Why you should read this leaflet
Please read this leaflet carefully before you use Topamax. It tells you what you should know to be able to use Topamax correctly. This leaflet does not contain the complete information about this medicine. If you have any questions about what is written here or wish for any further information, please ask your doctor or pharmacist.
What is this medicine made of?
Active ingredient: Topiramate.
Topamax is available as tablets containing either 25 50,100,200,300 or 400 mg of topiramate.
Lactose hydrous, pregelatinized starch, pregelatinized starch (modified), purified water, carnauba wax, microcrystalline cellulose (E460), sodium starch glycolate, magnesium stearate, hydroxypropyl methylcellulose, polyethylene glycol, polysorbate 80, titanium dioxide and synthetic iron oxide (except white tablets).
What should this medicine look like?
Topamax 25 mg: round white tablets, imprinted with "TOP" on one side and "25" on the other.
Topamax 50 mg: round light yellow tablets, imprinted with "TOP" on one side and "50" on the other.
Topamax 100 mg: round yellow tablets, imprinted with "TOP" on one side and "100" on the other.
Topamax 200 mg: round salmon tablets, imprinted with "TOP" on one side and "200" on the other.
Topamax is available in bottles containing 60 tablets.
What type of medicine is Topamax?
Topamax belongs to a group of medicines called antiepileptic drugs. Topamax affects chemicals in the brain that are involved in sending signals to the nerves.
Who is licensed to sell Topamax?
Janssen-Cilag Limited, Saunderton, High Wycombe, Buckinghamshire HP14 4HJ.
Who makes Topamax?
Janssen-Cilag Farmaceutica, Estrada de Barcarena, 2745 Queluz, Portugal.
What is Topamax for?
Topamax is used to treat various types of epilepsy. Your doctor will prescribe Topamax when your current treatment is not satisfactory.
Is Topamax safe for you?
Do not take these tablets if you are allergic to any of the ingredients in the product.
Please tell your doctor if you
Are you taking other medicines?
Please tell your doctor about all medicines you are using, including those you bought without a prescription and any other remedies or dietary supplements such as vitamins.
It is especially important that your doctor knows if you are taking digoxin, contraceptive pills or other antiepileptic drugs, such as phenytoin or carbamazepine.
Topamax may cause you to be less alert than normal. Make sure you know how you are affected by this medicine before you drive, use machines or do anything else that could be dangerous if you are not alert.
If you are taking a contraceptive pill as well as Topamax and your menstrual bleeding patterns change (e.g. if you experience breakthrough bleeding, spotting or if you miss a period) consult your doctor.
If you, or a close relative, have ever had kidney stones, you have a greater risk for kidney stone formation and Topamax may increase this risk.
How should you take Topamax?
It is important that you follow your doctor's instructions about when and how to take this medicine.
The usual dose is 200 to 600 mg per day. Topamax is taken twice a day but your doctor may tell you to use a higher or lower dose.
Your doctor will start with a low dose and slowly increase the dose to the lowest amount needed to control your epilepsy.
Always swallow the tablets with plenty of water. You can take the tablets with or without food.
If you miss a dose, take it as soon as you remember. But, if it is almost time for the next dose, do not take the missed dose and then carry on as before.
Do not suddenly stop taking this medicine without first checking with your doctor.
Always check that you have enough tablets and do not run out.
What to do if you overdose on Topamax?
If you accidentally take too many tablets, contact your doctor or nearest hospital casualty department immediately for advice.
What side effects may Topamax cause?
As with any other medicine Topamax may cause some unwanted effects.
The most often reported side-effects are:
Less frequently reported are:
If such effects occur and become troublesome frequent and/or more severe, please consult you; doctor for advice.
Tell your doctor or pharmacist if you notice any other unwanted effect not mentioned above.
How should you store Topamax?
Store in a dry place. Store at or below 256C.
Other important points
Keep out of reach of children.
Remember: This medicine is for you. Only a doctor can prescribe it for you. Never give it to others. It may harm them even if their symptoms are the same as yours.
Tell medical staff you are using Topamax. For example, if you go into hospital or see a dentist or doctor.
Do not use these tablets
After the expiry date shown on the label
If the tablets do not look as described above
Date of preparation of this leaflet: February 1996.
Product Licence Numbers:25 mg PL/0242/0301
50 mg PL/0242/0302
100 mg PL/0242/0303
200 mg PL/0242/0304
® Registered Trademark
© JANSSEN-CILAG LTD 1996