Infacetamol

Package leaflet: information for the user

Infacetamol, 100 mg/ml, oral solution
Paracetamolum
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by the doctor, 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 adverse reactions not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 2 days or if you feel worse, contact your doctor.

Table of contents

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

1. What Infacetamol is and what it is used for

The active substance in Infacetamol is paracetamol.
Paracetamol belongs to a group of medicines known as analgesics (pain relievers) and antipyretics (fever reducers). The medicine is used to treat pain and fever of various origins, for example teething, after vaccinations, colds, or flu-like conditions.
Infacetamol is intended for children with body weight up to 32 kg (approximately from 0 months to 10 years of age).
In cases of recurrent fever, high fever (>39°C), signs of secondary infection, persistence of symptoms beyond 2 days, worsening of condition, or appearance of new symptoms, the doctor should re-evaluate the clinical treatment.

2. Important information before taking Infacetamol

When not to take Infacetamol

• 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 Infacetamol, discuss this with your doctor or pharmacist:
• consult your doctor before giving this medicine to children under 3 years of age;
• do not exceed the recommended dose indicated in section 3;
• if the patient has impaired kidney, heart or lung function, or suffers from anaemia (reduced haemoglobin concentration in blood, associated or not with reduced number of red blood cells), or has low glucose-6-phosphate dehydrogenase enzyme activity in blood, contact your doctor before using the medicine;
• in case of liver disease (including Gilbert's syndrome), contact your doctor to discuss reducing the dose and/or increasing the interval between doses;
• in patients with body weight below 50 kg due to anorexia, malnutrition or dehydration, because of the potential for increased hepatotoxicity;
• drinking alcohol while taking paracetamol may cause liver damage;
• if high fever (>39°C) is present, consult your doctor before using Infacetamol.

Infacetamol with 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. This particularly applies to medicines containing any of the following active substances, as dose adjustment or discontinuation of one of the following medicines may be necessary:

• antibiotics (chloramphenicol);
• oral anticoagulants (acenocoumarol, warfarin);
• antiepileptic drugs (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine);
• antituberculosis drugs (isoniazid, rifampicin);
• barbiturates (used as hypnotics, sedatives and anticonvulsants);
• activated charcoal (used in the treatment of diarrhoea and flatulence);
• cholestyramine (used to reduce blood cholesterol levels);
• drugs used in the treatment of gout (probenecid and sulfinpyrazone);
• drugs 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);
• other medicines containing 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 Infacetamol with food, drink and alcohol
Infacetamol may be diluted with water, milk or fruit juices. Use of 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, breastfeeding, thinks she might be pregnant or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Infacetamol may be given to pregnant women if clinically justified. The lowest effective dose that adequately relieves pain or reduces fever should be used, and the medicine should be taken for the shortest possible duration and as infrequently as possible. If pain is not relieved or fever does not subside, or if increased dosing frequency is required, consult a doctor or midwife.
During pregnancy, paracetamol should not be used simultaneously with other medicines.
Paracetamol at therapeutic doses may be used during breastfeeding.

Driving and operating machinery
This medicine has no effect or negligible effect on the ability to drive and operate machinery.

Warnings concerning excipients
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 (E 1520) per 1 ml of solution. 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 Infacetamol

This medicine should always be taken exactly as described in the patient information leaflet or as advised by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.
Infacetamol is intended for use in children weighing 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 to determine the correct dose expressed in ml of oral solution.
The approximate age based on body weight is provided for informational purposes only.
In children under 3 years of age, paracetamol should be used only after consultation with a doctor.
The recommended daily dose of paracetamol is approximately 60 mg/kg body weight per day, administered in 4 to 6 divided 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 Infacetamol using the pipette provided in the 30 ml pack.
In children over 3 years of age, it is recommended to administer Infacetamol using the oral syringe provided in the 50 ml or 60 ml pack.
Below is the administration instruction for a dose of 15 mg/kg body weight 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 Infacetamol syrup 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 medicine may be
used more frequently than every 6 hours, i.e. every 4 hours. In such case, administer a dose of
10 mg/kg body weight.
Below is the dosing instruction for Infacetamol at a dose of 10 mg/kg body weight every 4 hours:

To determine the dose directly, multiply the child's body weight in kilograms by
0.10. The result is the number of ml of Infacetamol syrup to be administered.
In children, this dose should be given every 4 hours, including during the night.
In infants with body weight below 7 kg (approximately aged 0–8 months), suppositories are recommended, except in cases where administration of this pharmaceutical form is clinically impossible (e.g. diarrhea).
Under no circumstances should a dose higher than the maximum daily dose of 60 mg/kg/day be administered without prior consultation with a physician.
The maximum daily dose must not be exceeded due to the risk of severe liver damage.
For 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 symptoms subside, administration of the medicine should be discontinued.

