Leaflet: information for the user

Febrectal children 300 mg Suppositories

Paracetamol

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

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

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

3.How to use Febrectal children

4.Possible side effects

1. Storage of Febrectal children
2. Contents of the pack and additional information

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

This medicine is indicated, in children, for the treatment of mild to moderate pain and fever symptoms.Especially in children weighing20 kgor more, 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 niños

• 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 niños.

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

If you have asthma that is sensitive to acetylsalicylic acid, consult your doctor before taking 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 taking this medication.

If you are being treated with medication for epilepsy, consult your doctor before taking 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 niños, 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 respiratory difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Use in Children

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 that use allergens, etc…), inform your doctor that you are using 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 niños 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 alteration of blood and fluids (called metabolic acidosis with high anionic imbalance) that must be treated urgently (see section 2).

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

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

Administration of Febrectal 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.

Febrectal can be used during pregnancy if necessary.

Paracetamol passes into breast milk, so women breastfeeding 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.

Followexactly the administration instructions of the medication contained in this leaflet or those indicated byyour doctoror 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 kg 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:

• Children with a weight of more than20 kg(approximately from 5-6 years of age):A suppository (300 mg of paracetamol) can be administered every 6-4 hours,while symptoms persistandamaximum of up to 4 suppositories in24 hours inchildren with a weight of less than25 kg.The time interval between each administration will depend on the patient's weight.

• Children with a weight of more than30 kg(approximately from 8-10 years of age):A supositorio (300 mg of paracetamol) can be administered every 4-6hours,while symptoms persist.

• Children and adolescents with a weight of more than40 kg(approximately from 11-12 years of age): A suppository(300 mg of paracetamol)or two(600 mg of paracetamol) can be administered every 6-4 hours according to weight, while symptoms persist.

It is recommended not to administer more than 5 doses per 24 hours to children under 12 years, unless otherwise indicated by a doctor.

Patients with liver or kidney disease: consult your doctor.

The administration of themedication is subject to the appearance of painful or febrile 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 hoursand maintaining a minimum interval of 4 hours between them.

Administration form

Rectal route.

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

Try to hold back the urge as much as possible so that the medication can 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 childrenthan you should

Incase of overdose or accidental ingestionconsult your doctor or pharmacist immediately or call the Toxicological Information Service, phone:915 620 420(indicating the medication and the amountadministered).

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

The symptoms of overdose includedizziness, vomiting,loss of appetiteand abdominal pain. Ifyou haveadministeredan overdose (more than6 gin a single dose), you should go to the hospital even if you do notnotice thesymptoms, as these, very serious, may appear several days after administration.

The treatmentof intoxicationincludeshemodialysis and administration of acetilcisteína at adequate doses. Gastric lavage and oral administration of activated charcoalare also suitable when the overdose has occurred by oral route.

If you forgot to useFebrectal children

Do notadminister the childa double dose to compensate for the missed doses, simply administer the missed dose when you remember and the following doses with the separation betweentwo administrationsindicated in each case.Which will be at least 4 or 6 hours.

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

Like all medications, Febrectal niños can produce adverse effects, although not all people 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 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 leaflet. 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 about 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. Disposeof the packaging and medications you no longer need at the SIGRE collection pointofyourpharmacy.Incase of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Febrectal children

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

The other components areanhydrous colloidal silica and semisynthetic solid glycerides.

Appearance of the product and content of the packaging

Febrectal children 300 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 medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/