Consumer medicine information

TOPIRAMATE-GA

topiramate

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Topiramate-GA. 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 taking Topiramate-GA against the benefits it is expected to have for you.

If you have any concerns about taking Topiramate-GA, ask your doctor or pharmacist. Keep this leaflet with the medicine. You may need to read it again.

What Topiramate-GA is used for

Topiramate-GA is used for the treatment of various types of epilepsy in adults and children over 2 years of age, and for the prevention of migraines in adults. It prevents seizures and migraines by acting on the nerves and chemicals in the brain.

Your doctor may prescribe Topiramate-GA on its own, or in addition to another medicine for controlling your seizures or migraines.

Your doctor may have prescribed Topiramate-GA for another reason. Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Before you take Topiramate-GA

When you must not take it

Do not take Topiramate-GA:

  • if you have an allergy to topiramate or to any of the ingredients listed at the end of this leaflet
  • if the tablets do not look right
  • if the packaging is torn or shows signs of tampering
  • after the expiry date (month and year) printed on the pack.

Before you start to take it

You must tell your doctor if you:

  • are pregnant or planning to become pregnant. Topiramate has caused harm to the developing foetus when administered to a pregnant woman. Information available suggests that there may be an association between the use of topiramate in humans during pregnancy and birth defects including cleft lip/palate. However, it is very important to control your fits while you are pregnant. If it is necessary for you to take topiramate, your doctor can help you decide whether or not to take it during pregnancy.
  • are breast feeding or wish to breast feed. Topiramate may appear in breast milk and it is not recommended to breast feed while taking Topiramate-GA.
  • have or have ever had 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

If you have not told your doctor or pharmacist about any of the above, tell them before you start taking Topiramate-GA.

Your doctor will advise you whether or not to take Topiramate-GA or if you need to adjust the dose or adapt your treatment.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including medicines you can buy without a prescription from a pharmacy, supermarket or health food store.

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)
  • oral contraceptives (the pill)
  • metformin, pioglitazone, glibenclamide (used to treat diabetes)
  • acetazolamide (used to treat glaucoma)
  • lithium, risperidone (used to treat bipolar disorder and schizophrenia)
  • hydrochlorothiazide (used to treat swelling or high blood pressure)
  • propranolol
  • valproic acid
  • diltiazem (used to treat hypertension and prevent angina)
  • any medicine which slows your reactions. This may include medicines to help you sleep or relieve pain, antidepressants, tranquillisers or antihistamines which can make you drowsy.

These medicines may be affected by Topiramate-GA or may affect how well it works. Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.

Taking Topiramate-GA

How to take it

Follow your doctor’s instructions about when and how to take Topiramate-GA.

You can take the tablets with or without food. Always swallow the tablets whole with plenty of water.

The doses shown below 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.

At the start of treatment Topiramate-GA may be taken once a day, preferably at night. After the dose is increased, it is taken twice a day.

You should continue taking Topiramate-GA until your doctor tells you to stop. Before stopping, it is recommended that the dose be reduced gradually.

Adults

Epilepsy –
Treatment starts at a low dose of 25mg to 50mg per day. The dose is then gradually increased by 25mg to 100mg over weekly periods or longer, until the most suitable dose is reached.

Migraine –
Treatment starts at a low dose of 25mg 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 25mg 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.

If you forget to take it

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 have taken too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre on 13 11 26 for advice, or go to Accident & Emergency 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-GA, 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.

While you are taking Topiramate-GA

Things you must do

  • Drink plenty of water.
    Topiramate 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 Topiramate-GA.
  • Tell your doctor if you become pregnant while taking Topiramate-GA.

Things you must not do

  • Do not suddenly stop taking Topiramate-GA without checking with your doctor.
  • Do not drink alcohol.
  • Do not drive or operate machinery until you know how the medicine affects you.
  • Do not use Topiramate-GA 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

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-GA 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-GA or if the amount of Topiramate-GA or any other medicine you are taking is increased or decreased.

Effects of food and alcohol
Topiramate-GA can be taken with or without food.

