Tamate Tablets

Tamate Tablets is a brand of medicine containing the active ingredient topiramate (antiepileptic medicines).

Find out more about active ingredients.

Consumer medicine information (CMI) leaflet

Developed by the pharmaceutical company responsible for this medicine in Australia, according to TGA regulations.

Tamate

contains the active ingredient topiramate


Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Tamate tablets.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of you taking Tamate against the benefits expected for you.

If you have any concerns about taking this medicine, talk to your doctor or pharmacist.

Keep this leaflet with your medicine. You may need to read it again.

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What Tamate is used for

Tamate 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. Tamate is not used to treat severe migraines that come on suddenly (acute).

It prevents seizures and migraines by acting on the nerves and chemicals in the brain.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may prescribe Tamate on its own, or in addition to another medicine for controlling your seizures or migraines.

Your doctor may have prescribed Tamate for another reason.

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Before you take Tamate

When you must not take it

Do not take Tamate if you are allergic to:

  • medicines containing topiramate
  • any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include skin rash, itching or hives; swelling of the face, lips or tongue, which may cause difficulty in swallowing or breathing; wheezing or shortness of breath.

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or show signs of tampering. 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 are allergic to any other medicines, foods, dyes or preservatives.

Tell your doctor if you are pregnant or plan to become pregnant. Tamate has caused harm to the developing foetus in animal studies. Its safety has not been verified in pregnant humans. However, it is very important to control your fits while you are pregnant.

If it is necessary for you to take Tamate, your doctor can help you decide whether or not to take it during pregnancy.

Tell your doctor if you are breastfeeding or plan to breastfeed. Tamate may appear in breast milk and it is not recommended to breastfeed while taking Tamate.

Tell your doctor if you have, or have had, any medical conditions, especially the following:

  • personality disorder or mental illness
  • kidney stones, kidney disease or have a family history of kidney stones
  • liver disease
  • eye problems or high pressure in the eye.

Your doctor may want to take special care if you have any of these conditions.

If you have not told your doctor about any of the above, tell him/her before you start taking Tamate.

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

Taking other medicines

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

Some medicines may be affected by Tamate or may affect how well Tamate works. These include:

  • other medicines for epilepsy, such as phenytoin, carbamazepine or sodium valproate
  • digoxin, a medicine used to treat heart disease
  • oral contraceptives, such as the pill
  • medicines used to treat diabetes, such as metformin, pioglitazone, glibenclamide
  • medicines used to treat glaucoma, such as acetazolamide
  • medicines used to treat bipolar disorder and schizophrenia, such as lithium or risperidone
  • haloperidol, a medicine used to treat psychoses
  • medicines used to treat swelling or high blood pressure, such as hydrochlorothiazide
  • propranolol, a medicine used to treat high blood pressure, some heart conditions, tremors, tumour or migraine headaches
  • valproic acid, a medicine used to treat seizures or mood disorders
  • diltiazem, a medicine used to treat hypertension and prevent angina
  • amitriptyline, a medicine used to treat depression
  • flunarizine
  • any medicine which slows down your reactions. This may include medicines to help you sleep or relieve pain, antidepressants, tranquillisers or antihistamines which can make you drowsy.

Your doctor can tell you what to do if you are taking any of these medicines.

If you are not sure whether you are taking any of these medicines, check with your doctor or pharmacist.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking Tamate.

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How to take Tamate

Follow all directions given to you by your doctor and pharmacist carefully.

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the pack, ask your doctor or pharmacist.

How to take it

Always swallow the tablets whole with plenty of water.

You can take the tablets with or without food.

How much to take

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 Tamate may be taken once a day, preferably at night. After the dose is increased, it is taken twice a day.

You should continue taking Tamate 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 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 -
Treatment starts at a low dose of 25 mg nightly for one week. The dose is then increased over weekly periods or longer by 25 mg/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 body weight. This dose is then gradually increased over weekly periods or longer, until the most suitable dose is reached.

How long to take it for

Keep taking Tamate for as long as your doctor tells you to. Tamate helps you control your condition but does not cure it, so it is important to take it every day.

If you forget to take it

If it is almost time for 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 tablets as you would normally.

Do not take a double dose to make up for the dose you missed.

If you miss 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 or doctor for some hints.

If you take too much (overdose)

Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at the nearest hospital, if you think you or anyone else may have taken too much Tamate. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

If you take too much Tamate, 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.

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While you are taking Tamate

Things you must do

Before starting any new medicine, tell your doctor or pharmacist that you are taking Tamate.

Drink plenty of water. Tamate has been known to cause kidney stones and drinking water may help prevent this.

Tell all the doctors, dentists and pharmacists who are treating you that you are taking Tamate.

If you become pregnant while taking Tamate, tell your doctor immediately.

If you plan to have surgery (that requires an anaesthetic), including dental surgery, tell your doctor or dentist that you are taking Tamate.

Tell your doctor if you feel that Tamate is not helping your condition. If you continue to have seizures (fits) or migraines, your doctor may need to adjust or review your treatment.

Tell your doctor if, for any reason, you have not taken Tamate exactly as prescribed. Otherwise, your doctor may adjust your treatment unnecessarily.

Visit your doctor regularly so that they can check your progress. Your doctor may ask you to have regular blood tests to check your blood count, kidney and liver function.

