Paracetamol ................................... 80 mg
Excipients q.s ............................. 1 sachet
Effervescent powder.
Box of 24 sachets x 1.5 g. Box of 50 sachets x 1.5 g.
The drug does not affect the possibility of driving and using machines.
Safety of paracetamol on foetus has not been determined when administered to pregnant women. Therefore, the drug should be only used in pregnant women if clearly needed. Studies in breast-feeding mothers show that paracetamol does not cause any adverse effects at nursing infants
Chronic ingestion of large doses of paracetamol has been reported to potentiate the effects of coumarin- and indandione-derivative anticoagulants.
The possibility of severe hypothermia should be considered in patients receiving concomitant phenothiazine and antipyretic therapy.
Anticonvulsants (including phenytoin, barbiturates, carbamazepine), isoniazid, and antituberculosis drugs may increase paracetamol-induced liver toxicity.
Excessive consumption of alcohol may increase the risk of paracetamol-induced hepatotoxicity.
Uncommonly: rash; nausea, vomiting; rephropathy, renal toxicity due to long-term abuse; neutrophilopenia, pancytopenia, anemia.
Rarely: hypersensitive reactions.
Inform your physician about any adverse effects occur during the treatment.
Paracetamol toxicity may result from a single toxic dose, from repeated ingestion of large doses of paracetamol (e.g. 7.5 - 10 g daily for 1 - 2 days), or from chronic ingestion of the drug. Dose-dependent, hepatic necrosis is the most serious acute toxic effect associated with overdosage and potentially fatal.
Symptoms of paracetamol overdosage include nausea, vomiting, abdominal pain, cyanosis on skin, mucosa, and nails.
Signs of severe paracetamol toxicity: Mild irritation, irritability and delirium are initial signs. The following symptoms include central nervous system inhibition: hypothermia, fatigue, tachypnea and oligopnea; short, weak, irregular pulses, hypotension, and circular impairment.
Treatment: Early diagnosis is very important in treatment of paracetamol overdosage.
In the event of severe paracetamol intoxication, 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 the use of sulfhydryl compound. N-acetylcysteine gives its effect followed by oral route or an intravenous injection.
Methionine, activated charcoal and/or salt cleaners are also advised to treat overdose.
Store in dry places, not exceeding 30oC, protect from light.
Paracetamol produces effective analgesia, antipyresis. The drug acts on the hypothalamic heat-regulation center to produce antipyresis; heat dissipation is increased as a result of vasodilation and increased peripheral blood flow. Paracetamol lowers body temperature in patients with fever but rarely lowers normal body temperature. Paracetamol produces analgesia by elevation of the pain threshold.
At therapeutic dose, the analgesic and antipyretic effect of paracetamol is equivalent to that of aspirin; however, paracetamol appears to have little effect on cardiovascular and respiratory systems, no change in acid-base equilibrium, no causing gastric irritation, scratch or bleeding.
Paracetamol is rapidly and completely absorbed by the gastrointestinal tract. The elimination half-life of paracetamol varies from about 1.25 to 3 hours. Paracetamol is metabolized predominantly by the liver and excreted by the kidney.
Hapacol 80 contains 80 mg of paracetamol which is suitable for infants aged below 1 year. It is prepared in the dosage form of effervescent powder, dissolved in water before oral administration.
Individuals with phenylketonuria and other individuals who must restrict their intake of phenylalanine should be warned that paracetamol is not recommended to combine with aspartame-containing food or drugs.
Patients with hypersensitivity (asthma) should not use concurrently paracetamol and sulfite-containing food or drugs.
Use with caution in patients with previous anemia, hepatic and renal impairments.
Paracetamol may cause liver damage if you consume more alcoholic drinks; it is advised to avoid or reduce alcohol consumption.
The physician should warn patients of serious signs of skin reactions such as Steven-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) or Lyell syndrome, acute generalized exanthematous pustulosis (AGEP).
Analgesic and antipyretic actions on infants in cases of cold, flu, petechial fever, bacterial infections, viral infections, teething, post-vaccination, post-surgery,...
Hypersensitivity to any components of the drug. Patients with glucose - 6 - phosphate dehydrogenase deficiency.
Hapacol 80 is dissolved in water (suitable for infants) until ending effervescence.
It is orally taken every 6 hrs, not more than 5 times daily.
Average recommended doses are 10 - 15 mg/ kg body weight/ time.
Maximum recommended doses are not more than 60 mg/ kg body weight/ 24 hours.
Or the doses are as follows:
Infants aged from 0 to 3 months: ½ sachet each time.
Infants aged from 4 to 11 months: 1 sachet each time.
Or as prescribed by the physician.
Notes: Prolonged self-administration to infants should not be advised. Ask your physician if:
- new symptoms occur.
- fever gets worse (39.50C) and lasts for more than 3 days or recurs.
- pain gets worse or lasts for more than 5 days.
Read the directions carefully before use.
Consult the physician for more information.
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