Fervex bul i goromhka C Plus

Leaflet attached to the packaging: patient information

Fervex pain and fever C Plus, 330 mg + 200 mg, effervescent tablets

Paracetamol + Ascorbic acid

You should carefully read the contents of the leaflet before using the medicine, as it contains

important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor, pharmacist, or nurse.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.
• If pain does not improve in adults after 5 days, and symptoms of cold and flu or fever after 3 days, or if the patient feels worse, you should consult a doctor.

Table of contents of the leaflet

• 1. What is Fervex pain and fever C Plus and what is it used for
• 2. Important information before taking Fervex pain and fever C Plus
• 3. How to take Fervex pain and fever C Plus
• 4. Possible side effects
• 5. How to store Fervex pain and fever C Plus
• 6. Contents of the packaging and other information

1. What is Fervex pain and fever C Plus and what is it used for

Fervex pain and fever C Plus is a medicine with analgesic and antipyretic effects. It lowers elevated body temperature. Paracetamol, to a lesser extent than salicylates, irritates the gastric mucosa.
The addition of vitamin C supplements its deficiencies, which often occur in the course of colds.
Indications for use:

• Pain of mild and moderate severity of various origins (headaches, toothaches, joint pain, muscle pain, menstrual pain, neuralgia, and others).
• Symptomatic treatment of flu-like conditions and colds.
• Fever.

The medicine is intended for use in adults, adolescents, and children with a body weight of more than 27 kg (i.e., from about 8 years old).

2. Important information before taking Fervex pain and fever C Plus

When not to take Fervex pain and fever C Plus

• if you are allergic to paracetamol or propacetamol hydrochloride (a precursor to paracetamol), ascorbic acid, or any of the other ingredients of this medicine (listed in section 6),
• in children with a body weight of less than 27 kg,
• in pregnant women in the first trimester,
• if you have severe liver failure or active, uncontrolled liver disease,
• if you have a deficiency of glucose-6-phosphate dehydrogenase (G6PD), which may lead to hemolytic anemia,
• if you are being treated with MAO inhibitors (medicines used, among other things, in depression) and for 14 days after the end of treatment,
• if you have kidney stones, in case large doses of vitamin C are administered (more than 1 g).

Warnings and precautions

Before starting to take Fervex pain and fever C Plus, you should discuss it with your doctor, pharmacist, or nurse.
This medicine contains paracetamol. To avoid the risk of overdose, you should check if other medicines you are taking (including those available on prescription or over-the-counter) contain paracetamol.
You should not take doses higher than recommended. Taking doses higher than recommended carries the risk of very severe liver damage. Symptoms of liver damage usually appear one to two days after paracetamol overdose, with maximum severity usually occurring after 3-4 days.
Paracetamol may cause severe skin reactions (see section 4), such as acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which can be fatal. You should inform your doctor about skin reactions and stop taking the medicine in case of skin rash or any other sign of allergy.
You should consult your doctor before taking Fervex pain and fever C Plus if you have any of the following conditions:
liver function disorders, including Gilbert's syndrome (familial non-hemolytic hyperbilirubinemia),

• kidney function disorders (see section 3),
• alcoholic disease,
• anorexia, bulimia, or cachexia,
• chronic malnutrition (low glutathione reserves in the liver),
• dehydration,
• hypovolemia (reduced circulating blood volume),
• iron metabolism disorders - due to the presence of vitamin C,
• predilection to kidney stone formation - due to the presence of vitamin C.

You should not consume alcohol during treatment or take medicines containing alcohol.
During the use of Fervex pain and fever C Plus, you should immediately inform your doctor if you have severe diseases, including severe kidney function disorders or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). In these situations, patients have been reported to develop a severe condition called metabolic acidosis (a blood and body fluid disorder), which must be treated urgently (see section 2). Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, feeling of nausea (nausea) and vomiting.
During long-term (more than 3 months) use of painkillers in patients with chronic headache, when taken every other day or more frequently, medication-overuse headache (MOH) may develop or worsen. MOH should not be treated by increasing the dose. In such cases, in consultation with your doctor, you should stop taking painkillers.

