Fervex for pain and fever c plus

Package leaflet: Information for the patient

Fervex ból i gorączka C Plus, 330 mg + 200 mg, effervescent tablets
Paracetamolum + Acidum ascorbicum
Please read the entire leaflet carefully 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 a
physician, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your physician, pharmacist, or nurse. See section 4.
• If in adults the pain persists beyond 5 days, or if cold and flu symptoms or fever persist beyond 3 days, and in children and adolescents if there is no improvement after 3 days, or if the patient feels worse, you should contact a physician.

Table of contents

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

1. What Fervex ból i gorączka C Plus is and what it is used for

Fervex ból i gorączka C Plus is a medicine with analgesic and antipyretic properties. It reduces
elevated body temperature. Paracetamol irritates the gastric mucosa to a lesser extent than salicylates.
The addition of vitamin C helps to compensate for deficiencies commonly occurring during colds and viral infections.
Indications for use:

• Mild to moderate pain of various origins (headache, toothache, joint pain, muscle pain, menstrual pain, neuralgia, and others).
• Symptomatic treatment of influenza-like conditions and colds.
• Fever.

This medicine is intended for use in adults, adolescents, and children with body weight greater than 27 kg (approximately 8 years of age and older).

2. Important information before using Fervex ból i gorączka C Plus

When not to use Fervex ból i gorączka C Plus

• if the patient is allergic to paracetamol or propacetamol hydrochloride (a paracetamol precursor), ascorbic acid, or any of the other ingredients of this medicine (listed in section 6),
• in children with body weight below 27 kg,
• in women during the first trimester of pregnancy,
• if the patient has severe liver failure or active, untreated liver disease,
• if the patient has glucose-6-phosphate dehydrogenase (G6PD) deficiency, which may lead to haemolytic anaemia,
• if the patient is being treated with MAO inhibitors (medicines used e.g. for depression) and within 14 days after stopping such treatment,
• if the patient has kidney stones, when high doses of vitamin C (greater than 1 g) are administered.

Warnings and precautions
Before starting to use Fervex ból i gorączka C Plus, discuss this with your doctor, pharmacist, or nurse.
This medicine contains paracetamol. To avoid the risk of overdose, check whether other medicines being taken (including those prescribed or available without prescription) contain paracetamol.
Do not use doses higher than recommended. Using higher than recommended doses may result in severe liver damage. Symptoms of liver damage usually appear one to two days after paracetamol overdose, with maximum severity typically occurring after 3–4 days.
Paracetamol may cause severe skin reactions (see section 4), such as acute generalised exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which may be fatal. Inform your doctor if skin reactions occur and discontinue use of the medicine in case of skin rash or any other sign of allergy.
Consult your doctor before using Fervex ból i gorączka C Plus if the patient has any of the following conditions:
liver function disorders, including Gilbert's syndrome (hereditary hyperbilirubinaemia),

• kidney function disorders (see section 3),
• alcoholic liver 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,
• predisposition to urinary or kidney stones – due to the presence of vitamin C.

Do not consume alcohol during treatment or take medicines containing alcohol.
During treatment with Fervex ból i gorączka C Plus, inform your doctor immediately if the patient develops severe conditions, including severe kidney disorders or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic). In these situations, patients have been reported to develop a serious condition called metabolic acidosis (an imbalance in blood and body fluids) when taking paracetamol regularly over a prolonged period or when taking paracetamol together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.
Prolonged (over 3 months) use of painkillers in patients with chronic headache, taken every two days or more frequently, may lead to development or worsening of headache. Headache caused by overuse of painkillers (Medication-Overuse Headache, MOH) should not be treated by increasing the dose. In such cases, the use of painkillers should be discontinued in consultation with a doctor.

Fervex ból i gorączka C Plus and other medicines
Tell your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.
Concurrent use of Fervex ból i gorączka C Plus may alter the effect of the following medicines, or the use of the following medicines may alter the effect of Fervex ból i gorączka C Plus:

