Patient Information Leaflet

Fervex ból i gorączka baby, 80 mg, suppositories
Paracetamolum
Please read this leaflet carefully before using the medicine, as it contains important information for you.
Always use this medicine exactly as described in this patient leaflet or as directed by your doctor, pharmacist, or nurse.

Keep this leaflet for future reference.
If you need advice or further information, consult your pharmacist.
If you experience any side effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If there is no improvement or if you feel worse after 3 days, consult your doctor.

Table of Contents

What Fervex ból i gorączka baby is and what it is used for
Important information before using Fervex ból i gorączka baby
How to use Fervex ból i gorączka baby
Possible side effects
How to store Fervex ból i gorączka baby
Contents of the pack and other information

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

Fervex ból i gorączka baby is a medicine with analgesic and antipyretic properties. It reduces elevated body temperature occurring during illness but does not lower normal body temperature.
Indications:

fever,
symptomatic treatment of influenza-like conditions and colds,
various types of pain.

2. Important information before using Fervex ból i gorączka baby

When not to use Fervex ból i gorączka baby

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),
if the patient has severe liver failure or active, uncontrolled 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, among others, in depression) or within 14 days after stopping such treatment,
in patients who recently had inflammation of the anus, rectum, or rectal bleeding.

The medicine contains soya oil. Do not use if known hypersensitivity to peanuts or soya has been diagnosed.
Warnings and precautions
Before starting treatment with Fervex ból i gorączka baby, consult a doctor,
pharmacist, or nurse.
Fervex ból i gorączka baby contains paracetamol. To avoid overdose, check whether other medicines (including those prescribed and available without prescription) taken by the patient contain paracetamol. Overdose may lead to severe liver damage and death.
Fervex ból i gorączka baby may be used in children under 2 years of age only on medical advice. If a paracetamol dose of 60 mg/kg body weight/day is administered to a child, consider using other antipyretic medicines only if insufficient effect is observed.
When using suppositories, there is a risk of local irritation, the frequency and severity of which increase with treatment duration, frequency of use, and dose.
Do not use doses higher than recommended. Using paracetamol doses higher than recommended carries a risk of severe liver damage.
Paracetamol may cause severe skin reactions such as acute generalised exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which may be fatal.
Inform the doctor if skin reactions occur.
Consult a doctor before using Fervex ból i gorączka baby if the patient has any of the following conditions:

liver dysfunction, including Gilbert's syndrome (familial hyperbilirubinaemia),
severe kidney failure,
alcohol-related disease,
chronic malnutrition (low glutathione reserves in the liver), anorexia, bulimia, cachexia, or starvation,
dehydration,
reduced circulating blood volume.

During treatment with Fervex ból i gorączka baby, immediately inform the doctor if the patient develops serious conditions, including severe kidney dysfunction 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 abnormality in blood and body fluids), when paracetamol was used regularly over a prolonged period or when paracetamol was taken together 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 in patients with chronic headaches, taken on alternate days or more frequently, may lead to development or worsening of headaches. 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 baby and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Concurrent use of Fervex ból i gorączka baby may alter the effect of the following medicines, or the use of the following medicines may alter the effect of Fervex ból i gorączka baby taken simultaneously:
MAO inhibitors (a group of medicines used in the treatment of depression) – do not use concurrently with MAO inhibitors or 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 in feverish conditions) – concurrent use may prolong paracetamol elimination.
Enzyme-inducing substances: exercise caution when using paracetamol concurrently with medicines that increase liver metabolism, such as antiepileptic drugs, barbiturates (medicines mainly used in epilepsy), rifampicin (a medicine used in tuberculosis), and isoniazid (a medicine used in tuberculosis). This may lead to liver damage, even when recommended paracetamol doses are used (see section "Use of higher than recommended dose of Fervex ból i gorączka baby" in section 3).
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 concurrent use and for one week after stopping paracetamol.
Phenytoin (a medicine used in epilepsy) – concurrent use may reduce the effectiveness of paracetamol and increase the risk of liver toxicity. Patients treated with phenytoin should avoid high and/or long-term use of paracetamol. The doctor should monitor these patients for signs of hepatotoxicity.
Probenecid (a medicine used in gout) – reduces paracetamol elimination. When used concurrently with probenecid, the doctor should 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 the doctor about using this medicine if the doctor orders tests for blood uric acid or blood glucose levels.
Use of Fervex ból i gorączka baby with food, drink, and alcohol
Do not drink alcohol due to the risk of toxic liver damage.
Pregnancy, breastfeeding, and fertility
This medicine is intended for children (see section 3).
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor before using this medicine.
Other paracetamol-containing medicines, with paracetamol as the active substance, have been authorised for adults.
Paracetamol may be given to pregnant women if necessary. Use the lowest effective dose to relieve pain or reduce fever, and take the medicine for the shortest possible time.
If pain is not relieved or fever does not subside, or if increased frequency of dosing is required, consult a doctor.
This medicine may be used during breastfeeding only with a doctor's approval and in individual cases.
There are insufficient available data to determine whether paracetamol affects fertility.
Driving and operating machinery
The medicine does not affect psychomotor performance. There are no contraindications to driving vehicles or operating machinery.

