Fervex bul i goromhka kids

Leaflet attached to the packaging: patient information

Fervex pain and fever kids, 300 mg, rectal suppositories

Paracetamol

Read the leaflet carefully before using the medicine, as it contains

important information for the patient.
The medicine should always be taken exactly as described in this patient leaflet or as advised by a doctor, pharmacist, or nurse.

• The 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 any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

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

Fervex pain and fever kids is a medicine with analgesic and antipyretic effects. It reduces elevated body temperature that occurs during illness, without lowering normal temperature.
Indications for use:

• fever,
• symptomatic treatment of flu-like conditions and colds,
• pains of various origins.

2. Important information before taking Fervex pain and fever kids

When not to take Fervex pain and fever kids

• 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),
• if the patient has severe liver failure or active, uncompensated liver disease,
• if the patient has a deficiency of glucose-6-phosphate dehydrogenase (G6PD), which may lead to hemolytic anemia,
• if the patient is being treated with MAO inhibitors (medicines used, among other things, in depression) and for 14 days after the end of treatment,
• in patients who have recently had proctitis, proctocolitis, or rectal bleeding.

The medicine contains soybean oil. It should not be used in case of known hypersensitivity to peanuts or soy.

Warnings and precautions

Before starting treatment with Fervex pain and fever kids, the patient should discuss it with their doctor, pharmacist, or nurse.
Fervex pain and fever kids contains paracetamol. To avoid overdose, the patient should check if other medicines (including prescription and over-the-counter medicines) they are taking contain paracetamol. Overdose can lead to severe liver damage and death.
When using suppositories, there is a risk of local irritation, the frequency and severity of which increase with the duration of treatment, frequency of use, and dose of the medicine.
If a child is taking a dose of paracetamol of 60 mg/kg body weight/day, other antipyretic medicines may be considered only if the effect is insufficient.
Higher doses than recommended should not be used. Using higher doses of paracetamol than recommended carries the risk of very severe liver damage.
Paracetamol can cause severe skin reactions, 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.
The patient should consult their doctor before taking Fervex pain and fever kids if they have any of the following conditions:

• liver failure, including Gilbert's syndrome (familial hyperbilirubinemia),
• severe kidney failure,
• alcoholic disease,
• chronic malnutrition (low glutathione reserves in the liver), anorexia, bulimia, cachexia, or starvation,
• dehydration,
• reduced blood volume.

During treatment with Fervex pain and fever kids, the patient should immediately inform their doctor if they experience severe diseases, including severe kidney 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), which requires emergency treatment (see section 2).
Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, feeling of nausea (nausea) and vomiting.
During long-term (more than 3 months) use of painkillers in patients with chronic headache, when used every other day or more frequently, medication-overuse headache (MOH) may develop or worsen. MOH should not be treated by increasing the dose. In such cases, in agreement with the doctor, the patient should stop taking painkillers.

Fervex pain and fever kids 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 kids may alter the effect of the following medicines or the use of the following medicines may alter the effect of Fervex pain and fever kids:
MAO inhibitors (a group of medicines used in the treatment of depression) – should not be used concomitantly with MAO inhibitors and for 2 weeks after the end of treatment with these medicines due to the possibility of excitement and high fever.
Medicines containing salicylamide (a painkiller, also used in feverish conditions) – concomitant use may prolong the elimination of paracetamol.
Enzyme-inducing substances – caution should be exercised when concomitantly using paracetamol and 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 using the recommended doses of paracetamol (see "Using a higher dose of Fervex pain and fever kids than recommended" in section 3).
Nonsteroidal anti-inflammatory drugs (NSAIDs) – concomitant use increases the risk of kidney function disorders.
Oral anticoagulants – 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 INR monitoring 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. Patients treated with phenytoin should avoid high and/or long-term doses of paracetamol. These patients should be monitored by their doctor for signs of hepatotoxicity.
Probenecid (a medicine used in gout) – reduces the elimination of paracetamol. When concomitantly used with probenecid, the doctor should 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 treated urgently (see section 2).
The patient should inform their doctor about the use of this medicine if their doctor prescribes a test for uric acid or blood sugar.

Using Fervex pain and fever kids with food, drink, and alcohol

Alcohol should not be consumed 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, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
Other medicines containing paracetamol as the active substance, intended for adults, have been approved.
Paracetamol can be given to pregnant women if necessary. The lowest possible dose should be used to relieve pain or reduce fever, and the medicine should be taken for the shortest possible time.
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.
This medicine may be used during breastfeeding only with the doctor's consent and in individual cases.
There is no sufficient data available to determine whether paracetamol affects fertility.