Fervex pain and fever C Plus and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Concomitant use of Fervex pain and fever C Plus may alter the effect of the following medicines or the use of the following medicines may alter the effect of concomitantly used Fervex pain and fever C Plus:

• MAO inhibitors - it is contraindicated to use them concomitantly with MAO inhibitors and for 2 weeks after the end of treatment with these medicines due to the possibility of excitement and high fever.
• Medicines containing salicylamide (a pain reliever also used in feverish conditions) - concomitant use prolongs the elimination of paracetamol.
• Enzyme-inducing substances: caution should be exercised when used concomitantly.
• Liver metabolism-enhancing medicines - concomitant use of paracetamol and medicines such as St. John's wort, antiepileptic drugs, barbiturates (medicines used mainly in epilepsy), rifampicin (a medicine used in tuberculosis), may lead to liver damage, even when using the recommended doses of paracetamol (see "Using a higher dose of Fervex pain and fever C Plus than recommended" in section 3). Caution should be exercised when used concomitantly.
• Isoniazid (a medicine used in tuberculosis) and zidovudine (an antiviral medicine used in HIV infection) - caution should be exercised when used concomitantly with these medicines.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) - concomitant use increases the risk of kidney function disorders.
• Oral anticoagulants - concomitant use of paracetamol with anticoagulant medicines from the coumarin group, including warfarin, may lead to minor changes in INR values. In such cases, your doctor will increase the frequency of INR monitoring during concomitant use, as well as for one week after discontinuation of paracetamol.
• Phenytoin (a medicine used in epilepsy) - concomitant use may reduce the effectiveness of paracetamol and increase the risk of liver toxicity. During phenytoin treatment, you should avoid high and/or long-term doses of paracetamol. Patients should be constantly monitored for signs of liver damage.
• Probenecid (a medicine used in gout) - it causes a decrease in paracetamol elimination. When used concomitantly with probenecid, your doctor will consider reducing the dose of paracetamol.
• Flucloxacillin - you should inform your doctor or pharmacist if you are taking flucloxacillin (an antibiotic) due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which must be treated urgently (see section 2).
• Concomitant use of high doses of vitamin C with deferoxamine (a chelating agent) may increase tissue toxicity of iron and lead to heart failure.
• Vitamin C accelerates iron absorption from the gastrointestinal tract.
• Using high doses of vitamin C with acidic or basic substances may reduce the excretion of acidic products in the urine and increase the excretion of basic products in the urine.

You should inform your doctor about the use of this medicine if your doctor orders a test for uric acid, blood sugar, or urine sugar, or occult blood in the stool.

Using Fervex pain and fever C Plus with alcohol

During the use of the medicine, you should not consume alcohol or take medicines containing alcohol, due to the increased risk of toxic liver damage.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before taking this medicine.
Fervex pain and fever C Plus should not be used during pregnancy and lactation unless under medical supervision.
Fervex pain and fever C Plus can be given to pregnant women if necessary. You should use the smallest recommended dose that effectively relieves pain or reduces fever and take the medicine for the shortest possible time and as infrequently as possible.
Paracetamol may be used during breastfeeding only with the doctor's consent and in individual cases. You should exercise caution during the use of the medicine during lactation.
If pain is not relieved or fever does not decrease, or if it is necessary to increase the frequency of taking the medicine, you should consult your doctor.

Driving and using machines

Fervex pain and fever C Plus does not affect psychophysical abilities. There are no contraindications to driving vehicles and operating machinery.

Fervex pain and fever C Plus contains sodium, potassium, sorbitol, and sodium benzoate

Each effervescent tablet contains 330 mg of sodium (the main component of common salt). This corresponds to 16.5% of the maximum recommended daily intake of sodium in the diet for adults. If you take 1 or more effervescent tablets per day for a long time, patients, especially those controlling sodium intake in their diet, should consult their doctor or pharmacist.
Each effervescent tablet contains 17 mg of potassium, which should be taken into account in patients with reduced kidney function and patients controlling potassium intake in their diet.
Each effervescent tablet contains 300 mg of sorbitol. Sorbitol is a source of fructose. If you have previously been diagnosed with intolerance to some sugars or hereditary fructose intolerance (a rare genetic disease in which the body does not break down fructose), you should consult your doctor before taking the medicine or giving it to your child.
Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.
Fervex pain and fever C Plus contains sodium benzoate, which may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of age) whose mothers used this medicine during pregnancy.

3. How to take Fervex pain and fever C Plus

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor, pharmacist, or nurse. If you have any doubts, you should consult your doctor, pharmacist, or nurse.
The recommended single dose of paracetamol is 10 to 15 mg/kg body weight, every 4 to 6 hours, up to a maximum daily dose of 75 mg/kg body weight. The minimum interval between doses is 4 hours.
The approximate age corresponding to a given body weight is provided only as a guide.
The recommended dose is:
Adults and adolescents with a body weight over 50 kg(over 15 years old)
The single dose is one or two tablets. If necessary, the dose can be repeated, but not earlier than 4 hours. Usually, there is no need to use a daily dose of paracetamol higher than 3 g (9 tablets). However, in case of severe pain, the dose of paracetamol can be increased to a maximum daily dose of 4 g (12 tablets).
Children and adolescents with a body weight up to 50 kg
The dose is determined based on the child's body weight.
The recommended single dose of paracetamol is 10 mg/kg body weight. If necessary, the dose can be repeated, but not earlier than 4, 6, or 8 hours. The maximum daily dose of paracetamol is 60 mg/kg body weight.
Children with a body weight of 27 to 33 kg (from about 8 to 12 years old)
The single dose is one tablet, which can be repeated if necessary every 4 hours.
You should not take more than 6 tablets per day (1980 mg of paracetamol).
Children with a body weight of 33 to 50 kg (from 12 to 15 years old)
The single dose is one to two tablets, which can be repeated if necessary every 6 hours. You should not take more than 8 tablets per day (2640 mg of paracetamol).
Elderly patients
There is no need to modify the dose.
Patients with kidney function disorders
In patients with kidney function disorders, the minimum interval between doses should be in accordance with the following scheme:
Creatinine clearance
Interval between doses
CrCl ≥ 50 ml/min
4 hours
CrCl 10-50 ml/min
6 hours
CrCl <10 ml min
8 hours
Patients with liver function disorders
In patients with liver function disorders, the dose of the medicine should be reduced or the intervals between consecutive doses prolonged. In the following situations, the maximum daily dose should not exceed 60 mg/kg body weight per day (not more than 2 g/day):
in patients with a body weight below 50 kg,
chronic or compensated active liver disease, especially mild to moderate liver failure,
Gilbert's syndrome (familial non-hemolytic hyperbilirubinemia),
chronic alcoholic disease,
chronic malnutrition (low glutathione reserves in the liver),
dehydration.
Method of administration
Oral administration. The effervescent tablet should be dissolved in a glass of water and the prepared solution drunk.
Do not chew or swallow tablets.
Frequency of administration
To prevent periodic exacerbations of pain or fever:
in children, you should maintain a regular interval between doses, both during the day and at night,
in adults, the interval between doses should not be less than 4 hours.
Duration of use
In adults, do not use the medicine without a doctor's recommendation for more than 5 days in case of pain, and more than 3 days in case of cold and flu or fever. In children and adolescents, never use the medicine for more than 3 days.

Using a higher dose of Fervex pain and fever C Plus than recommended

In case of overdose or accidental ingestion of Fervex pain and fever C Plus, you should contact your doctor for advice.
Overdose is particularly dangerous in the elderly, small children, patients who are chronically malnourished, have liver disease, and patients taking medicines that induce liver enzymes, as these patients have an increased risk of liver damage.
Overdose of the medicine may cause symptoms such as nausea, vomiting, loss of appetite, pallor, excessive sweating, drowsiness, and general weakness within a few to several hours. These symptoms may resolve the next day, despite the fact that liver damage is beginning to develop, manifested by abdominal distension, return of nausea, and jaundice.
In every case of ingestion of this medicine in a single dose of 5 g of paracetamol or more, you should induce vomiting if it has not been more than an hour since ingestion and contact your doctor immediately. It is recommended to administer 60-100 g of activated charcoal orally, preferably mixed with water.
You should seek medical advice immediately.
Administration of a dose of vitamin C (ascorbic acid) higher than:

