Fervex for pain and fever baby

Package leaflet: Information for the patient

Fervex ból i gorączka baby, 150 mg, rectal suppositories
Paracetamolum
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by the
physician, 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 physician, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days, or if you feel worse, consult your physician.

Table of contents

1. What Fervex ból i gorączka baby is and what it is used for
2. Important information before using Fervex ból i gorączka baby
3. How to use Fervex ból i gorączka baby
4. Possible side effects
5. How to store Fervex ból i gorączka baby
6. 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 associated with illness, but does not lower normal body temperature.
Indications:

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

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, untreated 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 e.g. for 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 soybean oil. Do not use if known hypersensitivity to peanuts or soybeans has been diagnosed.

Warnings and precautions

Before starting to use Fervex ból i gorączka baby, discuss this with your doctor, pharmacist, or nurse.

Fervex ból i gorączka baby contains paracetamol. To avoid overdose, check whether other medicines taken by the patient (including those prescribed and available without prescription) 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 increase with the duration of treatment, frequency of administration, and dose of the medicine.

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 severe skin reactions such as acute generalised exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which may be fatal. Inform your 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 renal impairment,
• alcohol-related disease,
• chronic malnutrition (low glutathione reserves in the liver), anorexia, bulimia, cachexia, starvation,
• dehydration,
• reduced circulating blood volume.

During treatment with Fervex ból i gorączka baby, 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 these situations, patients taking paracetamol regularly over a prolonged period or taking paracetamol together with flucloxacillin have been reported to develop a serious condition called metabolic acidosis (an abnormality in blood and body fluids). Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.

Long-term (over 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 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 at the same time:

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 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 together with medicines that increase hepatic 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 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 doses 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 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 about using this medicine if your doctor orders tests for blood uric acid or blood glucose levels.

Food, drink, and alcohol

Do not drink alcohol due to the risk of toxic liver damage.

Pregnancy, breastfeeding, and fertility

This medicine is not intended for adults (see section 3).

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor before using this medicine.

Other paracetamol-containing medicines have been authorised for use in adults.

Paracetamol may be given to pregnant women if necessary. Use the lowest effective dose that adequately relieves pain or reduces fever, and take the medicine for the shortest possible time.

If pain is not relieved or fever does not subside, or if more frequent 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 using machines

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 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 only as a guideline.
In children, the recommended single dose of paracetamol is approximately 15 mg/kg body weight (bw). This dose may be
repeated 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, 150 mg rectal suppositories, is intended for children with a body weight
from 10 kg to 15 kg (approximately 24 months to 3 years of age).
The recommended single dose is 1 suppository (150 mg paracetamol). This 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 600 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 intervals between doses 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 liver insufficiency,
• Gilbert's syndrome (familial non-hemolytic hyperbilirubinemia),
• chronic alcohol-related disease,
• chronic malnutrition (low hepatic glutathione reserves),
• dehydration.

Method of administration
Rectal administration. Suppositories are not recommended for use 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 periodic exacerbations 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, because
life-threatening liver damage may occur.
Overdose is particularly dangerous in elderly individuals, young children, chronically malnourished patients, those with
alcohol-related disease, liver disorders, and patients taking drugs that induce liver enzymes, as these patients
have an increased risk of liver damage.
Overdose may result in 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 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 baby
Do not use a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult a 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 occurrence of the adverse effects listed below is defined as:
not known – cannot be estimated from the available data.
Not known: 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 or 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 disease taking paracetamol (see section 2).
*Very rare cases of hypersensitivity reactions requiring discontinuation of treatment have been reported (dyspnoea, bronchospasm, excessive sweating).

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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 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 baby

Keep the medicine out of the sight and reach of children.
Do not store at temperatures 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. 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 baby contains
The active substance is paracetamol. Each suppository contains 150 mg of paracetamol.
The other ingredients are: hard fat with additives, including lecithin derived from soybean oil.
What Fervex ból i gorączka baby looks like and contents of the pack
Rectal suppositories.
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