Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using TOPAMAX?
TOPAMAX contains the active ingredient topiramate. TOPAMAX is used for the treatment
of various types of seizures in adults and children, aged 2 years and over. It can
also be used for the prevention of migraines in adults.
For more information, see Section
1. Why am I using TOPAMAX? in the full CMI.
2. What should I know before I use TOPAMAX?
Do not use if you have ever had an allergic reaction to topiramate or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
4. How do I use TOPAMAX?
Epilepsy (adults): Treatment starts at a low dose of 25 mg to 50 mg per day. The dose
is then gradually increased by 25 mg to 100 mg over weekly periods or longer, until
the most suitable dose is reached.
Epilepsy (children 2 years and over): Treatment starts at 25 mg or less per day, depending
on the body weight. This dose is then gradually increased over weekly periods or longer,
until the most suitable dose is reached.
Migraine (adults): Treatment starts at a low dose of 25 mg nightly for one week. The
dose is then increased over weekly periods or longer by 25mg/day, until the most suitable
dose is reached.
5. What should I know while using TOPAMAX?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using TOPAMAX
Drink plenty of water
Women who can become pregnant must use highly effective contraception while taking
TOPAMAX
Tell your doctor immediately if you notice any of the following: become pregnant or
trying to become pregnant, notice changes to your menstrual bleeding while on contraceptives
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Things you should not do
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Do not stop using this medicine suddenly without checking with your doctor.
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Driving or using machines
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TOPAMAX may cause drowsiness, dizziness, visual disturbances and/ or blurred vision.
Make sure you know how you are affected by this medicine before you drive or use machinery.
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Drinking alcohol
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Do not drink alcohol while taking TOPAMAX. Alcohol may increase the risk of unwanted
side effects.
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Looking after your medicine
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Keep TOPAMAX in original pack in a cool, dry place where the temperature is below
25°C. Capsules: Do not store the drug/food mixture.
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6. Are there any side effects?
Like all medicines, TOPAMAX can cause side effects, although not everybody gets them.
Your doctor will discuss potential side effects with you and will explain the risks
and benefits of your treatment. Some side effects can be serious, and you may require
urgent medical attention.
Active ingredient(s):
topiramate
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using TOPAMAX. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using TOPAMAX.
Where to find information in this leaflet:
1. Why am I using TOPAMAX?
TOPAMAX contains the active ingredient topiramate. TOPAMAX belongs to a group of medicines known as antiepileptics. It prevents seizures
and migraines by acting on the nerves and chemicals in the brain.
TOPAMAX is used for the treatment of various types of seizures in adults and children,
aged 2 years and over. It can also be used for the prevention of migraines in adults.
TOPAMAX is not used to treat severe migraines that come on suddenly (acute).
Your doctor may prescribe TOPAMAX on its own, or in addition to another medicine for
controlling your seizures or migraines.
Your doctor may have prescribed TOPAMAX for another reason. Ask your doctor if you
have any questions about why this medicine has been prescribed for you.
2. What should I know before I use TOPAMAX?
Warnings
Do not use TOPAMAX if:
you are allergic to topiramate, or any of the ingredients listed at the end of this
leaflet.
Symptoms of an allergic or hypersensitivity reaction may include: rash, itching or
hives on the skin, shortness of breath, wheezing or difficulty breathing and swelling
of the face, lips, tongue or other parts of the body.
Always check the ingredients to make sure you can use this medicine.
the tablets or capsules are not as described under Product Details at the end of this
leaflet.
Migraine prevention
You must not take TOPAMAX if you are pregnant.
If you are a woman who can become pregnant, you must not take TOPAMAX, unless you
use highly effective contraception (birth control) during your treatment. See below
under "
Pregnancy and breastfeeding".
Treatment of epilepsy
You must not take TOPAMAX of you are pregnant, unless no other treatment gives sufficient
seizure control for you.
If you are a woman who can become pregnant, you must not take TOPAMAX unless you use
highly effective contraception (birth control) during your treatment. Do not stop
taking TOPAMAX or your contraception until you have discussed this with your doctor.
Your doctor will advise you further and make sure you are aware of and understand
all of the risks of taking TOPAMAX during pregnancy and the risks of seizures during
pregnancy. See below under "
Pregnancy and breast feeding".
Check with your doctor if you:
have any other medical conditions particularly:
have or have ever had a personality disorder or mental illness
have or have ever had kidney stones, kidney disease or have a family history of kidney
stones
have or have ever had liver disease
have eye problem or high pressure in the eye
have a history of metabolic acidosis (too much acid in the blood, which may cause
an increased rate of breathing).
take any medicines for any other condition
If you have not told your doctor or pharmacist about any of the above, tell them before
you start taking TOPAMAX.
