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This medicine is subject to additional monitoring. This will allow quick identication of new safety information.

You can help by reporting any side effects that you may get. You can talk to your doctor, pharmacist or nurse or

you can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for

MHRA Yellow Card in the Google Play or Apple App Store.

Prophylaxis of migraine

Patient Guide

Topiramate Pregnancy Prevention Programme

This medicine will be referred to as topiramate throughout this guide and covers the brands

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This guide is for patients who can get pregnant and are taking any medicine containing the

active ingredient topiramate. Topiramate is available as various brand names which are listed

at the top of this guide.

It contains important information about the risks of taking topiramate during pregnancy.

You might nd it helpful to talk about this guide with your partner, friends and family.

READ THIS GUIDE ALONG WITH THE PATIENT INFORMATION LEAFLET WHICH IS INCLUDED

IN YOUR BOX OF MEDICATION.

Keep this guide safe. You may need to read it again.

Ask your GP or other healthcare professional who is involved in the management of your

condition if you have any questions.

The information in this Guide has been approved by the UK medicines regulator, the MHRA.

1. Important information to remember Page 4

2. Contraception for patients who are able to become pregnant Page 5

3. What are the risks of taking topiramate during pregnancy? Page 6

o Effects on growth and development in the womb Page 6

o Birth defects Page 6

o Mental development and learning problems Page 7

4. What does this mean for me? Page 8

o I am starting treatment with topiramate Page 8

o I am taking topiramate and not planning to have a baby Page 9

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pregnancy. Some methods of birth control are more effective than others. Your

General Practitioner (GP) will discuss with you which method of birth control is best

for you.

• If you think you are pregnant, stop taking topiramate straight away. Contact your

GP as soon as possible to discuss your options.

• Consult your GP if you are thinking about having a baby. Do not stop using

contraception (birth control) until you have spoken to your GP.

• You should see your GP regularly – at least once a year. Your GP will discuss and

complete the Annual Risk Awareness Form with you. This is to make sure you are

aware of the risks of use of topiramate during pregnancy and the need to avoid

What type of contraception (birth control) should I use?

Some methods of birth control are more effective than others. The most effective

contraceptive methods include intrauterine devices (IUDs) with copper or hormones.

Topiramate can affect how well some hormonal contraceptive (birth control) methods work.

Using an additional barrier method, such as condom or vaginal ring pessary/diaphragm may

be necessary.

Discuss with your GP, professional at sexual health and contraception clinic, or contraception

service in your community pharmacy about which method of contraception (birth control) is

best for you and will be suitable alongside topiramate.

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If you take topiramate when you are pregnant it can seriously harm your baby.

and weigh less than expected at birth.

This compares with women in the general population, where around 5 babies in every 100 will

be smaller and weigh less than expected at birth.

Birth Defects

Taking topiramate during pregnancy can cause birth defects.

For women who take topiramate while pregnant, around 4 to 9 babies in every 100 will have

birth defects.

This compares with women in the general population, where around 1 to 3 babies in every 100

will have a birth defect.

What type of birth defects can happen?

Studies suggest that children of mothers with epilepsy who took topiramate during pregnancy

have a 2 to 3 times higher risk of these problems. This is compared with children of women

who do not have epilepsy and did not take an epilepsy medicine during pregnancy.

Although these studies were in children of mothers with epilepsy, the same risks are also

considered to apply when topiramate is used for other conditions, including prevention of

migraine.

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I am starting treatment with topiramate

Topiramate can affect how well some hormonal contraceptive (birth control) methods work.

Using an additional barrier method, such as condom or vaginal ring pessary/diaphragm may

be necessary

Your healthcare professional may ask you to perform a pregnancy test to exclude pregnancy

prior to starting topiramate.

Your healthcare professional will discuss and complete an Annual Risk Awareness Form with

you. This is to make sure you are aware of all the risks of use of topiramate during pregnancy

and the need to avoid becoming pregnant whilst taking topiramate.

If you and your healthcare professional agree that there are compelling reasons that you are

not at risk of becoming pregnant then you may not need to use contraception (birth control).

During the annual review your healthcare professional will decide with you whether the

benets of topiramate outweigh the risks for you.

If you are taking topiramate and able to have a baby, always use effective contraception

(birth control) during your treatment.

Topiramate can affect how well some hormonal contraceptive (birth control) methods work.

Using an additional barrier method, such as condom or vaginal ring pessary/diaphragm may

be necessary

If you and your healthcare professional agree that there are compelling reasons that you are

not at risk of becoming pregnant then you may not need to use contraception (birth control).

This joint decision should be documented in your Annual Risk Awareness form.

your GP.

• Discuss with you the risks related to the use of topiramate during pregnancy.

• Reassess your treatment as you may need to change or stop your medicine.

Topiramate can harm babies even in early pregnancy. It is important that you do not delay

seeing your GP if you think you may be pregnant.

If you are planning a baby, schedule an appointment with your GP but:

• Keep taking topiramate.

• Keep using contraception (birth control) until you have talked with your GP.

If topiramate is stopped, continue to use contraception (birth control) for four weeks after the

last dose of topiramate. This is to make sure that you do not become pregnant while there is a

risk that some topiramate may remain in your body.

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