Panadol Children’s suspension (with syringe) 120mg/5ml, 100ml

Composition

5 ml of suspension contains paracetamol 120 mg;

excipients:

malic acid,

xanthan gum,

maltitol (glucose syrup hydrogenate),

sorbitol,

citric acid,

sodium nipacept,

strawberry flavor,

azorubin,

water.

Pharmacological action

The drug has analgesic and antipyretic properties. Blocks cyclooxygenase in the central nervous system, affecting the centers of pain and thermoregulation. The anti-inflammatory effect is practically absent. It does not affect the state of the gastrointestinal mucosa and water-salt metabolism, since it does not affect the synthesis of prostaglandins in peripheral tissues.

Clinical pharmacology

Absorption is high-Panadol is rapidly and almost completely absorbed from the gastrointestinal tract. Binding to plasma proteins is about 15%. Peak plasma concentrations are reached after 30-60 minutes. The distribution of paracetamol in body fluids is relatively uniform. It is mainly metabolized in the liver with the formation of several metabolites. In newborns of the first two days of life and in children 3-10 years of age, the main metabolite of paracetamol is paracetamol sulfate, in children 12 years and older – conjugated glucuronide. Part of the drug (approximately 17%) undergoes hydroxylation to form active metabolites that conjugate with glutathione. When glutathione is deficient, these metabolites of paracetamol can block the enzyme systems of hepatocytes and cause their necrosis. The half-life of a therapeutic dose is from 2-3 hours. When taking therapeutic doses,90-100% of the dose taken is excreted in the urine within one day. The main amount of the drug is released after conjugation in the liver. No more than 3% of the received dose of paracetamol is released unchanged.

Indications

It is used in children from 3 months to 12 years as: an antipyretic agent-to reduce elevated body temperature against the background of colds, flu and children’s infectious diseases (chickenpox, mumps, measles, rubella, scarlet fever, etc. ); an analgesic for toothache, including teething, headache, ear pain with otitis media and sore throat. For children of the 2nd-3rd month of life, a single dose is possible to reduce the temperature after vaccination. If the temperature does not decrease, you should consult a doctor.

Contraindications

Hypersensitivity to paracetamol or any other ingredient of the drug; severe liver or kidney dysfunction; neonatal period. Use with caution in patients with impaired liver function (including Gilbert’s syndrome), kidneys, genetic absence of the enzyme glucose-6-phosphate dehydrogenase, severe forms of blood diseases (severe anemia, leukopenia, thrombocytopenia). If you have any of these diseases, you should consult your doctor before taking the drug.

Side effects

At the recommended doses, the drug is usually well tolerated. The following side effects were detected spontaneously during post-marketing use of the drug. Side effects are classified by organ system and frequency. The frequency of side effects is defined as follows: very common (greater than or equal to 1/10), common (greater than or equal to 1/100 and less than 1/10), infrequent (greater than or equal to 1/1000 and less than 1/100), rare (greater than or equal to 1/10,000 and less than 1/1000) and very rare (greater than or equal to 1/100,000 and less than 1/10,000). Allergic reactions: Very rarely – in the form of skin rashes, itching, urticaria, angioedema, Stevens-Johnson syndrome, anaphylaxis;From the hematopoietic system: Very rarely – thrombocytopenia, anemia, leukopenia from the respiratory system: Very rarely – bronchospasm (in patients with hypersensitivity to acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs); From the side of the hepatobiliary system: Very rarely – impaired liver function. Sometimes nausea, vomiting, and stomach pain are possible. If you experience any of the listed side effects, stop taking the drug and immediately consult a doctor.

Interaction

If the child is already taking other medications, you should consult a doctor before taking the drug “Children’s Panadol”. Barbiturates, carbamazepine, phenytoin, diphenine, primidone and other anticonvulsants, ethanol, rifampicin, zidovudine, flumecinol, phenylbutazone, butadion, St. John’s wort preparations and other inducers of microsomal oxidation increase the production of hydroxylated active metabolites, causing the possibility of severe liver damage with small overdoses of paracetamol (5 g or more). Inhibitors of microsomal liver enzymes reduce the risk of hepatotoxic effects. Under the influence of paracetamol, the elimination time of levomycetin (chloramphenicol) increases by 5 times, which increases the risk of poisoning with levomycetin (chloramphenicol). When taken regularly for a long time, the drug increases the effect of indirect anticoagulants (warfarin and other coumarins), which increases the risk of bleeding. Episodic use of a single dose of the drug does not significantly affect the effect of indirect anticoagulants. Metoclopramide and domperidone increase, and colestyramine reduces the rate of absorption of paracetamol. The drug may reduce the effectiveness of uricosuric drugs.

