NEOTIGASON®

Acitretin


Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about NEOTIGASON capsules.

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 NEOTIGASON Capsules 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 Neotigason used for

NEOTIGASON contains the active ingredient acitretin.

NEOTIGASON is used to treat severe psoriasis (skin disease with thickened patches of red skin, often with silvery scales) and other severe disorders of the skin.

NEOTIGASON belongs to a group of medicines called retinoids, which are very similar to Vitamin A. Vitamin A, which we obtain from food, is important for the normal growth and development of the body, especially the skin.

In severe psoriasis and some other skin disorders, where there is problem with the normal development of the skin, NEOTIGASON helps return the skin to normal.

There are many different types of medicines used to treat skin conditions.

Your doctor may have prescribed NEOTIGASON for another purpose.

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

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

Before you take Neotigason

Do not take NEOTIGASON if:

  • you are pregnant, or intend to become pregnant during treatment or in the 3 years after stopping treatment.

The possibility that you may be pregnant must be ruled out by you and your doctor before you start taking Neotigason.

A pregnancy test must be negative when performed within one week before beginning of treatment.

NEOTIGASON is highly teratogenic and there is an extremely high risk that a severely deformed baby will result if taken before or during pregnancy, no matter for how long or at what dose.

You must use effective contraception (preferably two complementary forms), without interruption for one month before, during and 3 years after treatment.

A combination hormonal contraceptive product or an intrauterine device should be used. It is recommended that a diaphragm is also used. Low dose minipills (progesterone only) are not recommended.

  • you are breastfeeding. Breastfeeding must be stopped before treatment begins. Do not breastfeed while taking NEOTIGASON.
  • you have had an allergic reaction to NEOTIGASON, Vitamin A, other retinoids or any ingredients listed in the Ingredients section of this leaflet.
  • you are taking tetracycline antibiotics (such as doxycycline HCl: In Australia, Doryx®, Vibramycin®; in New Zealand Doxine®, Doxy 50®, or Minocycline HCl, Minomycin®)
  • you are taking vitamin A, or preparations containing vitamin A.
  • You have severe liver or kidney disease or abnormally high fat levels in your blood
  • You are also taking methotrexate

Do not take NEOTIGASON after the expiry date (EXP) printed on the pack. It may have no effect or, worse, an entirely unexpected effect if you take it after the expiry date.

Do not take NEOTIGASON if the package is torn or shows signs of tampering.

If you are not sure if you should be taking NEOTIGASON, talk to your doctor.

You must tell your doctor if:

  1. you are allergic to any other medicines, foods, dyes or preservatives.
  2. you have any other health problems including:
  • diabetes, or a history of diabetes in your family
  • liver disease
  • high triglycerides or cholesterol levels in the blood, or a history of high blood t