FEBROVIR 100 MG/ML ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Febrovir 100 mg/ml Oral Solution

Paracetamol

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Febrovir and what is it used for
2. What you need to know before you take Febrovir
3. How to take Febrovir
4. Possible side effects
5. Storage of Febrovir
6. Contents of the pack and other information

1. What is Febrovir and what is it used for

Febrovir belongs to a group of medicines called analgesics and antipyretics.

This medicine is used in children from 0 to 10 years (up to 32 kg) for the symptomatic treatment of mild or moderate pain and to reduce fever.

You should consult a doctor if the pain worsens or does not improve after 5 days or if the fever does not improve after 3 days.

2. What you need to know before you take Febrovir

Do not takeFebrovir:

If you are allergic to paracetamol, propacetamol hydrochloride (a prodrug of paracetamol), or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before taking this medicine.

Do not take more than the recommended dose. Check that you are not taking other medicines that contain paracetamol used to treat pain, fever, or colds.

In patients with asthma who are sensitive to acetylsalicylic acid, you should consult your doctor before taking this medicine.

If you have liver, kidney, heart, or lung disease, suffer from chronic malnutrition, or are dehydrated or have anemia (reduced hemoglobin levels in the blood), you should consult your doctor before taking this medicine.

Consuming alcoholic beverages can cause paracetamol to damage the liver.

If the pain persists for more than 5 days, the fever for more than 3 days, or the pain or fever worsens, or other symptoms appear, you should consult your doctor and reassess the clinical situation.

If you have severe diseases, such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic), a serious disease called metabolic acidosis (an anomaly in the 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 breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Children:

In children over 10 years (weight over 32 kg), it is recommended to use other presentations. For more information, consult your doctor or pharmacist.

Other medicines and Febrovir:

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

Paracetamol may interact with the following medicines:

• Medicines to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)
• Medicines to treat epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medicines to treat tuberculosis: (isoniazid, rifampicin)
• Medicines to treat depression and seizures: Barbiturates (used as sleep inducers, sedatives, and anticonvulsants)
• Medicines to lower cholesterol levels in the blood: (cholestyramine)
• Medicines used to increase urine elimination (loop diuretics such as furosemide)
• Medicines used to treat gout (probenecid and sulfinpyrazone)
• Medicines used to prevent nausea and vomiting: (metoclopramide and domperidone)
• Medicines used to treat high blood pressure and heart rhythm disorders (arrhythmias): (propranolol)
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

Do not use other pain relievers (medicines that reduce pain) without consulting your doctor.

Interference with laboratory tests:

Consult your doctor if the patient needs to undergo a blood or urine test.

If you are going to have any laboratory tests (including blood tests, urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter the results of these tests.

TakingFebrovirwith food, drinks, and alcohol:

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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy:

Ask your doctor or pharmacist for advice before taking any medicine.

If you are pregnant or think you may be pregnant, consult your doctor before taking this medicine. The use of medicines during pregnancy can be dangerous for the embryo or fetus and should be monitored by your doctor.

If necessary, paracetamol can be used during pregnancy. You should use the lowest possible dose that reduces pain or fever and use it for the shortest possible time. Contact your doctor if the pain or fever does not decrease or if you need to take the medicine more frequently.

Paracetamol is excreted in breast milk, so breastfeeding women should consult their doctor or pharmacist before taking this medicine.

Breastfeeding:

Ask your doctor or pharmacist for advice before taking any medicine.

Small amounts of paracetamol may appear in breast milk, so it is recommended that you consult your doctor or pharmacist before taking this medicine.

Driving and using machines:

The influence of paracetamol on the ability to drive and use machines is negligible.

Febrovircontains azorubine (E 122) and benzoic acid (E 210)

This medicine may cause allergic reactions because it contains azorubine (E 122). It can cause asthma, especially in patients allergic to acetylsalicylic acid.

This medicine contains 2 mg of benzoic acid per ml.

Benzoic acid may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

3. How to take Febrovir

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

The recommended dose is:

Use in children:

This medicine is intended for use in children up to 32 kg (approximately from 0 months to 10 years). It is necessary to respect the dosages defined according to the child's weightand, therefore, choose the appropriate dosage in ml of oral solution. The approximate age based on weight is given for information purposes.

The recommended daily dose of paracetamol is approximately 60 mg/kg/day, divided into 4 or 6 daily doses, i.e., 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.

For the administration of 15 mg/kg every 6 hours, the schedule is as follows:

The doses in the following table can be repeated with a minimum interval of 4 hours, without exceeding a total of 5 doses in 24 hours:

These doses can be repeated every 6 hours.

If after 3-4 hours of administration the desired effects are not obtained, the dose can be taken every 4 hours, in which case 10 mg/kgwill be administered.

Instructions for the correct administration of the preparation:

This medicine should be taken orally. According to the patient's preferences, it can be diluted in water, milk, or fruit juice or taken directly. The bottle should be tightly closed after each administration.

• Children from 0 to 3 years:the 30 ml format is the most suitable for these ages. To do this, open the bottle by pressing the cap and turning it to the right (when opening for the first time, the seal will break). Insert the dosing syringe by pressing it into the hole in the cap, turn the bottle upside down, and remove the amount to be taken. The dosing syringe should be washed with water after each intake.
• Children from 4 to 10 years:the 60 ml format is the most suitable for these ages. To do this, open the bottle by following the instructions on the cap (when opening for the first time, the seal will break). Insert the dosing syringe by pressing it into the hole in the cap, turn the bottle upside down, and remove the amount to be taken. The dosing syringe should be washed with water after each intake.

If the child takes moreFebrovirthan they should:

In case of overdose or accidental ingestion, consult your doctor or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount ingested.

If an overdose has been ingested, you should go to a medical center immediately, even if you do not notice symptoms, since they often do not appear until 3 days after ingestion, including in cases of severe poisoning.

The symptoms of overdose may be: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

Treatment of overdose is most effective if started within 4 hours of ingestion of the medication.

Patients being treated with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

If you forget to takeFebrovir

Do not give the child a double dose to make up for forgotten doses, simply give the forgotten dose when you remember, taking the next doses with the indicated separation between doses (4-6 hours).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Frequency not known (cannot be estimated from the available data): A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Febrovir

No special storage conditions are required.

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month stated.

Once opened, the contents of the bottle should be used within 6 months.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition ofFebrovir

The active substance is paracetamol. Each ml contains 100 mg of paracetamol.

• The other ingredients are: polyethylene glycol 400, glycerol (E-422), benzoic acid (E-210), sodium saccharin, strawberry flavor, azorubine (carmoisine) (E-122), purified water.

Appearance ofFebrovirand contents of the pack

The medicine is presented in a transparent plastic bottle containing a clear red solution with a characteristic strawberry flavor.

30 ml bottle: Polyethylene terephthalate bottle with a tamper-evident cap. Includes a dosing syringe graduated in milliliters (divided into 0.2 ml) with a maximum volume of 1 ml.

60 ml bottle: Polyethylene terephthalate bottle with a tamper-evident cap. Includes a dosing syringe graduated in milliliters (divided into 0.2 ml) with a maximum volume of 5 ml.

Marketing authorization holder and manufacturer:

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/Laguna 66-70. Polígono Industrial URTINSA II.

28923 – Alcorcón (Madrid)

Spain

Date of last revision of this leaflet: February 2025

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