Febrectal Niños 300 mg suppositories

Patient Information Leaflet

Introduction

Patient Information Leaflet

Febrectal Children 300 mg Suppositories

Paracetamol

Read the entire leaflet carefully before starting to use this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.
• You should consult a doctor and stop treatment if pain persists for more than 3 days (2 days for sore throat), fever lasts more than 3 days, or if pain or fever worsen or new symptoms occur.

Leaflet contents:

1. What Febrectal niños is and what it is used for
2. What you need to know before using Febrectal niños
3. How to use Febrectal niños
4. Possible side effects
5. Storage of Febrectal niños
6. Package contents and additional information

1. What Febrectal children is and what it is used for

Febrectal children belongs to a group of medicines called analgesics and antipyretics.

This medicine is indicated in children for the treatment of symptoms of mild to moderate pain and fever. Especially in children weighing 20 kg or more in whom oral administration is difficult: for example, nausea, vomiting.

You should consult a doctor if symptoms worsen or do not improve after 3 days.

2. What you need to know before using Febrectal niños

Do not use Febrectal niños

• if you are allergic to paracetamol or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Febrectal niños.

Do not use more than the recommended doses stated in Section 3 “How to use Febrectal niños”. To avoid overdose, check that you are not simultaneously using other medications containing paracetamol.

In asthmatic patients who are sensitive to acetylsalicylic acid, consult your doctor before taking this medicine.

If you suffer from liver, kidney, heart, or lung disease, if you have anemia (reduced hemoglobin levels in the blood, with or without a reduction in red blood cells), or if you suffer from chronic malnutrition or dehydration, consult your doctor before taking this medicine.

If you are undergoing treatment with medications for epilepsy, consult your doctor before taking this medicine, as concomitant use may reduce efficacy and increase the hepatotoxicity of paracetamol, especially when high doses of paracetamol are used.

If symptoms worsen or if fever persists for more than 3 days, or pain for more than 3 days in children or 5 days in adults (2 days for sore throat), consult your doctor and reassess your clinical condition.

In case of diarrhea, the use of suppositories is not recommended.

During treatment with Febrectal niños, 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 known as metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients under these conditions when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

Use in children

Consult your doctor before using this medicine in children under 3 years of age or for prolonged treatments exceeding 3 days.

Interference with diagnostic tests

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

Paracetamol may alter the analytical values of uric acid and glucose.

Use of Febrectal niños with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

Paracetamol may interact with the following medicines:

• Medications to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin)
• Medications for epilepsy: antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medications for tuberculosis: (isoniazid, rifampicin)
• Medications for depression and seizures: barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medications used to increase urine elimination (loop diuretics such as furosemide)
• Medications used in the treatment of gout: (probenecid and sulfinpyrazone)
• Medications used for high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias): propranolol
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (known as metabolic acidosis with high anion gap) that requires urgent treatment (see section 2).

Do not use with other analgesics (pain-relieving medicines) without consulting your doctor.

Occasional use as an analgesic of choice may be acceptable during treatment with oral anticoagulants.

Taking Febrectal with food and drinks

The use of this medicine with food does not affect its efficacy.

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 medicine.

If necessary, Febrectal may be used during pregnancy.

Paracetamol passes into breast milk; therefore, women who are breastfeeding should consult their doctor before using this medicine.

Driving and using machines

The influence of paracetamol on the ability to drive and operate machinery is none or negligible.

3. How to use Febrectal niños

Follow exactly the instructions for administering this medicine as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The dose of paracetamol will be calculated according to the child's body weight. The age/weight correlation is approximate and provided for informational purposes only.

The recommended daily dose of paracetamol is approximately 60 mg/kg/day. In general, 15 mg of paracetamol per kg of body weight should be administered every 6 hours, or 10 mg/kg every 4 hours.

For children under two years of age, the dose must be individually determined by the doctor based on age and weight.

