Composition
Powder for the preparation of a solution for oral use.
For one sachet:
Active ingredients:
paracetamol (acetaminophen) 160 mg,
ascorbic acid 50 mg,
chlorpheniramine maleate 1 mg.
Auxiliary substances:
citric acid 50 mg,
dye enchanting Red 0,05 mg,
raspberry flavor,100 mg,
silicon dioxide (syloid) 4 mg,
silicon dioxide 20 mg,
sodium citrate dihydrate 2 mg
corn starch 1 mg,
powdered sugar 2794,95 mg,
sucrose 8800 mg,
titanium dioxide 1 mg,
calcium phosphate 1 mg.
Pharmacological properties
Pharmacotherapeutic group
Acute respiratory infections and “colds” symptoms remedy (non-narcotic analgesic + H1-histamine receptor blocker + vitamin).
ATX code: N02 BE 51
Pharmacological properties
Combined preparation with vitamin C and raspberry flavor. Paracetamol (acetam – nofen) has an analgesic and antipyretic effect.
Ascorbic acid (vitamin C) increases the body’s resistance to infections, improves the tolerance of paracetamol.
Chlorpheniramine maleate has an anti-allergic effect, eliminates runny nose, lacrimation, itching in the eyes and nose. Quickly relieves fever, headache and 2 muscle pain, sore throat, runny nose.
Indications
Symptomatic treatment of acute respiratory viral infections, including flu and “colds” in children from 2 to 12 years old, accompanied by high fever, chills, body aches, headache and muscle pain, sore throat, runny nose, nasal congestion, lacrimation, sneezing.
Use during pregnancy and lactation
It is not recommended for use during pregnancy and lactation.
Contraindications
Hypersensitivity to certain components of the drug, severe liver and kidney dysfunction, angle-closure glaucoma, prostatic hypertrophy, sucrose/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption, children under 2 years of age.
Use with caution in: arterial hypertension, severe cardiovascular diseases, diabetes mellitus, bronchial asthma, chronic obstructive pulmonary disease, thyrotoxicosis, pheochromocytoma, difficulty urinating in prostate adenoma, blood diseases, congenital hyperbilirubinemia (Gilbert’s, Dubin – Johnson’s and Rother’s syndromes), progressive malignant diseases, viral hepatitis, hyperoxalaturia, glucose – 6-phosphate dehydrogenase deficiency.
Side effects
Allergic reactions: skin rash, pruritus, urticaria, toxic epidermal necrolysis (Lyell’s syndrome), erythema polymorpho-bullosa (Stevens-Johnson syndrome), acute generalized exanthematous pustulosis, angioedema (Quincke’s edema), anaphylactic shock.
From the central nervous system: dizziness, sleep disturbance (drowsiness), headache, excitability, decreased speed of psychomotor reactions, fatigue.
From the hematopoietic system: anemia, thrombocytopenia, thrombocytopenic purpura, leukopenia, pancytopenia, agranulocytosis, hemolytic anemia, methemoglobinemia.
From the digestive system: nausea, vomiting, stomach discomfort, abdominal pain, diarrhea.
Liver and biliary tract disorders: liver damage (increased activity of “liver” enzymes), hepatitis, as well as dose-dependent liver failure, liver necrosis. Prolonged unjustified use can lead to liver fibrosis, cirrhosis of the liver.
From the urinary system: urinary retention, with prolonged use of high doses, nephrotoxic effect.
Respiratory disorders: bronchospasm or exacerbation of bronchial asthma, including in patients who are sensitive to acetylsalicylic acid or other NSAIDs.
Other: mydriasis, paresis of accommodation, increased intraocular pressure.
Interaction
It is not recommended to take simultaneously with sleeping pills, sedatives and drugs containing alcohol.
Increases the concentration of benzylpenicillin and tetracyclines in the blood. Improves intestinal absorption of iron preparations (converts trivalent iron to bivalent); may increase iron excretion when used concomitantly with deferoxamine. Increases the risk of crystalluria during treatment with short-acting salicylates and sulfonamides, slows down the excretion of acids by the kidneys, increases the excretion of drugs with an alkaline reaction (including alkaloids), reduces the concentration of oral contraceptives in the blood. Increases total ethanol clearance. When used concomitantly, it reduces the chronotropic effect of isoprenaline. Reduces the therapeutic effect of antipsychotic drugs (neuroleptics) – phenothiazine derivatives, tubular resorption of amphetamine and tricyclic antidepressants. Reduces the effectiveness of uricosuric drugs.
It can both increase and decrease the effect of anticoagulant drugs. Paracetamol (or its metabolites) interacts with enzymes involved in vitamin K-dependent synthesis of clotting factor. Interactions between paracetamol and warfarin or coumarin derivatives may lead to an increased international normalized ratio (INR) and an increased risk of bleeding. Patients taking oral anticoagulants should not take paracetamol for a long time without medical supervision.
