Febrectal Lactantes 150 mg suppositories

Patient Information Leaflet

Introduction

Patient Information Leaflet

Febrectal Infant 150 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 more 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 must 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 appear.

Leaflet contents:

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

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

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

This medicine is indicated for infants, for the treatment of symptoms of mild to moderate pain and fever. Particularly in children weighing at least 10 kg in whom oral administration is difficult: for example, due to nausea or 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 infant suppositories

Do not use Febrectal infant suppositories

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

Warnings and precautions

Talk to your doctor or pharmacist before using Febrectal infant suppositories.

Do not use more than the recommended dose indicated in section 3 “How to use Febrectal infant suppositories”. To ensure this, check that you are not simultaneously using other medicines containing paracetamol.

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

If you have liver, kidney, heart or lung disease, anaemia (reduced haemoglobin levels in the blood, with or without a reduction in red blood cells), chronic malnutrition or dehydration, consult your doctor before using this medicine.

If you are being treated with medicines for epilepsy, consult your doctor before using this medicine, as concomitant use may reduce efficacy and increase the hepatotoxic potential of paracetamol, especially with high-dose paracetamol regimens.

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 re-evaluate the clinical condition.

In cases of diarrhoea, the use of suppositories is not recommended.

During treatment with Febrectal infant suppositories, 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 have 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 circumstances 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, feeling unwell (nausea), and vomiting.

Use in infants

Due to the dosage, this medicine is not suitable for infants and children weighing less than 10 kg.

Consult your doctor before using this medicine in children under 3 years of age or for prolonged treatment lasting more than 3 days.

Interference with diagnostic tests

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

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

Using Febrectal infant suppositories with other medicines

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

Paracetamol may interact with the following medicines:

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

Do not use with other analgesics (medicines that relieve pain) without consulting your doctor.

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

Use of Febrectal infant suppositories with food and drink

Taking 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Febrectal may be used during pregnancy if necessary.

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

Driving and using machines

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

3. How to use Febrectal infant suppositories

Follow exactly the instructions for use of the medicine contained in this leaflet or as indicated 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 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 physician, based on age and weight.

The recommended doses are as follows:

• Infants and children weighing more than 10 kg (from approximately 1 year of age): 1 suppository (150 mg paracetamol) every 6 hours, and depending on the child's weight, up to a maximum of 4 or 5 suppositories in 24 hours.

• Infants and children weighing more than 15 kg (from approximately 3 years of age): 1 suppository (150 mg paracetamol) every 4 hours, up to a maximum of 6 suppositories in 24 hours.

• Children weighing >20 kg (from approximately 5 years of age): two suppositories may be administered at a time; however, dosage forms with more appropriate strengths are available—consult your doctor or pharmacist.

Administration of the medicine should be based on the onset of pain or fever symptoms. As these 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 cold running water before removing the wrapper, or if necessary afterward, to prevent softening.

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

Delay bowel evacuation as long as possible to allow the medicine to take effect. If you feel resistance during insertion, stop the procedure, as it could be harmful; consult your doctor.

If you use more Febrectal infant than you should

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or the Toxicology Information Service immediately 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 there are no symptoms, as severe symptoms may appear several days later.

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 has occurred via the oral route.

If you forget to use Febrectal infant

Do not administer a double dose to make up for missed doses. Simply administer the missed dose as soon as you remember, and continue with the next doses at the recommended intervals.

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 infant drops may cause adverse effects, although not everyone experiences them.

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

Very rare adverse effects (may affect up to 1 in 10,000 people) are: kidney disorders, cloudy urine, severe skin reactions, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, haemolytic anaemia), and hypoglycaemia (low blood sugar). Paracetamol can cause liver damage when taken at high doses or during prolonged treatment.

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

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 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 infant drops

Keep this medicine out of 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 is the last day of the month indicated.

Medicines must not be disposed of via wastewater or in household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Febrectal infants

The active substance is paracetamol. Each suppository contains 150 mg of paracetamol.

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

Appearance of the product and contents of the pack

Febrectal infants 150 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

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 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/