Compositon/Ingredients: Paracetamol

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.

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.

Paracetamol should not be used for self-medication of pain for longer than 10 days in adults or 5 days in children.

Paracetamol should not be used for self-medication of marked fever (greater than 39.5^oC), fever persisting longer than 3 days, or recurrent fever.

Adults and children >12 years of age: 500 – 1000 mg every 4 – 6 hours as necessary, but should not exceed 4 g daily.

Children 6 – 12 years of age: 250 – 500 mg every 4 – 6 hours when necessary up to a maximum of 4 doses in 24 hours.

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).

Infrequent paracetamol should remain the analgesic of choice in pregnancy.

Caution when use paracetamol for breastfeeding women. Patients should be aware of how they react to Paracetamol 500mg before driving or operating machinery.

Store at temperature below 30°C, protect from light.