Details for: AG-TOPIRAMATE

BEFORE you use AG-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/your child has had a rash or other skin reaction while taking AG-Topiramate or another medication (see table of Serious Side Effects below).
• you are breast-feeding (nursing).AG-Topiramate passes into breast milk and can harm your baby. You and your doctor should decide whether you should take AG-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 AG-Topiramate Tablets, and 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 AG-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 AG-Topiramate. If the decision is made to use AG-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 AG-Topiramate.
• Metabolic acidosis may have harmful effects on your baby. Talk to your healthcare provider if AGTopiramate has caused metabolic acidosis during your pregnancy.
• If you take AG-Topiramate during pregnancy, your baby may be born early. Talk to your healthcare provider if you have questions about this risk during pregnancy.
• Tell your doctor right away if you become pregnant while taking AG-Topiramate. You and your doctor should decide if you will continue to take AGTopiramate while you are pregnant.
  
  Pregnancy Registry: If you become pregnant while taking AG-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.aedpregnancyregistry.org/.

MIGRAINE PROPHYLAXIS
AG-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.