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Brand name: Roaccutane TM

Listen to the Pronunciation:

Active ingredients: isotretinoin

What it is used for

ROACCUTANE is indicated for the treatment of severe cystic acne, and a single course of therapy has been shown to result in complete and prolonged remission of disease in many patients. If a second course of therapy is needed, it should not be initiated until at least eight weeks after completion of the first course, since experience has shown that patients may continue to improve while off drug. Because of significant adverse effects associated with its use, ROACCUTANE should be reserved for patients with severe cystic acne who are unresponsive to conventional therapy, including systemic antibiotics.

How to take it

The way to take this medicine is: Oral. This medicine is taken by mouth.

  • Store below 25 degrees Celsius
  • Protect from Light
  • Shelf lifetime is 3 Years.

You should seek medical advice in relation to medicines and use only as directed by a healthcare professional.

Always read the label. If symptoms persist see your healthcare professional.

Visual appearance

one half brown-red, opaque, one half white, opaque, oval shaped, imprinted with 'ROA 20'.

Images are the copyright of the Pharmacy Guild of Australia

Do I need a prescription?

This medicine is available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.

Is this medicine subsidised?

This medicine was verified as being available on the PBS (Pharmaceutical Benefits Scheme) on August 1, 2022. To learn more about this subsidy, visit the Pharmaceutical Benefits Scheme (PBS) website.

Pregnant or planning a pregnancy?

For the active ingredient isotretinoin

This medicine is not considered safe during pregnancy. You should discuss this medicine with your doctor or pharmacist. They can help you balance the risks and the benefits of this medicine during pregnancy.

Consumer Medicines Information (CMI)

For side effects, taking other medicines and more

Print the CMI.

Listen to the CMI.


Reporting side effects

You can help ensure medicines are safe by reporting the side effects you experience.

You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems

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