FERVEX 1 g Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Fervex pain and fever Forte, 1 g, effervescent tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Fervex pain and fever Forte and what is it used for
4. Important information before taking Fervex pain and fever Forte
   1. When not to take Fervex pain and fever Forte:
   2. Warnings and precautions
   3. Fervex pain and fever Forte and other medicines
   4. Using Fervex pain and fever Forte with alcohol
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Fervex pain and fever Forte contains sodium, sorbitol (E420), sodium benzoate (E211), and fructose, glucose, sucrose with flavor
5. How to take Fervex pain and fever Forte
   1. Using a higher dose of Fervex pain and fever Forte than recommended
   2. Missing a dose of Fervex pain and fever Forte
6. Possible side effects
7. How to store Fervex pain and fever Forte
8. Contents of the packaging and other information
   1. What Fervex pain and fever Forte contains
   2. What Fervex pain and fever Forte looks like and what the packaging contains
   3. Marketing authorization holder
   4. Manufacturer

Leaflet attached to the packaging: patient information

Fervex pain and fever Forte, 1 g, 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.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• 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 pain does not subside in adults after 5 days, or fever after 3 days, or if the patient feels worse, they should consult a doctor.

Table of contents of the leaflet

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

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

Fervex pain and fever Forte 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 use in adults and adolescents with a body weight over 50 kg (over 15 years of age).

2. Important information before taking Fervex pain and fever Forte

When not to take Fervex pain and fever Forte:

• if the patient is allergic to paracetamol, propacetamol hydrochloride (a precursor to paracetamol), or any of the other ingredients of this medicine (listed in section 6),
• in individuals with a body weight less than 50 kg,
• in pregnant women in the first trimester,
• if the patient has severe liver failure or active, uncontrolled 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 within 14 days after their discontinuation.

Warnings and precautions

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

Due to the content of 1 g of paracetamol in 1 effervescent tablet of Fervex pain and fever Forte, it should not be used in children and adolescents under 15 years of age.

Fervex pain and fever Forte contains paracetamol and should be used taking into account the simultaneous use of other medicines containing paracetamol (including prescription and over-the-counter medicines), so as not to exceed the recommended daily dose (see section 3).

Higher doses than recommended should not be used. Using higher doses than recommended carries the risk of very severe liver damage. Symptoms of liver damage usually appear within one to two days after paracetamol overdose, with maximum severity usually occurring within 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 any 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 Forte 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).

Alcohol should not be consumed during treatment, nor should medicines containing alcohol be taken.

During treatment with Fervex pain and fever Forte, 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 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), when they took paracetamol in regular doses for a longer period or when they took paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include:

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

During long-term (over 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. Medication-overuse headache should not be treated by increasing the dose. In such cases, the patient should, in agreement with their doctor, stop taking the painkillers.

Fervex pain and fever Forte 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 Forte may alter the effect of the following medicines or the use of the following medicines may alter the effect of Fervex pain and fever Forte:

• MAO inhibitors - concomitant use is contraindicated, as well as within 2 weeks after discontinuation of these medicines, due to the possibility of excitement and high fever.
• Salicylamide-containing medicines (pain relievers, 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 (mainly used in epilepsy), rifampicin (used in tuberculosis), may lead to liver damage, even when recommended doses of paracetamol are used (see "Use of a higher dose of Fervex pain and fever Forte than recommended" in section 3). Caution should be exercised when used concomitantly.
• Isoniazid (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 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 will increase the frequency of monitoring INR values during concomitant use, as well as for one week after discontinuation of paracetamol.
• Phenytoin (used in epilepsy) - concomitant use may reduce the effectiveness of paracetamol and increase the risk of liver toxicity. During phenytoin treatment, large and/or long-term doses of paracetamol should be avoided. Patients should be constantly monitored for signs of liver damage.
• Probenecid (used in gout) - reduces the elimination of paracetamol. When used concomitantly with paracetamol, the doctor will consider reducing the dose of paracetamol.
• 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 must be urgently treated (see section 2).

The patient should inform their doctor if they are prescribed to have uric acid or blood sugar tests.

