The name of your medicine is APO-Topiramate. It contains the active ingredient topiramate.
It is used to:
Topiramate is not used to treat severe migraines that come on suddenly (acute).
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.
Topiramate prevents seizures and migraines by acting on the nerves and chemicals in the brain.
This medicine may be used to treat epilepsy only in children aged 2 years or older.
Do not take this medicine if:
Before you start taking this medicine, tell your doctor if:
1. You have allergies to:
2. You have or have had any medical conditions, especially the following:
3. You are currently pregnant or you 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.
4. You are currently breastfeeding or you plan to breast-feed. Do not take this medicine whilst breastfeeding until you and your doctor have discussed the risks and benefits involved.
5. You are planning to have surgery or an anaesthetic.
6. You are currently receiving or are planning to receive dental treatment.
7. You are taking or are planning to take any other medicines. This includes vitamins and supplements that are available from your pharmacy, supermarket or health food shop.
Some medicines may interact with topiramate. These include:
If you are taking any of these you may need a different dose or you may need to take different medicines.
Other medicines not listed above may also interact with topiramate.
Follow carefully all directions given to you by your doctor. Their instructions may be different to the information in this leaflet.
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.
Do not stop taking your medicine or change your dosage without first checking with your doctor.
The doses shown below are the usual recommended doses. However, your doctor may tell you to take higher or lower doses.
Epilepsy - Treatment starts at a dose of 25 mg to 50 mg nightly for one week or longer. The dose is then gradually increased by 25 mg to 100 mg/day over weekly periods or longer, until the most suitable dose is reached.
Migraine - Treatment starts at a 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 only -
Treatment starts at 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 the most suitable dose is reached.
Swallow the tablets whole with a glass of water.
Do not crush or chew the tablets.
Take this medicine at the same time each day. Taking it at the same time each day will have the best effect and will also help you remember when to take it.
It does not matter if you take it before, with or after food.
Continue taking your medicine for as long as your doctor tells you.
Make sure you have enough to last over weekends and holidays.
If it is almost time to take your next dose, skip the missed dose and take your next dose at the usual time. 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 to help you remember.
If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 in Australia) for advice. Alternatively, go to the Accident and Emergency department at your nearest hospital.
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, lightheadedness, drowsiness, convulsions, speech disturbances, double or blurred vision, difficulty with thinking, abnormal coordination, stomach pain, depression, agitation, faster breathing or you may lose consciousness.
Tell your doctor that you are taking this medicine if:
Drink plenty of water. Topiramate has been known to cause kidney stones and drinking water may help prevent this.
Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects. Go to your doctor regularly for a check-up.
Tell any other doctors, dentists and pharmacists who are treating you that you take this medicine.
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 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 topiramate or if the amount of topiramate or any other medicine you are taking is increased or decreased.
Effects of alcohol
Do not drink alcohol while taking topiramate. Alcohol may increase the risk of you experiencing side effects, such as drowsiness.
Tell your doctor as soon as possible if you do not feel well while you are taking topiramate or if you have any questions or concerns.
Do not be alarmed by the following lists of side effects. You may not experience any of them. All medicines can have side effects. Sometimes they are serious but most of the time they are not.
Tell your doctor if you notice any of the following:
Tell your doctor as soon as possible if you notice any of the following:
These may be serious side effects. You may need medical attention.
If any of the following happen, stop taking your medicine and either tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
These are very serious side effects. You may need urgent medical attention or hospitalisation.
Other side effects not listed above may occur in some patients.
If you think you are having an allergic reaction to topiramate, do not take any more of this medicine and tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital.
Symptoms of an allergic reaction may include some or all of the following:
Keep your medicine in its original packaging until it is time to take it.
If you take your medicine out of its original packaging it may not keep well.
Keep your medicine in a cool dry place where the temperature will stay 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.
If your doctor tells you to stop taking this medicine or it has passed its expiry date, your pharmacist can dispose of the remaining medicine safely.
The tablets are available in 4 different strengths:
Topiramate 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.
Topiramate 50 mg tablets
Light-yellow, round, unscored, film coated tablet, imprinted "APO" on one side and "TP over "50" on the other side.
Topiramate 100 mg tablets
Mustard yellow, round, unscored, film coated tablet, imprinted "APO" on one side and "TP over "100" on the other side.
Topiramate 200 mg tablets
Reddish-brown, round, unscored, film coated tablet, imprinted "APO" on one side and "TP over "200" on the other side.
Each tablet contains 25 mg, 50 mg, 100 mg or 200 mg of topiramate as the active ingredient.
It also contains the following inactive ingredients:
This medicine is gluten-free, lactose-free, sucrose-free, tartrazine-free and other azo dyes-free.
APO-Topiramate 25 mg tablets
Blister pack of 60 tablets
AUST R: 124729
APO-Topiramate 50 mg tablets
Blister pack of 60 tablets
AUST R: 124730
APO-Topiramate 100 mg tablets
Blister pack of 60 tablets
AUST R: 124731
APO-Topiramate 200 mg tablets
Blister pack of 60 tablets
AUST R: 124732