DONAPAN Tablet Ref.[51298] Active ingredients: Paracetamol

• Consult a doctor or pharmacist if pain or fever persists or gets worse at the recommended dosage, or if new symptoms occur.
• Do not use Donapan continuously without consulting a medical practitioner: Pain – for more than 7 days in adults (5 days for children); and Fever – for more than 3 days.
• Dosages in excess of those recommended may cause severe liver damage.
• Patients suffering from hepatitis or alcoholism, or recovering from any form of liver disease should not take excessive quantities of Donapan.
• Caution is recommended in patients with moderate renal failure and patients on dialysis, as plasma concentrations of Donapan and its conjugates are increased.
• Use with caution in renal impairment, chronic malnutrition or dehydration.
• Caution should be exercised in patients with glutathione depleted states, as the use of paracetamol may increase the risk of metabolic acidosis.
• Use with caution in patients with glutathione depletion due to metabolic deficiencies.

Donapan contains paracetamol which may be fatal in overdose. In the event of overdosage or suspected overdose and notwithstanding the fact that the person may be asymptomatic, the nearest doctor, hospital or Poison Centre must be contacted immediately.

Hepatotoxic medicines: Increased risk of hepatotoxicity.

Enzyme-inducing medicines: Increased risk of hepatotoxicity and possible decrease in therapeutic effects of Donapan.

Metoclopramide: Absorption of Donapan may be accelerated.

Probenecid: Pre-treatment with probenecid can decrease Donapan clearance, and increase its half-life.

Cholestyramine: Absorption of Donapan is reduced if given within one hour of cholestyramine.

Salicylates: Prolonged concurrent use of Donapan with salicylates increases the risk of adverse renal effects.

Antibiotics: Chronic use of isoniazid, an antibiotic medicine often prescribed for tuberculosis, may increase the risk of liver damage when combined with Donapan, even at recommended doses.

Warfarin: The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

Pregnancy

Donapan is generally considered safe for use in pregnant patients, if used infrequently (not daily or on most days).

Breastfeeding

Donapan is distributed into breastmilk, in amounts too small to be considered harmful to a breast-fed infant. No significant adverse effects have been seen in breast-fed infants whose mothers received paracetamol.

Fertility

There is no data on adverse effects on male or female fertility.

None.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Medicine Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8.

Not applicable.