FERVEX VITAMIN C 330mg/200mg x 20 eff tabl
Leaflet: Patient Information
Fervex vitamin C 330 mg/200 mg effervescent tablets
Paracetamol/ascorbic acid
Fervex vitamin C 330 mg/200 mg effervescent tablets
Paracetamol/Ascorbic acid
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 vitamin C effervescent tablets are and what they are used for
2. What you need to know before you take Fervex vitamin C effervescent tablets
3. How to take Fervex vitamin C effervescent tablets
4. Possible side effects
5. How to store Fervex vitamin C effervescent tablets
6. Contents of the pack and other information
1. What Fervex vitamin C effervescent tablets are and what they are used for
If you do not feel better after 3 to 5 days or your condition worsens, you should seek medical attention.
Fervex Vitamin C effervescent tablets contain the active ingredients paracetamol and ascorbic acid. Paracetamol is an analgesic and antipyretic with weak anti-inflammatory activity.
Vitamin C is an essential water-soluble vitamin.
Fervex Vitamin C effervescent tablets are 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 15 kg (over 4 years of age).
Read the “Dosage” section carefully.
2. What you need to know before you take Fervex vitamin C effervescent tablets
Do not take Fervex vitamin C effervescent tablets
- if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
- if you are allergic to propacetamol hydrochloride (a prodrug of paracetamol);
- in severe liver failure or decompensated active liver disease.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Fervex vitamin C effervescent tablets if you have or suffer from:
§ liver damage, including Gilbert's syndrome (an inherited disease characterized by increased bilirubin in the blood);
§ severe kidney damage;
§ 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).
Children and adolescents
In children, the dose depends on the child's weight, the age is given only as a guide to choose the appropriate dosage form. For children weighing less than 15 kg, other dosage forms are available. Ask your doctor or pharmacist.
Other medicines and Fervex vitamin C effervescent tablets
You should tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Consult your doctor or pharmacist if you are taking phenytoin, probenecid, salicylamide, medicinal products that are enzyme inducers (including but not limited to barbiturates, isoniazid, carbamazepine, rifampin, ethanol), deferoxamine, anticoagulants, substances that are acids or bases, iron-containing medicinal products.
There is a risk of changes in the acidity of the blood and body fluids (high anion gap metabolic acidosis) when paracetamol is used concomitantly with flucloxacillin, especially in certain groups of patients at risk, for example patients with severe renal impairment, sepsis, malnutrition and chronic alcoholism.
Tell your doctor if you are taking flucloxacillin.
If your doctor or your child's doctor orders a test to determine the level of uric acid in the blood and the level of blood sugar, inform him or her that you are taking this medicine.
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.
The use of Fervex Vitamin C effervescent tablets during pregnancy and breastfeeding is recommended under medical supervision. If necessary, Fervex Vitamin C 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 if the pain and/or fever have not decreased or if you need to take the medicine more often.
Driving and using machines
Fervex Vitamin Effervescent Tablets does not affect or has a negligible effect on the ability to drive and use machines.
Fervex vitamin C effervescent tablets contain sodium benzoate (E211), sodium and sorbitol (E420).
This medicine contains 50 mg sodium benzoate (E211) in each effervescent tablet.
This medicine contains 330 mg sodium (main ingredient of cooking/table salt) per
each effervescent tablet. This amount is equivalent to 16.5% 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 a day for a long period, especially if you have been advised to follow a low-salt (sodium) diet.
This medicine contains 300 mg of sorbitol 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 Fervex vitamin C effervescent tablets
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.
The recommended daily dose of paracetamol is 10 mg/kg to 15 mg/kg every 4 to 6 hours, up to a maximum daily dose of 75 mg/kg. The minimum interval between doses is 4 hours.
In patients with renal impairment, dosing should be at least every 4 hours (cl ≥50 ml/min), 6 hours (cl 10-50 ml/min) or 8 hours (cl < 10 ml/min).