The recommended doses are as follows:

• Children weighing over 20 kg (approximately from 5–6 years of age): One suppository (300 mg paracetamol) may be administered every 6–4 hours while symptoms persist, up to a maximum of 4 suppositories in 24 hours in children weighing less than 25 kg. The interval between administrations depends on the patient's weight.

• Children weighing over 30 kg (approximately from 8–10 years of age): One suppository (300 mg paracetamol) may be administered every 4–6 hours while symptoms persist.

• Children and adolescents weighing over 40 kg (approximately from 11–12 years of age): One suppository (300 mg paracetamol) or two suppositories (600 mg paracetamol) may be administered every 6–4 hours depending on weight, while symptoms persist.

It is recommended not to administer more than 5 doses in 24 hours to children under 12 years of age, unless otherwise directed by a physician.

Patients with liver or kidney disease: must consult their doctor.

Administration of the medicine should only occur when pain or fever symptoms appear. As symptoms subside, treatment should be discontinued.

Regular administration helps prevent fluctuations in pain or fever.

In children, doses should be regularly spaced, including during the night, preferably every 6 hours, maintaining a minimum interval of 4 hours between doses.

Method of administration

Rectal use.

After removing the suppository from its packaging, insert it deeply into the rectum. If the suppository is too soft for use, cool it in the refrigerator for 30 minutes or hold it under a stream of cold water before removing the wrapper, or if necessary afterward, to prevent softening.

The entire suppository must be used. Do not divide the suppositories before administration.

Delay bowel evacuation as long as possible to allow the medicine to take effect. If resistance is felt during administration, discontinue the procedure, as it may be harmful, and consult your doctor.

If you use more Febrectal niños than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 915 620 420 (indicating the medicine and amount administered).

Rectal overdose is uncommon and occurs much more frequently with oral administration.

Symptoms of overdose include dizziness, vomiting, loss of appetite, and abdominal pain. If an overdose has been administered (more than 6 g in a single dose), you must go to the hospital even if no symptoms are present, as serious symptoms may appear several days after administration.

Treatment of poisoning includes hemodialysis and administration of acetylcysteine at appropriate doses. Gastric lavage and oral administration of activated charcoal are also appropriate when overdose occurs via the oral route.

If you forget to use Febrectal niños

Do not administer a double dose to make up for missed doses. Instead, administer the missed dose as soon as you remember, and continue with the next doses at the recommended intervals, which must be at least 4 or 6 hours apart.

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

4. Possible adverse effects

Like all medicines, Febrectal Niños may produce adverse effects, although not everybody experiences them.

Rare adverse effects (may affect up to 1 in 1,000 people) are: malaise, drop in blood pressure (hypotension), and increased levels of transaminases in blood.

Very rare adverse effects (may affect up to 1 in 10,000 people) are: kidney disorders, cloudy urine, serious skin reactions, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, haemolytic anaemia), and hypoglycaemia (low blood sugar).

Paracetamol may damage the liver when taken at high doses or during prolonged treatment.

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Febrectal Niños

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

No special storage conditions are required.

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. If you have any doubts, ask your pharmacist how to properly dispose of medicines and their packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Febrectal niños

The active substance is paracetamol. Each suppository contains 300 mg of paracetamol.

The other components are anhydrous colloidal silica and solid semisynthetic glycerides.

Appearance of the product and contents of the pack

Febrectal niños 300 mg Suppositories are presented as white, waxy, ovoid suppositories in packs containing 6 suppositories.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Almirall, S.L.

General Mitre, 151

08022 - Barcelona (Spain)

Manufacturer

KERN PHARMA, S.L.

Polígono Ind. Colón II Venus, 72

08228 Terrassa (Barcelona)

Spain

Almirall Healthcare S.A. (Industrias Farmacéuticas Almirall, S.A.)

Ctra. de Martorell, 41-61

08740 Sant Andreu de la Barca - Barcelona (Spain)

Date of the most recent review of this package leaflet: February 2025

Detailed and up-to-date 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/