Hapacol Blue

Barcode: 8935206094879


Paracetamol................... 500 mg

Excipients.q.s................ 1 tablet

(Wheat starch, PVP K30, aerosil, magnesium stearate, sodium benzoate, HPMC, PEG 6000, titanium dioxide, talc).

DOSAGE FORM: Film coated tablets.

PRESENTATION: Box of 10 blisters x 10 film coated tablets.

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 the body temperature in fever patients, but rarely in the normal cases. Paracetamol produces analgesia by elevation of the pain threshold.

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.

INDICATIONS: - For treatment of painful symptoms in cases of headache, migraine, toothache, pains and aches caused by flu, sore throat, musculoskeletal pains, arthritis-associated pain, pains after vaccination or tooth extraction.

- Antipyretic action on patients suffering from cold or diseases related to fever.

CONTRAINDICATIONS: Hypersensitivity to paracetamol. Patients with anemia, cardiopathy, pneumopathy, renopathy. In some cases e.g. glucose-6-phosphate dehydrogenase deficiency; impaired hepatic function.

PRECAUTIONS: Paracetamol 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 paracetamol mildly increases the anticoagulant effect of coumarin and indandion derivative. A serious antipyretic effect may be reported in patients using phenothiazine and hypothermic therapy concomitantly. Anticonvulsants (phenytoin, barbiturate, carbamazepin) 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 isoniazide and paracetamol may show to increase risk of hepatotoxicity.


Less frequent: Skin: skin rash. Gastrointestinal tract: nausea, vomiting. Hematology: neutrophilopenia, pancytopenia, hypoleukemia, anemia.

Kidney: renopathy, rephrotoxicity due to prolonged abuse. Rarely: hypersensitive reactions. Prolonged, high-dose use of Hapacol Blue has been reported to 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: Adults and children aged > 12 years: oral dose of 1 tablet. Adults may be given 2 tablets in severe cases.

The interval between oral doses should be over 4 hours and do not take more than 8 tablets daily.

* For patients with severe renal impairment (creatinine clearance < 10 ml/min.), the interval between oral doses should be at least 8 hours.

Or as directed by the physician.

Notes: * Maximum dose/ 24 hours: not more than 4 g; the interval between oral doses should be over 4 hours.

* Prolonged administration by oneself should not be advised, 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: 36 months from the manufacturing date.

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

Specifications: Manufacturer's.


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