Driving and using machines

The medicine does not affect psychomotor performance. There are no contraindications to driving vehicles and operating machines.

3. How to take Fervex pain and fever kids

This medicine should always be taken exactly as described in this patient leaflet or as advised by a doctor, pharmacist, or nurse. In case of doubt, the patient should consult their doctor, pharmacist, or nurse.
In children, the dosage should be observed in relation to body weight, and therefore suppositories of the appropriate strength should be chosen. The approximate age corresponding to a given body weight is provided only as a guide.
In children, the recommended single dose of paracetamol is approximately 15 mg/kg body weight. If necessary, it can be given up to 4 times a day, but not more often than every 6 hours. The recommended maximum daily dose of paracetamol is approximately 60 mg/kg body weight.
Fervex pain and fever kids, rectal suppositories, 300 mg, is intended for children with a body weight of 15 kg to 30 kg (approximately 3 to 9 years old).
The recommended single dose is 1 suppository (300 mg of paracetamol). If necessary, the dose can be repeated, but not more often than every 6 hours. No more than 4 suppositories should be used per day (the maximum daily dose of paracetamol is 1200 mg).
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
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 adults with a body weight below 50 kg,
chronic or compensated active liver disease, mild to moderate liver failure,
Gilbert's syndrome (familial non-hemolytic hyperbilirubinemia),
chronic alcoholic disease,
chronic malnutrition (low glutathione reserves in the liver),
dehydration.
Method of administration
Rectal administration. It is not recommended to use suppositories in children with diarrhea.
Frequency of use
Due to the possibility of local irritating effects, it is not recommended to use suppositories more often than 4 times a day.
Regular use of the medicine allows for the prevention of periodic exacerbations of pain or fever.
In children, equal 6-hour intervals should be maintained between consecutive doses, both during the day and at night.
Duration of treatment
The duration of use of suppositories should be as short as possible. Without consulting a doctor, the medicine should not be used for more than 3 days.

Using a higher dose of Fervex pain and fever kids than recommended

In case of using a higher dose than recommended, the patient should immediately contact their doctor, even if no symptoms have occurred, as it may lead to life-threatening liver damage.
Overdose is particularly dangerous in the elderly, small children, patients who are chronically malnourished, have liver disease, and patients taking medicines that induce liver enzymes, as these individuals have an increased risk of liver damage.
Overdose of the medicine may cause the following symptoms to occur within a few to several hours: nausea, vomiting, loss of appetite, pallor, excessive sweating, drowsiness, and general weakness. These symptoms may resolve the next day, despite the fact that liver damage is developing, manifested by abdominal distension, return of nausea, and jaundice.
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 kids

A double dose should not be used to make up for a missed dose.
In case of doubts about the use of the 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 unknown - it cannot be estimated from the available data.
Unknown: increased liver enzyme activity, anaphylactic reaction (including hypotension), anaphylactic shock, hypersensitivity reactions*, angioedema (swelling of the deep layers of the skin and subcutaneous tissue); diarrhea, abdominal pain; thrombocytopenia (reduced platelet count), leukopenia (reduced white blood cell count), neutropenia (reduced neutrophil count); skin redness, rash, erythema, urticaria, purpura, acute generalized exanthematous pustulosis, toxic epidermal necrolysis, Stevens-Johnson syndrome, bronchospasm, fixed drug eruption; a serious condition that can cause blood acidification (called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).
*Very rare, treatment-requiring cases of hypersensitivity reactions (dyspnea, bronchospasm, excessive sweating) have been reported.
Reporting side effects
If any side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor or pharmacist. 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,
Jerozolimskie Avenue 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.
Reporting side effects allows for the collection of more information on the safety of the medicine.

5. How to store Fervex pain and fever kids

The medicine should be stored out of sight and reach of children.
It should not be stored at a temperature above 30°C.
The medicine should not be used 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. Package contents and other information

What Fervex pain and fever kids contains

The active substance of the medicine is paracetamol. Each suppository contains 300 mg of paracetamol.
The other ingredients are: solid fat with additives, including lecithin derived from soybean oil.

What Fervex pain and fever kids looks like and what the package contains

Rectal suppository.
Package: 2 blisters of PVC/polyurethane (as an adhesive layer)/LDPE, in a cardboard box, containing 5 suppositories each.

Marketing authorization 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
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.
Inflancka Street 4
00-189 Warsaw
tel: +48 22 570 27 00

Date of last revision of the leaflet: