Feverinex

Leaflet attached to the packaging: information for the user

Feverinex, 100 mg/mL, oral solution

Paracetamol

Read the leaflet carefully before taking the medicine, as it contains important information

for the patient.
This medicine should always be taken exactly as described in the patient leaflet or as advised by
the doctor, pharmacist, or nurse.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If after 2 days of taking the medicine there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Feverinex and what is it used for
• 2. Important information before taking Feverinex
• 3. How to take Feverinex
• 4. Possible side effects
• 5. How to store Feverinex
• 6. Contents of the pack and other information

1. What is Feverinex and what is it used for

The active substance of Feverinex is paracetamol.
Feverinex belongs to a group of pain-relieving and antipyretic medicines. The medicine is used for pain
and fever of various origins, e.g., after vaccinations, during teething, as well as during colds or flu-like
states.
Feverinex is intended for children with a body weight of up to 32 kg (approximately from 0 months to 10 years).
In children under 3 months of age, the medicine should only be used after consulting a doctor.
If after 2 days of taking the medicine there is no improvement or the patient feels worse, they should contact their doctor.

2. Important information before taking Feverinex

When not to take Feverinex

• if the patient is allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to take Feverinex, the patient should discuss it with their doctor or pharmacist.
Other warnings and precautions:

• consult a doctor before giving this medicine to children under 3 years of age;
• do not give a dose higher than the recommended dose indicated in section 3;
• if the patient has kidney, heart, or lung disorders, or anemia (reduced hemoglobin level in the blood, related or not to a reduced number of red blood cells), or the activity of the enzyme glucose-6-phosphate dehydrogenase in the blood is low, they should consult a doctor before taking the medicine;
• in case of liver disease (including Gilbert's syndrome), the patient should consult a doctor to reduce the dose and/or increase the intervals between doses;
• in patients with a body weight below 50 kg due to anorexia, malnutrition, or dehydration, because of the possibility of increased hepatotoxicity;
• drinking alcoholic beverages while taking paracetamol may cause liver damage;
• if the patient has a high fever (>39°C), they should consult a doctor before taking Feverinex;
• if the fever persists for more than 2 days, symptoms worsen, or other symptoms appear, the patient should stop the treatment and consult a doctor;
• if the patient has asthma and is allergic to acetylsalicylic acid (the medicine may cause asthma).

Feverinex and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
This is especially important when taking medicines containing any of the following active substances, as it may be necessary to change the dose or stop taking one of the following medicines:

• antibiotics (chloramphenicol);
• oral anticoagulants (acenocoumarol, warfarin);
• antiepileptic medicines (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine);
• oral contraceptives and estrogens;
• antituberculosis medicines (isoniazid, rifampicin);
• barbiturates (used as sedatives, tranquilizers, and anticonvulsants);
• activated charcoal, used to treat diarrhea and bloating;
• cholestyramine (used to reduce blood cholesterol levels);
• medicines used to treat gout (probenecid and sulfinpyrazone);
• medicines used to relieve spasms and cramps of the stomach, intestines, and bladder (anticholinergic medicines);
• metoclopramide (used to prevent nausea and vomiting);
• zidovudine (used to treat people infected with the human immunodeficiency virus that causes AIDS);
• flucloxacillin (an antibiotic), due to the serious risk of a blood and fluid disorder (metabolic acidosis with a large anion gap), which requires urgent treatment and may occur especially in patients with severe kidney disorders, sepsis (a condition in which bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, as well as in patients taking maximum daily doses of paracetamol.

Effect on laboratory tests:
In the case of planned laboratory tests (such as blood tests, urine tests, skin allergy tests, etc.), the patient should inform their doctor about taking this medicine, as it may affect the results of these tests.

Taking Feverinex with food, drink, and alcohol

Taking paracetamol in patients who regularly drink alcohol (three or more alcoholic drinks per day) may damage the liver.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Feverinex can be given to pregnant women if necessary. The lowest effective dose should be used 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 or midwife.

Driving and using machines

The medicine has no or negligible influence on the ability to drive and use machines.
The medicine contains less than 1 mmol (23 mg) of sodium per 1 mL, which means the medicine is considered "sodium-free".
The medicine contains 7.68 mg of propylene glycol per 1 mL. Before giving the medicine to a child under 4 weeks of age, the patient should consult their doctor or pharmacist, especially if the child is taking other medicines containing propylene glycol or alcohol.

3. How to take Feverinex

This medicine should always be taken exactly as described in the patient leaflet or as advised by
the doctor, pharmacist, or nurse. In case of doubt, the patient should consult their doctor, pharmacist, or nurse.
Feverinex is intended for use in children with a body weight of up to 32 kg (approximately from 0 months to 10 years). It is necessary to follow the dosing based on the child's body weight and determine the appropriate dose of the oral solution in milliliters.
The approximate age ranges given in relation to body weight are provided only as additional information for the patient.
The recommended daily dose of paracetamol is approximately 60 mg/kg body weight per day and is given in 4 to 6 doses per day, e.g., 15 mg/kg body weight every 6 hours or 10 mg/kg body weight every 4 hours.

