Consumer Information for: DOM-TOPIRAMATE

BEFORE you use Dom-TOPIRAMATE talk to your doctor or pharmacist if:

• you drive a vehicle, use machines, perform hazardous tasks during your work or do anything else that could be dangerous if you are not alert.
• you/ your child have or have had kidney stones or kidney disease. Your doctor may want you to increase the amount of fluids you/your child drink(s) while taking this medicine.
• you/your child have or have had liver disease.
• you/your child have or have had depression, mood
• problems, or suicidal thoughts or behaviour.
• you/your child have a history of metabolic acidosis (too
• much acid in the blood).
• you/your child have weak, brittle, or soft bones (osteomalacia, osteoporosis, osteopenia, or decreased bone density).
• you/your child have eye problems, especially glaucoma.
• you/your child have diarrhea.
• you/your child are having surgery.
• you/your child have or have had any medical problems or allergies.
• you are breast-feeding (nursing) Dom-TOPIRAMATE passes into breast milk and can harm your baby. You and your doctor should decide whether you should take Dom-TOPIRAMATE or breast-feed, but not both.
• you/your child are/is taking medicines that slow down the nervous system (CNS depressants).
• you/your child are taking oral contraceptives and Dom-TOPIRAMATE tablets; tell your doctor about any changes in your bleeding patterns (breakthrough bleeding/spotting).
• you are pregnant or plan to become pregnant.
• you are taking a ketogenic diet (a diet high in fat and low in protein and sugar).
• you consume alcohol regularly.
• you/your child have a growth problem.

EPILEPSY ONLY

• If you take Dom-TOPIRAMATE during pregnancy, your baby has a higher risk for birth defects called cleft lip and cleft palate. These defects can begin early in pregnancy, even before you know you are pregnant.
• Cleft lip and cleft palate may happen even in children born to women who are not taking any medicines and do not have other risk factors.
• There may be other medicines to treat your condition that have a lower chance of birth defects.
• All women of childbearing age who are being treated for epilepsy should talk to their healthcare providers about using other possible treatments instead of Dom-TOPIRAMATE. If the decision is made to use Dom-TOPIRAMATE, you should use effective birth control (contraception) unless you are planning to become pregnant. You should talk to your doctor about the best kind of birth control to use while you are taking Dom-TOPIRAMATE.
• Metabolic acidosis may have harmful effects on your baby. Talk to your healthcare provider if Dom-TOPIRAMATE has caused metabolic acidosis during your pregnancy.
• Tell your doctor right away if you become pregnant while taking Dom-TOPIRAMATE. You and your doctor should decide if you will continue to take Dom-TOPIRAMATE while you are pregnant.

Pregnancy Registry: If you become pregnant while taking Dom-TOPIRAMATE, talk to your doctor about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy. Information on the registry can also be found at the website http://www.massgeneral.org/aed/.

MIGRAINE PROPHYLAXIS
Dom-TOPIRAMATE is not to be used to prevent migraine headaches in pregnant women or women of childbearing potential who are not using an effective method of birth control.

Other Precautions:
Dom-TOPIRAMATE may cause some people to be less alert than normal. Make sure you know how you/your child are/is affected by this medication before you drive, use machines, or do anything else that could be dangerous if you are not alert.

Dom-TOPIRAMATE may reduce the efficacy of oral contraceptives even in the absence of breakthrough bleeding. Therefore, oral contraceptives containing not less than 30 µg of estrogen should be used.

A very small number of people may have thoughts of suicide.

Dom-TOPIRAMATEcan increase the level of acid in your blood (metabolic acidosis). If left untreated, metabolic acidosis can cause brittle or soft bones (osteoporosis, osteomalacia, osteopenia), kidney stones, can slow the rate of growth in children, and can harm your baby if you are pregnant. Metabolic acidosis can happen with or without symptoms.

Your doctor should do a blood test to measure the level of acid in your blood before and periodically during your treatment with Dom-TOPIRAMATE.

Rarely, blood tests have shown a slight increase in acidity. In many cases, there are no symptoms from this increased acidity but some people may experience symptoms such as rapid breathing, persistent lack of energy and loss of appetite. Some people may experience more serious symptoms such as heart problems, confused thinking or reduced consciousness.

Do not stop Dom-TOPIRAMATE without first talking to a healthcare provider. Stopping Dom-TOPIRAMATE suddenly can cause serious problems including seizures.