ISOTANE

10 mg

Isotretinoin

What is in this leaflet

This leaflet answers some common questions about ISOTANE. 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 ISOTANE 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 is Isotane used for

Your medicine is in the form of a capsule. Isotretinoin belongs to a group of medicines called retinoids that are similar to Vitamin A. ISOTANE works by cutting down the amount of oily substances made by the glands in your skin. Your doctor may prescribe ISOTANE to treat abnormal cystic acne.

There are many different types of medicines used to treat acne. ISOTANE is used for more severe cases that are resistant to other treatments.

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

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

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

Before you take ISOTANE

When you must not take it:

• If you are pregnant, or you intend to become pregnant. If you become pregnant while on ISOTANE, there is a high risk that the baby you have may be severely deformed. Adequate birth control must be used one month prior to starting ISOTANE treatment, during and up to at least one month after treatment completion.
• If you are breastfeeding. You must not breastfeed while taking ISOTANE.

• Do not take ISOTANE if you think you are allergic to Vitamin A, other retinoids or any of the ingredients listed at the end of this leaflet.
• If you have liver disease.
• If you have hypervitaminosis A (excessive amounts of Vitamin A obtained from the diet or supplements).
• If you have very high fat levels (cholesterol, triglycerides) in your blood.
• If you are taking tetracycline antibiotics.
• If the product has passed its expiry date printed on the label.
• If the package is not intact or if the packaging shows any sign of tampering.
• If there is a noticeable change to the appearance of the product.

Before you start to take it

You must tell your doctor or pharmacist if:

• you are depressed (have feelings of deep sadness and unworthiness or feel "down"), or have felt this way in the past
• you have abnormal thoughts or behaviour or a mental illness, or have had them in the past
• you have thoughts of harming yourself (suicidal thoughts or tendencies), or you have had them in the past.

• you have any other health problems or issues including:
  • you are considerably overweight
  • diabetes, or a history of diabetes in your family
  • a history of pancreatitis (inflamed pancreas)
  • kidney disease
  • very high fat levels (cholesterol, triglycerides) in your blood
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