Package leaflet: Information for the user

Fervex ból i gorączka, 500 mg effervescent tablets
Paracetamolum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
Always take this medicine exactly as described in this patient leaflet or as directed by your
doctor, pharmacist, or nurse.

Keep this leaflet. 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 doctor, pharmacist, or nurse. See section 4.
If in adults the pain persists beyond 5 days or fever beyond 3 days, and in adolescents if pain or fever persist beyond 3 days, or if the patient feels worse, consult a doctor.

Contents of the leaflet

What Fervex ból i gorączka is and what it is used for
What you need to know before taking Fervex ból i gorączka
How to take Fervex ból i gorączka
Possible side effects
How to store Fervex ból i gorączka
Contents of the pack and other information

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

Fervex ból i gorączka is an analgesic and antipyretic medicine. It reduces elevated body temperature. Paracetamol irritates the gastric mucosa to a lesser extent than salicylates.
Indications:

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

This medicine is intended for short-term use in adults and adolescents with body weight over 50 kg (i.e., aged above 15 years).

2. Important information before using Fervex ból i gorączka

When not to use Fervex ból i gorączka

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 body weight below 50 kg,
in women during the first trimester of pregnancy,
if the patient has severe liver failure or active, decompensated liver disease,
if the patient has glucose-6-phosphate dehydrogenase deficiency,
if the patient is being treated with MAO inhibitors (medicines used e.g. in depression) and within 14 days after discontinuation of such treatment.

Warnings and precautions
Before starting to use Fervex ból i gorączka, consult a doctor, pharmacist, or nurse.
Fervex ból i gorączka contains paracetamol and should be used considering the simultaneous intake of other medicines containing paracetamol (including those available by prescription or over-the-counter) to avoid exceeding the recommended daily dose (see section 3).
Do not use doses higher than recommended. Taking higher than recommended doses carries a risk of severe liver damage. Symptoms of liver damage usually appear one to two days after paracetamol overdose, with maximum severity typically occurring around days 3–4.
Paracetamol may cause serious skin reactions (see section 4), such as acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which may be fatal. Inform your doctor if skin reactions occur and discontinue the medicine if a skin rash or any other sign of hypersensitivity develops.
Consult a doctor before using Fervex ból i gorączka if the patient has any of the following conditions:
liver function disorders, including Gilbert's syndrome (familial hyperbilirubinemia),
kidney function disorders (see section 3),
alcohol-related disease,
chronic malnutrition (low glutathione reserves in the liver), anorexia, bulimia, cachexia, or starvation,
dehydration,
hypovolemia (reduced circulating blood volume).
During treatment with Fervex ból i gorączka, inform the doctor immediately if the patient develops serious 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 such cases, patients have been reported to develop a serious condition called metabolic acidosis (an abnormality in blood and body fluids) when paracetamol was taken regularly over a prolonged period or when paracetamol was taken concomitantly with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.
Do not consume alcohol during treatment, nor take medicines containing alcohol.
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, discontinuation of painkillers should be considered in consultation with a doctor.

Fervex ból i gorączka and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future use.
Concurrent use of Fervex ból i gorączka may alter the effect of the following medicines, or the use of the following medicines may alter the effect of Fervex ból i gorączka taken simultaneously:

MAO inhibitors – concurrent use with MAO inhibitors is contraindicated, as well as within 2 weeks after stopping such treatment, due to the risk of developing agitation and high fever.
Medicines containing salicylamide (an analgesic also used for fever) – concurrent use prolongs the elimination time of paracetamol.
Medicines increasing hepatic metabolism – concurrent use of paracetamol with medicines such as St. John's wort, antiepileptic drugs, barbiturates (medicines mainly used in epilepsy), or 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" in section 3). Caution is advised during concurrent use.
Isoniazid (used in tuberculosis) and zidovudine (an antiviral medicine used in HIV infection) – caution is advised 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 may 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 hepatotoxicity. During phenytoin treatment, high doses and/or prolonged use of paracetamol should be avoided. Such patients should be continuously monitored for signs of liver damage.
Probenecid (used in gout) – reduces paracetamol elimination. When used concomitantly with paracetamol, the doctor may consider reducing the paracetamol dose.
Flucloxacillin (an antibiotic) – inform the doctor or pharmacist if the patient is taking flucloxacillin due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which require urgent treatment (see section 2).

Inform your doctor about using this medicine if blood tests for uric acid or blood glucose are prescribed.

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

Pregnancy, breastfeeding, and effects on fertility
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.
Fervex ból i gorączka may be given to pregnant women if necessary. The lowest effective recommended dose should be used 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 should be exercised when using the medicine during lactation.
If pain is not relieved or fever does not subside, or if increased frequency of dosing is required, consult a doctor.
There are no sufficient available data to demonstrate an effect of paracetamol on fertility.

