FORMULA:
Paracetamol................................... 250 mg
Excipients sufficient to..................... 1 sachet
INDICATIONS:
Fever reduction, pain relief for children in cases of: flu, cold, dengue fever, bacterial infections, viral infections, teething, post-immunization, post-surgery, ...
CONTRAINDICATIONS:
Hypersensitivity to Paracetamol.
Cases: glucose-6-phosphate dehydrogenase deficiency; hepatic dysfunction.
Patients with repeated blood loss or with heart, lung, kidney diseases.
PRECAUTIONS: Severe renal impairment. Caution in individuals on salt-restricted diets.
PREGNANT AND LACTATING WOMEN: Paracetamol should only be used in pregnant women when absolutely necessary. Studies in breastfeeding mothers using Paracetamol have not shown any undesirable effects on breastfeeding infants.
DRUG INTERACTIONS: Long-term use of high doses of Paracetamol slightly enhances the anticoagulant effect of Coumarin and Indandione derivatives. Serious fever reduction may occur in patients concurrently using Phenothiazines and fever-reducing therapy. Anticonvulsants (Phenytoin, Barbiturates, Carbamazepine) induce microsomal liver enzyme activity, potentially increasing Paracetamol's hepatotoxicity by enhancing its metabolism into toxic metabolites. Concurrent use of Isoniazid with Paracetamol may increase the risk of hepatotoxicity.
ADVERSE REACTIONS: Rare allergic reactions. May cause hepatic failure (due to hepatocyte necrosis) at high, prolonged doses. Notify a physician of any adverse effects experienced when using the medication.
OVERDOSAGE AND MANAGEMENT:
Paracetamol overdose can result from a single acute dose, repeated ingestion of large doses of Paracetamol (7.5 - 10 g daily, for 1 - 2 days), or prolonged medication use. Hepatic necrosis, dose-dependent, is the most serious acute toxic effect of overdosage and can lead to death. Signs of Paracetamol overdose include nausea, vomiting, abdominal pain, cyanosis of the skin, mucous membranes, and nail beds. Management: In severe Paracetamol poisoning, aggressive supportive therapy is required. Gastric lavage should be performed in all cases, ideally within 4 hours of ingestion. The primary antidote is the use of sulfhydryl compounds. N-acetylcysteine is effective when administered orally or intravenously. Medication should be administered immediately if ingestion occurred less than 36 hours prior. Treatment with N-acetylcysteine is more effective when given within 10 hours of Paracetamol ingestion. When administered orally, N-acetylcysteine solution should be diluted with water or non-alcoholic beverages to achieve a 5% solution and should be ingested within 1 hour of preparation. Administer N-acetylcysteine at an initial dose of 140 mg/kg body weight, followed by 17 additional doses, each at 70 mg/kg body weight, spaced 4 hours apart. Methionine, activated charcoal, and/or osmotic diuretics may also be used.
DOSAGE AND ADMINISTRATION:
Dissolve the medication in water (suitable for children) until effervescence ceases. Administer every 6 hours, up to 5 times a day. Doses should be separated by at least 4 hours. Dosage: on average, 10 - 15 mg/kg body weight per dose. The total maximum dose should not exceed 60 mg/kg body weight per 24 hours. Alternatively, the dose can be divided as follows:
Children aged 4 - 6 years: 1 sachet per dose.
Or as directed by a physician.
**Note:** Prolonged self-medication for children is not advisable. Consult a doctor if: New symptoms appear. Fever persists at high levels (39.5°C) for more than 3 days or recurs. Pain persists and lasts longer than 5 days.
- Read the instructions carefully before use.
- If further information is needed, consult a physician.