Hapacol Extra

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COMPOSITION:

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

Caffeine ......................................... 65 mg

Excipients q.s............................... 1 caplet

(Pregelatinized starch, avicel, wheat starch, sodium starch glycolate, erythrosine lake color, talc, magnesium stearate, strawberry-flavored powder, PVP K30, sodium benzoate).

DOSAGE FORM: Caplets.

PRESENTATION: Box of 10 blisters x 10 caplets.

ACTIONS: Hapacol Extra is a combination of paracetamol and caffeine:

Paracetamol is effectively analgesic, antipyretic. Paracetamol acts on the hypothalamic heat-regulating center for hypothermia and increase in thermolysis due to vasodilation and peripheral hypervolemia; this relieves the body temperature in fever patients, but rarely reducing in the normal body temperature. At therapeutic dose, the analgesic and antipyretic effect is equivalent to aspirin; however, paracetamol has little action on cardiovascular and respiratory systems, no change in acid-base equilibrium, no causing irritation, scratch or gastrorrhagia. 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.

Caffeine gently irritates on central nervous system, supports to relieve pains, and helps muscles act easily. 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 by the urine.

INDICATIONS: Relief of painful attacks including headache, migraine, sore throat, dysmenorrhea, pains after tooth extraction or dental surgeries, toothache, myalgia, tenodynia, traumatic injuries, arthritis- and sinusitis-associated pains, pains and aches due to cold, flu.

CONTRAINDICATIONS: Hypersensitivity to any component of the drug. Patients with glucose-6-phosphate dehydrogenase deficiency.

PRECAUTIONS AND SPECIAL WARNINGS:

Patients suffering from phenylketonuria and those needing limit the intake of phenylalanine should not use concurrently paracetamol and 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.

High doses of caffeine may cause hypertension; use with caution in patients with hypertension.

For the paracetamol-containing drugs, the physician should warn patients of serious signs of skin reactions such as Steven-Jonhson syndrome (SJS), toxic epidermal necrolysis (TEN) or Lyell syndrome, acute generalized exanthematous pustulosis (AGEP).

PREGNANCY AND LACTATION: The drug only gives pregnant and nursing women if really necessary.

VEHICLE DRIVERS AND MACHINERY OPERATORS: The drug does not affect the possibility of driving vehicles and operating machinery.

INTERACTIONS: Long-term use of high doses of paracetamol mildly increases the anticoagulant effect of coumarin and indandione derivative. A serious antipyretic effect may be reported in patient co-administering phenothiazine and hypothermic therapy. Anticonvulsants (phenytoin, barbiturates, carbamazepine), isoniazid can increase liver toxicity by paracetamol. Abundant and long-term use of alcohol has been reported to increase liver toxicity by paracetamol.

Avoid combination of the drug with caffeine-containing drinks including tea, coffee, and some canned drinks. Increase in half-life time of caffeine has been reported by concurrently using with antibiotics including ciprofloxacin, enoxacin, lomefloxacin, norfloxacin, ofloxacin. Avoid concurrent use of caffeine and phenytoin, fluvoxamine, terbinafine, cimetidin, methoxsalen, contraceptives, phenylpropanolamine, ephedrin, theophylline.

ADVERSE EFFECTS: Paracetamol rarely causes adverse effects but sometimes causing allergy, rash, nausea, vomiting; and in some cases, it may induce pancytopenia, hypoleukemia, anemia. The prolonged use and high doses of paracetamol may lead to hepatic impairment (due to hepatolysis).

In concerning with caffeine: 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.

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.

Methionin, activated charcoal and/or salt cleaners are also advised to treat overdose.

Caffeine overdosage has been rarely reported. They can be drowsiness, palpitation, agitation, and delirum.

DOSAGE & ADMINISTRATION: Adults and children aged > 12 years are orally given 1 to 2 caplets, 1 to 4 times daily.

Do not exceed 8 caplets daily.

The interval between oral doses should be at least 4 hours.

Or as prescribed by the physician.

         Read the directions carefully before use.                     Shelf-life: 36 months from the manufacturing date.

         Consult the physician for more information.                  Storage conditions: Store in dry places, not exceeding 30oC, protect from light.

                                                            Specifications: Manufacturer's.

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