Febrovir 100 mg/ml oral solution
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Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Febrovir 100 mg/ml oral solution
Paracetamol
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Febrovir is and what it is used for
- What you need to know before taking Febrovir
- How to take Febrovir
- Possible adverse effects
- How to store Febrovir
- Contents of the pack and other information
1. What Febrovir is and what it is used for
Febrovir belongs to a group of medicines called analgesics and antipyretics.
This medicine is used in children from 0 to 10 years of age (up to 32 kg) for the symptomatic treatment of mild to moderate pain and for reducing fever.
You should consult a doctor if symptoms worsen or if pain does not improve after 5 days or fever after 3 days.
2. What you need to know before taking Febrovir
Do not take Febrovir:
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
Talk to your doctor, pharmacist, or nurse before starting to take this medicine.
Do not take more than the recommended dose indicated in section 3. To avoid overdose, check that you are not simultaneously taking other medicines containing paracetamol that are used to treat pain, fever, or cold symptoms.
In patients with asthma who are sensitive to acetylsalicylic acid, consult your doctor before taking this medicine.
If you have liver, kidney, heart, or lung disease, suffer from chronic malnutrition, are dehydrated, or have anemia (reduced hemoglobin levels in the blood, with or without a reduction in red blood cells), you should consult your doctor before taking this medicine.
Alcohol consumption may increase the risk of liver damage caused by paracetamol.
If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsens or new symptoms appear, you should consult your doctor and re-evaluate your clinical condition.
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 suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic), be aware that a serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients under these circumstances when paracetamol is used at regular doses for prolonged periods or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, general malaise (nausea), and vomiting.
Children:
In children aged 10 years and older (weighing more than 32 kg), other formulations are recommended. For further information, consult your doctor or pharmacist.
Other medicines and Febrovir:
Inform 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 sleep inducers, sedatives, and anticonvulsants)
- Medicines used to lower blood cholesterol levels: (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 (hypertension) and heart rhythm disorders (cardiac arrhythmias): (propranolol)
- Flucloxacillin (antibiotic), due to a serious risk of blood and fluid disorder (called metabolic acidosis) requiring urgent treatment (see section 2).
Do not use other analgesics (medicines that reduce pain) without consulting your doctor.
Interference with laboratory tests:
Consult your doctor if you are due to undergo blood or urine tests.
If you are scheduled for any laboratory 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 these tests.
Taking Febrovir with food, drinks, and alcohol:
The use of paracetamol in patients who habitually consume alcohol (three or more alcoholic drinks per day) may cause liver damage. |
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.
Pregnancy:
Consult your doctor or pharmacist before taking any medicine.
If you are pregnant or think you might be pregnant, consult your doctor before taking this medicine. Taking medicines during pregnancy may be dangerous for the embryo or fetus and should be monitored by your doctor.
If necessary, paracetamol may be used during pregnancy. You should use the lowest possible dose that relieves pain or fever and take it for the shortest possible time. Contact your doctor if pain or fever do not improve or if you need to take the medicine more frequently.
Paracetamol is excreted in breast milk; therefore, women who are breastfeeding should consult their doctor or pharmacist before using this medicine.
Breastfeeding:
Consult your doctor or pharmacist before taking any medicine.
Small amounts of paracetamol may pass into breast milk; therefore, it is recommended that you consult your doctor or pharmacist before taking this medicine.
Driving and operating machinery:
The influence of paracetamol on the ability to drive and operate machinery is none or negligible.
Febrovir contains cochineal red (E-122) and benzoic acid (E-210).
This medicine may cause allergic reactions because it contains cochineal red (E-122). It may 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 for this medicine as provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Remember to take your medicine.
Recommended dose:
Use in children:
This medicine is intended for use in children up to 32 kg (approximately from 0 months to 10 years of age). It is necessary to adhere to the dosage regimens defined according to the child's weight, and therefore to select the appropriate dose in ml of oral solution. The approximate age according to weight is provided for informational purposes only.
