Active ingredient: Paracetamol ............................. 650 mg
Excipients: q.s ………………………………………………… 1 tablet
Tablet.
Product description: A white to off-white, fragrant caplet, a break-line on one side, a diamond-shaped on the other, intact edges.
Box of 10 blisters x 5 tablets.
Box of 10 blisters x 10 tablets.
Box of 25 blisters x 10 tablets.
Bottle of 100 tablets.
Bottle of 200 tablets.
ATC code: N02B E01
Paracetamol produces effective analgesia, antipyresis. The drug acts on the hypothalamic heat-regulating 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.
With therapeutic doses, the analgesic, antipyretic effects of paracetamol are similar to those of aspirin. Paracetamol appears to have little effect on cardiovascular and respiratory system, causes no acid - base balance, no gastric irritation, scratch, 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.
The drug does not affect the possibility of driving and operating machinery.
Safety of paracetamol on foetus has not determined when administered to pregnant women. Therefore, the drug should be only used in pregnant women if clearly needed.
Studies in breast-feeding mothers showed that use of paracetamol causes no adverse effect in breast-fed 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.
Chronic, excessive consumption of alcohol may increase the risk of paracetamol-induced hepatotoxicity.
Uncommonly: rash; nausea, vomiting; nephropathy, renal toxicity due to long-term abuse; neutropenia, pancytopenia, anemia.
Rarely: hypersensitive reactions.
Please inform your doctor of all undesirable effects upon drug administration.
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.
In severe poisoning, mild stimulation, excitement, and delirium may occur initially. This may be followed by CNS depression; stupor; hypothermia; marked prostration; rapid, shallow breathing; rapid, weak, irregular pulses; low blood pressure; and circulatory failure.
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 use of sulfhydryl compound. N-acetylcysteine gives its effect followed by oral route or an intravenous infusion.
Methionine, activated charcoal and/or salt cathartics are also advised to treat overdose.
Store in dry places, not exceeding 30oC, protect from light.
Individuals with phenylketonuria and other individuals who must restrict their intake of phenylalanine should avoid co-administration of paracetamol and aspartame-containing medicines or food.
Patients with hypersensitivity (asthma) should not use concurrently paracetamol and sulfite-containing medicines or food.
Cautions should be taken in patients with previous anemia, liver and kidney failure.
Because chronic, excessive consumption of alcohol may increase the risk of paracetamol-induced hepatotoxicity, it is advised to avoid chronic ingestion of alcohol.
The physician should warn patients of serious signs of skin reactions such as Steven-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) or Lyell’s syndrome, acute generalized exanthematous pustulosis (AGEP).
Treatment of painful symptoms in cases of headache, migraine, toothache, aches and pains caused by flu, sore throat, musculoskeletal pains, arthritis-induced pains, pains after vaccination or tooth extraction.
Antipyretic actions on patients with cold or diseases associated with fever.
Hypersensitivity to any components of the drug. Patients with glucose - 6 - phosphate dehydrogenase deficiency.
Hapacol 650 should be orally given every 4 hours and not more than 6 tablets per day.
Adults and children aged > 12 years: 1 tablet each time.
Do not take the drug by self-administration for relief of fever for more than 3 days or for relief of pain for more than 10 days.
Or as prescribed by the physician.
Notes:
* Maximum dose/24 hours: not more than 4 g and given every 4 hours.
* Prolonged self-administration should not be advised, consult a physician if:
- New symptoms occur.
- Fever gets high (39.50C) and lasts more than 3 days or recurs.
- Pain gets worse or lasts more than 5 days.
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