Things you must not do

Do not drink alcohol while you are taking Tamate. Combining Tamate and alcohol can make you more sleepy or dizzy. Alcohol can also affect how well Tamate works and may even cause more seizures (fits) and/or migraines.

Do not drive or operate machinery until you know how Tamate affects you. Tamate may cause drowsiness, dizziness or affect alertness in some people. These effects may continue the following day.

Therefore, make sure you know how Tamate affects you before you drive a car, operate machinery or do anything else that could be dangerous.

Children should not ride a bike, climb trees or do anything else that could be dangerous if they are feeling sleepy or drowsy. Tamate may cause drowsiness or dizziness in some people and affect alertness.

Do not take Tamate for a longer time than your doctor has prescribed.

Do not stop taking Tamate or change the dose without first checking with your doctor. Stopping this medicine suddenly may make your epilepsy and/or migraine worse and cause some unwanted effects. Your doctor will tell you how to gradually reduce that amount of Tamate you are taking before stopping completely.

Do not let yourself run out of Tamate over the weekend or on holidays.

Do not use Tamate to treat any other conditions unless your doctor tells you to.

Do not give Tamate to anyone else, even if they have the same condition as you.

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.

Effects on driving and operating machinery.
Tamate may cause drowsiness, dizziness or other symptoms which could affect your ability to drive or operate machinery. Make sure you know how you are affected by this medicine before you drive or use machinery.

Particular care is recommended when you are first taking Tamate or if the amount of Tamate or any other medicine you are taking is increased or decreased.

Effects of food and alcohol
Tamate can be taken with or without food.

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

If Tamate is being given to a small child, you should be especially careful that they are breathing freely. Tamate may increase the amount of saliva and fluid in the airways.

Be careful if you are elderly, unwell or taking other medicines. Some people may experience side effects such as drowsiness, confusion, dizziness and unsteadiness, which may increase the risk of a fall.

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Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Tamate. Tamate helps most people with their epilepsy and/or migraine, but it may have unwanted side effects in some people.

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 of the 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 you notice any of the following and they 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 in fingers and toes
  • nose bleed
  • nausea, diarrhoea, constipation
  • taste disturbances or loss of taste

The above list includes the milder side effects of Tamate, some of which may disappear with continued treatment.

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

  • depression
  • nervousness or feeling anxious
  • disturbances in attention
  • difficulty with memory and/or thinking
  • slowing of thought processes
  • abnormal behaviour
  • expressive language disorder
  • balance disorder
  • coordination 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
  • unusual weakness
  • difficulty in speaking.

The above list includes serious side effects that may require medical attention. Serious side effects are rare.

See your doctor immediately or go to Accident and Emergency at the nearest hospital if you notice any of the following:

  • thoughts of harming yourself or thoughts of suicide
  • kidney stones
  • 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 eye
  • severe blisters and bleeding in mucosal sites (such as lips, eyes, mouth, nose, genitals).

The above list includes very serious side effects. You may require urgent medical attention or hospitalisation.

Tell your doctor if you notice anything that is making you feel unwell. Other side effects not listed above may also occur in some people. Tell your doctor if you notice any other effects.

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After taking Tamate

Storage

Keep your tablets in the pack until it is time to take them. If you take the tablets out of the pack they may not keep well.

Keep your tablets in a cool dry place where the temperature stays below 25°C.

Do not store Tamate 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 it 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.

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Product description

What it looks like

Tamate is available in 4 tablet strengths:

  • 25mg tablets are round and white and marked "G" on one side and "TO" over "25" on the other
  • 50mg tablets are round and yellow and marked "G" on one side and "TO" over "50" on the other
  • 100mg tablets are round and yellow and marked "G" on one side and "TO" over "100" on the other
  • 200mg tablets are round and red and marked "G" on one side and "TO" over "200" on the other

Each blister pack contains 60 tablets.

Ingredients

The active ingredient in Tamate is topiramate.

  • Each Tamate 25 tablet contains 25mg of topiramate.
  • Each Tamate 50 tablet contains 50mg of topiramate.
  • Each Tamate 100 tablet contains 100mg of topiramate.
  • Each Tamate 200 tablet contains 200mg of topiramate.

The tablets also contain the following inactive ingredients:

  • microcrystalline cellulose
  • povidone
  • colloidal silicon dioxide
  • sodium starch glycollate
  • magnesium stearate
  • water-purified
  • titanium dioxide
  • hypromellose
  • macrogol 400
  • polysorbate 80
  • iron oxide yellow (E172) (50mg and 100mg tablets only)
  • allura red aluminium lake (E129) (200mg tablets only)
  • sunset yellow aluminium lake (E110) (200mg tablets only)
  • indigo carmine aluminium lake (E132) (200mg tablets only)

Tamate tablets do not contain gluten.

Supplier

Tamate is supplied by:
Alphapharm Pty Limited
(ABN 93 002 359 739)
Level 1, 30 The Bond
30 - 34 Hickson Road
Millers Point NSW 2000
Phone: (02) 9298 3999
www.alphapharm.com.au

Australian Registration Numbers:
Tamate 25mg - AUST R 150447
Tamate 50mg - AUST R 150445
Tamate 100mg - AUST R 150446
Tamate 200mg - AUST R 150444

This leaflet was prepared on 03 February 2015.

Tamate_cmi\Feb15/00

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CMI provided by MIMS Australia, July 2015  

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