Feverinex

Patient Information Leaflet

Feverinex, 100 mg/mL, oral solution
Paracetamolum
Please read all of this leaflet carefully before taking this medicine, because it contains important information for you.
You must always take this medicine exactly as described in this patient leaflet or as your doctor, pharmacist or nurse has told you.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
• If there is no improvement after 2 days of treatment, or if you feel worse, contact your doctor.

Contents of the leaflet

1. What Feverinex is and what it is used for
2. What you need to know 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 Feverinex is and what it is used for

The active substance in Feverinex is paracetamol.
Feverinex belongs to a group of medicines called analgesics (pain relievers) and antipyretics (fever reducers). It is used to treat pain and fever of various causes, for example following vaccinations, during teething, or in the course of colds or flu-like conditions.
Feverinex is intended for children with body weight up to 32 kg (from 0 months up to 10 years of age).
In children under 3 months of age, Feverinex should be used only on medical advice.
If there is no improvement after 2 days of treatment, or if you feel worse, contact your 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 use Feverinex, discuss this with your doctor or pharmacist.
Other warnings and precautions:

• consult a doctor before giving this medicine to children under 3 years of age;
• do not take a higher dose than the recommended dose indicated in section 3;
• if the patient has impaired kidney, heart or lung function, or has anaemia (low haemoglobin levels in the blood, with or without reduced red blood cell count), or has low glucose-6-phosphate dehydrogenase enzyme activity in the blood, contact a doctor before using the medicine;
• in case of liver disease (including Gilbert's syndrome), contact a doctor to discuss reducing the dose and/or increasing the interval between doses;
• in patients weighing less than 50 kg due to anorexia, malnutrition or dehydration, due to the risk of increased hepatotoxicity;
• drinking alcoholic beverages while taking paracetamol may cause liver damage;
• if high fever (>39°C) is present, consult a doctor before using Feverinex;
• if fever persists for more than 2 days, symptoms worsen or new symptoms appear, discontinue treatment and consult a doctor;
• if the patient has asthma and is allergic to acetylsalicylic acid (the medicine may trigger asthma attacks).

Feverinex and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
This particularly applies to medicines containing any of the following active substances, as it may be necessary to adjust the dose or discontinue one of the following medicines:

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

Effect on laboratory tests:
If laboratory tests are planned (such as blood tests, urine tests, skin allergy tests, etc.), inform the doctor about the use of this medicine, as it may affect the results of these tests.

Taking Feverinex with food, drink and alcohol
Taking paracetamol in patients who regularly consume alcohol (three or more alcoholic drinks per day) may cause liver damage.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Feverinex may be given to pregnant women if necessary. Use the lowest effective dose sufficient 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 it becomes necessary to increase the frequency of dosing, consult a doctor or midwife.

Driving and operating machinery
This medicine has no effect or has negligible effect on the ability to drive and operate machinery.
The medicine contains less than 1 mmol (23 mg) of sodium per 1 mL, meaning the medicine is considered "sodium-free".
The medicine contains 7.68 mg of propylene glycol per 1 mL. Before administering the medicine to a child under 4 weeks of age, contact a 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 directed by a
doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or
nurse.
Feverinex is intended for use in children with body weight up to 32 kg (approximately from
0 months to 10 years of age). It is essential to follow the dosing instructions based on the child's body
weight and to determine the appropriate oral solution dose in millilitres.
Approximate age ranges related 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, administered 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.
In children under 3 years of age, it is recommended to administer Feverinex using the pipette provided with the 30 mL pack.
In children aged 3 years and older, it is recommended to administer Feverinex using the oral syringe provided with the 60 mL pack.
Below is the instructions for administering the dose of 15 mg/kg every 6 hours:

To calculate the dose directly, multiply the child's body weight in kilograms by
0.15. The result is the number of mL of Feverinex medication to be administered.
In children, this dose should be given every 6 hours, including during the night.
If the desired effect has not been achieved within 3–4 hours after administration, the medication may be
used more frequently than every 6 hours, i.e., every 4 hours. In such cases, the dose should be
10 mg/kg body weight.
Below is the dosing instruction for Feverinex at a dose of 10 mg/kg every 4 hours:

To determine the correct dose directly, multiply the child's body weight in kilograms by 0.1.
The result is the number of mL of Feverinex medication to be administered.
Under no circumstances should a dose greater than the maximum daily dose of 60 mg/kg/day be given without first consulting a doctor.
Patients with liver or kidney disease, see section 2, Warnings and precautions.
Administration of the medication depends on the presence of pain and fever symptoms. If symptoms subside, administration of the medication should be discontinued.