3. How to use Fervex ból i gorączka baby

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.
In children, dosing must be based on body weight; therefore, rectal suppositories of appropriate strength should be selected. The approximate age corresponding to a given body weight is provided only as a guideline.
The recommended single dose of paracetamol in children is approximately 15 mg/kg body weight (bw). This may be administered up to 4 times daily, no more frequently than every 6 hours. The recommended maximum daily dose of paracetamol is approximately 60 mg/kg bw.
Fervex ból i gorączka baby, 80 mg rectal suppositories, is intended for infants and children with body weight between 5 kg and 10 kg (approximately 2 to 24 months of age) and should be used only on a doctor's advice.
The recommended single dose is 1 suppository (80 mg paracetamol). The dose may be repeated if necessary, no more frequently than every 6 hours. Do not use more than 4 suppositories per day (maximum daily dose of paracetamol is 320 mg).

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

| Creatinine clearance | Dosing interval | 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 dosing intervals extended. In the following situations, the maximum daily dose should not exceed 60 mg/kg bw/day (should not exceed 2 g/day):

adults with body weight below 50 kg,
chronic or compensated active liver disease, mild to moderate liver failure,
Gilbert's syndrome (familial non-hemolytic hyperbilirubinemia),
chronic alcohol-related liver disease,
chronic malnutrition (low hepatic glutathione reserves),
dehydration.

Method of administration
Rectal administration. Use of suppositories is not recommended in children with diarrhoea.

Frequency of use
Due to the potential for local irritant effects, suppositories should not be used more than 4 times daily.
Regular administration of the medicine helps prevent recurrent episodes of pain or fever.
In children, equal 6-hour intervals between doses should be maintained both during the day and at night.

Duration of treatment
The duration of suppository use should be as short as possible. Do not use this medicine for longer than 3 days without consulting a doctor.

Use of a higher than recommended dose of Fervex ból i gorączka baby
If a dose higher than recommended is used, contact a doctor immediately, even if no symptoms are present, as life-threatening liver damage may occur.
Overdose is particularly dangerous in elderly individuals, young children, chronically malnourished patients, patients with alcohol-related disease, liver disorders, and patients taking drugs that induce liver enzymes, as these individuals have an increased risk of liver damage.
Overdose may cause symptoms appearing 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 be developing, manifesting as upper abdominal discomfort, recurrence of nausea, and jaundice.
After paracetamol overdose, the following events have been observed:

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

Missed dose of Fervex ból i gorączka baby
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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The frequency of adverse reactions listed below is defined as unknown – cannot be estimated from the available data.
Unknown: increased hepatic aminotransferase activity, anaphylactic reaction (including hypotension), anaphylactic shock, hypersensitivity reactions*, angioedema (swelling of deep skin layers and subcutaneous tissue), diarrhoea, abdominal pain; thrombocytopenia (reduced platelet count), leukopenia (reduced white blood cell count), neutropenia (reduced neutrophil count – a type of white blood cell); skin erythema, rash, erythema, urticaria, purpura, acute generalized exanthematous pustulosis, toxic epidermal necrolysis, Stevens-Johnson syndrome, bronchospasm, persistent drug eruption.
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 requiring discontinuation of treatment (dyspnoea, bronchospasm, excessive sweating) have been reported.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions may also be reported to the Marketing Authorisation Holder.
Reporting adverse reactions enables better assessment of the safety of the medicine.

5. How to store Fervex ból i gorączka baby

Keep this medicine out of sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the packaging 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. This will help protect the environment.

6. Contents of the pack and other information

What Fervex ból i gorączka baby contains
The active substance is paracetamol. Each suppository contains 80 mg of paracetamol.
Other ingredients: hard fat with additives, including lecithin derived from soybean oil.
What Fervex ból i gorączka baby looks like and contents of the pack
Suppository.
Pack: 2 blisters made of PVC/polyurethane (as adhesive layer)/LDPE, in a cardboard box,
containing 5 suppositories each.
Marketing Authorisation Holder
UPSA SAS
3 rue Joseph Monier
92500 Rueil-Malmaison, France
Manufacturer
UPSA SAS
304, Avenue du Dr Jean Bru
47000 Agen, France
UPSA SAS
979, Avenue des Pyrénées
47520 Le Passage, France
For further information about this medicinal product, contact the local representative of the Marketing Authorisation Holder:
MagnaPharm Poland sp. z o.o.
ul. Inflancka 4
00-189 Warsaw, Poland
tel: +48 22 570 27 00