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AntiFlu® Kids (Powder) Instructions for Use

Marketing Authorization Holder

Bayer Consumer Care, AG (Switzerland)

Manufactured By

Makiz-Pharma, LLC (Russia)

Contact Information

BAYER AG (Germany)

ATC Code

N02BE51 (Paracetamol in combination with other drugs, excluding psycholeptics)

Active Substances

Ascorbic acid (Rec.INN registered by WHO)

Paracetamol (Rec.INN registered by WHO)

Chlorphenamine (Rec.INN registered by WHO)

Dosage Form

Bottle OTC Icon AntiFlu® Kids Powder for oral solution 160 mg+50 mg+1 mg/1 sachet: sachet 12 g 5 or 8 pcs.

Dosage Form, Packaging, and Composition

Powder for oral solution white with slight shades, free-flowing, including crystalline particles, with a faint raspberry odor; the prepared solution is pale pink in color, opaque, with a faint raspberry odor.

1 sachet
Paracetamol 160 mg
Ascorbic acid 50 mg
Chlorphenamine maleate 1 mg

Excipients: citric acid – 50 mg, Allura Red AC dye – 0.05 mg, raspberry flavor – 100 mg, silicon dioxide (sylloid) – 4 mg, silicon dioxide – 20 mg, trisodium citrate – 2 mg, corn starch – 1 mg, powdered sugar – 2794.95 mg, sucrose – 8800 mg, titanium dioxide – 1 mg, tricalcium phosphate – 1 mg.

12 g – sachets made of laminated foil (5) – cardboard packs.
12 g – sachets made of laminated foil (8) – cardboard packs.

Clinical-Pharmacological Group

Drug for symptomatic therapy of acute respiratory diseases

Pharmacotherapeutic Group

Acute respiratory diseases and “common cold” symptoms elimination agent (non-narcotic analgesic agent + H1-histamine receptor blocker + vitamin)

Pharmacological Action

A combined drug for the symptomatic treatment of acute respiratory diseases and common cold.

Paracetamol is an analgesic-antipyretic, it has analgesic, antipyretic and weak anti-inflammatory effects.

Ascorbic acid (vitamin C) increases the body’s resistance to infections, improves the tolerability of paracetamol.

Chlorphenamine maleate is a histamine H1-receptor blocker, has an anti-allergic effect, relieves symptoms of rhinitis, lacrimation, itching in the eyes and nose.

The drug quickly reduces fever, headache and muscle pain, sore throat, and symptoms of rhinitis.

Pharmacokinetics

Data on the pharmacokinetics of AntiFlu Kids are not provided.

Indications

  • For the relief of flu and common cold symptoms in children aged 2 years and older.

ICD codes

ICD-10 code Indication
J06.9 Acute upper respiratory infection, unspecified
J10 Influenza due to identified seasonal influenza virus
R50 Fever of unknown origin
R51 Headache
ICD-11 code Indication
1E30 Influenza due to identified seasonal influenza virus
8A8Z Headache disorders, unspecified
CA07.0 Acute upper respiratory tract infection of unspecified site
MG26 Fever of other or unknown origin

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

It is administered orally regardless of food intake.

A single dose for children aged 2-5 years is the contents of 1 sachet, for children aged 6-12 years – the contents of 2 sachets. If necessary, the dose can be repeated every 4-6 hours, but no more than 3 doses within 24 hours. The maximum duration of treatment is 5 days. The need for longer use of the drug is determined by the doctor individually.

Before administration, the contents of the sachet should be dissolved in 150 ml of warm water.

Adverse Reactions

From the central nervous system rarely – drowsiness, slowed reaction.

From the digestive system rarely – stomach pain, nausea, vomiting, diarrhea.

Other rarely – hematopoiesis disorders, in predisposed individuals – allergic reactions.

Contraindications

  • Severe liver dysfunction;
  • Severe renal dysfunction;
  • Hypersensitivity to the components of the drug.

Use in Hepatic Impairment

Contraindicated in severe liver dysfunction.

Use in Renal Impairment

Contraindicated in severe renal dysfunction.

Pediatric Use

Used in children aged 2 years and older according to the dosage regimen.

Special Precautions

Given the ability of the drug to cause drowsiness, children should be exempted from activities requiring increased concentration for 4 hours after taking the drug.

Overdose

Symptoms impaired liver and kidney function.

Treatment drug withdrawal, symptomatic and supportive therapy under medical supervision.

Drug Interactions

It is not recommended to use the drug simultaneously with sleeping pills, sedatives and with drugs containing ethanol.

Storage Conditions

The drug should be stored out of the reach of children, in a dry place at a temperature from 15°C (59°F) to 30°C (86°F).

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

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