VERY IMPORTANT!

If you are female it is extremely important that you read and understand the information in this section.

Why MUST I Prevent Pregnancy?

Even if you are not sexually active it is important that you understand the effects that Oratane can have on the unborn child should you become pregnant while taking Oratane.

The medication in Oratane, isotretinoin, is teratogenic. This means that it can cause birth defects, that is, the unborn child can become deformed.

Birth defects can only be caused by Oratane if you use Oratane while you are pregnant, become pregnant while you are using Oratane or become pregnant within one month of stopping taking your Oratane.

Your doctor may give you a pregnancy test to ensure that you are not pregnant before allowing you to start taking Oratane. Should you become pregnant while taking Oratane or within one month after the end of your Oratane treatment you will need to discuss the action that may need to be taken with your doctor. This is a very serious situation.

For this reason it is vitally important to follow strict birth control procedures.

Who Needs To Be REALLY Careful?

ALL women of child bearing potential! This means any woman or girl, who is taking Oratane, who has started menstruating needs to follow a strict birth control procedure.

Before you can begin taking Oratane you may be required to take a pregnancy test.

You MUST use strict birth control for at least one month before you start your Oratane treatment, during the entire Oratane treatment and for at least one month after you stop taking Oratane.

You should wait until the 2nd or 3rd day of your next menstrual period before you start taking Oratane. This is an extra check to make sure you are not pregnant.

If you do become pregnant while you are taking Oratane, you should immediately stop taking your Oratane and tell your dermatologist straight away.

Oratane does not affect your fertility in the long term. So even after taking Oratane you should be able to become pregnant in the future.

Who Is Responsible For Making Sure I Don’t Get Pregnant?

You are! The only person who can make sure that you do not get pregnant while you are taking Oratane is you. It is relatively easy to prevent pregnancy. The details of the recommended strict birth control procedure are explained below.

Before you begin taking Oratane your doctor will go through the risks associated with Oratane and pregnancy. Your doctor may ask you to sign a Consent Form. Signing this form means that you understand these risks and that you will do everything possible to make sure that you do not become pregnant while you are taking Oratane or for one month after you stop taking Oratane.

What Is Strict Birth Control?

Strict birth control or contraception means carefully following a procedure to make sure you do not become pregnant. The most effective form of birth control or contraception is ‘the pill’ (oral contraceptive) plus a barrier method (condom or diaphragm). You should carefully follow all the directions for the use of these methods of contraception.

It is recommended that two complementary forms of contraception including a barrier method should be used. Progesterone only contraceptive tablets (Minipills) alone are an inadequate method of contraception while you are on isotretinoin.

Your doctor or your local Family Planning Clinic can provide you with more information about contraception. You will need a prescription for ‘the pill’, which can be provided by your doctor or local Family Planning Clinic.

When Can I Stop Being So Careful?

One month after the end of your Oratane treatment the risk of birth defects is no greater than normal.

Should you wish to become pregnant, you can do so one month after you have stopped taking Oratane.

Where Can I Get More Help and Information?

For further information about contraception or the address of your local Family Planning Clinic contact the Family Planning Association in New Zealand.