Topamax (Topiramate)

TOPAMAX is usually taken twice a day; however, your doctor may tell you to take it once a day or at a higher or lower dose.

Never stop taking, increase or decrease the amount of TOPAMAX you are taking unless your doctor tells you to.

Swallow the Tablets or the Sprinkle Capsules and take with plenty of water. You/your child can take the Tablets or the Sprinkle Capsules with or without food. Do not break or crush your tablets. You may swallow the Sprinkle Capsules whole with water or administer them by carefully opening the capsule and sprinkling the entire contents on a small amount (teaspoon) of soft food. This drug/food mixture should be swallowed immediately and not chewed. It should not be stored for future use.

Always check that you have enough Tablets or Sprinkle Capsules and do not run out. Do not suddenly stop taking this medicine without first checking with your doctor.

Epilepsy:

It is important that you take TOPAMAX exactly as your doctor has instructed. Your doctor will start with a low dose and slowly increase the dose to the lowest amount needed to control your/your child's epilepsy.

Usual dose:

TOPAMAX taken alone: The usual maintenance dose in adults and children (6 years of age and older) is between 100 mg/day and 400 mg/day. TOPAMAX is usually taken twice a day.

TOPAMAX taken in combination with other antiepileptic drugs: The usual adult maintenance dose is 200 mg to 400 mg per day.

In children, dosing is based on weight and the dose is approximately 5 to 9 mg/kg/day.

TOPAMAX is not indicated for use in patients under 2 years of age.

Migraine Prophylaxis:

It is important that you follow your doctor's instructions carefully to help reduce the chances of getting a migraine headache. Your doctor will start treatment with a dose of 25 mg to be taken at night. Your doctor will then increase your dose to the lowest amount needed to prevent migraine headaches.

Usual dose:

The usual adult dose is 100 mg per day. TOPAMAX is taken twice a day (50 mg in the morning and 50 mg at night). Your doctor may tell you to use a lower or higher dose.

TOPAMAX is not indicated for the prevention of migraine attacks in patients under 18 years of age.

Remember: This medicine has been prescribed for you/your child. Do not give it to anybody else.

Overdose:

In case of a drug overdose, immediately go to the nearest emergency room even if you do not feel sick. Make sure you take your medicine bottle with you to show the doctor.

Missed dose:

If you/your child miss/misses 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. Instead, take the next scheduled dose. Do not try to make up for the missed dose by taking a double dose next time.

• Any medicine may have unwanted effects. Tell your doctor or pharmacist about any unusual sign or symptom whether listed or not.
• Contact your doctor immediately or go to the Emergency Room if you/your child experience/experiences sudden worsening of vision, blurred vision or painful/red eye(s).
• TOPAMAX may cause decreased sweating and increased body temperature (fever). People, especially children, should be watched for signs of decreased sweating and fever, especially in hot temperatures. Some people may need to be hospitalized for this condition. Make sure you/your child increase/increases and maintain/maintains fluid intake prior to and during activities such as exercise and exposure to warm temperatures. Call your doctor right away if you/your child have/has a fever or decreased sweating.
• High ammonia in the blood can affect your mental activities, slow your alertness, make you feel tired, or cause vomiting.
• Taking TOPAMAX when you/your child are/is also taking valproic acid can cause a drop in body temperature to less than 35°C, a feeling of tiredness, confusion, or coma.
• Drink plenty of fluids when taking TOPAMAX to decrease your chances of getting kidney stones.
• Side effects reported most often in adults are: coordination problems, difficulty concentrating, slow thinking, confusion and forgetfulness, dizziness, tiredness, tingling, headache, upper respiratory tract infection (e.g., colds, bronchitis) and drowsiness. Less frequently reported side effects are: agitation, decrease in appetite, speech disorders (e.g., hesitancy or wordfinding difficulty), depression, emotional lability, vision disorders (e.g., double vision), mood swings, nausea, taste changes, weight loss and kidney stones (may include symptoms such as blood in the urine, or low back pain or pain in the genital area).
• In children, the following side effects were associated with the use of TOPAMAX: difficulty concentrating, forgetfulness, tiredness, drowsiness, nervousness, decrease in appetite, weight loss, upper respiratory tract infection (e.g., colds, bronchitis), headache, fever, tingling and aggressive behaviour.

BEFORE you use TOPAMAX 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). TOPAMAX passes into breast milk and can harm your baby. You and your doctor should decide whether you should take TOPAMAX 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 TOPAMAX Tablets or Sprinkle Capsules; 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 TOPAMAX 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 TOPAMAX. If the decision is made to use TOPAMAX, 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 TOPAMAX.
• Metabolic acidosis may have harmful effects on your baby. Talk to your healthcare provider if TOPAMAX has caused metabolic acidosis during your pregnancy.
• Tell your doctor right away if you become pregnant while taking TOPAMAX. You and your doctor should decide if you will continue to take TOPAMAX while you are pregnant.

Pregnancy Registry:

If you become pregnant while taking TOPAMAX, talk to your doctor.

Migraine Prophylaxis:

TOPAMAX 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:

TOPAMAX 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.

TOPAMAX 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.

TOPAMAX can 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 TOPAMAX.

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 TOPAMAX without first talking to a healthcare provider. Stopping TOPAMAX suddenly can cause serious problems including seizures.

Tell your doctor about all medications (prescription and non-prescription) and dietary supplements you/your child are/is using. It is especially important that your doctor know if you/your child are/is taking digoxin, oral contraceptives, glyburide, lithium, risperidone, diltiazem, or any other antiepileptic drugs, such as phenytoin, valproic acid or carbamazepine.