In patients with chronic or compensated active liver disease, especially those with liver failure, chronic alcoholism, chronic malnutrition (low hepatic glutathione levels) and dehydration, the dose of paracetamol should not exceed 3 g daily.
Use in children and adolescents
In children, the dose of paracetamol depends on the child's weight, the age is given as a guide only. If you do not know the child's weight, you should weigh him to administer the most appropriate dose.
- Children from 15 to 33 kg (4 to 8 years): one effervescent tablet, repeated if necessary after 4 hours, without exceeding 6 tablets per day.
- Children from 33 to 50 kg (8 to 11 years): two effervescent tablets, repeated if necessary after 6 hours, without exceeding 8 tablets per day.
- For adults and children weighing over 50 kg (approximately over 11 years): 2 effervescent tablets, repeated if necessary after 4 hours, without exceeding the total dose of 12 effervescent tablets per day.
Method and route of administration
Oral administration.
Do not chew or swallow the tablets.
Dissolve the effervescent tablet completely in a large glass of water and drink it immediately.
Regular application helps to avoid fluctuations in pain intensity and temperature:
- in children, the intake should be evenly distributed over time, both during the day and at night, preferably at intervals of 6 hours, with the shortest interval being 4 hours;
- in adult patients, doses should be spaced at least 4 hours apart.
The score line is not intended to break the tablet.
Since the medicine contains Vitamin C, it should not be taken in the evening.
If you take more Fervex vitamin C effervescent tablets than you should
Consult a doctor in cases of overdose or accidental poisoning.
If you forget to take Fervex vitamin C effervescent tablets
Do not take a double dose to make up for a missed dose.
If you stop taking Fervex vitamin C effervescent tablets
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.
Adverse reactions associated with paracetamol
Side effects with unknown frequency:
- thrombocytopenia (reduced platelet count), neutropenia (reduced number of certain types of white blood cells), leukopenia (abnormal decrease in white blood cell count);
- diarrhea, abdominal pain;
- increase in liver enzymes;
- anaphylactic reaction (including hypotension), anaphylactic shock, angioedema, hypersensitivity;
- urticaria, erythema, rash, purpura (red spots on the skin), acute generalized exanthematous pustulosis (acute skin rash), toxic epidermal necrolysis (potentially life-threatening skin disease), Stevens-Johnson syndrome (allergic reactions including serious skin rashes, high fever and enlarged lymph nodes);
Adverse reactions associated with vitamin C
Side effects with unknown frequency:
- abdominal pain, diarrhea;
- dizziness;
- hyperoxaluria, chromaturia;
- urticaria, rash.
High doses of vitamin C (over 1 g) promote the formation of kidney stones in certain patients and may increase hemolysis (destruction of red blood cells) in patients with glucose-6-phosphate dehydrogenase deficiency, in cases of chronic hemolysis.
Adverse reactions associated with Fervex vitamin C effervescent tablets
Side effects with unknown frequency:
- agranulocytosis;
- abdominal pain;
- hepatitis;
- anaphylactic reaction, hypersensitivity;
- angioedema, dermatitis, pruritus, rash, urticaria.
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 vitamin C effervescent tablets
Keep out of the reach of children.
Store below 25°C.
Protect from moisture. Close the tablet container carefully with the stopper immediately after use.
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 medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What does Fervex vitamin C effervescent tablets contain?
- Active substances:
Paracetamol 330 mg
Ascorbic acid (Ascorbic acid) 200 mg
- Other ingredients: potassium bicarbonate, sodium hydrogen carbonate, sorbitol, anhydrous citric acid, sodium benzoate, sodium docusate, povidone.
What Fervex vitamin C effervescent tablets look like and what the pack contains
Fervex Vitamin C effervescent tablets are effervescent tablets with a score line.
Box with 2 polypropylene tablet packs of 10 effervescent tablets each, closed with a polyethylene cap with a desiccant (molecular sieve).
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
UPSA SAS
3, rue Joseph Monier
92500 Rueil-Malmaison
France
Manufacturer
UPSA SAS
304, avenue du 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