• The preparation is a painkilling, antipyretic medicine (analgesic and antipyretic).
• The tablets are used for the symptomatic treatment of mild to moderate pain and/or fever.

• Always take this medicine exactly as described or exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are unsure.
• dosage
  • This medicine should be used at the lowest pain-controlling dose for the shortest possible period of time.
  • The dosage depends on the information in the table below. The number of tablets given applies only to patients who are not receiving other medicines containing paracetamol.
  • Paracetamol is dosed depending on body weight and age, usually with 10 to 15 mg/kg body weight as a single dose up to a maximum of 60 mg/kg body weight or up to a maximum of 8 tablets per day (corresponding to 4000 mg paracetamol as a total daily dose).
  • The maximum daily dose must not be exceeded.
  • The respective dosage interval depends on the symptoms and the maximum total daily dose. The time interval between two applications must be at least 6 hours.
  • Do not use the product for longer than 3 days without medical or dental advice.
  • Body weight or age
    • 17 - 25 kg (children: 4 - 8 years)
      • Single dose: ½ tablet (equivalent to 250 mg paracetamol)
      • Maximum daily dose (24 hours): 2 tablets (4 × ½ tablet) equivalent to 1000 mg paracetamol
    • 26 - 32 kg (children: 8 - 11 years)
      • Single dose: ½ tablet (equivalent to 250 mg paracetamol ¹ )
      • Maximum daily dose (24 hours): 2 tablets (4 × ½ tablet) equivalent to 1000 mg paracetamol ²
    • 33 - 42 kg (children: 11 - 12 years)
      • Single dose: 1 tablet (equivalent to 500 mg paracetamol)
      • Maximum daily dose (24 hours): 4 tablets (4 × 1 tablet) equivalent to 2000 mg paracetamol
    • from 43 kg. Children and young people aged 12 and over and adults
      • Single dose: 1 - 2 tablets (corresponding to 500 - 1000 mg paracetamol)
      • Maximum daily dose (24 hours): 8 tablets equivalent to 4000 mg paracetamol
  • ¹ Other dosage forms may be more beneficial for this patient group as they allow a more precise dosage of a maximum of 400 mg paracetamol.
    ² In exceptional cases, up to 3 tablets (6 × ½ tablet) can be used daily, with a dosage interval of at least 4 hours, ie up to 1500 mg paracetamol daily.
  • Liver dysfunction and mild impairment of kidney function
    • In patients with liver or kidney dysfunction or Gilbert-Meulengracht syndrome, the dose must be reduced or the interval between doses must be increased. A total daily dose of 4 tablets (2000 mg paracetamol) must not be exceeded without medical advice.
  • Moderate to severe impairment of renal function
    • Unless otherwise prescribed, a reduction in dose is recommended in patients with renal impairment. The interval between each dose must be at least 6 hours.
    • In case of severe renal impairment (creatinine clearance < 10 ml/min), the interval between individual doses must be at least 8 hours (see table).
    • Adult:
      • glomerular filtration rate: 10 - 50 ml/min
        • Dose: maximum 1 tablet* every 6 hours
      • glomerular filtration rate: < 10ml/min
        • Dose: maximum 1 tablet* every 8 hours
      • * corresponds to 500 mg paracetamol
  • Elderly patients
    • Experience has shown that no special dosage adjustment is required. However, in debilitated, immobilized elderly patients with impaired liver or kidney function, a reduction in dose or extension of the dosing interval may
      be necessary.
    • Without medical advice, the total daily dose of 60 mg/kg body weight (up to a maximum of 4 tablets per day, equivalent to 2000 mg paracetamol) should not be exceeded if you
      • weigh less than 50 kg
      • suffer from chronic alcoholism
      • are affected by dehydration
      • are chronically malnourished/malnourished
  • Children and young people with low body weight
    • The use of the tablets in children under 4 years of age or under 17 kg body weight is not recommended as the dosage strength is not suitable for this age group. However, suitable dosage strengths and dosage forms are available for this age group.

• If you have taken more than you should
  • The total dose of paracetamol must not exceed 4000 mg paracetamol (corresponding to 8 paracetamol 500 mg tablets) per day for adults and adolescents aged 12 and over or with a body weight of 43 kg or more and 60 mg/kg body weight per day for children.
  • With an overdose of paracetamol, symptoms generally occur within 24 hours and include nausea, vomiting, loss of appetite, paleness and abdominal pain. Serious liver damage can also occur.
  • If a larger amount of paracetamol has been taken than recommended, please call the nearest doctor immediately for help!

• If you forget to take it
  • Do not take a double dose if you forget to take the previous dose.

• If you have any further questions about using this medicine, talk to your doctor or pharmacist.

PARACETAMOL dura 500 mg tablets