Your doctor will advise you whether or not to take TOPAMAX or if you need to adjust
the dose or adapt your treatment.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
TOPAMAX can harm an unborn child. If you are a woman who can become pregnant, talk
to your doctor about other possible treatments. Visit your doctor to review your treatment
and discuss the risk.
Migraine prevention
For migraine, you must not use TOPAMAX if you are pregnant.
For migraine, you must not use TOPAMAX if you are a woman who can become pregnant
unless you are using highly effective contraception (birth control).
Before the start of treatment with TOPAMAX a pregnancy test should be performed in
a woman who can become pregnant.
Treatment of epilepsy
For epilepsy, you must not use TOPAMAX if you are pregnant, unless you and your doctor
have agreed that no other treatment gives sufficient seizure control for you.
For epilepsy, you must not use TOPAMAX if you are a woman who can become pregnant
unless you are using highly effective contraception. Do not stop taking TOPAMAX or
your contraception (birth control) until you have discussed this with your doctor.
Your doctor will make sure you have received information about the risks of taking
TOPAMAX during pregnancy and about the risks of seizures during pregnancy, which may
put you or your unborn child at risk.
Before the start of treatment with TOPAMAX a pregnancy test should be performed in
a woman who can become pregnant.
The risks of topiramate when taken during pregnancy:
The risks apply whether topiramate is taken for migraine prevention or treatment of
epilepsy.
There is a risk of harm to the unborn child if TOPAMAX is used during pregnancy.
If you take TOPAMAX during pregnancy, your child has a higher risk for birth defects,
particularly
Cleft lip (split in the top lip) and cleft palate (split in the roof of the mouth).
Newborn boys may also have a malformation of the penis (hypospadias).
These defects can develop early in pregnancy, even before you know you are pregnant.
Your child may be smaller and weigh less than expected at birth.
Your child may have higher risk for autism spectrum disorders, intellectual disabilities,
or attention deficit hyperactivity disorder (ADHD).
Talk to your doctor if you have questions about this risk during pregnancy.
Always use highly effective contraception (birth control) recommended by your doctor
during your treatment. Talk to your doctor about the method of birth control that is most appropriate for
you. If you are taking hormonal contraceptives, there is the risk for reduced effectiveness
of hormonal contraceptives due to topiramate. Therefore, an additional barrier contraceptive
method such as a condom or pessary/diaphragm should be used.
You must tell your doctor if you are breastfeeding or intend to breastfeed. TOPAMAX may appear in breast milk and it is not recommended to breastfeed while taking
TOPAMAX.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with TOPAMAX and affect how it works.
In particular, tell your doctor or pharmacist if you are taking:
other medicines for epilepsy, such as phenytoin or carbamazepine
digoxin (used to treat heart disease)
contraceptives such as oestrogen-containing or progestin only contraceptives
metformin, pioglitazone or glibenclamide (used to treat diabetes)
lithium or risperidone (used to treat bipolar disorder and schizophrenia)
haloperidol (used to treat psychoses)
hydrochlorothiazide (used to treat swelling or high blood pressure)
propranolol (used in high blood pressure, some heart conditions, tremors, tumor or
migraine headaches)
diltiazem (used to treat hypertension and prevent angina)
valproic acid (used to treat epilepsy or mood disorders)
vitamin K-antagonist anticoagulant medications (such as warfarin)
amitriptyline (used to treat depression)
flunarizine
any medicine which slows your reactions (CNS depressants). This may include medicines
to help you sleep or relieve pain, antidepressants, tranquillisers or antihistamines
which can make you drowsy.
any medicine which may cause kidney stone
These medicines may be affected by TOPAMAX or may affect how well TOPAMAX works. Your
doctor or pharmacist can tell you what to do if you are taking any of these medicines.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect TOPAMAX.
4. How do I use TOPAMAX?
How much to take
Adults
Epilepsy
Treatment starts at a low dose of 25 mg to 50 mg per day. The dose is then gradually
increased by 25 mg to 100 mg over weekly periods or longer, until the most suitable
dose is reached.
Migraine prevention
Treatment starts at a low dose of 25 mg nightly for one week. The dose is then increased
over weekly periods or longer by 25mg/day, until the most suitable dose is reached.
Children (2 years and over)
Epilepsy
Treatment starts at 25 mg or less per day, depending on the body weight. This dose
is then gradually increased over weekly periods or longer, until the most suitable
dose is reached.
