FERVEX children 300mg x 10 supp
Patient information leaflet
Fervex for children 300 mg suppositories
Fervex children 300 mg suppositories
Paracetamol/Paracetamol
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist 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, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
- If you do not feel better after 3 days or your condition worsens, you should seek medical attention.
What this leaflet contains
1. What Fervex for children is and what it is used for
2. What you need to know before using Fervex for children
3. How to use Fervex for children
4. Possible side effects
5. How to store Fervex for children
6. Contents of the pack and other information
1. What Fervex for children is and what it is used for
This medicine contains paracetamol.
Fervex for children is used for the symptomatic treatment of mild to moderate pain and/or febrile conditions (conditions with high fever).
This dosage form is intended for children weighing 15 to 30 kg (aged 3 to 9 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 using Fervex for children
Do not use Fervex for children
- 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.
Warnings and precautions
Talk to your doctor or pharmacist before using Fervex for children 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);
§ dehydration, hypovolemia (a condition in which the volume of plasma in the blood is reduced).
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 active substance. Do not combine such medicines to avoid exceeding the recommended daily dose (see dosage section).
Other medicines and Fervex for children
You should tell your doctor or pharmacist if you are using, have recently used or might use any other medicines:
- flucloxacillin (an antibiotic), due to a serious risk of blood and fluid abnormality (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.
Tell your doctor if you are taking flucloxacillin.
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.
If necessary, Fervex for children 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 fever have not decreased or if you need to take the medicine more often.
Driving and using machines
Not applicable
Fervex for children contains soybean oil
This medicine contains lecithin, which is extracted from soybean oil. If you are allergic to peanuts or soybeans, do not use this medicine.
3. How to use Fervex for children
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
In children, the dose is determined by the child's weight. The approximate age is given as a guide only. To avoid the risk of overdose, check that other medicines you are taking, whether prescription or non-prescription, do not contain paracetamol.
The recommended daily dose of paracetamol suppositories is approximately 60 mg/kg per day, divided into 4 doses, i.e. approximately 15 mg/kg every 6 hours.
Due to the risk of local irritation, it is not recommended to use suppositories more than 4 times a day and the duration of rectal treatment should be as short as possible.
Suppositories are not suitable for use in case of diarrhea.
Fervex for children is intended for use in children weighing 15 to 30 kg (aged 3 to 9 years), the dosage being one 300 mg suppository with a repeat dose if necessary after 6 hours. The minimum interval between doses is 6 hours.
It is available without a prescription.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Method and route of administration
Rectal administration
Additionally, if the child's temperature exceeds 38.5°C, the following actions will make treatment more effective:
- undress the child,
- give him fluids to drink,
- do not leave the child in an overly warm room.
Frequency of use
Regular use helps to avoid fluctuations in the intensity of pain and fever.
In children, an administration interval of 6 hours is required, both during the day and at night.
In renal failure, the interval between doses should be at least 6 hours.
If you use more Fervex for children than you should
Consult a doctor immediately in cases of overdose or accidental poisoning.
The following events have been observed after paracetamol overdose:
- acute inability of the kidneys to work properly
- a condition in which small blood clots develop in the bloodstream, blocking small blood vessels
- rare cases of inflammation of the pancreas
If you forget to use Fervex for children
Do not use a double dose to make up for a missed dose.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
- In rare cases, skin rashes, redness of the skin, itching 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) may occur.
- In very rare cases, serious skin reactions have been reported, 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), reddish/purple spot on the skin that reappears in the same place.
If this happens, stop treatment immediately, inform your doctor and do not take any more medicines that contain paracetamol.
- In very rare cases, excessive and prolonged contraction of the muscles of the airways may occur, causing difficulty breathing.
- In extremely rare cases, changes in laboratory parameters have been observed, which require regular blood tests: abnormally low levels of some white blood cells or certain types of blood cells (platelets), which may lead to nosebleeds or bleeding gums. If this happens, consult a doctor.
- In extremely rare cases, diarrhea and abdominal pain have been reported.
- In extremely rare cases, an increase in liver enzymes has 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 (see details below). By reporting side effects, you can help to provide more information on the safety of this medicine.
Executive Agency for Medicines
Sofia 1303, 8 Damyan Gruev Str.
Tel.: +359 28903417
website: www.bda.bg
5. How to store Fervex for children
Keep out of the reach of children. Store below 30°C.
Do not use after the expiry date stated on the packaging.
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 to protect the environment.
6. Contents of the pack and other information
What does Fervex for children contain?
- Active substance: paracetamol (paracetamol) 300 mg
- Other ingredients: solid fats per suppository (containing lecithin extracted from soybean oil).
What Fervex for children looks like and what the pack contains
Box of 10 suppositories (300 mg)
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