Hapacol 250

Antipyretic analgesics for children
Barcode: 8935206094916


Paracetamol...................... 250 mg

Excipients q.s.................. 1 sachet

(Anhydrous citric acid, mannitol, aspartame, sodium hydrocarbonate, PVP K30, refined sugar, sunset yellow, orange-flavored powder).

DOSAGE FORM: Effervescent powder.

PRESENTATION: Box of 24 sachets x 1.5 g.

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.

Hapacol 250 containing 250 mg of paracetamol is prepared in the dosage form of effervescent powder, dissolved in water before use. Therefore, it is effectively analgesic, antipyretic in children. The drug is quickly and mostly absorbed by the gastrointestinal system.

INDICATIONS: Antipyretic and analgesic actions on children in cases of cold, flu, petechial fever, bacterial infections, viral contamination, teething, post-vaccination, post-surgery,..

CONTRAINDICATIONS: Hypersensitivity to paracetamol. In cases of glucose-6-phosphate dehydrogenase (G6PD) deficiency; impaired hepatic function. Patients with anemia or cardiopathy, pneumopathy, renopathy.

PRECAUTIONS: Caution in patients with severe renal impairment has been reported. Patients on sodium-free diets are warned.

PREGNANCY AND LACTATION: Paracetamol only gives to pregnant women if really necessary.

Studies in the mothers taking paracetamol during breast-feeding period showed no adverse effects in the neonate.

INTERACTIONS: High doses of paracetamol for a long time gently increase the effect of coumarin and indandion derivative. Possibility of severe antipyretic action on patients concurrently using phenothiazine and antipyretic therapy may be reported. Anti-convulsants 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.


Allergic reactions have been rarely reported. High doses and prolonged use of the drug may cause hepatic impairment (due to hepatolysis).

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.

DOSAGE & ADMINISTRATION: Dissolve the effervescent powder in some fresh water (suitable for children) until ending effervescence. 

Orally taken every 6 hours, not more than 5 times daily. The interval between oral doses should be at least 4 hours.

Average usual dose: 10 - 15 mg / kg body-weight.

Total maximal doses: not more than 60 mg/ kg body-weight/ 24 hours.

Or the doses are as follows:

Children 4 - 6 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:

- New symptoms occur.

- Fever gets worse (39.50C) and lasts for more than 3 days.

- Pain gets worse or lasts for more than 5 days.

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.

Specifications: Manufacturer's.


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