Follow the instructions provided and use TOPAMAX until your doctor tells you to stop.
How to take it
You can take the tablets or capsules with or without food. Always swallow the tablets
whole with plenty of water.
TOPAMAX Sprinkle capsules are available for people who cannot swallow tablets. These
capsules can be opened and all of the contents sprinkled onto a teaspoon of soft food
which does not require chewing. This mixture should be swallowed immediately and not
chewed. It should not be stored for future use. The capsules can also be swallowed
whole with water.
The doses shown above are the usual recommended doses. However, your doctor may tell
you to take higher or lower doses. Your doctor will start with a low dose and slowly
increase the dose to the lowest amount needed to control your epilepsy.
When to take TOPAMAX
At the start of treatment TOPAMAX may be taken once a day, preferably at night. After
the dose is increased, it is taken twice a day.
TOPAMAX should be used as prescribed by your doctor depending on your condition. Follow
the instructions provided and use TOPAMAX until your doctor tells you to stop. Before
stopping, it is recommended that the dose be reduced gradually
If you forget to use TOPAMAX
TOPAMAX should be used regularly at the same time each day. If you miss your dose
at the usual time, take your dose as soon as you remember, and then continue to take
it as you would normally.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
If you have missed more than one dose, or are not sure what to do, check with your
doctor or pharmacist.
If you have trouble remembering when to take your medicine, ask your pharmacist for
some hints.
If you use too much TOPAMAX
If you think that you have used too much TOPAMAX, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(in Australia telephone 13 11 26 and in New Zealand telephone 0800 POISON or 0800 764 766), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
If you take too much TOPAMAX, 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.
5. What should I know while using TOPAMAX?
Things you should do
Drink plenty of water. TOPAMAX has been known to cause kidney stones and drinking
water may help prevent this.
Always follow your doctor’s instructions carefully.
If you are about to start taking a new medicine, tell your doctor or pharmacist that
you are taking TOPAMAX.
If you wish to become pregnant while taking TOPAMAX:
Schedule an appointment with your doctor.
Do not stop using your contraception until you have discussed this with your doctor
and do not become pregnant until you have discussed your options with your doctor.
Call your doctor straight away if you:
notice changes to your menstrual bleeding while on contraceptives
become pregnant or think you may be pregnant while taking TOPAMAX.
If you are taking TOPAMAX for epilepsy, do not stop taking this medicine until you
have discussed this with your doctor, as this may worsen your illness. Worsening of
your epilepsy may put you or your unborn child at risk.
If you are taking TOPAMAX to prevent migraine, stop taking the medicine straight away,
and contact your doctor to evaluate if you need alternative treatment.
Remind any doctor, dentist or pharmacist you visit that you are using TOPAMAX.
Things you should not do
Do not stop using this medicine suddenly without checking with your doctor, unless
you become pregnant or think you may be pregnant. See additional information under
Section
5. What should I know while using TOPAMAX? – Call your doctor straight away if you.
Do not drink alcohol.
Do not use TOPAMAX to treat any other complaint unless your doctor says so.
Do not give this medicine to anyone else to use.
Things to be careful of
Changes to your medication
If you are seizure free or your seizures are well controlled, a reduction in your
dose, discontinuation or substitution of your current medication should first be assessed
by your doctor and pharmacist, and any changes should be implemented gradually.
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.
Decreased sweating and elevation in body temperature
TOPAMAX 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 hospitalised for this condition.
Call your healthcare provider right away if you have a high fever, a fever that does
not go away, or decreased sweating.
Serious skin reactions
Tell your doctor immediately if you develop a skin rash and/or blisters.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how TOPAMAX
affects you.
TOPAMAX may cause drowsiness, dizziness or other symptoms which could affect your
ability to drive or operate machinery. It may also cause visual disturbances and/
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 TOPAMAX or if the amount
of TOPAMAX or any other medicine you are taking is increased or decreased.
Drinking alcohol
Tell your doctor if you drink alcohol.
Do not drink alcohol while taking TOPAMAX. Alcohol may increase the risk of unwanted
side effects.
Looking after your medicine
Keep TOPAMAX tablets or capsules in the original pack until it is time to take them.
Keep TOPAMAX tablets in a cool, dry place where the temperature is below 25°C.
