Fervex for pain and fever forte

Package leaflet: Information for the user

Fervex ból i gorączka Forte, 1 g, effervescent tablets
Paracetamolum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
You must always take this medicine exactly as described in this patient information leaflet or as
advised by your doctor, pharmacist, or nurse.

• Keep this leaflet so that you can read it again if necessary.
• 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 persists beyond 3 days, or if the patient feels worse, consult a doctor.

Contents of the leaflet

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

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

Fervex ból i gorączka Forte 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 use in adults and adolescents with body weight above 50 kg (aged over 15 years).

2. Important information before using Fervex ból i gorączka Forte

When not to use Fervex ból i gorączka Forte:

• 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 individuals with body weight below 50 kg,
• in women during the first trimester of pregnancy,
• in patients with severe hepatic insufficiency or active, uncompensated liver disease,
• in patients with glucose-6-phosphate dehydrogenase deficiency,
• in patients being treated with MAO inhibitors (medicines used, among others, in depression) and within 14 days after discontinuation of such treatment.

Warnings and precautions
Before starting treatment with Fervex ból i gorączka Forte, discuss it with your doctor, pharmacist, or nurse.
Due to the content of 1 g paracetamol per effervescent tablet, Fervex ból i gorączka Forte should not be used in children and adolescents under 15 years of age.
Fervex ból i gorączka Forte contains paracetamol and should be used with consideration of simultaneous intake of other medicines containing paracetamol (including prescription or over-the-counter medicines) to avoid exceeding the recommended daily dose (see section 3).
Do not use doses higher than recommended. Using higher than recommended doses carries a risk of severe liver damage. Symptoms of liver injury usually appear one to two days after paracetamol overdose, with maximum severity typically occurring around days 3–4.
Paracetamol may cause severe 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 use of the medicine if a skin rash or any other sign of hypersensitivity appears.
Consult your doctor before using Fervex ból i gorączka Forte if the patient has 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 hepatic glutathione reserves), anorexia, bulimia, cachexia, or starvation,
dehydration,
hypovolemia (reduced circulating blood volume).
Do not consume alcohol during treatment, nor take medicines containing alcohol.
During treatment with Fervex ból i gorączka Forte, immediately inform your doctor if the patient develops any serious illness, 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 (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.
Prolonged use (over 3 months) of painkillers taken on alternate days or more frequently in patients with chronic headache may lead to development or worsening of headache. Medication-overuse headache (MOH) should not be treated by increasing the dose. In such cases, in consultation with a doctor, painkillers should be discontinued.

Fervex ból i gorączka Forte and other medicines
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.
Concurrent use of Fervex ból i gorączka Forte may alter the effect of the following medicines, or the use of the following medicines may alter the effect of Fervex ból i gorączka Forte:

• MAO inhibitors – concomitant use with MAO inhibitors is contraindicated, as well as within 2 weeks after discontinuation of these medicines, due to the risk of excitation and high fever.
• Medicines containing salicylamide (an analgesic also used in fever) – concomitant use prolongs paracetamol elimination time.
• Medicines increasing hepatic metabolism – concomitant 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 higher than recommended dose of Fervex ból i gorączka Forte" in section 3). Caution is advised during concomitant use.
• Isoniazid (used in tuberculosis) and zidovudine (an antiviral medicine used in HIV infection) – caution is advised during concomitant use.
• Non-steroidal anti-inflammatory drugs (NSAIDs) – concomitant use increases the risk of kidney function disorders. Oral anticoagulants – concomitant use of paracetamol with coumarin anticoagulants, including warfarin, may lead to minor changes in INR values. In such cases, the doctor will increase the frequency of INR monitoring during concomitant use and 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, high and/or prolonged doses of paracetamol should be avoided. These patients should be continuously monitored for signs of liver damage.
• Probenecid (used in gout) – reduces paracetamol excretion. During concomitant use with paracetamol, the doctor may consider reducing the paracetamol dose.
• Flucloxacillin (antibiotic) – inform your 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 that you are taking this medicine if your doctor orders tests for uric acid or blood glucose.

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

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Fervex ból i gorączka Forte may be given to pregnant women if necessary. The lowest effective recommended dose should be used, and the medicine should be 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 should be exercised when using the medicine during lactation.
If pain is not relieved or fever does not subside, or if it becomes necessary to increase the frequency of dosing, 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 Forte does not affect psychophysical performance. There are no contraindications to driving or operating machinery.

