Indications
For treatment of mild to moderate pain and fever, especially in patients in whom salicylates are contraindicated or not tolerated. The drug is most effective in relieving low intensity pain of non-visceral origin.
Contraindications
Patients with anemia or cardiac, pulmonary, renal, or hepatic disease.
Patients with alcohol dependence.
Patients with known hypersensitivity to paracetamol or any of the excipients listed in.
Patients with known glucose – 6 – phosphate dehydrogenase deficiency.Uncommon: Rash, nausea, vomiting, blood dyscrasias (neutropenia, pancytopenia, leukopenia), anemia, nephropathy, nephrotoxicity with chronic abuse.
Compositon/Ingredients
Paracetamol 500mg
Dosage and administration
Paracetamol should not be used for self-medication of pain for longer than 10 days in adults and 5 days in children.
Paracetamol should not be used for self-medication of marked fever (greater than 39.5oC), fever persisting longer than 3 days, or recurrent fever.
Adults and children ≥ 11 years of age: 1 tablet every 4 – 6 hours as necessary, not exceed 4 g daily.
Precaution
Paracetamol should be used with caution in patients with preexisting anemia, since cyanosis may not be apparent despite dangerously high blood concentrations of methemoglobin.
Excessive intake of alcohol may increase the risk of paracetamol induced hepatotoxicity; avoid or limit alcohol intake.
Caution is recommended when giving to patients with hepatic or renal impairment, susceptible individuals.
The physicians need to warn the patients of the signs of serious skin reactions known as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) or Lyell’s syndrome, acute generalized exanthematous pustulosis (AGEP).
Hapacol 500mg contains aspartame. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
Hapacol 500mg contains anhydrous sodium bicarbonate, anhydrous sodium carbonate, sodium benzoate, sodium saccharin; therefore, patients should have dietary sodium restriction.
Paracetamol should be only used in pregnant women when clearly needed. Caution when use paracetamol for breastfeeding women.
Patients should be aware of how they react to Hapacol 500mg before driving or operating machinery.
Storage
Store at temperature below 30°C, protect from light.
