“The convenient form of Pedicetamol in the form of an oral solution and the included five-milliliter oral syringe make the drug suitable for use by children.
Pedicetamol is intended for use in children weighing up to 32 kg (approximately 0 months to 10 years of age).
Symptomatic treatment of fever lasting no more than 3 days and mild to moderate pain.
The active ingredient is paracetamol. Each ml of solution contains 100 mg of paracetamol.
Other ingredients (excipients): macrogol 600, glycerin, raspberry flavor (propylene glycol, ethyl and benzyl alcohol), sodium saccharin, azorubine (carmoisin) (E122) and purified water.
Always take this medicine exactly as described in this leaflet or as directed by your doctor, pharmacist, or nurse. If you are not sure, ask your doctor, pharmacist or nurse.
Pedicetamol is intended for use in children weighing up to 32 kg (approximately 0 months to 10 years of age). It is necessary to observe the dosage determined based on the child’s body weight, and determine the appropriate dose of the solution for oral administration in milliliters.
Approximate age ranges based on body weight are provided for additional patient information only.
The recommended daily dose of paracetamol is approximately 60 mg/kg body weight per day, administered in 4 to 6 doses per day, for example 15 mg/kg body weight. every 6 hours or 10 mg/kg body weight every 4 hours.
For children under 3 years of age, the oral solution is recommended to be administered in the form of drops (4 mg/drop), using the pipette (1) included in the 30 ml package.
For children over 3 years of age, it is recommended that the oral solution be administered in milliliters (ml) using the 60 ml syringe (2) included in the package.
Below are instructions for administering the drug at a dose of 15 mg/kg every 6 hours:
Child’s body weight – Age (approx.) – Volume in ml – mg of paracetamol – Equivalent in drops
up to 4 kg – from 0 to 3 months – 0.6 ml – 60 mg – 15 drops
up to 7 kg – from 4 to 8 months – 1.0 ml – 100 mg – 25 drops
up to 8 kg – from 9 to 11 months – 1.2 ml – 120 mg – 30 drops
up to 10.5 kg – from 12 to 23 months – 1.6 ml – 160 mg – 40 drops
up to 13 kg – from 2 to 3 years – 2.0 ml – 200 mg
up to 18.5 kg – from 4 to 5 years – 2.8 ml – 280 mg
up to 24 kg – from 6 to 8 years – 3.6 ml – 360 mg
up to 32 kg – from 9 to 10 years – 4.8 ml – 480 mg
To directly determine the dose, multiply the child’s weight in kilograms by 0.15.
The result is the number of ml of Pedicetamol that should be administered.
For children, this dose should be administered every 6 hours, including at night.
If the desired effect is not achieved within 3–4 hours, the drug can be administered every 4 hours. In this case, a dose of 10 mg/kg body weight should be administered.
In young children weighing less than 7 kg (6 months), it is recommended to use suppositories (if available), except in cases where the use of this dosage form is impossible for clinical indications (for example, diarrhea).
Doses exceeding the maximum daily dose of 60 mg/kg/day should never be administered without first consulting a physician.
Patients with liver or kidney disease: See section 2, Warnings and Precautions.
Administration of the drug depends on the presence of pain and symptoms of fever. If the symptoms disappear, the drug should be discontinued.
Instructions for proper use of the drug
Pedicetamol is administered orally.
60 ml bottle with child resistant cap and 5 ml oral syringe:
1. – Open the bottle following the instructions on the cap (the first time you open it, you must break the disposable seal).
2. – Insert the oral syringe by pressing the perforated hole.
3. – Turn the bottle upside down and take the required amount of solution.
4. – Serve directly or diluted with water, milk or juice.
5. – After use, the oral syringe should be rinsed with water.
Close the bottle carefully after each use.”
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