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 administration of 15 mg/kg every 6 hours, the regimen is as follows:
The doses in the following table may be repeated with a minimum interval of 4 hours, without exceeding a total of 5 doses in 24 hours:
Weight (age) | Dosage |
Up to 4 kg (from 0 to 3 months): | 0.6 ml (60 mg) |
Up to 7 kg (from 4 to 8 months): | 1.0 ml (100 mg) |
Up to 8 kg (from 9 to 11 months): | 1.2 ml (120 mg) |
Up to 10.5 kg (from 12 to 23 months): | 1.6 ml (160 mg) |
Up to 13 kg (from 2 to 3 years): | 2.0 ml (200 mg) |
Up to 18.5 kg (from 4 to 5 years): | 2.8 ml (280 mg) |
Up to 24 kg (from 6 to 8 years): | 3.6 ml (360 mg) |
Up to 32 kg (from 9 to 10 years): | 4.8 ml (480 mg) |
These doses may be repeated every 6 hours.
If the desired effects are not achieved within 3-4 hours after administration, the dosing interval may be reduced to every 4 hours, in which case 10 mg/kg should be administered.
Instructions for correct administration of the preparation:
This medicine is taken orally. According to patient preference, it may be diluted in water, milk, or fruit juice, or taken directly. Close the bottle tightly after each administration.
- Children from 0 to 3 years of age: the 30 ml pack size is the most suitable for this age group. To use, press and turn the cap to the right to open the bottle (on first opening, the seal will break). Insert the dosing syringe through the pierced hole in the cap, turn the bottle upside down, and draw out the required amount. The dosing syringe should be washed with water after each use.
- Children from 4 to 10 years of age: the 60 ml pack size is the most suitable for this age group. To use, open the bottle following the instructions on the cap (on first opening, the seal will break). Insert the dosing syringe through the pierced hole in the cap, turn the bottle upside down, and draw out the required amount. The dosing syringe should be washed with water after each use.
If the child takes more Febrovir than they should:
In case of overdose or accidental ingestion, contact your doctor immediately or call the Toxicology Information Service (telephone 91 562 04 20), indicating the name of the medicine and the amount ingested.
If an overdose has been ingested, seek immediate medical attention even if no symptoms are apparent, as symptoms often do not appear until 3 days after the overdose, even in cases of severe poisoning.
Symptoms of overdose may include: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.
Treatment of overdose is most effective if initiated within 4 hours of ingestion of the medicine.
Patients undergoing treatment with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.
If you forgot to give the child Febrovir:
Do not give a double dose to make up for missed doses. Simply give the missed dose as soon as you remember, then continue with the next doses at the recommended intervals (4-6 hours).
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Rare adverse effects (occurring in up to 1 in 1,000 people) include: malaise, drop in blood pressure (hypotension), and increased blood transaminase levels.
Very rare adverse effects (occurring in up to 1 in 10,000 people) include: kidney disorders, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, haemolytic anaemia), and hypoglycaemia (low blood sugar). Paracetamol may cause liver damage when taken in high doses or during prolonged treatment. Very rare cases of serious skin reactions have been reported.
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 are using paracetamol (see section 2).
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
After first opening, the contents of the bottle must be used within 6 months.
Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Febrovir
The active substance is paracetamol. Each ml contains 100 mg of paracetamol.
- The other components are: polyethylene glycol 400, glycerol (E-422), benzoic acid (E-210), sodium saccharin, strawberry flavouring, azorubine (carmoisine) (E-122), purified water.
Appearance of Febrovir and contents of the pack
The medicine is presented in a transparent plastic bottle containing a clear red solution with a characteristic strawberry odour.
30 ml bottle: Polyethylene terephthalate bottle with tamper-evident cap. Includes a graduated oral syringe marked in millilitres (divided into 0.2 ml increments) with a maximum volume of 1 ml.
60 ml bottle: Polyethylene terephthalate bottle with tamper-evident cap. Includes a graduated oral syringe marked in millilitres (divided into 0.2 ml increments) 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 the most recent revision of this leaflet: February 2025
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es