Using Fervex pain and fever Forte with alcohol

During treatment with this medicine, 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 Forte can be given to pregnant women if necessary. The lowest recommended dose should be used to effectively relieve pain or reduce fever, and the medicine should be taken 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 pain is not relieved or 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 Forte does not affect psychophysical fitness. There are no contraindications to driving vehicles and operating machines.

Fervex pain and fever Forte contains sodium, sorbitol (E420), sodium benzoate (E211), and fructose, glucose, sucrose with flavor

Each effervescent tablet contains 394 mg of sodium (the main component of table salt). This corresponds to approximately 20% 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, especially those controlling sodium intake in their diet, they should consult their doctor or pharmacist.

Each effervescent tablet contains 252 mg of sorbitol (E420). Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to some sugars or has a hereditary fructose intolerance (a rare genetic disorder 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 1.93 mg of fructose, 1.65 mg of glucose, and 0.55 mg of sucrose (flavor components).

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Fervex pain and fever Forte contains 100 mg of sodium benzoate (E211) in each effervescent tablet, which may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of age).

3. How to take Fervex pain and fever Forte

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 recommended single dose of paracetamol is 10 to 15 mg/kg body weight (bw) every 4 to 6 hours, up to a maximum daily dose of 75 mg/kg bw. The total daily dose of paracetamol should not exceed 4 g.

Recommended dose:

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

The recommended single dose of Fervex pain and fever Forte is 1 effervescent tablet (1 g of paracetamol), every 4 to 6 hours, up to 3 times a day, for a total of no more than 3 effervescent tablets (3 g of paracetamol). However, in case of severe pain, the dose can be increased to a maximum daily dose of 4 g of paracetamol (4 effervescent tablets). The patient should always maintain at least a 4-hour interval between doses.

Elderly patients

Usually, there is no need to modify the dose. However, consideration should be given to concomitant risk factors, some of which occur more frequently in the elderly 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 should be 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)

Fervex pain and fever Forte should not be used in patients with kidney function disorders, as reduced doses are used in these patients. Fervex pain and fever, 500 mg effervescent tablets, have been approved for marketing.

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 bw/day (should not exceed 2 g/day):

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.

Fervex pain and fever Forte should not be used in patients with liver function disorders, as reduced doses of paracetamol are used in these patients, and a prolonged interval between doses is required. Fervex pain and fever, 500 mg effervescent tablets, are available on the market.

Method of administration

Oral administration.

The effervescent tablet should be dissolved in a glass of water and the prepared solution should be drunk. The tablets should not be chewed or swallowed.

Frequency of administration

To prevent periodic exacerbations of pain or fever, the interval between doses should be 6 hours and should never be less than 4 hours.

Duration of treatment

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 Forte than recommended

In case of overdose or accidental ingestion of Fervex pain and fever Forte, the patient should contact their doctor for appropriate advice.

Overdose is particularly dangerous in the elderly, small children, patients who are chronically malnourished, have liver disease, or are 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 developing, 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 been less 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 advice 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 Forte

A double dose should not be taken 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:

common: in less than 1 in 100 patients, but more than 1 in 1,000 patients treated,

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

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

not known: 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.

Not known: anaphylactic reaction (including hypotension), anaphylactic shock, hypersensitivity reactions, angioedema (swelling of the deep layers of the skin and subcutaneous tissue); diarrhea, abdominal pain;

increased liver transaminase activity; 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; a serious condition that can cause acidification of the blood (so-called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).

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

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their 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, more information can be collected on the safety of the medicine.

5. How to store Fervex pain and fever Forte

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

Store in the original packaging.

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 Forte contains

• The active substance of the medicine is paracetamol. Each effervescent tablet contains 1 g of paracetamol.
• The other ingredients are: citric acid, sodium hydrogen carbonate, sodium carbonate, sorbitol (E420), sodium docusate, povidone, sodium saccharin, sodium benzoate (E211), grapefruit-orange flavor (contains, among others, fructose, glucose, sucrose).

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

Effervescent tablet.

Flat, white to off-white, round tablet, with beveled edges, with a dividing line, effervescent after dissolution in water.

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

Packaging: polypropylene (PP) tube with a low-density polyethylene (LDPE) cap with a desiccant, containing 8 effervescent tablets, in a cardboard box, or aluminum/polyethylene (Al/PE) foil containing 8 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:…