Do not drink alcohol while taking Topiramate-GA. Alcohol may increase the risk of unwanted side effects, such as drowsiness.

Side effects

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some side effects. Do not be alarmed by this list of possible 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 any of the following continue or worry you:

  • 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, constipation
  • taste disturbance or loss of taste
  • faster breathing
  • unsteady or abnormal way of walking
  • difficulty in controlling emotions

Tell your doctor as soon as possible if you have any of the following as you may need medical attention:

  • 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
  • unusual weakness
  • difficulty in speaking
  • depression, mood problems, abnormal thoughts, thoughts of harming yourself
  • reduced sweating/ overheating (mainly in children) feeling flushed or overheated more than usual, particularly during exercise or hot weather
  • frequent infections with symptoms such as fever, severe chills, sore throat or mouth ulcers

Tell your doctor immediately if you have:

  • kidney stones
  • pain when passing urine
  • blood in your urine or severe pain in the lower back or genital area
  • sudden severe pain in the chest, arms or legs
  • sudden changes in your eyesight (eg. blurred or loss of vision), red eye or eye pain
  • abnormal tiredness, dark urine, pale stools, yellowing of the skin or eyes

These are serious side effects. You may need urgent medical attention. Serious side effects are rare.

Other side effects not listed above may also occur in some people.

Tell your doctor if you notice any other effects.

After using Topiramate-GA

Storage

Keep Topiramate-GA tablets in the original pack until it is time to take them.

Keep Topiramate-GA in a cool, dry place where the temperature is below 25°C. Protect from light.

Do not store Topiramate-GA or any medicine in the bathroom or near a sink. Do not leave medicines in the car or on window sills. Heat and dampness can destroy some medicines.

Keep Topiramate-GA where children cannot reach it. A locked cupboard at least one and a half metres (1.5 m) above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking Topiramate-GA, or your medicine has passed its expiry date, ask your pharmacist what to do with any tablets which may be left over.

Product description

What it looks like

Topiramate-GA tablets are available in four different strengths in blister packs of 60 tablets.

  • Topiramate-GA 25mg
    – white to off white, circular, biconvex film coated tablets, imprinted “25” (in black ink) on one side and plain on the other side.
  • Topiramate-GA 50mg
    – light yellow, circular, biconvex film coated tablets, imprinted “50” (in black ink) on one side and plain on the other side.
  • Topiramate-GA 100mg
    – dark yellow, circular, biconvex film coated tablets, imprinted “100” (in black ink) on one side and plain on the other side.
  • Topiramate-GA 200mg
    – reddish pink, oval shaped, biconvex film coated tablets imprinted “200” (in black ink) on one side and plain on the other side.

Ingredients

Active Ingredient:
25mg, 50mg, 100mg or 200mg of topiramate per tablet.

Inactive Ingredients:

  • Lactose
  • Pregelatinized maize starch
  • Microcrystalline cellulose
  • Sodium starch glycollate
  • Colloidal silicon dioxide
  • Magnesium stearate
  • Opadry White, Yellow, Pink, (depending on the colour) contains Hypromellose, Titanium dioxide, Macrogol, Iron Oxide and polysorbate 80
  • Opacode S-1-8152 HV Black containing: Shellac Glaze-47.5 % (22 % Esterified) in IMS 74 OP, Iron Oxide Black JPE, Industrial methylated Spirit 74 OP, Lecithin (Soya) NF, Antifoam DC 1510 (Food grade).

Supplier

www.ascentpharma.com.au

Ascent Pharma Pty Ltd
151-153 Clarendon St
South Melbourne VIC 3205

For further information call 1800 554 414

Australian Registration Numbers:
Topiramate-GA 25mg tablets blister pack: AUST R 155203
Topiramate-GA 50mg tablets blister pack: AUST R 155178
Topiramate-GA 100mg tablets blister pack: AUST R 155198
Topiramate-GA 200mg tablets blister pack: AUST R 155185

This leaflet was prepared in February 2012.

Published by MIMS April 2015