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Roaccutane TM

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.

Active ingredients: isotretinoin

Brand name

(ARTG)

: ROACCUTANE isotretinoin 20mg capsule blister pack

Download the Consumer Medicine Information Leaflet

Download consumer medicine information leaflet (pdf) from the Therapeutic Goods Administration (TGA) website

What this medicine is used for

(ARTG)

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 use this medicine

(ARTG)

This medicine contains one component only.

Component :

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

Storage conditions

(ARTG)

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

Do I need a prescription ?

(ARTG)

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

  • 30 capsules pack
  • 60 capsules pack

Pregnant or planning a pregnancy ?

(AHT)

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.

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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