DOSAGE FORM: Effervescent powder.
ACTIONS: Paracetamol is effectively analgesic, antipyretic. Paracetamol has action on the hypothalamic heat-regulating center causing hypothermia, increase in thermolysis due to vasodilation and peripheral hypervolemia; this relieves body temperature in fever patients, but rarely occurring in a normal temperature body. Paracetamol produces analgesia by elevation of the pain threshold. In the body, Vitamin C participates in the synthetic, metabolic processes of essential substances for body's development and plays an important role in intensification of immune function, resistant capacity against infections. Hapacol Kids containing 150 mg of paracetamol and 75 mg of vitamin C is prepared in the dosage form of effervescent powder, dissolved in water before use. Hapacol Kids is effective to relieve fever and pain, to intensify immunity in children aged above 1 year. The drug is quickly and completely absorbed by the gastro-intestinal tract.
INDICATIONS: Antipyretic, analgesic actions and immune intensification for children in cases ofcold, flu, headache, musculoskeletal pains, sprain, arthralgia, infections, viral contamination, post-vaccination, postoperative tonsillectomy, tooth extraction, teething, toothache,...
CONTRAINDICATIONS: Patients with hypersensitivity to any components of the drug. Patients suffering glucose-6-phosphate dehydrogenase deficiency, impaired hepatic function, a history of nephritic calculus, oxalosis, thalassemia.
PRECAUTIONS: Caution in patients with severe renal impairment has been reported. Sleeplessness is reported when administration of high-dose vitamin C in the evening. Patients on sodium-free diets are warned.
INTERACTIONS: Related to Paracetamol: High doses of paracetamol for a long time gently increase the anticoagulant effect of coumarin and indandion derivative. Possibility of severe antipyretic action on patients concurrently using phenothiazine and antipyretic therapy may be reported. Anticonvulsants including phenytoin, barbiturate, carbamazepine may cause hepatic microsomal enzyme induction, probably increasing the hepatotoxicity of paracetamol because of accelerated metabolism to substances harmful to the liver. Concurrent use of isoniazid and paracetamol may increase risk of hepatotoxicity.
Related to vitamin C: Concurrent administration of vitamin C and aspirin may increase vitamin C excretion and decrease aspirin excretion in the urine. Concurrent administration of vitamin C and fluphenazine may reduce plasma fluphenazine concentration. Urinary acidification after administration of vitamin C may change the excretion of other drugs. Vitamin C is a strong reducing agent; therefore, vitamin C may influence biological tests (such as creatinine and glucose assay in blood, urine) in the paraclinical tests.
ADVERSE EFFECTS: Related to paracetamol:
Less frequently: Skin: skin rash. Gastrointestinal tract: nausea, vomiting. Hematology: neutrophilopenia, pancytopenia, hypoleukemia, anemia. Kidney: renopathy, rephrotoxicity due to long-time abuse. Rarely: hypersensitive reactions. Possibility of hepatic impairment (due to hepatolysis) has been reported when taking the drug at high dose for a long time.
Related to vitamin C: Vitamin C is well tolerated. High doses are reported to cause diarhoea, other gastrointestinal disturbances, and hemolytic symptoms in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Vitamin C excess may cause uricaciduria, renal oxalate accumulation
Inform your physician about any adverse effects occur during the treatment.
OVERDOSAGE: Paracetamol overdosage is due to a single-dose or repeated large doses ingestion (7.5 - 10 g daily for 1 - 2 days), or long-time ingestion. In acute paracetamol overdosage, dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Symptoms of overdose include nausea, vomiting, colic, cyanosis on skin, mucosa, nails.
Treatment of overdosage: In the event of severe paracetamol overdose, full supportive measures should also be instituted. Gastric lavage should be carried out especially if the overdose was taken within the previous 4 hours. The main detoxication therapy is use of sulfhydryl compound. N-acetylcysteine gives its effect followed by oral route or an intravenous infusion. N-acetylcysteine should be administered as soon as possible, preferably within 36 hours of overdosage. N-acetylcysteine is more effective if administered within 10 hours of overdosage. It can be diluted with water or alcohol-free drinks to a 5% solution and orally taken within 1 hour. Oral N-acetylcysteine is given as a 140 mg/kg body-weight initial dose followed by 70 mg/kg body-weight every four hours for 17 more doses. Methionin, activated charcoal and/or salt cathartic are also advised to treat overdose.
Symptoms of vitamin C overdose include renal calculus, nausea, gastritis, and diarrhea. Forced diuresis by perfusion may be useful after taking large doses.
DOSAGE & ADMINISTRATION: Dissolve the effervescent powder in some fresh water (ideal for children) until ending effervescence.The dosage is orally taken every 6 hours, not more than 5 times daily. The average dosage equivalent to paracetamol is 10 to 15 mg per kg body-weight.
Total maximal dose of paracetamol is not more than 60 mg per kg body-weight per 24 hours.
Or the doses are as follows: Children 1 - 3 years of age: oral dose of 1 sachet.
Or as directed by the physician.
Notes: A long-term treatment should not be applied in children if there is no physician's advice, consult a physician if:
Read the directions carefully before use.
Consult the physician for more information.
Shelf-life: 24 months from the manufacturing date.
Storage conditions: Store in dry places, temperature not exceeding 300C.