Fervex bul i goromhka

Leaflet attached to the packaging: patient information

Fervex pain and fever, 500 mg, effervescent tablets

Paracetamol

Read the leaflet carefully before taking 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 doctor, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If in adults the pain does not subside after 5 days, and the fever after 3 days, or in adolescents the pain or fever does not subside after 3 days, or if the patient feels worse, they should contact a doctor.

Table of contents of the leaflet

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

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

Fervex pain and fever is a medicine with analgesic and antipyretic effects. It lowers elevated body temperature. Paracetamol is less irritating to the stomach lining than salicylates.

Indications for use:

• Pain of various origins (headaches, toothaches, joint pain, muscle pain, menstrual pain, neuralgia, and others).
• Fever.

The medicine is intended for short-term use in adults and adolescents with a body weight of over 50 kg (i.e., over 15 years of age).

2. Important information before taking Fervex pain and fever

When not to take Fervex pain and fever

• if the patient is allergic to paracetamol, propacetamol hydrochloride (a paracetamol precursor), or any of the other ingredients of this medicine (listed in section 6),
• in children with a body weight of less than 50 kg,
• in women during the first trimester of pregnancy,
• if the patient has severe liver failure or active liver disease,
• if the patient has a deficiency of glucose-6-phosphate dehydrogenase,
• if the patient is being treated with MAO inhibitors (medicines used, among others, in depression) and for 14 days after their discontinuation.

Warnings and precautions

Before starting treatment with Fervex pain and fever, the patient should discuss it with their doctor, pharmacist, or nurse.

Fervex pain and fever contains paracetamol and should be taken into account when taking other medicines containing paracetamol (including prescription and over-the-counter medicines) to avoid taking a daily dose greater than recommended (see section 3).

Do not take higher doses than recommended. Taking higher doses than recommended carries the risk of severe liver damage. Symptoms of liver damage usually appear 1-2 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. The patient should inform their doctor about skin reactions and stop taking the medicine in case of a skin rash or any other sign of an allergic reaction.

The patient should consult their doctor before taking Fervex pain and fever if they have any of the following conditions:

liver function disorders, including Gilbert's syndrome (familial hyperbilirubinemia),

kidney function disorders (see section 3),

alcoholic liver disease,

chronic malnutrition (low glutathione reserves in the liver), anorexia, bulimia, cachexia, or starvation,

dehydration,

hypovolemia (reduced blood volume).

During treatment with Fervex pain and fever, the patient should immediately inform their doctor if they experience severe diseases, including severe kidney function disorders or sepsis (when bacteria and their toxins are present in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or if they are 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 requires emergency treatment (see section 2).

Metabolic acidosis symptoms may include:

severe breathing difficulties, including rapid deep breathing, drowsiness, nausea (nausea) and vomiting.

Do not consume alcohol during treatment or take medicines containing alcohol, due to the increased risk of toxic liver damage.

Fervex pain and fever and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Concomitant use of Fervex pain and fever 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:

• MAO inhibitors - it is contraindicated to use them concomitantly with MAO inhibitors and for 2 weeks after discontinuation 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.
• Medicines that increase liver metabolism - 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 than recommended" in section 3). Caution should be exercised when using concomitantly.
• Isoniazid (a medicine used in tuberculosis) and zidovudine (an antiviral medicine used in HIV infection) - caution should be exercised when using concomitantly with these medicines.
• Non-steroidal anti-inflammatory drugs (NSAIDs) - concomitant use increases the risk of kidney function disorders. Oral anticoagulant medicines - concomitant use of paracetamol with anticoagulant medicines from the coumarin group, including warfarin, may lead to minor changes in INR values. In such cases, the doctor may increase the frequency of monitoring INR values during concomitant use and 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, the patient should avoid high doses of paracetamol and (or) long-term paracetamol doses. These 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 paracetamol, the doctor will consider reducing the paracetamol dose.
• Flucloxacillin (an antibiotic) - the patient should inform their doctor or pharmacist if they are taking flucloxacillin due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which require emergency treatment (see section 2).

The patient should inform their doctor about the use of this medicine if the doctor prescribes a test for uric acid or blood sugar.

Using Fervex pain and fever with alcohol

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

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.

Fervex pain and fever can be given to pregnant women if necessary. The patient 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. Caution should be exercised when using the medicine during lactation.

If the pain is not relieved or the fever does not subside, or if it is necessary to increase the frequency of taking the medicine, the patient should consult their doctor.

There are no available, sufficient data to demonstrate the effect of paracetamol on fertility.

Driving and using machines

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

Fervex pain and fever contains sodium, sorbitol, sodium benzoate, and fructose, glucose, and sucrose in the flavor

Each effervescent tablet contains 197 mg of sodium (the main component of table salt). This corresponds to approximately 10% of the maximum recommended daily dose of sodium in the diet for adults. If the patient takes 1 or more effervescent tablets per day for a long time, they should contact their doctor or pharmacist, especially if they are controlling their sodium intake.

Each effervescent tablet contains 126 mg of sorbitol. Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to some sugars or hereditary fructose intolerance (a rare genetic disease in which the patient's body does not break down fructose), they should consult their doctor before taking the medicine.

Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.

Each effervescent tablet contains 50 mg of 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).

The medicine contains 0.96 mg of fructose in each effervescent tablet. If the patient has previously been diagnosed with intolerance to some sugars or hereditary fructose intolerance (a rare genetic disease in which the patient's body does not break down fructose), they should consult their doctor before taking the medicine.