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

Fervex ból i gorączka contains sodium, sorbitol, sodium benzoate, and fructose, glucose, and sucrose in the flavour
Each effervescent tablet contains 197 mg of sodium (main component of table salt). This corresponds to approximately 10% of the maximum recommended daily sodium intake in the diet of adults. If taking 1 or more effervescent tablets per day over a long period, patients, especially those monitoring sodium intake in their diet, should consult a doctor or pharmacist.
Each effervescent tablet contains 126 mg of sorbitol. Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance (a rare genetic disorder in which the patient's body cannot break down fructose), the patient should consult a 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 certain sugars or hereditary fructose intolerance (a rare genetic disorder in which the patient's body cannot break down fructose), consult a doctor before taking the medicine.

3. How to use Fervex ból i gorączka

This medicine should always be used exactly as described in this patient leaflet or as directed by a
doctor, pharmacist, or nurse. If in doubt, consult a 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 guideline.
The recommended single dose of paracetamol is 10 to 15 mg/kg body weight (b.w.), every 4 to 6 hours, up to a maximum daily dose of 75 mg/kg b.w. The total daily dose of paracetamol must not exceed 4 g.
Recommended dose:
Adults and adolescents with body weight above 50 kg (aged over 15 years)
The recommended single dose of Fervex ból i gorączka is 500 mg or 1000 mg paracetamol (one or two effervescent tablets), every 4 to 6 hours, with a total of no more than 3 g paracetamol (6 effervescent tablets per day). However, in the case of severe pain, the daily dose may be increased to the maximum dose of 4 g paracetamol (8 effervescent tablets per day). There must always be at least a 4-hour interval between doses.
Elderly patients
Dose adjustment is usually not necessary.
However, coexisting risk factors, some of which are more common in elderly patients, should be taken into account, as they may require dose adjustment.
Patients with renal impairment
In patients with impaired kidney function, the minimum interval between doses and the maximum daily dose should be adjusted 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 8 hours 2000 mg (2 g)
Patients with hepatic impairment
In patients with impaired liver function, the dose should be reduced or the intervals between doses extended. In the following situations, the maximum daily dose should not exceed 60 mg/kg b.w./day (should not exceed 2 g/day):

in 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 should be dissolved in a glass of water and the resulting solution consumed.
The break line is not intended for dividing the tablet into equal doses.
Do not chew or swallow the tablets whole.
Frequency of administration
To prevent periodic exacerbations of pain or fever, the interval between doses should be 6 hours and must not be shorter 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 fever without medical advice. In adolescents, never use the medicine for longer than 3 days.
Use of a higher than recommended dose of Fervex ból i gorączka
If an excessive dose is taken or if Fervex ból i gorączka is taken by mistake, contact a doctor immediately for appropriate advice.
Overdose is particularly dangerous in elderly individuals, young children, chronically malnourished patients, patients with alcohol-related disease, liver disease, and 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 subside the next day, even though liver damage may have started developing, manifesting as upper abdominal discomfort, recurrence of nausea, and jaundice.
In any case where this medicine has been taken in a single dose of 5 g paracetamol or more, vomiting should be induced if less than one hour has passed since ingestion, and medical advice should be sought immediately. Administration of 60–100 g of activated charcoal orally is recommended, preferably mixed with water.
Seek immediate medical advice.
The following events have been observed after paracetamol overdose:

acute renal failure,
disseminated intravascular coagulation,
rare cases of acute pancreatitis.

Missed dose of Fervex ból i gorączka
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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The frequency of the adverse effects listed below is defined as follows:
rare: in less than 1 in 1,000 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 deep skin layers and subcutaneous tissue); diarrhoea, abdominal pain; increased liver aminotransferase activity; thrombocytopenia (reduced number of blood platelets), leukopenia (reduced number of white blood cells), neutropenia (reduced number of neutrophils – a type of white blood cell); rash, erythema, urticaria, purpura, acute generalized exanthematous pustulosis, toxic epidermal necrolysis, Stevens-Johnson syndrome; bronchospasm, persistent drug-induced exanthema; serious condition which may cause blood acidification (so-called metabolic acidosis) in patients with severe illness taking paracetamol (see section 2).

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

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Fervex ból i gorączka

Keep the medicine 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 stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Fervex ból i gorączka contains

The active substance 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 docecyl sulfate, povidone, sodium saccharin, sodium benzoate (E211), grapefruit-orange flavour (containing fructose, glucose and sucrose).

What Fervex ból i gorączka looks like and contents of the pack
Effervescent tablet.
Flat, white to off-white tablet with bevelled edges, effervescent when dissolved in water, with a division line.
The division line is not intended for dividing the tablet into equal doses.
Pack: Polypropylene tube closed with a stopper (PE) with a moisture absorber, containing 6 effervescent tablets, in a cardboard box.
Al/PE foil pack containing 8 effervescent tablets – two packs of 4 effervescent tablets, in a cardboard box.
Al/PE foil pack containing 16 effervescent tablets – four packs of 4 effervescent tablets, in a cardboard box.

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 Warszawa
tel: +48 22 570 27 00