Instructions for correct administration of the product
Feverinex is administered orally.

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

3. – To open the bottle, press down on the triangle and turn the cap to the left (counter-clockwise). Draw up the required amount of solution using the pipette. The solution may be administered directly.
4. – To close the bottle, turn the cap to the right (clockwise) until a click is heard. The bottle must be closed tightly after each use. If visibly soiled, rinse the pipette with water and dry thoroughly before reattaching it to the bottle.

60 mL bottle with child-resistant closure and 5 mL oral syringe:

• Open the bottle according to the instructions on the cap (on first opening, break the single-use seal).
• Insert the oral syringe by pressing it through the perforated opening.
• Turn the bottle upside down and draw up the required amount of solution.
• Administer directly.
• After use, the oral syringe should be washed with water. The bottle must be closed tightly after each use.

Taking more than the recommended dose of Feverinex
If an overdose of paracetamol (more than the recommended dose) has been taken (administered to a child), consult a doctor or pharmacist immediately and provide the name of the medication and the amount taken. It is helpful to bring the packaging and the leaflet with you to show the healthcare professional.
In case of overdose, seek medical attention at a healthcare facility as quickly as possible, even if no symptoms are present, because symptoms of overdose may not appear for up to 3 days, even in severe poisoning. Symptoms of overdose may include dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.
An overdose of paracetamol is considered to have occurred when an adult has taken more than 6 g in a single dose, or a child has taken more than 100 mg per kilogram of body weight. Treatment for overdose is most effective if initiated within 4 hours of ingestion.
Patients taking barbiturates or those with chronic alcoholism may be more susceptible to paracetamol overdose.
Generally, treatment of paracetamol overdose is symptomatic.

Missed dose of Feverinex
Do not take a double dose to make up for a missed dose.
If a dose has been missed, take (administer to the child) the next dose as soon as possible, then continue taking the medication according to the normal schedule. However, if it is almost time for the next scheduled dose, skip the missed dose and take the next dose at the regular time according to the recommended dosing schedule.

Stopping treatment with Feverinex
If you have any further questions about the use of this medication, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
Adverse reactions associated with the use of paracetamol usually occur rarely (in 1 to 10 out of 10,000
patients) or very rarely (less frequently than in 1 out of 10,000 patients).
Rarely occurring adverse effects include general malaise, hypotension, and increased liver enzyme activity.
Very rarely, when high doses of the medicine are used or during prolonged treatment, liver damage may occur. Also very rarely, hypoglycemia, cloudy urine, adverse effects on the kidneys, skin rash, urticaria, anaphylactic shock, and changes in blood cell counts such as neutropenia and leukopenia may occur.
In very rare cases, severe skin reactions have been reported.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse.
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.: 22 49-21-301, fax: 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 collect more information on the safety of using this medicine.

5. How to store Feverinex

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton.
The expiry date refers to the last day of the stated month.
Store the product below 25°C.
Keep in the original packaging to protect from light.
Do not store in the refrigerator.
Expiry after first opening: 6 months.
Medicines must not be disposed of via the sewage system or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
This will help protect the environment.

6. Contents of the packaging and other information

What Feverinex contains

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

What Feverinex looks like and contents of the pack
Feverinex is a thick, viscous, clear solution with a very faint pink tint and a strawberry odour, packed in 30 mL and 60 mL bottles.

• 30 mL bottle: PET bottle (polyethylene terephthalate), orange with a child-resistant polypropylene (PP) cap, connected to an LDPE (low-density polyethylene) pipette with volume graduations from 0.4 mL to 2 mL, in a cardboard box.
• 60 mL bottle: PET bottle, orange with a child-resistant high-density polyethylene (HDPE) cap with tamper-evident ring (HDPE), with an LDPE adapter for oral syringe, and an oral syringe made of LDPE/PS (low-density polyethylene/polystyrene) with a capacity of 5 mL, graduated from 0.4 to 5 mL in 0.2 mL increments, in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
MEDICOFARMA S.A.
ul. Sokołowska 9 lok. U19
01-142 Warszawa
Phone number: +48 22 654 77 70

Manufacturer
Laboratorium Galenowe Olsztyn Sp. z o.o.
ul. Spółdzielcza 25A
11-001 Dywity