Keep TOPAMAX Sprinkle capsules in a cool, dry place where the temperature is below
25°C. Do not store the drug/food mixture.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
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Less serious side effects
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What to do
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Metabolism and nutrition-related:
decrease in appetite or weight loss
Skin-related:
itchy skin or skin rash
Gastrointestinal-related:
nausea, diarrhoea, vomiting or constipation
abdominal pain or discomfort
Ear-related:
ear pain, buzzing or ringing in ears, deafness
Psychiatric-related:
inability to sleep
mood alterations such as aggression, agitation or anger
expressive language disorder
depression
nervousness or feeling anxious
Nervous system-related:
dizziness
disturbance in attention
difficulty with memory or memory impairment
slowing of thought processes
abnormal behaviour
difficulty in speaking
balance disorder
co-ordination problems
decreased feeling or sensitivity, especially in the skin
tingling and numbness of hands and feet (pins and needles)
unusual weakness
Other-related:
unusual hair loss or thinning
abnormal frequent urination
fever or high temperature
decreased or lack of sweating or overheating (mainly in children) ever or high temperature
taste disturbance or loss of taste
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Speak to your doctor if you have any of these less serious side effects and they worry
you
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Serious side effects
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Serious side effects
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What to do
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Nervous system-related:
unusual tiredness, drowsiness, irritability or lack of energy
Respiratory-related:
difficulty breathing, fast or irregular heartbeat or tightening of chest
Psychiatric-related:
thoughts of harming yourself or thoughts of suicide
Kidney-related:
kidney stones
pain when passing urine
Vision-related:
sudden changes in your eyesight (e.g. blurred vision, double vision or loss of vision)
or rapid uncontrollable movements of the eyes
eye pain or increased pressure in eye
Other-related:
unexplained bleeding or bleeding more frequently
severe blisters and bleeding in mucosal sites (such as lips, eyes, mouth, nose, genitals).
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What TOPAMAX tablets contain
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Active ingredient
(main ingredient)
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topiramate
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Other ingredients
(inactive ingredients)
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lactose monohydrate
pregelatinised maize starch
carnauba wax
microcrystalline cellulose
sodium starch glycollate
magnesium stearate
25 mg strength: Opadry White YS-1-7706-G (ARTG PI No. 2635)
50 mg strength: Opadry Light Yellow YS-1-6382-G (ARTG PI No. 2636)
100 mg strength: Opadry Yellow YS-1-6370-G (ARTG PI No. 2637)
200mg strength: Opadry Pink YS-1-1456-G (ARTG PI No. 2638)
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Potential allergens
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sugars as lactose
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What TOPAMAX capsules contain
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Active ingredient
(main ingredient)
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topiramate
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Other ingredients
(inactive ingredients)
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sucrose
povidone
cellulose acetate
15 mg strength: Empty Hard Gelatin Capsule Size 2 White Op/Nat G2HCSRR0446 (ARTG PI
No. 106893)
25 mg strength: Empty Hard Gelatin Capsule Size 1 White Op/Nat Part # G1HCSRR0602
(ARTG PI No. 106866)
50 mg strength: Empty Hard Gelatin Capsule Size 0 White Op/Nat Part # G0HCSRR0796
(ARTG PI No. 106894)
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Potential allergens
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sugars
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Do not take this medicine if you are allergic to any of these ingredients.
What TOPAMAX tablets look like
TOPAMAX tablets are available in blister packs of 20 (25 mg only), 30 (50 mg only
- sample pack) or 60:
25 mg tablets are round and white and marked "TOP" on one side and "25" on the other
(AUST R 62709)
50 mg tablets are round and light yellow and marked "TOP" on one side and "50" on
the other (AUST R 62710)
100 mg tablets are round and yellow and marked "TOP" on one side and "100" on the
other (AUST R 62711)
200 mg tablets are round and salmon coloured and marked "TOP" on one side and "200"
on the other (AUST R 62712)
Not all pack type or pack sizes may be marketed.
What TOPAMAX capsules look like
TOPAMAX Sprinkle capsules are available in bottles of 60. The capsules consist of
a clear cap and a white body. They contain white to off-white spheres:
15 mg capsules are marked "TOP" on the cap and "15 mg" on the body (AUST R 167729)
25 mg capsules are marked "TOP" on the cap and "25 mg" on the body (AUST R 167730)
50 mg capsules are marked "TOP" on the cap and "50 mg" on the body (AUST R 167731)
Who distributes TOPAMAX
JANSSEN-CILAG Pty Ltd
1-5 Khartoum Road, Macquarie Park NSW 2113
Australia
Telephone: 1800 226 334
NZ Office: Auckland New Zealand
Telephone: 0800 800 806
This leaflet was prepared on 19 December 2024.