Paracetamol baby

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PARACETAMOL BABY (PARACETAMOL BABY)

Composition:

Active ingredient: paracetamol;

5 ml of the preparation contains 120 mg of paracetamol;

Excipients: sorbitol (E 420); citric acid, monohydrate; glycerol; methylparaben (E 218); propylparaben (E 216); xanthan gum; "Strawberry" flavoring containing propylene glycol, flavoring substances (natural and nature-identical); purified water.

Pharmaceutical form. Oral suspension.

Main physicochemical characteristics: viscous white suspension with white crystals and a fruity odor.

Pharmacotherapeutic group. Analgesics and antipyretics. Paracetamol.

ATC code: N02B E01.

Pharmacological properties.

Pharmacodynamics.

The analgesic and antipyretic effects of paracetamol are due to inhibition of prostaglandin synthesis and predominant action on the thermoregulatory center in the hypothalamus.

Pharmacokinetics.

Paracetamol is well absorbed in the gastrointestinal tract. Peak plasma concentration is reached within 20–30 minutes after administration. It is metabolized in the liver, forming paracetamol glucuronide and sulfate. It is excreted mainly by the kidneys. The half-life ranges from 1 to 4 hours.

Clinical characteristics.

Indications.

Pain associated with teething, toothache, sore throat, fever in colds, influenza and childhood infections such as chickenpox, whooping cough, measles, mumps.

The drug is also recommended for the treatment of post-vaccination hyperthermia in infants aged 3 months and older.

Contraindications.

Hypersensitivity to the components of the drug, severe impairment of liver and/or kidney function, congenital hyperbilirubinemia, glucose-6-phosphate dehydrogenase deficiency, alcoholism, blood disorders, Gilbert's syndrome, marked anemia, leukopenia.

Age under 3 months.

Interaction with other medicinal products and other types of interactions.

The absorption rate of paracetamol may be increased when used concomitantly with metoclopramide and domperidone, and decreased with cholestyramine.

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged concomitant use of paracetamol. Occasional use has no significant effect.

Barbiturates reduce the antipyretic effect of paracetamol.

Anticonvulsant drugs (including phenytoin, barbiturates, carbamazepine), which stimulate the activity of hepatic microsomal enzymes, may enhance the hepatotoxic effect of paracetamol due to increased conversion of the drug into hepatotoxic metabolites.

Concomitant use of paracetamol with hepatotoxic agents increases the toxic effect of the drug on the liver. Concurrent use of high doses of paracetamol with isoniazid increases the risk of developing hepatotoxic syndrome.

Paracetamol reduces the effectiveness of diuretics.

Caution is advised when using paracetamol concomitantly with flucloxacillin, as this combination has been associated with metabolic acidosis with a high anion gap due to 5-oxoproline (pyroglutamic acid) accumulation, particularly in patients with risk factors (see section "Special precautions").

Do not use concomitantly with alcohol.

High concentrations of paracetamol may interfere with laboratory test results for blood glucose by the oxidase-peroxidase method and for uric acid when using the phosphotungstic acid method.

Special precautions for use.

Do not use this medicinal product together with any other medicinal products containing paracetamol, such as those used for fever reduction, pain relief, treatment of flu and cold symptoms, or insomnia. Concurrent use with other paracetamol-containing products may lead to overdose. Paracetamol overdose may cause liver failure, which could result in the need for liver transplantation or lead to fatal outcomes.

Consult a physician before using this product if the patient has liver or kidney disease, or reduced glutathione levels.

It should be noted that patients with liver disease have an increased risk of hepatotoxic effects of paracetamol. Treatment should be discontinued if acute viral hepatitis is diagnosed.

Cases of impaired liver function or liver failure have been reported in patients with reduced glutathione levels, such as those with severe malnutrition, anorexia, low body mass index, chronic alcoholism, or sepsis.

Cases of high anion gap metabolic acidosis (HAGMA) due to pyroglutamic acidosis have been reported in patients with severe underlying conditions, such as severe renal insufficiency and sepsis, or in those with malnutrition and other causes of glutathione deficiency (e.g., chronic alcoholism), who were treated with paracetamol at therapeutic doses over a prolonged period or with a combination of paracetamol and flucloxacillin. If HAGMA due to pyroglutamic acidosis is suspected, immediate discontinuation of paracetamol is recommended, along with close monitoring of the patient. Measurement of urinary 5-oxoproline levels may be helpful in identifying pyroglutamic acidosis as the underlying cause of HAGMA in patients with multiple risk factors. Symptoms of metabolic acidosis include deep, rapid, or labored breathing, nausea, vomiting, and loss of appetite. Immediate medical attention should be sought if these symptoms occur.

If symptoms persist or worsen after 3 days of treatment, consult a physician.

If the glomerular filtration rate is less than 10 mL/min, the dosing interval should be extended to 8 hours.

Prolonged use or use in excessive doses may lead to impaired liver and kidney function, as well as blood abnormalities.

Each 120 mg/5 mL of suspension contains 2 g of sorbitol per 5 mL of suspension. If the patient has been diagnosed with intolerance to certain sugars, consult a physician before taking this medicinal product.

The presence of methylparaben (E 218) and propylparaben (E 216) in the formulation may cause allergic reactions (possibly delayed).

Use during pregnancy or breastfeeding.

This product is intended for use in children.

