Paracetamol 500 mg

OTC

Indications

• Symptomatic treatment of mild to moderate pain and/or feverish states for adults and children from 27kg (i.e. from about 8 years old).

Dosage

• The dosage for children is determined based on their weight.
• Recommended daily dose: 60 mg/kg/day, divided into 4 or 6 doses. (Equivalent to approximately 15 mg/kg every 6 hours or 10 mg/kg every 4 hours).
• Children weighing 27-40 kg (approximately 8-13 years old): 1 tablet (500 mg) per dose. May be repeated every 4 hours, but no more than 4 tablets per day.
• Children weighing 41-50 kg (approximately 12-15 years old): 1 tablet (500 mg) per dose. May be repeated every 4 hours, but no more than 6 tablets per day.
• Adults and children weighing 50 kg or more (approximately 15 years old): 1-2 tablets (500-1000 mg) per dose. May be repeated after a minimum of 4 hours.
• Generally, do not use more than 3g of paracetamol (equivalent to 6 tablets) per day. In cases of severe pain, the dose may be increased to 3 g of paracetamol (equivalent to 8 tablets) per day.
• Adults should always maintain a minimum interval of 4 hours between two doses of paracetamol.
• Children should take paracetamol at regular intervals, including at night, ideally every 6 hours, and at least every 4 hours.
• Patients with renal impairment: Do not exceed 3g (6 tablets) per day, with a minimum interval of 8 hours between doses.
• The following cases require consideration of the lowest effective daily dose, not exceeding 6 mg/kg/day:
  Adults weighing less than 50 kg,
  Mild to moderate hepatic impairment,
  Chronic alcoholism,
  Dehydration,
  Prolonged malnutrition, fasting, recent weight loss,
  Over 65 years of age with multiple comorbidities, chronic viral hepatitis, cystic fibrosis, familial cholemia.

Usage

• Oral route.
• The tablets are to be swallowed as is with a drink (e.g. water, milk, fruit juice).

• Children under 6 years old,
• Hypersensitivity to the active substance or to any of the excipients of the drug,
• Severe hepatic impairment.

• Although rare, paracetamol may cause rash, hives, or in severe cases, liver failure if overdosed.

• Strictly adhere to the recommended dosage.
• Do not use alcoholic beverages while being treated with paracetamol.
• Discontinue paracetamol if acute viral hepatitis is detected.
• Caution is advised when using paracetamol concurrently with flucloxacillin.
• Discontinue paracetamol if skin rash or any other signs of hypersensitivity reaction are detected. Individuals who have previously experienced severe skin reactions due to paracetamol should not use the medication again.
• Paracetamol may be used during pregnancy if clinically necessary; however, the lowest effective dose should be used for the shortest possible duration and as infrequently as possible.
• At therapeutic doses, paracetamol can be used during breastfeeding.
• Paracetamol does not affect the ability to drive or operate machinery.