Safety Information

Safety Information

Safety Information

Warnings and Precautions

Panadol contains Paracetamol. Do not take more than the recommended dose as it may cause serious harm to your liver. Do not use this medicine if you are taking any other prescription or non-prescription medicines containing paracetamol as it may lead to an overdose.

Always read and follow the label

In case of any of the below situations, you may need to avoid using this product altogether or limit the amount of paracetamol that you take.

Check with your doctor before use if you:

  • has liver or kidney problems.
  • has depleted glutathione levels, such as those who have a severe infection, are severely malnourished, severely underweight as this may increase the risk of metabolic acidosis. Signs of metabolic acidosis include:
    • deep, rapid, difficult breathing,
    • feeling sick (nausea), being sick (vomiting),
    • loss of appetite.

Contact a doctor immediately if you get a combination of these symptoms. Please see your doctor if your symptoms do not improve.

Before administering, check when paracetamol last administered and cumulative paracetamol dose over previous 24 hours; body-weight under 50 kg; chronic alcohol consumption; chronic dehydration; chronic malnutrition; hepatocellular insufficiency; long-term use (especially in those who are malnourished) Some patients may be at increased risk of experiencing toxicity at therapeutic doses, particularly those with a body-weight under 50 kg and those with risk factors for hepatotoxicity. Clinical judgement should be used to adjust the dose of oral and intravenous paracetamol in these patients.

Co-administration of enzyme-inducing antiepileptic medications may increase toxicity; doses should be reduced.

Adverse effects

Stop taking this medicine and tell your doctor immediately if:

  • you experience allergic reactions such as skin rash or itching, sometimes with breathing problems or swelling of the lips, tongue, throat or face.
  • you experience a skin rash or peeling, or mouth ulcers.
  • you have previously experienced breathing problems with aspirin or non-steroidal anti- inflammatory drugs, and experience a similar reaction with this product.
  • you experience unexplained bruising or bleeding.

These reactions are rare.

Drug interaction

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.

Before taking this medicine, make sure you consult your doctor if you are taking warfarin or similar medicines used to thin the blood.

Severe interactions with: Alcohol, Dapsone, Imatinib, Phenindione, Prilocaine

Moderate interactions with: Acenocoumarol, Busulfan, Carbamazepine, Fosphenytoin, Phenobarbital, Phenytoin, Primidone, Rifampicin, Warfarin.

Pregnancy and lactation

Pregnancy: As with the use of any medicine during pregnancy, pregnant women should seek medical advice before taking paracetamol. The lowest effective dose and shortest duration of treatment should be considered.

Lactation: Paracetamol is excreted in breast milk but not in a clinically significant amount at recommended dosages. Available published data do not contraindicate breastfeeding.

Hepatic Impairment

This has dose-related toxicity, so avoid large doses.

Patients who have been diagnosed with renal impairment must seek medical advice before taking this medication

Renal Impairment

Patients who have been diagnosed with renal impairment must seek medical advice before taking this medication

Overdose

Important: liver failure and less frequently renal damage can occur following overdose. Underlying liver disease increases the risk of paracetamol-related liver damage.

Symptoms and Signs

Paracetamol overdose may cause liver failure which may require liver transplant or lead to death. Acute pancreatitis has been observed, usually with hepatic dysfunction and liver toxicity.

Nausea and vomiting, the only early features of poisoning, usually settle within 24 hours. Persistence beyond this time, often associated with the onset of right subcostal pain and tenderness, usually indicates development of hepatic necrosis

Treatment

Immediate medical management is required in the event of overdose, even if symptoms of overdose are not present, refer patient to the nearest Emergency Medical Centre for management and expert treatment.

If overdose is confirmed or suspected, seek immediate advice from your Poison Centre even in patients without symptoms or signs of overdose due to the risk of delayed liver damage.

Details of the same are as below:

National Poison Information Centre

National Hospital, Colombo, Sri Lanka

Tel-0112686143 email -www.toxbaselanka.info

  • This product contains paracetamol; do not take it with other medicines that also contain paracetamol. Paracetamol is an ingredient in many medicines to treat pain, fever, symptoms of cold and flu, and sleep medicines.
  • If you have liver or kidney disease, talk to your doctor before taking paracetamol.
  • Do not take more than recommended dose, as this may be harmful, including serious harm to your liver.

    Do not use if you are allergic to paracetamol or any of the other ingredients in the product.