Paracetamol ................................. 650 mg
Caffeine ......................................... 65 mg
Excipients q.s ............................... 1 tablet
Tablet.
Box of 10 blisters x 10 tablets.
The drug does not affect the possibility of driving and using machines.
The drug is only used in pregnant and nursing women if really necessary.
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 may increase paracetamol-induced liver toxicity. Excessive consumption of alcohol may increase the risk of paracetamol-induced hepatotoxicity. Concurrent administration of the drug with caffeine-containing drinks including tea, coffee, and some canned drinks is not recommended. Half-life of caffeine has been increased by concurrently using with antibiotics including ciprofloxacin, enoxacin, lomefloxacin, norfloxacin, ofloxacin. No concurrent use of caffeine with phenytoin, fluvoxamine, terbinafine, cimetidin, methoxsalen, contraceptives, phenylpropanolamine, ephedrin, theophylline is recommended.
Paracetamol rarely causes adverse effects. It sometimes causes allergy, rash, nausea, vomiting; pancytopenia, hypoleukemia, anemia. Chronic ingestion of large doses of paracetamol may lead to hepatic impairment (due to hepatolysis).
High doses of caffeine may cause hypertension, daytime sleepiness. Besides, other side effects include nausea, vomiting, diarrhea, insomnia, headache, tremble, palpitations, anxiety.
Inform your physician about any adverse effects occur during the treatment.
Paraceramol overdosage: 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 overdose include nausea, vomiting, colic, cyanosis on skin, mucosa, nails.
Treatment: 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.
Methionin, activated charcoal and/or salt cleaners are also used to treat overdose.
Caffeine overdosage has been rarely reported. They can be drowsiness, palpitation, agitation, and delirum.
Store in dry places, not exceeding 30oC, protect from light.
Hapacol 650 Extra is a combination of paracetamol and caffeine.
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. 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 systems, causes no acid-base balance, no gastric irritation, scratch, bleeding. Paracetamol has no effect on inflammatory treatment. 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 kidneys.
Caffeine stimulates all levels of the CNS. Caffeine is well absorbed by the gastrointestinal tract and obtained plasma maximum concentration in adults after 1 hour. The plasma half-life is about 3 to 7 hours. Caffeine is metabolized predominantly by the liver and excreted in urine.
Individuals with phenylketonuria and other individuals who must restrict their intake of phenylalanine should be advised no concurrent administration of paracetamol and aspartame-containing drugs or food.
In patients with hypersensitivity (asthma), concomitant administration of paracetamol and sulfite-containing foods or drugs should not be recommended. Caution should be exercised in patients with previous anemia, hepatic and renal impairment. Because excessive consumption of alcohol may increase the risk of paracetamol-induced hepatotoxicity; it is advised to avoid chronic ingestion of alcohol.
High doses of caffeine may cause hypertension; the drug should be used cautiously in patients with hypertension.
For paracetamol-containing agents: The physician should warn patients of serious signs of skin reactions such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) or Lyell’s syndrome, acute generalized exanthematous pustulosis (AGEP).
Relief of painful attacks including headache, migraine, sore throat, dysmenorrhea, tooth extraction or dental surgeries, toothache, myalgia, tenodynia, traumatic injuries, arthritis- and sinusitis-associated pains, pains due to cold or flu.
Hypersensitivity to any ingredients of the drug. Patients with glucose-6-phosphate dehydrogenase deficiency.
Adults and children aged > 12 years: The recommended dose is 1 tablet, 3 to 4 times daily. The interval between oral doses should be at least 4 to 6 hours. Do not exceed 6 tablets daily.
For patients with severe renal impairment (creatinine clearance < 10 ml per minute), the interval between oral doses should be at least 8 hrs.
Or as prescribed by the physician.
Read the directions carefully before use.
Consult the physician for more information.
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