FERVEX BABY oral sol 30mg/ml 90ml
Patient information leaflet
Fervex baby 30 mg/ml oral solution
Paracetamol
Fervex baby 30 mg/ml oral solution
Paracetamol
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you.
- Keep this leaflet. You may need to read it again.
- If you need further information or advice, ask your pharmacist.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
- If you do not feel better after 3 to 5 days or your condition worsens, you should seek medical attention.
What this leaflet contains
1. What Fervex baby is and what it is used for
2. What you need to know before you take Fervex baby
3. How to take Fervex baby
4. Possible side effects
5. How to store Fervex baby
6. Contents of the pack and other information
1. What Fervex baby is and what it is used for
This medicine contains paracetamol.
Fervex baby is used for the symptomatic treatment of pain of mild to moderate intensity and/or febrile conditions.
This dosage form is intended for children weighing 4 to 32 kg (or from about 1 month to 12 years).
Read the “Dosage” section carefully.
For children of different weights, there are other dosage forms containing paracetamol. Consult your doctor or pharmacist.
2. What you need to know before you take Fervex baby
Consult your doctor before taking this medicinal product if he has told you that you have an intolerance to some sugars.
Do not take Fervex baby
- 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).
- if you suffer from severe liver disease.
Consult your doctor immediately in cases of overdose or accidental ingestion of a large dose.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Fervex baby if you have or suffer from:
§ liver failure, including Gilbert's syndrome (a hereditary disease characterized by an increase in bilirubin in the blood);
§ severe renal failure;
§ glucose-6-phosphate dehydrogenase deficiency;
§ chronic alcoholism;
§ chronic malnutrition, anorexia (loss of appetite), cachexia (extreme degree of exhaustion of the body), bulimia (eating disorder), starvation;
§ dehydration, hypovolemia (a condition in which the volume of plasma in the blood is reduced).
Paracetamol can cause serious and possibly fatal skin reactions; therefore, treatment should be discontinued immediately at the first appearance of a skin rash or other signs of hypersensitivity and a doctor should be consulted.
It is not recommended to consume alcohol during treatment.
Frequent, long-term use of analgesics can cause or worsen headaches. If you suffer from chronic headaches and have been taking analgesics at least every other day for longer than 3 months, you should not increase the dose of analgesics, but consult your doctor.
This medicine contains paracetamol. Other medicines also contain this substance. Do not combine such medicines to avoid exceeding the recommended daily dose (see dosage section).
Other medicines and Fervex baby
You should tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Please tell your doctor or pharmacist if you or your child are taking:
- flucloxacillin (an antibiotic), due to a serious risk of an abnormality of the blood and body fluids (high anion gap metabolic acidosis) which must be treated urgently and which may occur particularly in case of severe kidney damage, sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism and if maximum daily doses of paracetamol are used.
Take special care if you are taking any of the following medications: phenytoin, probenecid, salicylamide, enzyme inducers (e.g., but not limited to: barbiturates, isoniazid, carbamazepine, rifampin, and ethanol), anticoagulants.
Do not combine Fervex Baby with other medicines containing paracetamol, so as not to exceed the recommended daily dose. It is not recommended to combine paracetamol with other painkillers.
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
This medicine is intended for use in children. If necessary, Fervex Baby can be used during pregnancy.
You should use the lowest possible dose that reduces pain and/or lowers fever and for the shortest possible time. Contact your doctor or midwife if the pain
and/or the temperature has not decreased or if you need to take the medicine more often.
Fervex baby with food and drinks
This medicine can be taken with or without food.
Driving and using machines
This medicine does not affect the ability to drive or use machines.
Fervex baby contains sucrose, propylene glycol (E1520).
This medicine contains 0.67 g of sucrose per 4 kg division of the measuring spoon. This should be taken into account by patients with diabetes mellitus. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine contains 146 mg propylene glycol (E1520) per 100 ml oral solution, which is equivalent to 3.9 mg/kg/day. If your baby is under 4 weeks old, talk to your doctor or pharmacist before giving this medicine, especially if your baby is being given other medicines that contain propylene glycol or ethanol.
3. How to take Fervex baby
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. If you are not sure, ask your doctor or pharmacist.
Method of release:
Without a doctor's prescription.
If use is necessary in children aged 1 to 3 months, consultation with a doctor is recommended.
In children, it is mandatory to follow the dosage, which is determined depending on the child's weight.
To avoid the risk of overdose, check whether concomitant medications (prescription and over-the-counter) contain paracetamol.
The approximate age is given as a guide only, depending on the child's weight. If you do not know the child's weight, weigh them to administer the most appropriate dose.
There are different dosage forms of paracetamol, so the treatment can be adapted to each child's weight.
The recommended dose of Fervex Baby is 10 to 15 mg/kg every 4 to 6 hours, up to a maximum daily dose of 75 mg/kg/day. The maximum daily dose should not exceed 75 mg/kg. The minimum interval between each dose is 4 hours.
