Fervex for pain and fever kids

Package leaflet: Information for the user

Fervex ból i gorączka kids, 300 mg, suppositories
Paracetamolum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed 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 contact 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 there is no improvement or if you feel worse after 3 days, consult your doctor.

Table of contents of the leaflet

1. What Fervex ból i gorączka kids is and what it is used for
2. Important information before using Fervex ból i gorączka kids
3. How to use Fervex ból i gorączka kids
4. Possible side effects
5. How to store Fervex ból i gorączka kids
6. Contents of the pack and other information

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

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

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

2. Information before using Fervex ból i gorączka kids

When not to use Fervex ból i gorączka kids

• 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, uncompensated 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 monoamine oxidase inhibitors (MAO inhibitors) (medicines used e.g. in depression), or within 14 days after stopping such treatment,
• in patients who have recently had anal, rectal inflammation or bleeding from the anus.

This medicine contains soya oil. Do not use if there is a known hypersensitivity to peanuts or soya.

Warnings and precautions

Before starting to use Fervex ból i gorączka kids, consult a doctor, pharmacist, or nurse.

Fervex ból i gorączka kids contains paracetamol. To avoid overdose, check whether other medicines (including those prescribed and those available without prescription) taken by the patient contain paracetamol. Overdose may lead to severe liver damage and death.

When using suppositories, there is a risk of local irritation, the frequency and severity of which increases with duration of treatment, frequency of use, and dose.

If a child is receiving a paracetamol dose of 60 mg/kg body weight/day, other antipyretic medicines may be considered only if the effect is insufficient.

Do not use doses higher than recommended. Using paracetamol doses higher than recommended carries a risk of severe liver damage.

Paracetamol may cause serious skin reactions such as acute generalised exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which may be fatal. Inform a doctor if skin reactions occur.

Consult a doctor before using Fervex ból i gorączka kids 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 kids, inform the doctor immediately if the patient develops severe illness, 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, severe metabolic acidosis (a blood and body fluid imbalance) has been reported in patients taking paracetamol regularly over a prolonged period or taking paracetamol together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.

Prolonged (more than 3 months) use of painkillers in patients with chronic headache, taken on alternate 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 kids 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 kids may alter the effect of the following medicines, or the use of the following medicines may alter the effect of Fervex ból i gorączka kids taken simultaneously:

MAO inhibitors (a group of medicines used in the treatment of depression) – do not use simultaneously with MAO inhibitors or within 2 weeks after stopping treatment with these medicines due to the risk of excitation and high fever.

Medicines containing salicylamide (an analgesic also used in febrile conditions) – concurrent use may prolong paracetamol elimination time.

Enzyme-inducing substances – exercise caution when using paracetamol together with medicines that increase liver metabolism, such as antiepileptic drugs, barbiturates (medicines mainly used in epilepsy), rifampicin (used in tuberculosis), and isoniazid (used in tuberculosis). This may lead to liver damage, even when recommended doses of paracetamol are used (see section "Use of doses higher than recommended for Fervex ból i gorączka kids" in section 3).

Non-steroidal anti-inflammatory drugs (NSAIDs) – concurrent use increases the risk of kidney dysfunction.

Oral anticoagulants – concurrent use of paracetamol with coumarin anticoagulants, including warfarin, may lead to minor 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 (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. These patients should be monitored by a doctor for signs of hepatotoxicity.

Probenecid (a medicine used in gout) – reduces paracetamol elimination. When using this medicine together 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 disturbances (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.

Taking Fervex ból i gorączka kids 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 is planning to have a child, she should consult a doctor before using this medicine.

Other paracetamol-containing medicines have been authorised for adult use.

Paracetamol may be given to pregnant women if necessary. Use the lowest effective dose to relieve pain or reduce fever, and use the medicine for the shortest possible time.

If pain is not relieved or fever does not subside, or if it becomes necessary to increase the frequency of dosing, 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 kids

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 should be based on body weight; therefore, suppositories of appropriate strength should be selected.
The approximate age corresponding to a given body weight is provided as a guideline only.
The recommended single dose of paracetamol in children is approximately 15 mg/kg body weight (bw).
It 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 kids, 300 mg rectal suppositories, is intended for children with a body weight of
15 kg to 30 kg (approximately 3 to 9 years of age).
The recommended single dose is 1 suppository (300 mg paracetamol). The dose may be repeated if necessary,
but no more frequently than every 6 hours. Do not use more than 4 suppositories per day (the maximum
daily dose of paracetamol is 1200 mg).

Patients with impaired renal function
In patients with impaired renal function, the minimum interval between doses should be adjusted 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 impaired hepatic function
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 (and should not exceed 2 g/day):

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

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

Frequency of administration
Due to the potential for local irritant effects, suppositories should not be used more than 4 times per day.
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 treatment with suppositories 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 kids
If a dose higher than recommended is used, contact a doctor immediately, even if no symptoms are present, because life-threatening liver damage may occur.
Overdose is particularly dangerous in elderly individuals, young children, chronically malnourished patients, those with alcoholic liver disease, liver disorders, and patients taking drugs that induce liver enzymes, as these patients are at increased risk of liver damage.
Overdose may result in symptoms appearing within several to several dozen hours, such as: nausea, vomiting, anorexia, pallor, excessive sweating, drowsiness, and general weakness. These symptoms may resolve the next day, even though liver damage may already be developing, manifesting as abdominal distension, recurrence of nausea, and jaundice.
The following events have been observed after paracetamol overdose:

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

Missed dose of Fervex ból i gorączka kids
Do not take a double dose to make up for a missed dose.
If in doubt about how to use the medicine, consult a 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 occurrence of the adverse reactions listed below is defined as unknown – cannot be
estimated based on available data.
Unknown: increased hepatic aminotransferase activity, anaphylactic reaction (including hypotension),
anaphylactic shock, hypersensitivity reactions*, angioedema (swelling of deep layers of skin and subcutaneous tissue); diarrhoea, abdominal pain; thrombocytopenia (reduced number of blood platelets), leukopenia (reduced number of white blood cells), neutropenia (reduced number of neutrophils – a type of white blood cells); skin redness, 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 disease taking paracetamol (see section 2).
*Very rare, treatment-discontinuing cases of hypersensitivity reactions (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 your 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 can also be reported to the marketing authorization holder.
Reporting adverse reactions enables continued monitoring of the medicine's safety.

5. How to store Fervex ból i gorączka kids

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 carton after EXP.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Please ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Fervex ból i gorączka kids contains
The active substance is paracetamol. Each suppository contains 300 mg of paracetamol.
The other ingredients are: hard fat with additives, including lecithin derived from soybean oil.

What Fervex ból i gorączka kids looks like and contents of the pack
Rectal 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 medicine, 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