• MAO inhibitors – concurrent use with MAO inhibitors is contraindicated, as well as within 2 weeks after stopping treatment with these medicines, due to the risk of agitation and high fever.
• Medicines containing salicylamide (an analgesic also used for fever) – concurrent use prolongs the elimination of paracetamol.
• Enzyme-inducing substances: caution is required during concurrent use.
• Medicines increasing hepatic metabolism – concurrent use of paracetamol with medicines such as St. John's wort, antiepileptic drugs, barbiturates (medicines mainly used in epilepsy), rifampicin (used in tuberculosis) may lead to liver damage, even when recommended doses of paracetamol are used (see "Use of doses higher than recommended of Fervex ból i gorączka C Plus" in section 3). Caution is required during concurrent use.
• Isoniazid (used in tuberculosis) and zidovudine (an antiviral medicine used in HIV infection) – caution is required during concurrent use with these medicines.
• Non-steroidal anti-inflammatory drugs (NSAIDs) – concurrent use increases the risk of kidney function disorders.
• Oral anticoagulants – concurrent use of paracetamol with coumarin anticoagulants, including warfarin, may lead to slight changes in INR values. In such cases, the doctor will increase the frequency of INR monitoring during and for one week after discontinuation of paracetamol.
• Phenytoin (used in epilepsy) – concurrent use may reduce the effectiveness of paracetamol and increase the risk of liver toxicity. During phenytoin treatment, avoid high and/or prolonged use of paracetamol. These patients should be continuously monitored for signs of liver damage.
• Probenecid (used in gout) – reduces the elimination of paracetamol. When used concurrently with probenecid, the doctor may consider reducing the paracetamol dose.
• Flucloxacillin – inform your doctor or pharmacist if the patient is taking flucloxacillin (an antibiotic) due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which require urgent treatment (see section 2).
• Concurrent use of high doses of vitamin C with deferoxamine (a chelating agent) may increase tissue iron toxicity and lead to heart failure.
• Vitamin C accelerates iron absorption from the gastrointestinal tract.
• High-dose vitamin C used with substances having acidic or alkaline properties may reduce the excretion of acidic substances in urine and increase the excretion of alkaline substances in urine.

Inform your doctor about using this medicine if your doctor orders tests for uric acid, blood or urine glucose, or occult blood in stool.

Use of Fervex ból i gorączka C Plus with alcohol
Do not consume alcohol or take medicines containing alcohol during treatment, due to increased risk of toxic liver damage.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor before using this medicine.
Use of Fervex ból i gorączka C Plus is not recommended during pregnancy and lactation unless under medical supervision.
Fervex ból i gorączka C Plus may be used in pregnant women if necessary. The lowest effective recommended dose should be used, taken for the shortest possible duration and as infrequently as possible.
Paracetamol may be used during breastfeeding only with a doctor's approval and in individual cases. Caution is required when using the medicine during lactation.
If pain is not relieved or fever does not subside, or if increased dosing frequency is required, consult a doctor.

Driving and operating machinery
Fervex ból i gorączka C Plus does not affect psychomotor performance. There are no contraindications to driving or operating machinery.

Fervex ból i gorączka C Plus contains sodium, potassium, sorbitol, and sodium benzoate
Each effervescent tablet contains 330 mg of sodium (main component of table salt). This corresponds to 16.5% of the maximum recommended daily dietary sodium intake for adults. Patients, especially those monitoring sodium intake, who take 1 or more effervescent tablets daily over a long period, should consult their doctor or pharmacist.
Each effervescent tablet contains 17 mg of potassium, which should be considered in patients with reduced kidney function and those monitoring potassium intake.
Each effervescent tablet contains 300 mg of sorbitol. Sorbitol is a source of fructose. If intolerance to certain sugars or hereditary fructose intolerance (a rare genetic disorder in which the patient's body cannot break down fructose) has been diagnosed in the patient (or their child), the patient should consult a doctor before taking the medicine or giving it to a child.
Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.
Fervex ból i gorączka 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 use Fervex ból i gorączka C Plus

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor, pharmacist, or nurse. If in doubt, consult a doctor, pharmacist, or nurse.

The recommended single dose of paracetamol is 10 to 15 mg/kg body weight (b.w.), repeated every 4 to 6 hours, up to a maximum daily dose of 75 mg/kg b.w. The minimum interval between doses is 4 hours.

The approximate age corresponding to a given body weight is provided only as a guideline.

Recommended dose:

Adults and adolescents with body weight above 50 kg (aged over 15 years)
The single dose is one or two effervescent tablets. If necessary, the dose may be repeated, but not more frequently than every 4 hours. Usually, there is no need to exceed a daily dose of 3 g of paracetamol (9 tablets). However, in cases of severe pain, the daily dose of paracetamol may be increased to the maximum of 4 g (12 tablets).

Children and adolescents with body weight up to 50 kg
The dose should be calculated based on the child's body weight.
The recommended single dose of paracetamol is 10 mg/kg b.w. If necessary, the dose may be repeated, but not more frequently than every 4, 6, or 8 hours. The maximum daily dose of paracetamol is 60 mg/kg b.w.

Children with body weight 27 to 33 kg (approximately 8 to 12 years of age)
The single dose is one tablet, which may be repeated every 4 hours if necessary. Do not take more than 6 tablets per day (1980 mg paracetamol).

Children with body weight 33 to 50 kg (aged 12 to 15 years)
The single dose is one to two tablets, which may be repeated every 6 hours if necessary. Do not take more than 8 tablets per day (2640 mg paracetamol).

Elderly patients
Dose adjustment is not required.

Patients with renal impairment
In patients with impaired renal function, the minimum interval between doses should follow the scheme below:

| Creatinine clearance | Dosing interval | |----------------------|-----------------| | CrCl ≥ 50 ml/min | 4 hours | | CrCl 10–50 ml/min | 6 hours | | CrCl < 10 ml/min | 8 hours |

Patients with hepatic impairment
In patients with impaired liver function, the dose should be reduced or the dosing intervals extended. In the following conditions, the maximum daily dose should not exceed 60 mg/kg b.w. (and should not exceed 2 g/day):

• patients with 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 alcohol-related disease,
• chronic malnutrition (low hepatic glutathione reserves),
• dehydration.

Method of administration
Oral use. The effervescent tablet must be dissolved in a glass of water and the resulting solution drunk. Do not chew or swallow the tablets whole.

Frequency of use
To prevent recurrent episodes of pain or fever:

• in children, maintain regular dosing intervals both during the day and night,
• in adults, the interval between doses must not be less than 4 hours.

Duration of treatment
In adults, do not use this medicine for more than 5 days for pain, or more than 3 days for cold/flu or fever, unless advised by a doctor. In children and adolescents, never use the medicine for longer than 3 days.

Use of a higher than recommended dose of Fervex ból i gorączka C Plus
If an excessive dose has been taken or if the medicine has been taken by accident, contact a doctor immediately for appropriate advice.

Overdose is particularly dangerous in elderly individuals, young children, chronically malnourished patients, those with alcohol-related disease, liver disorders, or patients taking drugs that induce liver enzymes, as these patients have an increased risk of liver damage.

Overdose may cause symptoms within a few to several hours, such as nausea, vomiting, loss of appetite, pallor, excessive sweating, drowsiness, and general weakness. These symptoms may resolve the next day, even though liver damage may already be developing, manifesting as upper abdominal discomfort, recurrence of nausea, and jaundice.

In any case where this medicine has been taken in a single dose containing 5 g of paracetamol or more, induce vomiting if less than one hour has passed since ingestion, and contact a doctor immediately. Administration of 60–100 g of activated charcoal orally is recommended, preferably mixed with water. Seek immediate medical advice.

Taking vitamin C (ascorbic acid) in doses higher than:

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

Rare cases of acute pancreatitis have been observed.

Missed dose of Fervex ból i gorączka C Plus
Do not take a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following occur:

• allergic reactions including itching, rash, urticaria, erythema, dyspnea, bronchospasm, acute generalized exanthematous pustulosis, angioedema (swelling of eyes, lips, tongue, larynx, difficulty breathing), or anaphylactic shock (sudden and severe drop in blood pressure leading to fainting)
• toxic epidermal necrolysis (a severe, rapidly progressing condition characterized by rupturing giant blisters, extensive skin erosions, shedding of large sheets of epidermis, and fever), Stevens-Johnson syndrome (a serious condition characterized by

blisters and erosions on the skin, in the mouth, eyes, and genital organs, fever, and joint pain)
discontinue use of Fervex ból i gorączka C Plus immediately and seek medical advice, because
these reactions may be life-threatening.

Listed below are adverse reactions associated with the use of Fervex ból i gorączka C Plus, as well as those associated with paracetamol and vitamin C alone, reported during the post-marketing period.
The frequency of these adverse reactions is classified as unknown (frequency cannot be estimated from the available data).
Agranulocytosis (reduced granulocyte count), thrombocytopenia (reduced platelet count), leukopenia (reduced white blood cell count), neutropenia (reduced neutrophil count – a type of white blood cell), abdominal pain, diarrhoea, hepatitis, increased hepatic aminotransferase activity, anaphylactic reaction, hypersensitivity reactions, anaphylactic shock, angioedema, dermatitis, itching, rash, purpura, urticaria, erythema, acute generalized exanthematous pustulosis, toxic epidermal necrolysis, Stevens-Johnson syndrome, dizziness, hyperoxaluria (excessive oxalate in urine), change in urine colour, serious condition that may lead to blood acidification (so-called metabolic acidosis) in patients with severe disease taking paracetamol (see section 2).

Additionally, paracetamol very rarely causes tachycardia, renal colic, necrosis of renal papillae, acute renal failure, vomiting and nausea, and rarely malaise.

Large doses of ascorbic acid (greater than 1 g) may in some individuals lead to the development of oxalate and urate kidney stones and may exacerbate hemolysis in patients with G6PD deficiency who have chronic hemolytic forms.

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorization holder.

Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Fervex ból i gorączka C Plus

Keep this medicine out of sight and reach of children.
Store 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Fervex ból i gorączka C Plus contains

• The active substances are: paracetamol and ascorbic acid. Each effervescent tablet contains 330 mg of paracetamol and 200 mg of ascorbic acid (vitamin C).
• Other components are: potassium hydrogen carbonate, sodium hydrogen carbonate, sorbitol (E420), anhydrous citric acid, sodium benzoate (E211), sodium lauryl sulfate, povidone.

What Fervex ból i gorączka C Plus looks like and contents of the pack
Effervescent tablet.
Pack: polypropylene tube closed with a polyethylene cap (containing a desiccant: molecular sieve), in a cardboard box containing 1 or 2 tubes with 10 effervescent tablets each.
Marketing Authorisation 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
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
MagnaPharm Poland sp. z o.o.
ul. Inflancka 4
00-189 Warsaw
tel: +48 22 570 27 00