–    Panadol Extend is a bilayer tablet having an immediate release and a sustained release dose of Paracetamol which provides a pain relief which may last up to 8 hours.
–    Panadol Extend is analgesic and antipyretic.
–    Panadol Extend relieves mild to moderate pain of Osteoarthritis and Muscle aches.

– It also relieves mild to moderate pain including: headache, migraine, period pain, sore throat, pain after dental procedures/tooth extraction, toothache and relieves fever and pain after vaccination.

a. Do not use Panadol Extend tablet if you have:

– Known or previous history of hypersensitivity to paracetamol, or any other ingredient in the product.

b. Take special care with Panadol Extend if:

–    You have been diagnosed with liver or kidney Impairment , seek medical advice before taking this medicine. Underlying liver disease increases the risk of paracetamol-related liver damage.
–    Your symptoms do not improve, get worsen or new symptoms persist, you must consult your doctor as these could be signs of serious condition.
–    Keep this and all medication out of sight and reach of children.

– Cases of hepatic dysfunction/failure have been reported in patients with depleted glutathione levels, such as those who are severely malnourished, anorexic, have a low body mass index or are chronic heavy users of alcohol.

 Check with your doctor before use if you:
–    Have liver or kidney problems.
–    Your are underweight or malnourished.
–    Regularly drink alcohol.

You may need to avoid using this product altogether or limit the amount of paracetamol that you take.

–    Check with your doctor if:
You have glutathione depleted states such as sepsis or you have a severe infection as the use of Paracetamol 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.

–    Do not exceed the stated dose.
–    This product contains Paracetamol, do not take with any other product containing Paracetamol. The concomitant use with other products containing paracetamol may lead to an overdose.

–    Taking too much paracetamol can cause serious harm to your liver. Paracetamol overdose may cause liver failure which can lead to liver transplant or death.
–    Always read and follow the label.

c. Taking other medications:

-The liver toxic effects of Paracetamol may be increased by the use of alcohol.
-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.

-The speed of absorption of paracetamol is reduced by colestyramine. Therefore, the colestyramine should not be taken within one hour if maximal analgesia is required.
-The speed of absorption of paracetamol may be increased by metoclopramide and domperidone. However, concurrent use need not be avoided.

– Do not use this medicine if you are taking any other prescription or non-prescription medicines containing paracetamol to treat pain, fever, symptoms of cold and flu, or to aid sleep.

d.Pregnancy and breast feeding:
- Humanandanimalstudieswithparacetamolhavenotidentified any risk to pregnancyor embryo-foetal development or lactation or the breast-fed offspring. Paracetamol crosses the placental barrier and is excreted in breast milk.

– Seek medical advice before taking this product if you are pregnant or breast feeding.

e. Driving and using machines:
Panadol Extend is unlikely to cause an effect on ability to drive and use machines.

For oral administration only.
Adults (including the elderly) and children aged 12 years and over:

–    2 tablets taken every 8 hours.
–    Do not take more than 6 tablets (4000mg paracetamol) in 24 hours.
–    Do not take more frequently than every 6 hours.
–    Do not use for more than 10 days unless directed by a doctor.
–    Do not exceed the stated dose.
–    Always use the lowest effective dose to relieve your symptoms.
–    Do not suck or chew this tablet.

Children:

Panadol Extend is not recommended for children under 12 years of age.

Overdose

–    Paracetamol overdose may cause liver failure.
–    Immediate medical management is required in the event of overdose, even if symptoms of overdose are not present.
–    In massive over dosage exceeding 10g of Paracetamol may cause liver failure. Early symptoms may include pallor, nausea, vomiting, (diaphoresis) and general malaise.
–    Clinical and laboratory evidence of liver damage may not be apparent until 48 to 72 hours past ingestion. Overdose should be promptly treated by gastric lavage followed by intravenous N-acetylcysteine or Methionine without waiting for the results of plasma paracetamol levels.
–    General supportive measures must be available. Additional antidote therapy is normally considered in light of further plasma paracetamol levels and the time elapsed since ingestion. In all cases of suspected overdose,
prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

-    Because the dosage form is a sustained release formulation of paracetamol, absorption will be prolonged in overdose. It is recommended to obtain an additional plasma paracetamol level 4-6 hours after initial measurement. If either level is above or close to the treatment line on the paracetamol overdose nomogram, administration of antidote would be indicated.

These reactions are very rare.
Stop using Panadol Extend and consult 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 experience angiodema or Stevens Johnson syndrome.
–    You have previously experienced breathing problems or bronchospasm with aspirin or non-steroidal anti-inflammatory, and experience a similar reaction with this product.
–    You experience unexplained bruising or bleeding.
–    You experienced liver dysfunction related symptoms or signs.

–    Store below 30°C.
–    Store in original container. Protect from Light and Heat.
–    This product is protected in a sealed blister. Do not use if blister is broken.
–    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.