Effect on the ability to drive or operate machinery.

This product is intended for use in children.

No effect on reaction speed during operation of vehicles or machinery is expected.

Method of Administration and Dosage

The medication is intended for oral administration.

Before use, shake the bottle for 10 seconds or make the suspension homogeneous by kneading the sachet. Do not exceed the recommended dose. The lowest effective dose required to achieve therapeutic effect should be used. The interval between doses must be at least 4 hours.

For relief of post-vaccination reactions.
Children aged 3 months to 12 years: the single dose of paracetamol is 10–15 mg/kg body weight; the maximum daily dose is 60 mg/kg body weight. If a second dose is required, it may be administered no sooner than 4 hours after the previous one. If fever persists after the second dose, consult a physician.

For other cases of pain and fever.
Children aged 3 months to 12 years: the single dose of paracetamol is 10–15 mg/kg body weight. If a second dose is required, it may be administered no sooner than 4 hours after the previous one; the maximum daily dose is 60 mg/kg body weight. Do not take more than 4 doses within 24 hours. The maximum duration of use without medical consultation is 3 days.

The approximate dosage of the medication based on the child's body weight and age is provided in the table below; however, in all cases, ensure that the dosage does not exceed 10–15 mg of paracetamol per kilogram of the child's body weight.

In case of kidney or liver dysfunction in a child, consult a physician before administering this medicinal product. This is due to the presence of paracetamol in the formulation.

For convenient dosing of the suspension, the measuring device has markings from 0 to 5 mL. If a dose greater than 5 mL is required, measure the first 5 mL of suspension first, then measure the remaining amount.

In cases where the dose is a multiple of 5 mL or 10 mL, the medicinal product in sachet form may be used.

Children.

The use of this medicinal product is not recommended in children under 3 months of age. It is recommended for children aged from 3 months to 12 years.

Overdose.

Paracetamol overdose can cause liver failure, which may lead to the need for liver transplantation or result in death. Clinical experience shows that signs of liver damage after paracetamol overdose usually appear within 24–48 hours after overdose and peak at 4–6 days.

In case of overdose, prompt medical attention is required. Treatment should be initiated immediately and the patient should be taken to a hospital, even if early symptoms of overdose are absent.

Symptoms within the first 24 hours: pallor, nausea, vomiting, loss of appetite, and abdominal pain. Glucose metabolism disturbances and metabolic acidosis may occur. In severe poisoning, liver failure may progress to encephalopathy, hemorrhage, hypoglycemia, coma, and may be fatal. Acute kidney injury with acute tubular necrosis may present with severe flank pain, hematuria, proteinuria, and may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have also been reported, usually accompanied by liver function disturbances and hepatotoxicity.

With prolonged use of the drug at high doses, blood-forming organs may develop aplastic anemia, pancytopenia, agranulocytosis, neutropenia, leukopenia, and thrombocytopenia. High doses may cause central nervous system effects such as dizziness, psychomotor agitation, and disorientation; urinary system effects may include nephrotoxicity (renal colic, interstitial nephritis, capillary necrosis).

Symptoms may be limited to nausea and vomiting or may not reflect the severity of the overdose or risk of organ damage.

In case of overdose, prompt medical attention is required. Treatment for overdose or even suspected overdose should be initiated immediately by taking the patient to a hospital, even if early symptoms are absent, as liver damage may not develop immediately. Treatment with N-acetylcysteine or methionine should be considered.

Side effects.

Side effects of paracetamol occur rarely.

Immune system disorders: anaphylaxis, hypersensitivity reactions including skin itching, skin and mucous membrane rashes (usually generalized rash, erythematous rash, urticaria), angioneurotic edema, erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome).

Gastrointestinal disorders: nausea, epigastric pain. The drug may have a mild laxative effect.

Endocrine system disorders: hypoglycemia up to hypoglycemic coma.

Blood and lymphatic system disorders: thrombocytopenia, agranulocytosis, anemia, sulfhemoglobinemia, and methemoglobinemia (cyanosis, dyspnea, chest pain), hemolytic anemia, bruising or bleeding.

Respiratory system disorders: bronchospasm in patients sensitive to acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs (NSAIDs).

Hepatobiliary disorders: liver function abnormalities, increased liver enzyme activity, usually without jaundice, hepatonecrosis.

Cardiovascular disorders: decreased blood pressure.

Renal and urinary system disorders: aseptic pyuria, renal colic.

Metabolism and nutrition disorders: metabolic acidosis with high anion gap, frequency “unknown” (cannot be estimated from available data).

Cases of metabolic acidosis with high anion gap, resulting from pyroglutamic acidosis, have been observed in patients with risk factors during paracetamol use (see section "Special precautions for use"). Pyroglutamic acidosis may occur due to low glutathione levels in these patients.

Shelf life. 3 years.

Storage conditions. Store in original packaging at temperature not exceeding 25 °C. Do not freeze.

Keep out of reach and sight of children.

Packaging. 100 ml in a bottle with a dosing device in a box; 5 ml or 10 ml in sachets, pack of 20 in a box.

Availability. Over-the-counter.

Manufacturer.

CORPORATION "ZDOROVIYA" LIMITED LIABILITY COMPANY.

Manufacturer's address and location of business activity.

22 Shevchenka Street, Kharkiv, Kharkiv region, 61013, Ukraine.