Instructions for correct administration of the product
Infacetamol is administered orally.
[Graphic illustrating how to open and close the bottle]

30 ml bottle with child-resistant dropper (2 ml):

• 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.
• To open the bottle, press down on the triangle and unscrew the cap by turning it to the left (counterclockwise). Draw up the required amount of solution using the dropper. The solution may be administered directly or diluted with water.
• 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.

50 ml bottle with child-resistant closure and 5 ml oral syringe:

• Open the bottle following 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 or after dilution with water, milk, or juice.
• After use, the oral syringe should be washed with water. The bottle must be closed tightly after each use.

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

• Open the bottle following 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 or after dilution with water, milk, or juice.
• After use, the oral syringe should be washed with water. The bottle must be closed tightly after each use.

Accidental overdose of Infacetamol
If an amount of paracetamol exceeding the recommended dose has been taken (administered to a child), consult a physician or pharmacist immediately and provide the name of the medicine and the amount ingested. It is helpful to bring the packaging and leaflet along and hand them to the healthcare professional. In case of overdose, seek medical attention 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. The maximum daily dose must not be exceeded due to the risk of severe liver damage. Loss of consciousness does not typically occur, but immediate medical assistance is required. Prolonged use without medical supervision may be harmful. Overdose of paracetamol is considered to occur when an adult has ingested more than 6 g in a single dose, or a child has ingested more than 100 mg per kilogram of body weight. Treatment of overdose is most effective if initiated within 4 hours of ingestion. Patients taking barbiturates or with chronic alcoholism may be more susceptible to paracetamol overdose. In general, treatment of paracetamol overdose is symptomatic.

Missed dose of Infacetamol
Do not administer 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 medicine according to the regular schedule. However, if the time until the next scheduled dose is very short, the missed dose should be skipped and the next dose taken according to the recommended dosing schedule.

Discontinuation of Infacetamol
If you have any further doubts regarding the use of this medicine, consult your physician, 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 with paracetamol occur usually rarely (in 1 to 10 out of 10,000 patients) or very rarely (less frequently than in 1 out of 10,000 patients).
Rare adverse effects include general malaise, hypotension, and increased liver enzyme activity.
Very rarely, when using high doses of the medicine or during long-term treatment, liver damage (jaundice) may occur. Also very rarely, hypoglycaemia, 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.
By reporting adverse effects, additional information on the safety of the medicine can be collected.

5. How to store Infacetamol

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 in the original packaging to protect from light.
Store below 25°C.
Do not store this medicine in the refrigerator.
After opening, the contents of the bottle should be used within a maximum of 6 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Infacetamol 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 Infacetamol looks like and contents of the pack
Infacetamol is a thick, viscous, clear solution ranging in colour from colourless or pink to orange, with a strawberry odour, packed in 30 ml, 50 ml and 60 ml bottles.
Patient perception of the colour may vary.

• 30 ml bottle: orange PET (polyethylene terephthalate) bottle closed with a child-resistant PP (polypropylene) cap, with an LDPE (low-density polyethylene) pipette graduated from 0.6 ml to 2 ml, in a cardboard box with the package leaflet.
• 50 ml bottle: orange PET (polyethylene terephthalate) bottle closed with a child-resistant HDPE (high-density polyethylene) cap, with a tamper-evident ring and an LDPE connector for an oral syringe, together with 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 with the package leaflet.
• 60 ml bottle: orange PET (polyethylene terephthalate) bottle closed with a child-resistant HDPE (high-density polyethylene) cap, with a tamper-evident ring and an LDPE connector for an oral syringe, together with 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 with the package leaflet.

Marketing Authorisation Holder and Manufacturer
Farmina sp. z o.o.
ul. Lipska 44
30-721 Kraków
For further information on this medicinal product, please contact the Marketing Authorisation Holder: Farmina sp. z o.o., tel.: +48 12 290 90 00.