Hapacol ACE

Barcode: 8935206007848


Acetaminophen ................................................... 500 mg

Excipients.q.s................................................... 1 capsule

(Sodium starch glycolate, PVP, talc, magnesium stearate).


DOSAGE FORM: Capsules.


PRESENTATION: Box of 10 blisters x 10 capsules;     Bottle of 200 capsules;     Bottle of 500 capsules.


ACTIONS: Acetaminophen is effectively analgesic, antipyretic. Acetaminophen has action on the hypothalamic heat-regulating center causing hypothermia, increase in thermolysis due to vasodilation and peripheral hypervolemia; this relieves the body temperature in fever patients, but rarely occuring in those with the normal temperature body. Acetaminophen produces analgesia by elevation of the pain threshold.

Acetaminophen is rapidly and completely absorbed by the gastrointestinal tract. The elimination half-life of acetaminophen varies from about 1.25 to 3 hours. Acetaminophen is metabolized predominantly by the liver and excreted by the kidney.


INDICATIONS: 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, menstruation-related pains.

 Antipyretic actions on patients with cold or diseases associated with fever.


CONTRAINDICATIONS: Hypersensitivity to acetaminophen. Patients with anemia, cardiopathy, pneumopathy, renopathy.

In cases of glucose - 6 - phosphate dehydrogenase deficiency; impaired hepatic function.


PRECAUTIONS: Acetaminophen may cause liver damage if you consume more alcoholic drinks; it is advised to avoid or reduce alcohol consumption.


INTERACTIONS: Long-term use of high-dose Acetaminophen mildly increases the anticoagulant effect of coumarin and indandion derivative.

A serious antipyretic effect may be reported in patients who concurrently use phenothiazine and hypothermic therapy.

Anticonvulsants (phenytoin, barbiturate, carbamazepin) may cause hepatic microsomal enzyme induction, probably increasing the hepatotoxicity of Acetaminophen because of accelerated metabolism to substances harmful to the liver.

Concurrent use of isoniazide and Acetaminophen may show to increase risk of hepatotoxicity.


ADVERSE EFFECTS: Uncommonly: Skin: skin rash.

Gastrointestinal tract: nausea, vomiting.

Hematology: neutrophilopenia, pancytopenia, hypoleukemia, anemia.

Kidney: renopathy, rephrotoxicity due to prolonged abuse.

Rarely: hypersensitive reactions.

Prolonged or high-dose use of Hapacol Ace shows to cause hepatic impairment (due to hepatolysis).

Inform your physician about any adverse effects occur during the treatment.


OVERDOSAGE: Acetaminophen overdosage is due to a toxic single-dose or repeated large-dose ingestion (7.5 - 10 g daily for 1 - 2 days), or long-time ingestion. In acute Acetaminophen overdosage, dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect.

Symptoms of Acetaminophen overdosage include nausea, vomiting, colic, cyanosis on skin, mucosa, and nails.

Treatment: In the event of severe Acetaminophen 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. 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: Adults: oral dose of 1 - 2 capsules x 1 - 3 times daily.

Or as directed by the physician.

Read the directions carefully before use.

Consult the physician for more information.

Shelf-life: 36 months from the manufacturing date.

Storage conditions: Store in dry places, not exceeding 300C.

Specifications: Vietnamese Pharmacopoeia.


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