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What is in this leaflet:

1.    What Topiramate is and what it is used for

2.    What you need to know before you take Topiramate

3.    Howtotake Topiramate

4.    Possible side effects

5.    HowtostoreTopiramate

6.    Contents of the pack and other information

1. WHAT TOPIRAMATE IS AND WHAT IT IS USED FOR

Topiramate belongs to a group of drugs called

“antiepileptic medicines”.

Topiramate is used:

•    alone to treat seizures in adults and children over age 6

•    with other medicines to treat seizures in adults and children over age 2

•    to prevent migraine headaches in adults aftercareful evaluation of possible alternative treatment options. Topiramate is not intended to treat an individual migraine attack.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE

TOPIRAMATE

Do not take Topiramate

•    if you are allergic to Topiramate or any of the other ingredients of this medicine (listed in section 6).

•    for migraine prevention if you are pregnantoryou are able to become pregnant but you are not using effective contraception (see section 'pregnancy and breastfeeding'forfurther information)

If you are not sure if the above applies to you, talk to your doctoror pharmacist before using Topiramate.

Warnings and precautions

Talk to your doctor or pharmacist before taking Topiramate

•    have kidney problems, especially kidney stones, or are getting kidney dialysis

•    have a history of blood and body fluid abnormality (metabolic acidosis)

•    have liver problems

•    have eye problems, especially glaucoma.

•    have a growth problem

•    are on a high fat diet (ketogenicdiet)

There have been reports of impairment of cognitive function (problem in thought processes) in adults on topiramate therapy. In this case your doctor may discontinue or decrease the dose of this medicine.

While taking this medicine if you develop:

•    deep and labored breathing, difficulty in breathing, loss of appetite, nausea, vomiting, excessive tiredness, changes in the rhythm or rate of the heart beat. These symptoms may be due to metabolic acidosis. Your doctorwould monitoryourserum bicarbonate level.

•    decreased sweating and rise in body temperature. These may occur especially in young children exposed to high ambient temperature. Inform your doctor as soon as possible.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using Topiramate.

It is important that you do not stop taking your medicine withoutfirst consulting your doctor.

You should also talk to your doctor before taking any medicine containing topiramate that is given to you as an alternative to Topiramate.

You may lose weight if you use topiramate so your weight should be checked regularly when using this medicine. If you are losing too much weight or a child using this medicine is not gaining enough weight, you should consultyourdoctor.

A small number of people being treated with antiepileptic medicines such as Topiramate have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.

Other medicines and Topiramate:

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Topiramate and certain other medicines can affect each other. Sometimes the dose of some of your other medicines or Topiramate will have to be adjusted.

Especially, tell your doctor or pharmacist if you are taking:

•    other medicines that impair or decrease your thinking, concentration, or muscle coordination (e.g. central nervous system depressant medicines such as muscle relaxantsand sedatives).

•    birth control pills. Topiramate may make your birth control pills less effective.

Tell your doctor if your menstrual bleeding changes while you are taking birth control pills and topiramate.

Keep a list of all the medicines you take. Show this list to your doctor and pharmacist before you start a new medicine.

Other medicines you should discuss with your doctor or pharmacist include other antiepileptic medicines, risperidone, lithium, hydrochlorothiazide, metformin, pioglitazone, glyburide, amitriptyline, propranolol, diltiazem, venlafaxine, flunarizine.

If you are not sure if any of the above apply to you, talkto your doctor or pharmacist before using Topiramate.

Topiramate tablets with food and drink

You can take Topiramate with or without food. Drink plenty of fluids during the day to prevent kidney stones while taking Topiramate. You should avoid drinking alcohol when taking Topiramate.

Pregnancy and breast-feeding

Ifyou are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advise before taking this medicine. Your doctor will decide if you can take Topiramate. As with other antiepilepsy medicines, there is a risk of harm to the unborn child if Topiramate is used during pregnancy. Make sure you are very clear about the risks and the benefits of using Topiramate for epilepsy during pregnancy.

You should not take Topiramate for migraine prevention if you are pregnant or you are able to become pregnant and you are not using effective contraception.

Mothers who breastfeed while taking Topiramate must tell the doctor as soon as possible if the baby experiences anything unusual.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Dizziness, tiredness, and vision problems may occur during treatment with Topiramate. Do not drive or use any tools or machines without talking to yourdoctorfirst.

Topiramate contains lactose monohydrate

Ifyou have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. HOWTO TAKE TOPIRAMATE

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist ifyou are not sure.

•Take Topiramate exactly as prescribed. Your doctor will usually start you on a low dose of Topiramate and slowly increase your dose until the best dose is found foryou.

•    Topiramate tablets are to be swallowed whole. Avoid chewing the tablets as they may leave a bitter taste

•    Topiramate can be taken before, during, or after a meal. Drink plenty of fluids during the day to prevent kidney stones while taking Topiramate.

Ifyou take more Topiramate than you should

•    See a doctor right away. Take the medicine pack with you.

Signs and symptoms of over dosage may include convulsions, drowsiness, speech disturbances, double vision, impaired thinking, abnormal coordination, dulling of consciousness, low blood pressure, abdominal pain, agitation, dizziness and depression. Overdose can happen ifyou are taking other medicines together with Topiramate.

Ifyou forget to take Topiramate

•    If you forget to take a dose, take it as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue as usual. If you miss two or more doses, contact your doctor.

•    Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

Ifyou stop taking Topiramate

Do not stop taking this medicine unless told to do by your doctor. Your symptoms may return. Ifyourdoctordecides to stop this medication, your dose may be decreased gradually overafew days.

If you have any further questions on the use of this medicine, askyour doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common side effects (may affect more than 1 in 10 people)

•    Weight loss

•    Tingling in thearmsand legs

•    Drowsiness or sleepiness

•    Dizziness

•    Diarrhoea

•    Nausea

•    Stuffy, runny nose and sore throat

•    Tiredness

•    Depression

Common side effects (may affect up to 1 in 10 people)

•    Changes in mood or behaviour, including anger,