Ethanol enhances the sedative effect of chlorphenamine. Antidepressants, antiparkinsonian and phenothiazine antipsychotic medications increase the risk of side effects (urinary retention, dry oral mucosa, constipation). Glucocorticosteroids increase the risk of glaucoma.
Inducers of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites of paracetamol, which causes the possibility of severe hepatotoxic reactions even with a small overdose. Microsomal oxidation inhibitors (including cimetidine) reduce the risk of hepatotoxic effects of paracetamol. Diflunisal increases the plasma concentration of paracetamol by 50%, increases hepatotoxicity. Ethanol reduces the concentration of ascorbic acid in the body, and also contributes to the development of acute pancreatitis. The use of barbiturates reduces the effectiveness of paracetamol, increases the excretion of ascorbic acid in the urine. Enhances the effect of sleeping pills.
When used concomitantly with chloramphenicol, it is possible to increase the half-life of chloramphenicol from the blood plasma and increase the toxic effect.
Medications that delay gastric emptying, such as propanthelin, may cause delayed absorption of paracetamol and thus delay the onset of its action.
Medications that lead to accelerated gastric emptying, such as metoclopramide, can lead to faster absorption of paracetamol and thus accelerate the onset of its action.
Tropisetron and granisetron,5-hydroxytryptamine type 3 antagonists can completely inhibit the analgesic effect of paracetamol through pharmacodynamic interaction.
Paracetamol should not be taken together with zidovudine without a doctor’s recommendation due to the increased tendency to a decrease in the number of white blood cells (neutropenia).
Continuous combination therapy with more than one painkiller should be avoided; because of the possible summation of side effects.
How to take, course of use and dosage
Inside.
A single dose for children 2-5 years is the contents of 1 sachet, for children 6-12 years-the contents of 2 sachets.
Take orally, regardless of food intake, after dissolving the contents of the package in 150 ml of warm water.
If necessary, repeat the dose every 4-6 hours, but no more than 3 doses during the day.
If the temperature does not decrease, pain, chills, runny nose do not stop-be sure to consult your doctor.
The total duration of treatment should not exceed 5 days.
Overdose
In case of overdose, seek immediate medical attention.
Paracetamol
Symptoms: diarrhea, decreased appetite, nausea and vomiting, abdominal discomfort and / or abdominal pain, increased sweating. The clinical picture of acute paracetamol overdose develops within 6-14 hours after taking paracetamol. Symptoms of chronic overdose occur 2-4 days after increasing the dose of the drug. In the case of severe poisoning, severe liver failure can develop up to hepatic encephalopathy, coma, and death. Hypokalemia and metabolic acidosis (including lactic acidosis) can also develop in conditions of acute and / or chronic overdose. Common clinical manifestations after 3-5 days are jaundice, fever, hepatic bad breath, hemorrhagic diathesis, hypoglycemia, and liver failure. Acute renal failure with acute tubular necrosis, which is diagnosed by severe pain in the lumbar region, hematuria and proteinuria, can develop without severe liver dysfunction.
Treatment: gastric lavage, activated charcoal in the first 6 hours, use of SH-group donors and glutathione – methionine synthesis precursors 8-9 hours after overdose and N-acetylcysteine in 12 hours.
Chlorpheniramine
Symptoms: dizziness, agitation, sleep disturbances, depression, seizures, and coma.
Treatment: symptomatic.
Ascorbic acid
High doses of ascorbic acid (more than 3000 mg) can cause temporary osmotic diarrhea and disorders of the gastrointestinal tract, such as nausea, stomach discomfort.
Treatment: symptomatic, forced diuresis.
Special instructions
Given the ability of the drug to cause drowsiness, it is necessary to release children from activities that require increased concentration of attention within 4 hours after taking the drug.
Contains natural sugar. Each sachet contains 1 XE.
Very rare cases of serious skin reactions have been reported. If the skin becomes red, rashes, blisters, or flakes, you should stop using paracetamol and immediately consult a doctor.
Paracetamol and ascorbic acid can distort laboratory tests (quantitative determination of plasma glucose and uric acid, bilirubin, activity of “hepatic” transaminases, LDH).
In case of hyperthermia lasting more than 3 days and pain syndrome lasting more than 5 days, a doctor’s consultation is required.
Form of production
White or white with a yellowish tinge loose powder, including crystalline particles, with a raspberry smell.
Description of the solution after dissolution: opaque solution of light pink color with a raspberry smell.
Storage conditions
At a temperature of 15-30 °C
Shelf life
3 years
Active ingredient
Paracetamol, Chlorphenamine, [Ascorbic Acid]
Dosage form
solution for oral use
Purpose
Children over 2 years old
Indications
Runny Nose, Sore Throat, Flu, Cold
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