of liver damage caused by paracetamol.
• If pain persists for more than 3 days in children (2 days for sore throat) or fever lasts longer than 3 days, or if symptoms worsen or new symptoms appear, stop treatment and consult your doctor.

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

You have serious conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients under these conditions when paracetamol is used at regular doses for prolonged periods or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Children

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

Other medicines and Difenatil Infantil

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In particular, if you are taking medicines containing any of the following active substances, as it may be necessary to adjust the dose or discontinue treatment:

• Antibiotics (chloramphenicol, flucloxacillin). In the case of flucloxacillin, due to a serious risk of blood and fluid disorder (called metabolic acidosis) requiring urgent treatment (see section 2).
• Oral anticoagulants (acenocoumarol, warfarin).
• Oral contraceptives and estrogen treatments.
• Antiepileptic drugs (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Antituberculosis agents (isoniazid, rifampicin).
• Barbiturates (used as sleep inducers, sedatives, and anticonvulsants).
• Activated charcoal, used for diarrhea or treatment of gas.
• Colestyramine (used to lower blood cholesterol levels).
• Medicines used to treat gout (probenecid and sulfinpyrazone).
• Medicines used to relieve spasms or contractions of the stomach, intestine, and bladder (anticholinergics).
• Metoclopramide and domperidone (used to prevent nausea and vomiting).
• Propranolol, used to treat high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias).
• Zidovudine (used in the treatment of patients infected with the human immunodeficiency virus, HIV, which causes AIDS).

Interference with laboratory tests

If you are due to have any laboratory tests (including blood and urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter the results of these tests.

Taking Difenatil Infantil with food, drinks, and alcohol

This medicine can be diluted with water, milk, or fruit juice. Using paracetamol in patients who regularly consume alcohol (three or more alcoholic drinks per day) may cause liver damage.

Pregnancy, breastfeeding, and fertility

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

If necessary, this medicine may be used during pregnancy. Use the lowest possible dose that relieves pain or fever, and use it for the shortest possible time. Contact your doctor or midwife if pain or fever do not improve or if you need to take the medicine more frequently.

Paracetamol passes into breast milk, so breastfeeding women should consult their doctor before using this medicine.

Driving and using machines

No effects affecting the ability to drive or operate machinery have been reported.

Difenatil Infantil contains aspartame (E-951)

This medicine contains 6 mg of aspartame per millilitre.

Aspartame contains a source of phenylalanine, which may be harmful in individuals with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

Difenatil Infantil contains carmoisine (E-122)

It may cause allergic-type reactions.

Difenatil Infantil contains benzyl alcohol

This medicine contains 0.000016 mg of benzyl alcohol per millilitre 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 disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (metabolic acidosis).

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

Do not administer this medicine to your newborn (up to 4 weeks of age) unless specifically recommended by your doctor.

This medicine should not be used for longer than one week in children under 3 years of age unless directed by your doctor or pharmacist.

Difenatil Infantil contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per millilitre, which is essentially “sodium-free”.

3. How to take Difenatil Infantil

Follow exactly the dosing instructions for the medicine provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

This medicine is administered orally.

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

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

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

In children under 2–3 years of age, it is recommended to measure the oral solution using the oral syringe provided with the 30 ml pack.

In children aged 3 years or older, it is recommended to measure the oral solution using the oral syringe provided with the 60 ml and 90 ml packs.

The solution dose is measured in millilitres (ml) using the oral syringe included in the 30 ml, 60 ml, and 90 ml packs.

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

For direct calculation, the child's weight in kg may also be multiplied by 0.15; the result is the number of ml of paracetamol to be administered.

These doses may be repeated every 6 hours.

If the desired effects are not achieved within 3-4 hours after administration, the dosing interval may be reduced to every 4 hours, in which case 10 mg/kg should be administered.

Administration of the preparation is dependent on the presence of painful or febrile symptoms. As these symptoms subside, this medication should be discontinued.

Instructions for correct administration of the medicine

1. Open the bottle following the instructions indicated on the cap (on first opening, the seal will break).
2. Insert the oral syringe, pressing it into the pierced hole in the cap.
3. Invert the bottle and withdraw the required dose.
4. Administer directly or dilute with water, milk, or fruit juice.
5. The oral syringe should be washed with water after each use. 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 Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the medicine's packaging and leaflet to the healthcare professional.

If an overdose has been ingested, immediate medical attention is required, even if no symptoms are present, as symptoms often do not appear until after 3 days following the overdose, even in cases of severe poisoning. Symptoms of overdose may include dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

An overdose of paracetamol is considered to occur when a single dose exceeding 6 g is ingested in adults or more than 100 mg per kg of body weight in children. Treatment for overdose is most effective if initiated within 4 hours of ingestion of the medicine.

Patients undergoing treatment with barbiturates or suffering from chronic alcoholism may be more susceptible to paracetamol overdose.

In general, symptomatic treatment will be provided.

If you forget to take Difenatil Infantil

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

If you have forgotten a dose, take it as soon as possible and then continue with your regular dosing schedule. However, if the time for the next dose is approaching, skip the missed dose and take the next dose at the usual time.

If you stop treatment with Difenatil Infantil

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Adverse reactions to paracetamol are generally rare or very rare.

Rare (may affect up to 1 in 1,000 people): malaise, increased levels of hepatic transaminases, and hypotension.

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

Frequency not known (cannot be estimated from the available data): A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who are using paracetamol (see section 2).

Liver damage may very rarely occur at high doses or with prolonged treatment. Very rare cases of severe skin reactions have been reported.

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Difenatil Infantil

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

This medicine does not require any special storage conditions.

After opening the container, do not use the medicine after 12 months have passed.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Difenatil Infantil

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

Appearance of the product and contents of the pack

Red, transparent raspberry-scented oral solution. It is supplied in bottles containing 30 ml, 60 ml or 90 ml of oral solution.

Packs with 30 ml bottles:

Each pack contains one transparent plastic (PET) bottle with a plastic (LDPE) press-in adapter for inserting the oral dosing syringe, a child-resistant screw cap made of plastic (HDPE), and a 2 ml oral dosing syringe graduated in ml.

Packs with 60 ml and 90 ml bottles:

Each pack contains one transparent plastic (PET) bottle with a plastic (LDPE) press-in adapter for inserting the oral dosing syringe, a child-resistant screw cap made of plastic (HDPE), and a 5 ml oral dosing 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 most recent review of this leaflet: February 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).