• 1 g per day may cause: gastrointestinal disorders (heartburn, diarrhea, bloating) and kidney and urinary disorders (oxalate, cystine, and/or uric acid stones);
• 2 g per day may affect the results of laboratory tests for creatinine or glucose in blood and urine and may also cause disorders of iron metabolism;
• exceeding the dose of ascorbic acid of 3 g per day carries the risk of hemolysis in patients with glucose-6-phosphate dehydrogenase deficiency.

Rare cases of acute pancreatitis have been observed.

Missing a dose of Fervex pain and fever C Plus

You should not take a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, you should consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience:

• allergic reactions including itching, rash, urticaria, erythema, dyspnea, bronchospasm, acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, and anaphylactic shock (a sudden and significant drop in blood pressure leading to fainting)
• toxic epidermal necrolysis (a severe, rapidly progressing disease characterized by blistering, large areas of peeling skin, and fever), Stevens-Johnson syndrome (a severe disease characterized by blisters and peeling skin, mouth, eyes, and genitals, fever, and joint pain)

you should stop taking Fervex pain and fever C Plus and immediately consult your doctor, as these reactions can be life-threatening.
The following side effects are related to the use of Fervex pain and fever C Plus, as well as paracetamol and vitamin C, after the medicine has been placed on the market. The frequency of these side effects is unknown (the frequency cannot be determined based on available data).
Agranulocytosis (reduced number of granulocytes), thrombocytopenia (reduced number of blood platelets), leukopenia (reduced number of white blood cells), neutropenia (reduced number of neutrophils - a type of white blood cell), abdominal pain, diarrhea, liver inflammation, increased liver enzyme activity, anaphylactic reaction, hypersensitivity reactions, anaphylactic shock, angioedema, skin inflammation, itching, rash, urticaria, erythema, acute generalized exanthematous pustulosis, toxic epidermal necrolysis, Stevens-Johnson syndrome, dizziness, hyperoxaluria (excessive amount of oxalates in the urine), change in urine color, severe condition that can cause acidification of the blood (so-called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).
Paracetamol very rarely causes tachycardia, renal colic, renal papillary necrosis, acute renal failure, vomiting, and nausea, and rarely general malaise.
High doses of ascorbic acid (more than 1 g) may cause the development of oxalate and uric acid stones in some people, as well as exacerbate hemolysis in people with G6PD deficiency with chronic hemolysis.
Reporting side effects
If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fervex pain and fever C Plus

The medicine should be stored out of the sight and reach of children.
Store in a temperature below 25°C. Protect from moisture.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Fervex pain and fever C Plus contains

• The active substances of the medicine are paracetamol and ascorbic acid. Each effervescent tablet contains 330 mg of paracetamol and 200 mg of ascorbic acid (vitamin C).
• The other ingredients are potassium bicarbonate, sodium bicarbonate, sorbitol (E420), anhydrous citric acid, sodium benzoate (E211), sodium docusate, povidone.

What Fervex pain and fever C Plus looks like and what the pack contains

Effervescent tablet.
Packaging: polypropylene tube, closed with a polyethylene cap (containing a desiccant: molecular sieve), in a cardboard box, containing 1 or 2 tubes of 10 effervescent tablets each.

Marketing authorization holder

UPSA SAS
3 rue Joseph Monier
92500 Rueil-Malmaison, France

Manufacturer

UPSA SAS
979, Avenue des Pyrénées
47520 Le Passage, France
UPSA SAS
304, avenue du Dr Jean Bru
47000 Agen, France
To obtain more detailed information about this medicine, you should contact the local representative of the marketing authorization holder:
MagnaPharm Poland sp. z o.o.
ul. Inflancka 4
00-189 Warsaw
tel: +48 22 570 27 00

Date of the last update of the leaflet: …