How to take, course of use and dosage

For oral use. Before use, the contents of the bottle should be shaken well for at least 10 seconds. A measuring syringe inserted inside the package allows you to correctly and optionally dose the drug. The dose of the drug depends on the age and body weight of the child. Children (3 months to 12 years)The maximum single dose is 15 mg / kg of body weight. The maximum daily dose is 60 mg / kg of body weight. The frequency of admission is no more than 3-4 times a day. If necessary, you can give your child the recommended dose every 4-6 hours, but no more than 4 doses within 24 hours. In all other cases, a doctor’s consultation is necessary before taking the drug “Children’s Panadol”. The duration of use without consulting a doctor is 3 days. Do not exceed the recommended dose!If you accidentally exceed the recommended dose, you should immediately consult a doctor, even if the child feels well, as there is a risk of developing liver damage (see “Overdose”). If the child’s condition does not improve while taking the drug, consult a doctor.

Overdose

Symptoms: within the first 24 hours after overdose, nausea, vomiting, stomach pain, sweating, pallor of the skin, anorexia. After 1-2 days, signs of liver damage are detected (soreness in the liver area, increased activity of “liver” enzymes). It is possible to develop a violation of carbohydrate metabolism and metabolic acidosis. In adult patients, liver damage develops after taking more than 10 g of paracetamol in children-when taking more than 125 mg/kg of body weight of the child. In the presence of factors affecting the toxicity of paracetamol to the liver (see the section “Interaction with other drugs”, ” Special instructions”), liver damage is possible after taking 5 or more grams of paracetamol. <br>In severe cases of overdose, as a result of liver failure, encephalopathy (impaired brain function), bleeding, hypoglycemia, brain edema, up to a fatal outcome can develop. It is possible to develop acute renal failure with acute tubular necrosis, the characteristic signs of which are pain in the lumbar region, hematuria (an admixture of blood or red blood cells in the urine), proteinuria (increased protein content in the urine), while severe liver damage may be absent. There were cases of cardiac arrhythmias, pancreatitis. With prolonged use in excess of the recommended dose, hepatotoxic and nephrotoxic effects may occur (renal colic, nonspecific bacteriuria, interstitial nephritis, papillary necrosis). Treatment: If an overdose is suspected, even in the absence of pronounced first symptoms, it is necessary to stop using the drug and immediately seek medical help. Within 1 hour after overdose, gastric lavage and use of enterosorbents (activated charcoal, polyphepan) are recommended. It is necessary to determine the level of paracetamol in the blood plasma, but not earlier than 4 hours after overdose (earlier results are unreliable). use of acetylcysteine within 24 hours of overdose. The maximum protective effect is provided during the first 8 hours after an overdose; over time, the effectiveness of the antidote drops sharply. If necessary, acetylcysteine is administered intravenously. If there is no vomiting before the patient is admitted to the hospital, methionine may be used. The need for additional therapeutic measures (further use of methionine, intravenous use of acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as on the time elapsed after taking it. Treatment of patients with severe hepatic impairment 24 hours after taking paracetamol should be carried out in conjunction with specialists of the toxicology center or specialized department of liver diseases.

Description

Suspension for oral use from pink to dark pink, opaque, viscous, strawberry smell; c crystals may be present in the suspension.

Special instructions

Children under 3 months of age and children born prematurely can only be given “Children’s Panadol” if prescribed by a doctor. When performing tests to determine uric acid and blood sugar levels, inform your doctor about the use of the drug “Children’s Panadol”. When taking the drug for more than 7 days, monitoring of peripheral blood and liver function is recommended.Glutathione deficiency due to eating disorders, cystic fibrosis, HIV infection, starvation, exhaustion causes the possibility of severe liver damage with small overdoses of paracetamol (5 g or more). The drug should not be used simultaneously with other paracetamol-containing drugs. Detsky Panadol contains maltitol and sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine. The drug contains a mixture of parahydroxybenzoic acid esters (methyl -, ethyl -, propyl-parahydroxybenzoates of sodium), which can cause delayed allergic reactions. Detsky Panadol does not contain sugar, alcohol or acetylsalicylic acid.

Form of production

Primary packaging: 100 ml in dark glass bottles. Secondary packaging 1 bottle together with the measuring syringe and instructions for use will be placed in a cardboard box.

Storage conditions

At a temperature not exceeding 30° C. Protect from light. Do not freeze it. Keep out of reach of children.

Shelf

life is 3 years.

Active ingredient

Paracetamol

Dosage form

suspension for oral use

Purpose

Children over 3 months of age

Indications

Cold, Flu, Otitis Media, Infectious Diseases, Migraines