contains the active ingredient isotretinoin

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Roaccutane. It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking Roaccutane against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Roaccutane is used for

Roaccutane contains the active ingredient isotretinoin.

Roaccutane is used to treat acne.

Roaccutane belongs to a group of medicines called retinoids, which are similar to vitamin A.

Retinoids work by reducing the amount of the oily substance (i.e. sebum) made by glands in your skin, reducing bacteria and inflammation and opening clogged pores.

There are many different types of medicines used to treat acne. Roaccutane is used for more severe cases.

Your doctor, however, may have prescribed Roaccutane for another purpose.

Ask your doctor if you have any questions about why Roaccutane has been prescribed for you.

This medicine is available only with a doctor's prescription.

Roaccutane is not addictive.

Before you take Roaccutane

When you must not take it

Do not take Roaccutane if:

  1. you are pregnant, or for at least one month before you plan to fall pregnant

If you fall pregnant while taking Roaccutane there is an extremely high risk of having a baby that is severely deformed. You must use effective contraception for one month before, during and one month after treatment.

  1. you are breastfeeding

You must stop breastfeeding before treatment begins. Do not breastfeed while taking Roaccutane.

  1. you have had an allergic reaction to Roaccutane, vitamin A, other retinoids or any of the ingredients listed at the end of this leaflet
  2. you are taking tetracycline antibiotics
  3. you have severe liver disease
  4. you have very high fat levels (cholesterol, triglycerides) in your blood
  5. you have hypervitaminosis A

This is a condition caused by an excessive amount of vitamin A in the diet.

  1. the packaging is torn or shows signs of tampering
  2. the expiry date (EXP) printed on the pack has passed.

If you take this medicine after the expiry date has passed, it may not work as well.

If you are not sure if you should start taking Roaccutane, contact your doctor.

Do not give Roaccutane to children. Roaccutane may be associated with slowing of growth when used in children before puberty. The use of Roaccutane in children less than 12 years of age is not recommended.

Before you start to take it

You must tell your doctor if:

  1. you have any allergies to any other medicines, foods, preservatives or dyes

Roaccutane capsules contain soya oil, which may contain traces of arachidic acid (a component of peanut oil)

  1. you have or have had any other health problems or issues including:
  • diabetes, or a history of diabetes in your family
  • depression
  • liver disease
  • kidney disease
  • lipid (cholesterol or triglyceride) disorder
  • hormone disorder
  • eye disorders
  • stomach or bowel disease
  1. you drink large amounts of alcohol.

If you have not tol