The graduated measuring spoon, showing 4 - 8 - 12 - 16 kg (with divisions for each kilogram), ensures that the correct dose is given at each feeding depending on the child's weight.
For example:
§ from 4 to 16 kg: use the measuring spoon corresponding to the child's weight. The dose, if necessary, should be repeated after 6 hours.
§ from 16 to 32 kg: first fill the measuring spoon to the 16 kg mark and then add the required amount by filling the spoon a second time until the child's weight is reached. The dose should be repeated after 6 hours if necessary.
The approximate age ranges related to weight are given as a guide only.
Caution: Use only the measuring spoon provided as it is specifically designed for use with this medicinal product. You should not use any other dosing device.
If you are not sure about anything, ask your doctor or pharmacist.
Method and route of administration
Oral administration.
To be taken in its pure form or dissolved in a small amount of water, milk or fruit juice.
Press and twist the special, child-resistant cap to open the bottle.
Close the bottle after each use.
Additionally, if the temperature exceeds 38.5°C, take the following actions while you wait for your doctor to arrive:
- undress the child,
- give the child fluids to drink,
- turn down the heating.
Frequency of intake
Regular use helps to avoid fluctuations in the intensity of pain and fever.
In children, a regular interval of preferably 6 hours, but not less than 4 hours, is required between doses, both during the day and at night.
In cases of severe kidney disease (severe renal failure), the dosing interval should be adjusted according to the creatinine clearance. For creatinine clearance (CL) CL ≥50 ml/min, the minimum dosing interval should be 4 hours; for CL 10-50 ml/min – 6 hours and for CL <10 ml/min – 8 hours.
Duration of treatment
The duration of treatment is limited:
§ up to 5 days in case of pain;
§ up to 3 days in case of fever/febrile condition.
If pain persists for more than 5 days, or fever for more than 3 days, if symptoms become more severe or other symptoms develop, do not continue treatment without consulting your doctor or pharmacist.
Kidney failure
In severe renal failure, the interval between doses should be at least 6-8 hours.
Liver damage
Patients with hepatic impairment should reduce the dose or extend the interval between applications.
If you take more Fervex baby than you should
Consult a doctor immediately in cases of overdose or accidental poisoning.
Early symptoms (during the first day) of overdose may include nausea, vomiting, loss of appetite, sweating, pallor, drowsiness and malaise. However, despite possible improvement of symptoms by the second day, irreversible liver damage may develop.
After an overdose of paracetamol, the following is observed:
- acute inability of the kidneys to work properly
- a condition in which small blood clots develop throughout the bloodstream, blocking small blood vessels due to severe liver damage
- rare cases of inflammation of the pancreas
If you forget to take Fervex baby
Do not take a double dose to make up for a missed dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
- Paracetamol may cause bronchospasm (excessive and prolonged contraction of the muscles of the airways, causing difficulty breathing) in people sensitive to acetylsalicylic acid and other NSAIDs (a group of painkillers containing anti-inflammatory and antipyretic effects), fixed drug eruption (reddish/purple spot on the skin that reappears in the same place), serious skin reactions such as acute generalized exanthematous pustulosis (acute skin rash), toxic epidermal necrolysis (a potentially life-threatening skin disease), Stevens-Johnson syndrome (allergic reactions including serious skin rashes, high fever and enlarged lymph nodes). If this happens, stop treatment immediately, tell your doctor and do not give your child any more medicines containing paracetamol.
Skin rashes, redness of the skin or allergic reactions in the form of sudden swelling of the face or neck or sudden malaise with a drop in blood pressure, purpura (red spots on the skin) have been reported.
- Changes in laboratory parameters have been observed, which require regular blood tests: abnormally low levels of white blood cells or certain types of blood cells (platelets), which may lead to nosebleeds or bleeding gums. If this happens, consult your doctor.
- Diarrhea, abdominal pain have been reported.
- Elevations in liver enzymes have been reported.
Reporting side effects
If you get any side effects, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:
Executive Agency for Medicines
8 Damyan Gruev Street,
Sofia 1303,
tel.: +359 28903417,
website: www.bda.bg
By reporting side effects, you can help provide more information about the safety of this medicine.
5. How to store Fervex baby
Keep out of the reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date which is stated on the packaging.
The expiry date refers to the last day of that month.
Shelf life after first opening: 3 months.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What does Fervex baby contain?
- Active ingredient: paracetamol - 3.0 g per 100 ml of oral solution.
- Other ingredients: macrogol 6000, sucrose solution, saccharin sodium, potassium sorbate, citric acid anhydrous, caramel-vanilla flavor, purified water.
What Fervex baby looks like and what the pack contains
Oral solution in a 90 ml or 150 ml bottle.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
UPSA SAS
3, rue Joseph Monier
92500 Rueil-Malmaison
France
Manufacturer
UPSA SAS
304, avenue Docteur Jean Bru
47000 Agen, France
or
UPSA SAS
979, avenue des Pyrenees
47520 Le Passage, France
Date of last revision of the leaflet 03/2024