FERVEX RAPID 500mg x 16 eff tabl
Patient information leaflet
FERVEX rapid 500 mg effervescent tablets
FERVEX rapid 500 mg effervescent tablets
Paracetamol (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 FERVEKS rapid is and what it is used for
2. What you need to know before you take FERVEKS rapid
3. How to take FERVEKS rapid
4. Possible side effects
5. How to store FERVEKS rapid
6. Contents of the pack and other information
1. What FERVEKS rapid is and what it is used for
This medicine contains paracetamol.
FERVEX rapid is used for the symptomatic treatment of mild to moderate pain and/or febrile conditions, such as headache, flu-like conditions, toothache, muscle pain, menstrual pain.
This dosage form is intended for adults and children weighing over 14 kg (over 4 years).
Read the “Dosage” section carefully.
For children weighing less than 14 kg, other dosage forms containing paracetamol are available. Consult your doctor or pharmacist.
If you do not feel better after 3 to 5 days or your condition worsens, you should seek medical attention.
2. What you need to know before you take FERVEKS rapid
Consult your doctor before taking this medicinal product if he has told you that you have an intolerance to some sugars.
Do not take FERVEKS rapid
- 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 FERVEKS rapid 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 substance. Do not combine such medicines to avoid exceeding the recommended daily dose (see dosage section).
Other medicines and FERVEX rapid
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.
- pay special attention if you are taking any of the following medicines: phenytoin, probenecid, salicylamide, enzyme inducers (e.g., but not limited to: barbiturates, isoniazid, carbamazepine, rifampin and ethanol), anticoagulants.
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, FERVEKS rapid can be administered during pregnancy. You should
use the lowest possible dose that reduces pain and/or lowers fever and for
as soon as possible. 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.
Driving and using machines
FERVEKS rapid does not affect or has a negligible effect on the ability to drive and use machines.
FERVEX rapid contains sodium benzoate (E211), sodium and sorbitol (E420) and in the flavor, fructose, glucose and sucrose.
This medicine contains 50 mg sodium benzoate (E211) in each effervescent tablet.
This medicine contains 0.96 mg fructose in each effervescent tablet. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicinal product contains 197 mg sodium (main ingredient of cooking/table salt) in each effervescent tablet. This amount is equivalent to 10% of the recommended maximum daily dietary intake of sodium for an adult. Talk to your doctor or pharmacist if you need one or more effervescent tablets per day for a long period, especially if you have been advised to follow a low-salt (sodium) diet.
This medicinal product contains 126 mg of sorbitol (E420) in each effervescent tablet. Sorbitol is a source of fructose. If you have been told by your doctor that you or your child have an intolerance to some sugars or have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which people cannot break down fructose, talk to your doctor before you or your child take or are given this medicine.
3. How to take FERVEKS rapid
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.
This medicine is intended for adults and children over 14 kg (over 4 years).
In children, it is mandatory to follow the dosage, which is determined depending on the child's weight.
The approximate age is given only as a guide depending on the child's weight. If you do not know the child's weight, weigh him/her to administer the most appropriate dose.
To avoid the risk of overdose, check whether other medicines you are taking (prescription and over-the-counter) contain paracetamol.
There are different dosage forms of paracetamol, so the treatment can be adapted to each child's weight.
FERVEKS rapid should be administered in doses of 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 administration is 4 hours.
The recommended dose is:
For children weighing 14 to 20 kg (aged approximately 4 to 7 years), the dose is half a tablet (250 mg) per dose, and if necessary, the dose can be repeated after 6 hours, without exceeding the maximum daily dose of 2 tablets (1000 mg divided into four doses of half a tablet).
For children weighing 20 to 27 kg (aged approximately 7 to 10 years), the dose is half a tablet (250 mg) per dose, and if necessary, the dose is repeated after 4 hours, without exceeding the maximum daily dose of 3 tablets (1500 mg divided into six doses of half a tablet).
For children weighing 27 to 40 kg (approximately 10 to 11 years of age), the dose is one tablet (500 mg) per dose, and if necessary, the dose is repeated after 6 hours, without exceeding the maximum daily dose of 4 tablets (2000 mg divided into four doses of one tablet).
For children weighing 40 to 50 kg (approximately 11 to 12 years of age), the dose is one tablet (500 mg) per dose, and if necessary, the dose is repeated after 4 hours, without exceeding the maximum daily dose of 6 tablets (3000 mg divided into six doses of one tablet).
For adults and children weighing more than 50 kg (over 12 years of age), the usual dose is one to two 500 mg tablets per dose (depending on the intensity of the pain), repeated if necessary after 4 to 6 hours, without exceeding the maximum daily dose of 8 tablets (4000 mg divided into four to six doses).
It is usually not necessary to exceed the daily dose of 3 g of paracetamol, i.e. 6 tablets per day.
In case of more severe pain and after consulting a doctor, the total dose may be increased to 4 g of paracetamol per day or 8 tablets per day.
For doses higher than 3 g of paracetamol per day, it is necessary to consult a doctor.
Never take more than 4 g of paracetamol per day (taking into account all medicines that contain paracetamol).
There should always be an interval of 4 hours between doses.
If you are not sure about anything, ask your doctor or pharmacist.
Method and route of administration
Oral administration.
Do not chew or swallow the tablets. The tablet should be completely dissolved in a large glass of water and drunk immediately. In addition, if the child's temperature exceeds 38.5°C, the following actions will make treatment with this medicine more effective:
- undress the child;
- give him fluids to drink;
- do not leave the child in an overly warm room.
Frequency of intake
Regular use helps to avoid fluctuations in the intensity of pain and fever.
In children, a regular interval is required, preferably 6 hours, but not less than 4 hours between doses, both during the day and at night.
In adults, there should be an interval of at least 4 hours between doses.
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.
If you take more FERVEKS rapid 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 take FERVEKS rapid
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.
- In rare cases, 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) 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 containing 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 white blood cells or certain types of blood cells (platelets), which may lead to nosebleeds or bleeding gums. In this case, consult your doctor.
- In extremely rare cases, diarrhea, abdominal pain have been reported
- In extremely rare cases, increases 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 FERVEKS rapid
This medicinal product does not require any special storage conditions.
Keep out of the reach of children.
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.
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 FERVEKS rapid contains
- Active substance: paracetamol (paracetamol) 500 mg
for one effervescent tablet
- Other ingredients: anhydrous citric acid, anhydrous sodium carbonate, sodium hydrogen carbonate, sorbitol, saccharin sodium, docusate sodium, povidone, sodium benzoate, grapefruit-orange flavor (fructose, glucose and sucrose).
What FERVEKS rapid looks like and what the pack contains
Box of 16 effervescent tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
UPSA SAS
3, rue Joseph Monier
92500 Rueil-Malmaison
France
Manufacturer
UPSA SAS
979, avenue des Pyrenees
47520 Le Passage, France
or
UPSA SAS
304, avenue Docteur Jean Bru
47000 Agen, France
Date of last revision of the leaflet 09/2024