APO-Topiramate

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

Topiramate
Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about topiramate. 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 using this medicine 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 want to read it again.

What this medicine is used for

Topiramate is used to:
treat various types of epilepsy in adults and children over 2 years of age
prevent migraines in adults – it is not used to treat severe migraines that come on suddenly (acute)
Topiramate belongs to a group of medicines called antiepileptic drugs.

How it works

Topiramate prevents seizures and migraines by acting on the nerves and chemicals in the brain.
Your doctor may prescribe topiramate on its own, or in addition to another medicine for controlling your seizures or migraines.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed this medicine for another reason.
This medicine is available only with a doctor's prescription.
This medicine is not addictive.
This medicine may be used to treat epilepsy in children aged 2 years or older.

Before you take this medicine

When you must not take it

Do not take this medicine if you have an allergy to:
topiramate
any of the ingredients listed at the end of this leaflet
Some of the symptoms of an allergic reaction may include:
shortness of breath, wheezing or difficulty breathing
swelling of the face, lips, tongue, throat or other parts of the body
rash, itching or hives on the skin
Do not breastfeed if you are taking this medicine.
It is not recommended to breastfeed whilst taking this medicine, as topiramate may pass into breast milk and your baby may be affected.
Do not take this medicine after the expiry date printed on the pack or if the packaging is torn, shows signs of tampering or it does not look quite right.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
personality disorder or mental illness
kidney or liver disease
kidney stones or a family history of kidney stones
eye problems or high pressure in the eye
history of metabolic acidosis (too much acid in the blood, which may cause an increased rate of breathing)
Tell your doctor if you are pregnant or plan to become pregnant.
It is very important to control your fits during pregnancy, however, there is evidence topiramate may cause harm to the developing foetus, especially if you are taking other anti-epileptic medications as well.
Do not take this medicine until you and your doctor have discussed the risks and benefits involved.
Tell your doctor if you are planning to have surgery, dental treatment or an anaesthetic.
If you have not told your doctor about any of the above, tell them before you start taking this medicine.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and topiramate may interfere with each other. These include:
other medicines for epilepsy (e.g. phenytoin, carbamazepine, valproic acid)
digoxin, diltiazem or propranolol, used to treat heart problems
oral contraceptives (the pill)
metformin, pioglitazone or glibenclamide, used to treat diabetes
acetazolamide, used to treat glaucoma
lithium or risperidone, used to treat mood disorders
haloperidol, used to treat psychoses
hydrochlorothiazide, used to treat swelling or high blood pressure
medicines that slow your reactions or makes you drowsy (e.g. pain relievers, antidepressants, tranquillisers or antihistamines)
vitamin K-antagonist anticoagulant medications (such as warfarin)
amitriptyline, used to treat depression
flunarizine
These medicines may be affected by topiramate or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.
Other medicines not listed above may also interact with topiramate.

How to take this medicine

Follow all directions given to you by your doctor carefully.
They may differ to the information contained in this leaflet.
If you do not understand the instructions on the pack, ask your doctor or pharmacist for help.

How much to take

Your doctor will tell you how much of this medicine you should take. This will depend on your condition and whether you are taking any other medicines.
The doses shown below are the usual recommended doses. However, your doctor may tell you to take higher or lower doses.
Adults – Epilepsy
The usual starting dose is 25 mg to 50 mg taken at night for one week or longer. The dose can be gradually increased by 25 mg to 100 mg over weekly periods or longer, until a suitable dose is reached.
Adults – Migraine
The usual starting dose is 25 mg taken at night for one week. The dose can be gradually increased by 25mg over weekly periods or longer, until a suitable dose is reached.
Children (2 years and over) - Epilepsy
The usual starting dose is 25 mg or less per day, depending on the child's body weight. The dose is then gradually increased over weekly periods or longer, until a suitable dose is reached.

How to take it

Swallow the tablets whole with a glass of water.
Do not crush or chew the tablets.

When to take it

Take this medicine at about the same time each day.
Taking it at the same time each day will have the best effect. It will also help you remember when to take it.
It does not matter if you take it with or without food.

How long to take it for

Continue taking your medicine for as long as your doctor tells you.
This medicine helps to control your condition but does not cure it. It is important to keep taking your medicine even if you feel well.

If you forget to take it

If it is almost time to take your next dose, skip the dose you missed and take your next dose when you are meant to.
Otherwise, take it as soon as you remember and then go back to taking your medicine as you would normally.
Do not take a double dose to make up for missed doses.
This may increase the chance of you experiencing side effects.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice or go to Accident and Emergency at your nearest hospital if you think that you or anyone else may have taken too much of this medicine.
Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
If you take too much topiramate you may experience headache, dizziness, light-headedness, drowsiness, convulsions, speech disturbances, double or blurred vision, difficulty with thinking, abnormal coordination, stomach pain, depression, agitation, faster breathing or you may lose consciousness.

While you are taking this medicine

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking this medicine.
Tell any other doctors, dentists and pharmacists who are treating you that you take this medicine.
If you become pregnant or start to breastfeed while taking this medicine, tell your doctor immediately.
Tell your doctor if you are going to have surgery or an anaesthetic or are going into hospital.
Drink plenty of water. Topiramate has been known to cause kidney stones and drinking water may help prevent this.
Keep all of your doctor's appointments so that your progress can be checked.
Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects.