To determine the dose directly, the child's body weight in kilograms should be multiplied by

0.15. The result is the number of mL of Feverinex to be given.
In children, this dose should be given every 6 hours, also at night.
If the desired effect is not achieved within 3-4 hours of administration, the medicine may be given more frequently than every 6 hours, i.e., every 4 hours. In this case, a dose of 10 mg/kg body weight should be given.

To determine the dose directly, the child's body weight in kilograms should be multiplied by 0.1.

The result is the number of mL of Feverinex to be given.

Never give a dose higher than the maximum daily dose of 60 mg/kg/day without consulting a doctor first.

Patients with liver or kidney disease, see section 2, Warnings and precautions.
Administration of the medicine depends on the presence of pain and fever symptoms. If the symptoms subside, the medicine should be stopped.

Instructions for proper administration of the product

Feverinex is given orally.

Bottle of 30 mL with a child-resistant pipette (2 mL):
1 and 2. Hold the bottle firmly in one hand. With the other hand, grasp the cap with your thumb and index finger in the place marked with triangles on the cap, where the word "PRESS" is written.

• 3. To open the bottle, press on the triangle and unscrew the cap by turning it to the left (counterclockwise). Take the required amount of solution using the pipette. It can be given directly.
• 4. To close the bottle, screw the cap to the right (clockwise) until you hear a click. Close the bottle tightly after each use. If the pipette is heavily soiled, rinse it with water and dry it before putting it back on the bottle.

Bottle of 60 mL with a child-resistant closure and a 5 mL oral syringe:

• Open the bottle according to the instructions on the cap (when opening for the first time, break the one-time seal).
• Insert the oral syringe by pressing the perforated hole.
• Turn the bottle upside down and take the required amount of solution.
• Give it directly.
• After use, the oral syringe should be washed with water. Close the bottle tightly after each use.

Taking a higher dose of Feverinex than recommended

In case of taking (giving to a child) a higher dose of paracetamol than recommended, the patient should immediately consult a doctor or pharmacist and provide the name of the medicine and the amount taken. It is helpful to take the packaging and leaflet with them and give them to the specialist.
In case of overdose, the patient should go to a healthcare facility as soon as possible, even if no symptoms have appeared, because even in severe poisoning, symptoms may not appear until up to 3 days after taking the medicine. Symptoms of overdose may include dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.
Overdose of paracetamol is considered when an adult has taken more than 6 grams in a single dose, and a child has taken more than 100 mg per kilogram of body weight. Treatment of overdose is more effective if started within 4 hours of taking the medicine.
Patientstaking barbiturates and those with chronic alcoholism may be more susceptible to paracetamol overdose.
Generally, in case of paracetamol overdose, treatment is symptomatic.

Missing a dose of Feverinex

Do not take a double dose to make up for a missed dose.
If a dose is missed, the next dose should be taken as soon as possible, and then the medicine should be continued according to the normal schedule. However, if the time to the next dose is very short, the missed dose should be skipped and the next dose taken according to the recommended dosing schedule.

Stopping Feverinex

In case of any further doubts about taking the medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Feverinex can cause side effects, although not everybody gets them.
Adverse reactions to paracetamol are rare (occurring in 1 to 10 per 10,000 patients) or very rare (occurring in less than 1 per 10,000 patients).
Rare side effects include general malaise, hypotension, and increased liver enzyme activity.
Very rare side effects include liver damage, hypoglycemia, cloudy urine, kidney disorders, skin rash, hives, anaphylactic shock, and changes in blood cell count, such as neutropenia and leukopenia.
Very rare cases of severe skin reactions have been reported.
Reporting side effects
If side effects occur, the patient should inform their doctor, pharmacist, or nurse about them, including any side effects not listed in the leaflet.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, phone: 22 49-21-301, fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Feverinex

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton.
The expiry date refers to the last day of the month.
The product should be stored at a temperature below 25°C.
Store in the original packaging to protect from light.
Do not store in the refrigerator.
Shelf life after first opening: 6 months. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Feverinex contains

• The active substance of Feverinex is paracetamol. Each mL of the solution contains 100 mg of paracetamol.
• The other ingredients (excipients) are: glycerol, macrogol 600, sodium saccharin, strawberry flavor PHL-132200 (propylene glycol, flavoring substances), purified water.

What Feverinex looks like and contents of the pack

Feverinex is a thick, viscous, clear solution with a very light pink color and a strawberry flavor, packaged in bottles of 30 and 60 mL.

• -bottle of 30 mL:PET (polyethylene terephthalate) bottle, orange with a PP (polypropylene) cap with a child-resistant mechanism connected to a 2 mL LDPE (low-density polyethylene) pipette with a scale from 0.4 mL to 2 mL, in a cardboard box.
• -bottle of 60 mL:PET bottle, orange with an HDPE (high-density polyethylene) cap with a child-resistant mechanism and a LDPE oral syringe with a scale from 0.4 to 5 mL, in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder
MEDICOFARMA S.A.
Sokołowska Street 9, suite U19
01-142 Warsaw
Phone: +48 22 654 77 70
Manufacturer
Laboratorium Galenowe Olsztyn Sp. z o.o.
Spółdzielcza Street 25A
11-001 Dywity

Date of last revision of the leaflet: