INFACETAMOL 100 mg /Ml Solution

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Infacetamol, 100 mg/ml, oral solution
   1. Read the leaflet carefully before taking the medicine, as it contains important information
   2. Table of contents of the leaflet
3. What is Infacetamol and what is it used for
4. Important information before taking Infacetamol
   1. When not to take Infacetamol
   2. Warnings and precautions
   3. Infacetamol and other medicines
   4. Taking Infacetamol with food, drinks, and alcohol
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
5. How to take Infacetamol
   1. To determine the dose directly, multiply the child's body weight in kilograms by
   2. To determine the dose directly, multiply the child's body weight in kilograms by
   3. Never administer a dose greater than the maximum daily dose of 60 mg/kg body weight per day without consulting a doctor first.
   4. Instructions for proper administration of the product
   5. Taking a higher dose of Infacetamol than recommended
   6. Missing a dose of Infacetamol
   7. Stopping Infacetamol treatment
6. Possible side effects
7. How to store Infacetamol
8. Contents of the packaging and other information
   1. What Infacetamol contains
   2. What Infacetamol looks like and what the packaging contains
   3. Marketing authorization holder and manufacturer
   4. Date of the last update of the leaflet:

Leaflet attached to the packaging: information for the user

Infacetamol, 100 mg/ml, oral solution

Paracetamol

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

important for the patient.
The medicine should always be taken exactly as described in the patient leaflet or as directed 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 not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. See section 4.
• If there is no improvement after 2 days or the patient feels worse, the doctor should be contacted.

Table of contents of the leaflet

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

1. What is Infacetamol and what is it used for

The active substance of Infacetamol is paracetamol.
Paracetamol belongs to a group of pain-relieving and antipyretic medicines. The medicine is used for pain and fever of various origins, e.g., teething, after vaccinations, in colds or flu-like conditions.
Infacetamol is intended for children with a body weight of up to 32 kg (approximately from 0 months to 10 years).
In case of recurrent fever, high fever (>39°C), signs of secondary infection, persistence of symptoms for more than 2 days, worsening, or appearance of new symptoms, the doctor should re-evaluate the 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 treatment with Infacetamol, the doctor or pharmacist should be consulted:

• it is recommended to consult a doctor before giving this medicine to children under 3 years of age;
• do not exceed the recommended dose specified in section 3;
• if the patient has kidney, heart, or lung disorders, or anemia (reduced hemoglobin level in the blood, associated or not with a reduced number of red blood cells), or the activity of the enzyme glucose-6-phosphate dehydrogenase in the blood is low, the doctor should be consulted before taking the medicine;
• in case of liver disease (including Gilbert's syndrome), the doctor should be consulted 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 there is a high fever (>39°C), the doctor should be consulted before taking Infacetamol;

Infacetamol and other medicines

The doctor or pharmacist should be informed about all medicines the patient is taking or has recently taken, as well as about medicines the patient plans to take.
This is especially important when taking medicines containing any of the following active substances, as a dose change 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 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 stomach, intestinal, and bladder spasms and cramps (anticholinergic medicines);
• metoclopramide (used to prevent nausea and vomiting);
• zidovudine (used to treat people infected with the human immunodeficiency virus that causes AIDS);
• other medicines containing paracetamol. Effect on laboratory tests: In the case of planned laboratory tests (such as blood tests, urine tests, skin allergy tests, etc.), the doctor should be informed about the use of this medicine, as it may affect the results of these tests.

Taking Infacetamol with food, drinks, and alcohol

Infacetamol can be diluted with water, milk, or fruit juices. Taking paracetamol in patients who regularly drink alcohol (three or more alcoholic drinks per day) may cause liver damage.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before taking this medicine.
Infacetamol can be given to pregnant women if it is clinically justified. The lowest effective dose should be used to relieve pain or reduce fever, and the medicine should be taken for the shortest possible time and as infrequently as possible. If the pain is not relieved or the fever does not decrease, or if it is necessary to increase the frequency of taking the medicine, the doctor or midwife should be consulted.
During pregnancy, paracetamol should not be taken with other medicines.
Paracetamol can be used in therapeutic doses during breastfeeding.

Driving and using machines

The medicine has no or negligible influence on the ability to drive and use machines.
Warnings about excipients
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 (E 1520) per 1 ml of solution. Before giving the medicine to a child under 4 weeks of age, the doctor or pharmacist should be consulted, 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 leaflet or as directed by the doctor, pharmacist, or nurse. In case of doubt, the doctor, pharmacist, or nurse should be consulted.
Infacetamol is intended for use in children with a body weight of up to 32 kg (approximately from 0 months to 10 years). The dosing should be based on the child's body weight, and the appropriate dose should be determined in ml of oral solution.
The approximate age based on body weight is provided for information purposes only.
In children under 3 years of age, paracetamol should be used after consulting a doctor.
The recommended daily dose of paracetamol is approximately 60 mg/kg body weight per day, divided into 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 Infacetamol using the pipette provided with the 30 ml packaging.
In children over 3 years of age, it is recommended to administer Infacetamol using the oral syringe provided with the 50 ml or 60 ml packaging.
Below is the instruction for administering the medicine in a dose of 15 mg/kg body weight, every 6 hours:

To determine the dose directly, multiply the child's body weight in kilograms by

0.15. The result is the number of ml of Infacetamol to be administered.
In children, this dose should be administered every 6 hours, also at night.
If the desired effect is not achieved within 3-4 hours after administration, the medicine may be taken more frequently than every 6 hours, i.e., every 4 hours. In this case, a dose of 10 mg/kg body weight should be administered.
Below is the instruction for administering the medicine in 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 to be administered.
In children, this dose should be administered every 4 hours, also at night.
In infants with a body weight below 7 kg (approximately from 0 to 8 months), it is recommended to use suppositories, except in cases where administration of this pharmaceutical form is impossible for clinical reasons (e.g., diarrhea).

Never administer a dose greater than the maximum daily dose of 60 mg/kg body weight per day without consulting a doctor first.

Do not exceed the maximum daily dose due to the risk of severe liver damage.
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 disappear, the administration of the medicine should be stopped.

Instructions for proper administration of the product

Infacetamol is administered orally.
[Graphic representation showing how to open and close the bottle]

Bottle of 30 ml with a child-resistant pipette (2 ml):

• 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, where the word "PRESS" is written. To open the bottle, press the triangle and unscrew the cap by turning it to the left (counterclockwise). Use the dropper to take the required amount of solution. It can be administered directly or diluted with water.
• To close the bottle, turn the cap to the right (clockwise) until you hear a click. Close the bottle tightly after each use. Bottle of 50 ml with a child-resistant closure and an oral syringe of 5 ml:
• 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.
• Administer directly or after diluting with water, milk, or juice.
• After use, the oral syringe should be washed with water. Close the bottle tightly after each use. Bottle of 60 ml with a child-resistant closure and an oral syringe of 5 ml:
• 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.
• Administer directly or after diluting with water, milk, or juice.
• After use, the oral syringe should be washed with water. Close the bottle tightly after each use.

Taking a higher dose of Infacetamol than recommended

In case of taking (administering to a child) a higher dose of paracetamol than recommended, consult a doctor or pharmacist immediately and provide the name of the medicine and the amount taken. It is helpful to take the packaging and leaflet with you and give them to the specialist.
In case of overdose, 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 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. Do not exceed the maximum daily dose due to the risk of severe liver damage. There is no loss of consciousness, but immediate medical attention is necessary. Prolonged use without medical supervision can be harmful.
Paracetamol overdose is considered when an adult takes more than 6 g in a single dose, and a child takes more than 100 mg per kilogram of body weight. Treatment of overdose is more effective if started within 4 hours of taking the medicine.
Patients taking 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 Infacetamol

Do not take a double dose to make up for a missed dose.
If a dose is missed, take (administer to a child) the next dose as soon as possible, and then continue taking the medicine according to the normal schedule. However, if the time to take the next dose is very short, skip the missed dose and take the next one according to the recommended dosing schedule.

Stopping Infacetamol treatment

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

4. Possible side effects

Like all medicines, Infacetamol 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 (jaundice). Also, very rare side effects may include hypoglycemia, cloudy urine, kidney disorders, skin rash, hives, anaphylactic shock, and changes in blood cell count, such as neutropenia and leukopenia.
In very rare cases, severe skin reactions have been reported.
Reporting side effects
If any side effects occur, including any not listed in this leaflet, the doctor, pharmacist, or nurse should be informed.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Infacetamol

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.
Store in the original packaging to protect from light.
Store at a temperature below 25°C.
Do not store in the refrigerator.
After opening, the contents of the bottle should be used within 6 months.
Medicines should 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 packaging and other information

What Infacetamol contains

• The active substance of Infacetamol is paracetamol. Each ml of 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 Infacetamol looks like and what the packaging contains

Infacetamol is a thick, viscous, clear solution with a color ranging from colorless or pink to orange and a strawberry flavor, packaged in bottles of 30, 50, and 60 ml capacity.
The perception of color may vary from patient to patient.

• -bottle of 30 ml:orange PET (polyethylene terephthalate) bottle with a child-resistant cap made of PP (polypropylene) with a pipette made of LDPE (low-density polyethylene) with a scale from 0.6 ml to 2 ml, in a carton with a patient information leaflet.
• -bottle of 50 ml:orange PET bottle with a child-resistant cap made of HDPE (high-density polyethylene) with a guarantee ring and a connector made of LDPE for an oral syringe, and an oral syringe made of LDPE/PS (low-density polyethylene/polystyrene) with a capacity of 5 ml and a scale from 0.4 to 5 ml, in increments of 0.2 ml, in a carton with a patient information leaflet.
• -bottle of 60 ml:orange PET bottle with a child-resistant cap made of HDPE (high-density polyethylene) with a guarantee ring and a connector made of LDPE for an oral syringe, and an oral syringe made of LDPE/PS (low-density polyethylene/polystyrene) with a capacity of 5 ml and a scale from 0.4 to 5 ml, in increments of 0.2 ml, in a carton with a patient information leaflet.

Marketing authorization holder and manufacturer

Farmina sp. z o.o.
Lipska 44 Street
30-721 Krakow
To obtain more detailed information about this medicine, please contact the representative of the marketing authorization holder: Farmina sp. z o.o., phone: +48 12 290 90 00.

Date of the last update of the leaflet: