TOPAMAX®
topiramate
25 mg, 50 mg, 100 mg, 200 mg tablets
15 mg, 25 mg, 50 mg Sprinkle capsules
What is in this leaflet
This leaflet answers some of the common questions about Topamax tablets and Sprinkle capsules. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist.
If you have any concerns about taking Topamax, ask your doctor or pharmacist. Your doctor and pharmacist have more information.
Keep this leaflet with your Topamax. You may need to read it again.
What Topamax is used for
Topamax is used for the treatment of various types of epilepsy in adults and children over 2 years of age. It prevents seizures by acting on the nerves and chemicals in the brain.
Your doctor may prescribe Topamax on its own, or in addition to another medicine for controlling your seizures.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.
Before you take Topamax
When you must not take it
Do not take Topamax if you know you are allergic to any of the ingredients. (See the last section of this leaflet for a list of ingredients). Signs of allergy include a skin rash, itching, shortness of breath and/or a swollen face.
Do not take Topamax if the packaging is torn or shows signs of tampering. Do not use Topamax beyond the expiry date (month and year) printed on the pack.
Before you start to take it
Certain people must use Topamax with caution. Ask your doctor for advice.
Driving and Operating Machinery
Topamax 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 first start taking Topamax or if the amount of Topamax or any other medicine you are taking is increased or decreased.
You must tell your doctor if you:
- are pregnant or planning to become pregnant
- are breast feeding or wish to breastfeed
- have or have ever had kidney stones, kidney disease or have a family history of kidney stones
- have or have ever had liver disease.
If you have not told your doctor or pharmacist about any of the above, tell them before you start taking or are given Topamax.
Your doctor will advise you whether or not to take Topamax or if you need to adjust the dose, or adapt your treatment.
Other medicines and alcohol
Tell your doctor or pharmacist if you are taking any other medicines, including medicines you can buy from a pharmacy, supermarket or health food shop.
In particular, tell your doctor or pharmacist if you are taking any of the following:
- other medicines for epilepsy, such as phenytoin or carbamazepine
- digoxin (used to treat heart disease)
- oral contraceptives (the pill)
- alcohol or 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.
There may also be some other medicines that may cause problems if used together with Topamax. So, make a point of telling your doctor or pharmacist which medicines you are taking at the moment, and before you start taking any new medicines. They will tell you which medicines should not be taken or what other measures (for example, a change of dose) are necessary.
Taking Topamax
How to take it
Follow your doctor's instructions about when and how to take Topamax.
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 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, Topamax may be taken once a day, preferably at night. After the dose is increased, it is taken twice a day.
You should continue taking Topamax until your doctor tells you to stop. Before stopping, it is recommended that the dose be reduced gradually.
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. Daily doses above 1000 mg are not recommended.
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.
If you do not understand the instructions provided with this medicine, ask your doctor or pharmacist for help.
If you forget to take a dose
- Take the dose you missed as soon as you remember, and then continue taking 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 one 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, or go to the Accident and Emergency at your nearest hospital immediately if you think you or anybody else has taken too much Topamax.
Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
If you take too much Topamax you may experience dizziness, lightheadedness, drowsiness, or you may lose consciousness.
While you are taking Topamax
Things you must do
- Always follow your doctor's instructions carefully.
- Drink plenty of water. Topamax has been known to cause kidney stones and drinking water may help prevent this.
- Tell your doctor if you become pregnant while taking Topamax.
- If you are about to start taking a new medicine, tell your doctor and pharmacist that you are taking Topamax.
Things you must not do
- Do not use Topamax to treat any other complaint unless your doctor says so.
- Do not take more than the recommended amount.
- Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
- Do not suddenly stop taking Topamax without checking with your doctor.
Things to be careful of
- Do not drink alcohol as it may increase the risk of unwanted side effects, such as drowsiness.
Side Effects
All medicines 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 you notice any of the following:
- unusual tiredness, drowsiness, weakness, dizziness
- decrease in appetite or weight loss
- headache
- unsteady or abnormal way of walking
- tingling and numbness in fingers and toes
- nausea, diarrhoea, increased saliva, altered sense of taste, stomach pain
- difficulty in controlling emotions.
Tell your doctor immediately if you notice any of the following as you may need urgent medical care:
- difficulty with concentration or attention; confusion
- difficulty with memory and/or thinking
- depression, mood problems, abnormal thoughts
- agitation, unusual nervousness
- co-ordination problems, tremor or slow reaction
- speech or language problems
- effects on eyes or vision (e.g. double vision)
- frequent infections with symptoms such as fever, severe chills, sore throat or mouth ulcers.
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if any of the following happen:
- you have an allergic reaction to Topamax
- you have blood in your urine or severe lower back pain which spreads towards the groin area
- you have sudden severe pain in the chest, arms or legs.
Other side effects not listed above may also occur in some people. Do not hesitate to report any other side effects to your doctor or pharmacist.
After taking Topamax
Storage
- Keep Topamax tablets or Sprinkle capsules in the pack until it is time to take them.
- Keep your Topamax tablets and Sprinkle capsules in a cool dry place where the temperature is below 25°C or 77°F.
- Keep your medicines where children cannot reach them. A locked cupboard at least one-and-a-half metres (1.5 m) above the ground is a good place to store medicines.
- Do not store Topamax, or any medicine, in the bathroom or near a sink. Heat and dampness can destroy some medicines.
Disposal
If your doctor tells you to stop taking Topamax tablets or Sprinkle capsules, or your medicine has passed its expiry date, ask your pharmacist what to do with any which may be left over.
Product Description
What it looks like
Tablets
Topamax tablets are available in bottles of 60:
- 25 mg tablets are round and white and marked "TOP" on one side and "25" on the other.
- 50 mg tablets are round and light yellow and marked "TOP" on one side and "50" on the other.
- 100 mg tablets are round and yellow and marked "TOP" on one side and "100" on the other.
- 200 mg tablets are round and salmon coloured and marked "TOP" on one side and "200" on the other.
Capsules
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.
- 25 mg capsules are marked "TOP" on the cap and "25 mg" on the body.
- 50 mg capsules are marked "TOP" on the cap and "50 mg" on the body.
Ingredients
Each Topamax tablet contains:
- 25, 50, 100 or 200 mg of topiramate as the active ingredient.
- lactose, pregelatinised maize starch, purified water, carnauba wax, microcrystalline cellulose, sodium starch glycollate, magnesium stearate, titanium dioxide, hypromellose, lauromacrogol 400 and polysorbate 80. In addition, Topamax 50 mg and 100 mg tablets contain iron oxide yellow, and the 200 mg tablets contain iron oxide red.
Each Topamax Sprinkle capsule contains:
- 15, 25 mg or 50 mg of topiramate as the active ingredient.
- sucrose, povidone, cellulose acetate, gelatin and titanium dioxide. The capsules are imprinted with black ink
| 