Fervex ból i gorączka Forte contains sodium, sorbitol (E420), sodium benzoate (E211), and fructose, glucose, sucrose from flavouring
Each effervescent tablet contains 394 mg of sodium (main component of table salt). This corresponds to approximately 20% of the maximum recommended daily sodium intake in the diet of adults. Patients who take 1 or more effervescent tablets daily over a long period, especially those monitoring sodium intake, 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 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 1.93 mg fructose, 1.65 mg glucose, and 0.55 mg sucrose (components of flavouring).
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicine.
Fervex ból i gorączka Forte contains 100 mg 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 life).

3. How to use Fervex ból i gorączka Forte

This medicine should always be taken exactly as described in this patient leaflet or as directed by your
doctor, pharmacist, or nurse. If in doubt, consult your 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 (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 Forte is 1 effervescent tablet (1 g paracetamol),
every 4 to 6 hours up to 3 times a day, not exceeding 3 effervescent tablets (3 g paracetamol) in total.
However, in case of severe pain, the dose may be increased to the maximum daily dose of
4 g paracetamol (4 effervescent tablets). A minimum interval of at least 4 hours must always be maintained 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 renal function, 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 8 hours 2000 mg (2 g)
Fervex ból i gorączka Forte should not be used in patients with renal impairment, as reduced doses are required in these patients. Fervex ból i gorączka 500 mg effervescent tablets are available on the market.
Patients with hepatic impairment
In patients with impaired liver function, the dose of the medicine 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 alcoholic liver disease,
• chronic malnutrition (low hepatic glutathione reserves),
• dehydration.
  Fervex ból i gorączka Forte should not be used in patients with hepatic impairment, as reduced doses of paracetamol are required and longer intervals between doses are necessary.
  Fervex ból i gorączka 500 mg effervescent tablets are available on the market.
  Method of administration
  Oral use.
  The effervescent tablet should be dissolved in a glass of water and the resulting solution drunk. Do not chew or swallow the tablets.
  Frequency of use
  To prevent periodic exacerbations of pain or fever, the interval between doses should be 6 hours and must in no case be shorter than 4 hours.
  Duration of treatment
  In adults, do not use this medicine for longer than 5 days for pain or 3 days for fever without medical advice. In adolescents, do not use the medicine for longer than 3 days.
  Use of a higher than recommended dose of Fervex ból i gorączka Forte
  If an overdose is taken or Fervex ból i gorączka Forte is taken by mistake, contact a doctor immediately for appropriate advice.
  Overdose is particularly dangerous in elderly patients, young children, chronically malnourished patients, patients with alcoholic liver disease, liver diseases, and patients taking medicines that induce liver enzymes, as these patients are at 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 already be developing, manifested by upper abdominal discomfort, recurrence of nausea, and jaundice.
  In any case of single intake of this medicine at a dose of 5 g paracetamol or more, vomiting should be induced if less than one hour has passed since ingestion, and immediate medical advice should be sought. 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 Forte
  Do not take a double dose to make up for a missed dose.
  If you have any further doubts regarding 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 everybody will experience them.
The frequency of occurrence of 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: low blood pressure.
Very rare: tachycardia, nausea, vomiting, renal colic, necrosis of renal papillae, acute kidney failure.
Not known: anaphylactic reaction (including hypotension), anaphylactic shock, hypersensitivity reactions,
angioedema (swelling of deep layers of skin and subcutaneous tissue); diarrhoea, abdominal pain;
increased hepatic aminotransferase activity; thrombocytopenia (reduced number of platelets),
leukopenia (reduced number of white blood cells), neutropenia (reduced number of neutrophils – a type
of white blood cells); rash, erythema, urticaria, purpura, generalised pustular eruption, toxic epidermal
necrolysis, Stevens-Johnson syndrome, bronchospasm, persistent drug-induced urticaria; 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 adverse effects not listed in this leaflet, inform your doctor,
pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring of 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Fervex ból i gorączka Forte

Keep this medicine 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 specified 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 Forte contains

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

What Fervex ból i gorączka Forte looks like and contents of the pack
Effervescent tablet.
Flat, white to off-white, round tablet with bevelled edges and a break line, effervescent upon
dissolution in water.
The break line is not intended for dividing the tablet into equal doses.
Pack: polypropylene tube (PP) closed with an LDPE cap and containing a moisture absorber,
containing 8 effervescent tablets in a cardboard box, or Al/PE foil containing 8 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 on 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