Things you must not do

Do not give this medicine to anyone else, even if they have the same condition as you.
Do not take your medicine to treat any other complaint unless your doctor tells you to.
Do not stop taking your medicine or change the dosage without first checking with your doctor.
If you stop taking topiramate for seizures abruptly, your epilepsy may worsen or come back (this is known as 'rebound seizures').
Your doctor will advise you if you need to stop taking topiramate and, if so, how to do this safely. Talk to your doctor if you are unsure whether you should stop taking topiramate.

Things to be careful of

Effects on thoughts and behaviour
Medicines used to treat epilepsy can increase the risk of suicidal thoughts and behaviour. If you experience feelings of deep sadness and unworthiness (depression) or a worsening of these feelings, any unusual changes in your mood or the emergence of suicidal thoughts, behaviour or thoughts of self-harm, you should report this to your doctor immediately.
Effects on driving and operating machinery
Topiramate may cause drowsiness, dizziness or other symptoms which could affect your ability to drive or operate machinery. It may also cause visual disturbances or blurred vision. Make sure you know how you are affected by this medicine before you drive or use machinery.
Particular care is recommended when you first start taking topiramate or if your dose of topiramate or any other medicine changes.
Effects of alcohol
Do not drink alcohol while taking topiramate. Alcohol may increase the risk of you experiencing side effects, such as drowsiness.
Decreased sweating and elevation in body temperature
Topiramate may cause decreased sweating and increased body temperature (fever). People, especially children, should be watched for signs of decreased sweating and fever, especially in hot temperatures. Some people may need to be hospitalized for this condition.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking topiramate.
This medicine helps most people, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following:
unusual tiredness, drowsiness, weakness, dizziness
decrease in appetite or weight loss
itchy skin or skin rash
inability to sleep
headache
tingling and numbness of hands and feet
nose bleed
nausea, diarrhoea, vomiting or constipation
taste disturbance or loss of taste
abdominal pain or discomfort
ear pain, buzzing or ringing in ears, deafness
The above list includes the more common side effects of your medicine.
Tell your doctor as soon as possible if you notice any of the following:
depression, nervousness or feeling anxious
disturbance in attention
difficulty with memory or memory impairment
slowing of thought processes
abnormal behaviour
expressive language disorder
balance disorder, co-ordination problems
unusual hair loss or thinning
abnormal frequent urination
decreased feeling or sensitivity, especially in the skin
fever or high temperature
decreased or lack of sweating or overheating
unusual weakness
difficulty in speaking
The above list includes serious side effects. You may need medical attention.
If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
thoughts of harming yourself or thoughts of suicide
kidney stones
unexplained bleeding or bleeding more frequently
pain when passing urine
sudden changes in your eyesight (e.g. blurred or loss of vision) or rapid uncontrollable movements of the eyes
eye pain or increased pressure in the eye
shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin (signs of an allergic reaction)
The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may occur in some patients.
Some of these side effects such as changes to your kidney function, or increased levels of calcium in your kidneys (nephrocalcinosis), can only be found when your doctor does tests from time to time to check your progress.

Storage and disposal

Storage

Keep your medicine in the pack until it is time to take it.
If you take your medicine out of the pack it may not keep well.
Keep your medicine in a cool dry place where the temperature stays below 25°C.
Do not store your medicine or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.
Heat and dampness can destroy some medicines.
Keep this medicine where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

The tablets are available in 4 different strengths:
25 mg tablets:
White to off-white, round, unscored, film coated tablet, imprinted "APO" on one side and "TP over "25" on the other side.
Blister pack of 60 tablets
AUST R 124729
Bottle of 60 tablets
AUST R 124733
50 mg tablets:
Light-yellow, round, unscored, film coated tablet, imprinted "APO" on one side and "TP over "50" on the other side.
Blister pack of 60 tablets
AUST R 124730
Bottle of 60 tablets
AUST R 124734
100 mg tablets:
Mustard yellow, round, unscored, film coated tablet, imprinted "APO" on one side and "TP over "100" on the other side.
Blister pack of 60 tablets
AUST R 124731
Bottle of 60 tablets
AUST R 124735
200 mg tablets:
Reddish-brown, round, unscored, film coated tablet, imprinted "APO" on one side and "TP over "200" on the other side.
Blister pack of 60 tablets
AUST R 124732
Bottle of 60 tablets
AUST R 124736
* Not all strengths, pack types and/or pack sizes may be available.

Ingredients

Each tablet contains 25 mg, 50 mg, 100 mg or 200 mg of topiramate as the active ingredient.
It also contains the following:
methylcellulose
croscarmellose sodium
magnesium stearate
colloidal anhydrous silica
hypromellose
hyprolose
macrogol
titanium dioxide
iron oxide yellow (50 mg & 100 mg only)
iron oxide red (200 mg only).
This medicine does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.

Sponsor

Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113
Apotex Pty Ltd is the licensee of the registered trademarks APO and APOTEX from the registered proprietor, Apotex Inc.
This leaflet was prepared in August 2019.