FEBRECTAL LACTANTES 150 mg SUPPOSITORIES

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

Febrectal Infants belongs to the group of medications called analgesics and antipyretics.

This medication is indicated for infants for the treatment of symptoms of mild to moderate pain and fever. Especially in those children weighing over 10 kg, where oral administration is difficult: e.g., nausea, vomiting.

You should consult a doctor if it worsens or does not improve after 3 days.

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

Do not use Febrectal Infants

• 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 Infants.

Do not use more than the recommended doses in Section 3 "How to use Febrectal Infants". Check that you are not using other medications that contain paracetamol at the same time.

In patients with asthma who are sensitive to acetylsalicylic acid, consult your doctor before using this medication.

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

When you are being treated with medication for epilepsy, consult your doctor before using this medication, as when used at the same time, the efficacy of paracetamol is reduced and hepatotoxicity is increased, especially in high-dose paracetamol treatments.

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 throat pain), you should consult your doctor and reevaluate the clinical situation.

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

During treatment with Febrectal Infants, inform your doctor immediately if:

If you have severe illnesses, such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (an anomaly in 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 respiratory distress 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 of age or in prolonged treatments for more than 3 days.

Interference with Laboratory Tests

If you are going to have any laboratory tests (including blood tests, urine tests, skin tests that use 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 analytical determinations of uric acid and glucose.

Use of Febrectal Infants with Other Medications

Inform your doctor or pharmacist that you are using, have recently used, 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 convulsions: barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medications used to increase urine elimination (loop diuretics such as furosemide)
• Medications used to treat gout (probenecid and sulfinpyrazone)
• Medications used to treat high blood pressure and heart rhythm disorders (arrhythmias): propranolol
• Flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (called 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 analgesic of choice.

Use of Febrectal Infants with Food and Drinks

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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

In case of necessity, Febrectal can be used during pregnancy.

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

Driving and Using Machines

The influence of paracetamol on the ability to drive and use machines is nil or insignificant.

3. How to Use Febrectal Infants

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

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

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

For children under 2 years of age, the dose must be individualized by the doctor, according to age and weight.

The recommended doses are as follows:

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

• In children weighing over 20 kg (from approximately 5 years of age): 2 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 febrile symptoms. As these symptoms disappear, this medication should be discontinued.

Systematic use allows avoiding fluctuations in pain or fever.

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.

Method of Administration

Rectal route.

After removing the suppository from the package, insert it deeply into the rectum. If the suppository is too soft to use, cool it in the refrigerator for 30 minutes or put it under cold running water before removing the wrapper or, if necessary, afterwards, to avoid softening.

The entire suppository should be used. Do not fractionate the suppositories before administration.

Refrain from evacuating as much as possible so that the medication can take effect. If you notice resistance during administration, you should interrupt it, as it may be harmful, consult your doctor.

If You Use More Febrectal Infants Than You Should

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

By rectal route, overdose is not usually common, which occurs much more frequently by oral route.

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 you do not have symptoms, as very serious symptoms may appear several days after administration.

Treatment of intoxication includes hemodialysis and administration of acetylcysteine in adequate doses. Gastric lavage and oral administration of activated charcoal are also suitable when overdosing has occurred by oral route.

If You Forget to Use Febrectal Infants

Do not administer a double dose to the infant to make up for forgotten doses, simply administer the forgotten dose when you remember and the following doses with the indicated separation between administrations in each case.

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

4. Possible Side Effects

Like all medications, Febrectal Infants can cause side effects, although not everyone will experience them.

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

Side effects of unknown frequency (cannot be estimated from available data): A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe illness using paracetamol (see section 2).

Reporting Side Effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are 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 Febrectal Infants

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

No special storage conditions are required.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Febrectal Infants

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

The other components are anhydrous colloidal silica and semi-synthetic solid glycerides.

Appearance of the Product and Package Contents

Febrectal Infants 150 mg Suppositories are presented in the form of white, ovoid suppositories, in packages 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 Last Revision of this Package Leaflet: February 2025

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