Sandoz Topiramate: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Sandoz Topiramate has been prescribed to you/your child to control epilepsy.

Sandoz Topiramate may also be prescribed to you to prevent your migraine headaches if you are an adult patient (over 18 years of age) with 4 or more attacks per month and are not responding to acute treatment.

What it does:

Sandoz Topiramate affects chemicals in the brain that are involved in sending signals to the nerves. Sandoz Topiramate belongs to a group of medicines used to treat epilepsy.

When it should not be used:

You/your child should not use Sandoz Topiramate if you are allergic to any of the ingredients in the product. Contact your doctor immediately if you experience an allergic reaction (e.g. skin rash, hives) or any severe or unusual side effects.

You should not use Sandoz Topiramate to prevent your migraine headaches if you are pregnant or a woman of childbearing potential and are not using an effective method of birth control.

For the prevention of other types of headaches that are different from migraine attacks.

For the acute treatment of migraine headache.

What the medicinal ingredient is:

Topiramate

What the nonmedicinal ingredients are:

Lactose monohydrate, pregelatinized starch, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, titanium dioxide, hydroxypropyl methylcellulose, polyethylene glycol, polysorbate 80.

• 25 mg tablets do not contain colouring dye

• 100 mg tablets contain yellow iron oxide

  • 200 mg tablets contain red iron oxide

What dosage forms it comes in:

Tablets: 25 mg, 100 mg and 200 mg

WARNINGS AND PRECAUTIONS

BEFORE you use Sandoz 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). Sandoz Topiramate passes into breast milk and can harm your baby. You and your doctor should decide whether you should take Sandoz 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 Sandoz 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 Sandoz 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 Sandoz Topiramate. If the decision is made to use Sandoz 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 Sandoz Topiramate.
• Metabolic acidosis may have harmful effects on your baby. Talk to your healthcare provider if Sandoz Topiramate has caused metabolic acidosis during your pregnancy.
• If you take Sandoz 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 Sandoz Topiramate. You and your doctor should decide if you will continue to take Sandoz Topiramate while you are pregnant.

  Pregnancy Registry: If you become pregnant while

  taking Sandoz Topiramate, talk to your doctor about

  registering with the North American Antiepileptic

  Drug Pregnancy Registry (NAAED). 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

Sandoz 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:

Sandoz 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.

Sandoz Topiramate may reduce the efficacy of oral contraceptives even in the absence of breakthrough bleeding. Therefore, oral contraceptives containing not less than 30 mcg of estrogen should be used.

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

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

INTERACTIONS WITH THIS MEDICATION

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, blood thinners, or any other antiepileptic drugs, such as phenytoin, valproic acid or carbamazepine.

PROPER USE OF THIS MEDICATION

Sandoz Topiramate 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 Sandoz Topiramate you are taking unless your doctor tells you to.

Swallow the tablets and take with plenty of water. You/your child can take the tablets with or without food. Do not break or crush your tablets.

Always check that you have enough tablets 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 Sandoz Topiramate 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:

Sandoz Topiramate 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. Sandoz Topiramate is usually taken twice a day.

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

In children, dosing is based on weight and the dose is

approximately 5 to 9 mg/kg/day.

Sandoz Topiramate 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. Sandoz Topiramate 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.

Sandoz Topiramate 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:

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.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

• 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).
• Sandoz Topiramate 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 Sandoz Topiramate when you/your child are/is also taking valproic acid can cause a drop in body temperature to less than 35ºC (95ºF), a feeling of tiredness, confusion, or coma.

• Drink plenty of fluids when taking Sandoz Topiramate 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 word finding 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 topiramate: 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.

Uncommon side effects – between 1 and 10 reports in every 1000 patients exposed

Rare side effects – from 1 to less than 10 reports in every 10,000 patients exposed

Very rare side effects – less than 1 report in every 10,000 patients exposed

This is not a complete list of side effects. If you have any unexpected effects while taking this drug, contact your doctor or pharmacist.

HOW TO STORE IT

• Do not use this product after the expiry date written on the package.
• Store at controlled room temperature (15 to 30°C).

Keep out of reach and sight of children.

REPORTING SIDE EFFECTS

MORE INFORMATION

If you want more information about Sandoz Topiramate:

• Talk to your healthcare professional

• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada

  • website( https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website Sandoz Canada Inc. www.sandoz.ca, or by calling at: 1-800-361-3062

or

by written request at:

110 rue de Lauzon

Boucherville, (QC), Canada

J4B 1E6 or by e-mail at :

medinfo@sandoz.com

Last revised: June 11, 2019