3. How to take Fervex pain and fever

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse.

In case of doubt, the patient should consult their doctor, pharmacist, or nurse.

The dose is determined based on the patient's body weight. The approximate age corresponding to a given body weight is provided only as a guide.

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 total daily dose of paracetamol should not exceed 4 g.

The recommended dose is:

Adults and adolescents with a body weight over 50 kg (over 15 years of age)

The recommended single dose of Fervex pain and fever is 500 mg or 1000 mg of paracetamol (one or two effervescent tablets), every 4 to 6 hours, for a total of no more than 3 g of paracetamol (6 effervescent tablets per day). However, in case of severe pain, the daily dose can be increased to a maximum of 4 g of paracetamol (8 effervescent tablets per day). The patient should always maintain an interval of at least 4 hours between doses.

Elderly patients

Usually, there is no need to modify the dose.

However, concomitant risk factors should be taken into account, some of which occur more frequently in elderly patients and require dose adjustment.

Patients with kidney function disorders

In patients with kidney function disorders, the minimum interval between doses should be modified and the maximum daily dose reduced, according to the following scheme:

Creatinine clearance

Interval between doses

Maximum daily dose

CrCl 10-50 ml/min

6 hours

3000 mg (3 g)

CrCl <10 ml min< p>

8 hours

2000 mg (2 g)

Patients with liver function disorders

In patients with liver function disorders, the dose of the medicine should be reduced or the intervals between doses prolonged. In the following situations, the maximum daily dose should not exceed 60 mg/kg body weight/day (should not exceed 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 liver 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.

The dividing line is not intended for dividing the tablet into equal doses.

The tablets should not be chewed or swallowed.

Frequency of use

To prevent periodic exacerbations of pain or fever, the interval between doses should be 6 hours and not less than 4 hours.

Duration of use

In adults, the medicine should not be used without a doctor's recommendation for more than 5 days in case of pain and more than 3 days in case of fever. In adolescents, the medicine should never be used for more than 3 days.

Using a higher dose of Fervex pain and fever than recommended

In case of taking too high a dose or accidental ingestion of Fervex pain and fever, the patient should contact their doctor for appropriate advice.

Overdose is particularly dangerous in elderly patients, small children, patients with chronic malnutrition, alcoholic liver disease, 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 subside 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 taking this medicine in a single dose of 5 g of paracetamol or more, the patient should induce vomiting if it has not been more than an hour since ingestion and contact their doctor immediately. It is recommended to administer 60-100 g of activated charcoal orally, preferably mixed with water.

The patient should seek medical attention immediately.

After paracetamol overdose, the following events have been observed:

• acute kidney failure,
• disseminated intravascular coagulation,
• rare cases of acute pancreatitis.

Missing a dose of Fervex pain and fever

The patient should not take a double dose to make up for a missed dose.

In case of any further doubts about the use of this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

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

The frequency of side effects listed below is defined as follows:

rare: in less than 1 in 1,000 but more than 1 in 10,000 treated patients,

very rare: in less than 1 in 10,000 treated patients,

unknown: frequency cannot be estimated from the available data.

Rare: lowering of blood pressure.

Very rare: tachycardia; nausea, vomiting; renal colic, renal papillary necrosis, acute kidney failure,

Unknown: anaphylactic reaction (including hypotension), anaphylactic shock, hypersensitivity reactions, angioedema (swelling of the deep layers of the skin and subcutaneous tissue); diarrhea, abdominal pain;

increased activity of liver transaminases; thrombocytopenia (reduced platelet count), leukopenia (reduced white blood cell count), neutropenia (reduced neutrophil count - a type of white blood cell); rash, erythema, urticaria, purpura, acute generalized exanthematous pustulosis, toxic epidermal necrolysis, Stevens-Johnson syndrome; bronchospasm, fixed drug eruption; severe disease that can cause acidification of the blood (so-called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).

Very rare, requiring withdrawal of treatment, cases of hypersensitivity reactions (skin redness, shortness of breath, bronchospasm, excessive sweating) have been reported.

Reporting side effects

If side effects occur, including those not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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, more information can be collected on the safety of the medicine.

5. How to store Fervex pain and fever

The medicine should be stored out of sight and reach of children.

Store in the original packaging to 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 stated.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 contains

• The active substance of the medicine is paracetamol. Each effervescent tablet contains 500 mg of paracetamol.
• The other ingredients are: anhydrous citric acid, sodium hydrogen carbonate, anhydrous sodium carbonate, sorbitol (E420), sodium docusate, povidone, sodium saccharin, sodium benzoate (E211), grapefruit-orange flavor (contains fructose, glucose, and sucrose).

What Fervex pain and fever looks like and what the packaging contains

Effervescent tablet.

Flat, white to off-white tablet, with beveled edges, effervescent when dissolved in water, with a dividing line.

The dividing line is not intended for dividing the tablet into equal doses.

Packaging: polypropylene tube with a PE cap, containing 6 effervescent tablets, in a cardboard box.

Al/PE foil packaging containing 8 effervescent tablets - two packages of 4 effervescent tablets, in a cardboard box.

Al/PE foil packaging containing 16 effervescent tablets - four packages of 4 effervescent tablets, in a cardboard box.

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, the patient 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 last revision of the leaflet:….