Panadol baby
Ukraine
Table of Contents
INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PANAДOL BABY (PANADOL BABY)
Composition:
Active substance: paracetamol;
5 ml of suspension contains 120 mg of paracetamol;
Excipients: xanthan gum, maltitol liquid, strawberry flavoring, non-crystallizing sorbitol solution, methylparaben, propylparaben, disodium edetate, anhydrous citric acid, trisodium citrate dihydrate, glycerol, sucralose, purified water.
Pharmaceutical form. Oral suspension.
Main physicochemical properties: opaque or semi-transparent, white to brownish suspension.
Pharmacotherapeutic group. Analgesics and antipyretics. Anilides. Paracetamol.
ATC code N02BE01.
Pharmacological properties.
Pharmacodynamics.
The drug contains paracetamol, an analgesic and antipyretic (pain-relieving and fever-reducing agent). The effect is based on the inhibition of prostaglandin synthesis in the central nervous system.
Pharmacokinetics.
Paracetamol is rapidly and almost completely absorbed in the gastrointestinal tract and distributed into most tissues of the body. Plasma protein binding of paracetamol is minimal when administered at therapeutic concentrations.
Paracetamol is primarily metabolized in the liver and excreted in the urine as metabolites. The mean elimination half-life in plasma after oral administration of paracetamol is approximately 2.3 hours.
Clinical characteristics.
Indications.
Pain associated with teething, toothache, sore throat, fever in colds, influenza, and childhood infections such as chickenpox, pertussis, measles, mumps (epidemic parotitis).
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, pronounced anemia, leukopenia. Age under 3 months.
Interaction with other medicinal products and other forms of interaction.
The absorption rate of paracetamol may be increased when used with metoclopramide and domperidone, and decreased when used with cholestyramine. The anticoagulant effect of warfarin and other coumarins, with an increased risk of bleeding, may be enhanced during prolonged concomitant use of paracetamol. Occasional use does not have a 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 hepatotoxic effects of the drugs. Simultaneous use of high doses of paracetamol with isoniazid increases the risk of developing hepatotoxic syndrome.
Paracetamol should be used with caution when administered concomitantly with floxacin, as co-administration has been associated with metabolic acidosis with a high anion gap due to pyroglutamic acidosis, particularly in patients with risk factors (see section "Special precautions").
Paracetamol reduces the efficacy of diuretics. Do not use concomitantly with alcohol.
High concentrations of paracetamol may interfere with laboratory test results for blood glucose measured by the oxidase-peroxidase method, and for uric acid when using the phosphotungstic acid method.
Special precautions for use.
Contains paracetamol. Do not use this medicine together with any other medicines containing paracetamol used, for example, to reduce fever, treat pain, flu and cold symptoms, or insomnia. Concurrent use with other paracetamol-containing medicines may result in overdose. Paracetamol overdose can cause liver failure, which may require liver transplantation or lead to death.
Consult a doctor before using this medicine if you have 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/liver failure have been reported in patients with reduced glutathione levels, such as in 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 failure and sepsis, or in patients with inadequate nutrition or other sources of glutathione deficiency (e.g., chronic alcoholism), who were treated with paracetamol at therapeutic doses for prolonged periods or in combination with flucloxacillin. Symptoms of metabolic acidosis include deep, rapid, or labored breathing, nausea, vomiting, and loss of appetite. Seek immediate medical attention if these symptoms occur. If symptoms do not resolve or worsen after 3 days of taking the medicine, consult a doctor.
If HAGMA due to pyroglutamic acidosis is suspected, immediate discontinuation of paracetamol and close monitoring of the patient are recommended.
Measuring urinary 5-oxoproline levels may be useful in identifying pyroglutamic acidosis as the underlying cause of HAGMA in patients with multiple risk factors.
If the glomerular filtration rate is below 10 mL/min, the dosing interval should be extended to 8 hours.
Prolonged use or use in high doses may lead to impaired liver and kidney function, as well as blood abnormalities.
The medicine contains maltitol (E 965) and sorbitol solution (E 420). Each 5 mL of suspension contains 666.5 mg of sorbitol. This medicine must not be used by patients with rare hereditary fructose intolerance. Patients with intolerance to certain sugars should consult their doctor before taking this medicine.
The medicine contains methylparaben, propylparaben, disodium edetate, and trisodium citrate dihydrate, which may cause allergic reactions (including delayed reactions).
Keep the medicine out of the sight and reach of children.
Use during pregnancy or breastfeeding.
This medicine is intended for use in children.
Ability to affect reaction speed when driving or operating machinery.
This medicine is intended for use in children.
No effect on reaction speed during work with machines or other mechanisms is expected.
Administration and Dosage
The medicine is intended for oral administration.
Before use, the bottle should be shaken. The dosing device is contained within the packaging.
Do not exceed the recommended dose. The lowest effective dose required to achieve the therapeutic effect should be used. The interval between doses should be at least 4 hours.
For relief of post-vaccination reactions.
Children aged 3 months to 12 years: single dose of paracetamol – 10–15 mg/kg body weight; maximum daily dose – 60 mg/kg body weight. If a second dose is needed, it may be administered no sooner than 4 hours after the first. If fever persists after the second dose, medical advice should be sought.
For other cases of pain and fever.
Children aged 3 months to 12 years: single dose of paracetamol – 10–15 mg/kg body weight. If a second dose is needed, it may be administered no sooner than 4 hours after the first. Maximum daily dose – 60 mg/kg body weight. Do not take more than 4 doses within 24 hours. Maximum duration of use without medical consultation – 3 days.
The approximate dosage of the medicine according to the child's body weight and age is given in the table below. However, in all cases, it must be ensured that the dosage does not exceed 10–15 mg of paracetamol per kilogram of the child's body weight.
| Body weight, kg |
Age |
Dosage per dose, mL |
| 6– 8 |
3– 6 months |
3.5– 4 |
| 8– 10 |
6– 12 months |
4.5– 5 |
| 10– 13 |
1– 2 years |
6– 6.5 |
| 13– 15 |
2– 3 years |
7– 8 |
| 15– 21 |
3– 6 years |
9– 10 |
| 21– 29 |
6– 9 years |
13– 14 |
| 29– 42 |
9– 12 years |
18– 19 |
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.
Use of the syringe
- Press the plunger fully to close the syringe, then firmly insert it into the neck of the bottle.
- Turn the bottle upside down and carefully draw up the required dose for your child. The correct dose is determined at the point where the widest sides of the plunger align with the appropriate "ml" mark (corresponding to the number of milliliters) on the syringe barrel.
- Turn the bottle upright and carefully twist the syringe as you remove it.
After use:
- Rinse the syringe;
- Wipe the bottle neck;
- To securely close the cap, press down and twist it until you hear a clicking sound.
Children.
Do not administer this medication to children under 3 months of age. It is recommended for use in children aged from 3 months to 12 years.
Overdose.
Paracetamol overdose may cause liver failure, which may necessitate liver transplantation or result in death. Clinical experience shows that signs of liver damage following paracetamol overdose typically appear within 24–48 hours after overdose and peak at 4–6 days.
In case of overdose, prompt medical attention is required. Treatment should begin 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. Disturbances in glucose metabolism 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 as severe lumbar pain, hematuria, proteinuria, and may develop even in the absence of severe liver damage. Cardiac arrhythmias and acute pancreatitis have also been reported, usually accompanied by liver function abnormalities and hepatotoxicity.
With prolonged use of the drug in high doses, blood-forming organs may develop aplastic anemia, pancytopenia, agranulocytosis, neutropenia, leukopenia, or thrombocytopenia. Central nervous system effects may include 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 in case of overdose or even suspected overdose should begin immediately by taking the patient to a hospital, even if early symptoms are absent, as liver damage may not develop immediately. Consider treatment with N-acetylcysteine or methionine.
Adverse Reactions
Adverse reactions to paracetamol occur rarely. The adverse reactions observed from extensive post-marketing experience, considered to be caused by paracetamol, are listed below by system organ class and frequency.
Blood and lymphatic system disorders (rare: < 1/10,000): thrombocytopenia.
Immune system disorders (rare: < 1/10,000): anaphylaxis, skin hypersensitivity reactions including skin rash, angioedema, Stevens-Johnson syndrome, and toxic epidermal necrolysis.
Respiratory, thoracic and mediastinal disorders (rare: < 1/10,000): bronchospasm in patients sensitive to acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs.
Hepatobiliary disorders (rare: < 1/10,000): liver function abnormalities.
Metabolism and nutrition disorders (frequency unknown, cannot be estimated from available data): metabolic acidosis with high anion gap.
Cases of metabolic acidosis with high anion gap as a consequence of pyroglutamic acidosis have been observed in patients with risk factors who used paracetamol (see section "Special Warnings and Precautions for Use"). Pyroglutamic acidosis may occur due to low glutathione levels in these patients.
Additional adverse reactions reported for paracetamol-containing products include: pruritus, erythema multiforme, nausea, epigastric pain, hypoglycemia up to hypoglycemic coma, agranulocytosis, anemia, sulfhemoglobinemia, and methemoglobinemia (cyanosis, dyspnea, chest pain), hemolytic anemia, bruising or bleeding, increased liver enzyme activity (usually without development of jaundice), Quincke's edema (angioedema), urticaria, hypotension, renal colic, hepatonecrosis.
Shelf life.
3 years. After first opening, use before the end of the shelf life.
Storage conditions.
Store below 30 °C in a place inaccessible and out of sight of children. Do not freeze.
Packaging.
100 ml in a bottle; 1 bottle and a measuring device in the form of a syringe in a cardboard box labeled in Ukrainian and English.
Prescription status.
Over-the-counter (without prescription).
Manufacturer.
Haleon CH S.a.r.l.
Manufacturer's address and location of business operations.
Route de l’Etraz 2, Nyon, 1260, Switzerland / Route de l’Etraz 2, Nyon, 1260, Switzerland