Leaflet: information for the user

Febrectal infants 150 mg Suppositories

Paracetamol

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

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

2.What you need to know before starting to use Febrectal infants

3.How to use Febrectal infants

4.Possible side effects

1. Storage of Febrectal infants
2. Contents of the package and additional information

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

This medication is indicated for infants, for the treatment of mild to moderate pain symptoms and fever.Especially in children weighing at least 10 kg in whom oral administration is difficult: for example, nausea, vomiting.

Consult a doctor if symptoms worsen or do not improve after 3 days.

No use Febrectal lactantes

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

Warnings and Precautions

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

Do not use more than the recommended doses in the section 3 “How to use Febrectal lactantes”. Check that you are not using other medications that contain paracetamol at the same time.

If you have asthma and are sensitive to acetylsalicylic acid, consult your doctor before using this medication.

If you have liver, kidney, heart, or lung disease, anemia (decreased hemoglobin levels in the blood, due or not to a decrease in red blood cells), or chronic malnutrition or dehydration, consult your doctor before using this medication.

If you are being treated with medication for epilepsy, consult your doctor before using this medication, as when used together, the efficacy is decreased and the hepatotoxicity of paracetamol is increased, especially with high doses of paracetamol.

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 reevaluate the clinical situation.

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

During treatment with Febrectal lactantes, immediately inform your doctor 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 have 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 difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Use in Infants

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

Consult your doctor before using this medication in children under 3 years or in prolonged treatments for more than 3 days.

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.

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

Use of Febrectal lactantes with Other Medications

Inform your doctor or pharmacist that you are using, have used recently, or may need to use any other medication.

Paracetamol may interact with the following medications:

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

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

In case of treatment with oral anticoagulants, it can be administered occasionally as the preferred analgesic.

Use of Febrectal lactantes with Food and Beverages

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

Pregnancy, Breastfeeding, and Fertility

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

In case necessary, Febrectal can be used during pregnancy.

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

Driving and Operating Machines

The influence of paracetamol on the ability to drive and operate machines is negligible or insignificant.

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

The paracetamol dose will be calculated based on the child's weight.The age/weight correspondence is approximate and provided for informational purposes only.

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

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

The recommended doses are as follows:

• Infants and children with a weight of more than 10 kg (from approximately 1 year of age): 1 suppository (150 mg of 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 with a weight of more than 15 kg (from approximately 3 years of age): One suppository (150 mg of paracetamol) every 4 hours and up to 6 suppositories in 24 hours.

• For children with a weight of >20 kg (from approximately 5 years of age):Two suppositories can be administered at a time, however, there are presentations with more suitable doses, consult your doctor or pharmacist.

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

Systematic use allows for the avoidance of pain or fever oscillations.

In children, they should be spaced out regularly, including at night, preferably every 6 hours and maintaining a minimum interval of 4 hours between them.

Administration Form

Rectal.

After removing the suppository from the packaging, insert it deeply into the rectum. If the suppository is too soft to use, chill it in the refrigerator for 30 minutes or place it under cold running water before removing the packaging or, if necessary afterwards, to prevent softening.

The suppository should be used in its entirety. Do not break the suppositories before administration.

Try to hold back as much as possible to allow the medication to take effect. If you experience resistance at the time of administration, you should interrupt it, as it may be harmful, consult your doctor.

If you usemoreFebrectal Lactantesthan you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 915 620 420 (indicating the medication and the amount administered).

Rectal administration is not usually a cause of overdose, which occurs much more frequently by oral administration.

The symptoms of overdose include dizziness, vomiting, loss of appetite, and abdominal pain. If you have administered an overdose (more than 6 g in a single dose), you should go to the hospital even if there are no symptoms, as these, very serious, may appear several days after administration.

The treatment of intoxication includes hemodialysis and administration of acetaminophen at suitable doses. Gastric lavage and oral administration of activated charcoal are also suitable when the overdose has occurred by oral administration.

If you forgot to useFebrectal Lactantes

Do not administer a double dose to the infant to compensate for the missed doses, simply administer the missed dose when you remember and the subsequent doses with the indicated interval between administrations.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, Febrectal lactantes may produce adverse effects, although not everyone will experience them.

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

Very rare adverse effects (may affect up to 1 in 10,000 people) are: kidney diseases, cloudy urine, severe skin reactions, allergic dermatitis (skin rash), jaundice (yellow discoloration of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia) and hypoglycemia (low blood sugar). Paracetamol can damage the liver when taken in high doses or prolonged treatments.

Adverse effects of unknown frequency (cannot be estimated from available data): A serious disease that can make the blood more acidic (designated as metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse even if it is possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of sightand out of reachof children.

No special storage conditions are required.

Do not use this medicationafter the expiration datethat appearson the packagingafter 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 packaging and unused medications at the SIGRE collection pointatthe pharmacy.If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Febrectal for infants

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

The other components areanhydrous colloidal silica and semisynthetic solid glycerides.

Appearance of the product and content of the packaging

Febrectal for infants 150 mg Suppositories are presented in the form of white creamy-colored, oval-shaped suppositories, in packaging containing 6 suppositories.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Almirall, S.L.

General Mitre, 151

08022‑Barcelona (Spain)

Responsible for manufacturing

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)

Last review date of this leaflet: February 2025

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