NRA-Topiramate: Uses, Side Effects and Dosage

What NRA-TOPIRAMATE is used for:

NRA-TOPIRAMATE is used:

• to control epilepsy (seizures) in adults and children (6 years of age or older).
• with other antiepileptic drugs to manage epilepsy in adults and children (2 years of age or older).
• to prevent migraine headaches in adults (18 years and older).

How NRA-TOPIRAMATE works:

NRA-TOPIRAMATE is an antiepileptic drug used to treat epilepsy. It affects chemicals in the brain that are involved in sending signals to the nerves. This reduces the chances of having seizures and migraines.

The ingredients in NRA-TOPIRAMATE are:

Medicinal ingredient: topiramate

Non-medicinal ingredients:

Lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate.

The tablet coatings contain the following inactive ingredients:

25 mg: hydroxypropyl methyl cellulose, polyethylene glycol 400, polysorbate 80, and titanium dioxide.

100 mg and 200 mg: hydroxypropyl methyl cellulose, iron oxide red, iron oxide yellow, polyethylene glycol 400, polysorbate 80, and titanium dioxide.

NRA-TOPIRAMATE comes in the following dosage forms:

Tablets: 25 mg, 100 mg, and 200 mg

Do not use NRA-TOPIRAMATE if:

• you/your child are allergic to topiramate, or any of the ingredients in NRA-TOPIRAMATE.
• you require treatment for migraine headaches and are pregnant or a woman of childbearing potential and are not using a highly effective method of birth control.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take NRA-TOPIRAMATE. Talk about any health conditions or problems you may have, including if you/your child:

• have or have had kidney stones.
• have or have had metabolism or kidney problems.
• have or have had liver problems.

• have conditions that may increase the risk of developing metabolic acidosis (high levels of acid in the blood) such as:

  • renal disease,
  • severe respiratory disorders,
  • status epilepticus (seizure lasting more than 5 minutes, or more than one seizure within 5 minutes),
  • diarrhea,
  • surgery, and
  • ketogenic diet (low carbohydrate and high fat diet).
• have a family history of hypercalciuria (high levels of calcium in the urine).
• engage in activities where loss of consciousness could result in serious danger to themselves or those around them (including swimming, driving a car, climbing in high places, etc.).
• are breastfeeding (nursing) or plan to breastfeed. NRA-TOPIRAMATE can pass into breast milk and can harm your baby.
• are pregnant or plan to become pregnant. NRA-TOPIRAMATE for migraine prevention is contraindicated in pregnant women.
• have a growth problem.

Other warnings you should know about:

NRA-TOPIRAMATE can cause serious effects, including:

• Hyperammonemia:

  Treatment with NRA-TOPIRAMATE can cause hyperammonemia (high levels of ammonia in the blood) that can affect the brain. Tell your healthcare professional if you notice or develop any unexplained lethargy (lack of energy), vomiting, changes in mental status, or hypothermia (low body temperature). Your healthcare professional may monitor your health and the ammonia levels of your blood. This will help them decide to discontinue your treatment with NRA-TOPIRAMATE.

• Oligohidrosis and hyperthermia:

  Treatment with NRA-TOPIRAMATE can cause oligohidrosis (decreased or absence of sweating) and hyperthermia (high body temperature), especially in children. Your healthcare professional will monitor you/your child closely for symptoms of decreased sweating and increased body temperature. However, if you/your child notices or develops any of these symptoms, tell your healthcare professional immediately. You/your child should be adequately hydrated before and during activities such as exercise or exposure to warm temperatures. Tell your healthcare professional if you/your child are taking drugs that increase the risk of developing heat-related disorders (e.g., carbonic anhydrase inhibitors and drugs with anticholinergic activity).

• Metabolic acidosis:

  Treatment with NRA-TOPIRAMATE can cause metabolic acidosis (high levels of acid in the blood) in both adults and children. This can lead to brittle or soft bones (osteoporosis, osteomalacia, or osteopenia), rapid breathing, persistent lack of energy, loss of appetite, heart problems, confused thinking or reduced consciousness. If you/your child develops or notices any of these symptoms, tell your healthcare professional immediately. Your healthcare professional may perform a blood test to measure the level of acid in your/your child’s blood before and regularly during your treatment with NRA-TOPIRAMATE.

• Mental and motor impairment:

  Treatment with NRA-TOPIRAMATE can affect your mental and motor performance. These can cause psychomotor slowing, difficulty with concentration, speech problems, word- finding difficulties, drowsiness, fatigue, and mood disturbances.

• Eye problems:

  Treatment with NRA-TOPIRAMATE can cause eye problems that can lead to vision loss. If you/your child notices any changes to vision or eye pain, tell your healthcare professional immediately and seek medical help. Your healthcare professional may discontinue treatment with NRA-TOPIRAMATE.

• Kidney stones:

  Treatment with NRA-TOPIRAMATE has been associated with the formation of kidney stones, especially those with an increased risk of developing kidney stones. Your healthcare professional will recommend you/your child to drink lots of fluids when taking NRA-TOPIRAMATE to decrease your chances of getting kidney stones.

• Serious skin reactions:

  Treatment with NRA-TOPIRAMATE and allergic reactions can cause serious skin reactions including Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN). This can lead to symptoms such as rashes, sore throats, fevers, and mouth ulcers. If you/your child notices any signs of serious skin reactions (even mild symptoms), tell your healthcare professional immediately. Your healthcare professional may discontinue treatment with NRA-TOPIRAMATE.

• Suicidal thoughts or behaviour:

  Antiepileptic drugs such as NRA-TOPIRAMATE may increase the risk of suicidal thoughts and behaviours (harming or killing themselves). If at any time you have these thoughts, immediately contact your healthcare professional.

• Weight loss:

  Treatment with NRA-TOPIRAMATE can lead to weight loss. Your healthcare professional may instruct you/your child to take a dietary supplement or increase your food intake.

See the Serious side effects and what to do about them table, below, for more information on these and other serious side effects.

Driving and using machines: NRA-TOPIRAMATE can cause drowsiness, dizziness, visual disturbances, blurred visions, and other NRA-TOPIRAMATE related symptoms. Before you drive or do tasks that require special attention, wait until you know how you respond to NRA-TOPIRAMATE.

Laboratory tests and monitoring: Your healthcare professional may monitor and assess your health by performing blood tests. These tests can be performed before and during your treatment with NRA-TOPIRAMATE to measure your bicarbonate and ammonia.

Pregnancy and breastfeeding:

NRA-TOPIRAMATE can affect how well hormonal birth control works. If you are using hormonal birth control, tell your healthcare professional about any changes in your bleeding patterns (breakthrough bleeding/spotting). This may be a sign that your birth control is not working as well as it should be.In addition, your healthcare professional may ask you to take a pregnancy test before you start taking NRA-TOPIRAMATE. Your healthcare professional will provide you with a Patient Guide containing important safety information for female patients who are able to become pregnant and are receiving treatment with NRA-TOPIRAMATE.

Epilepsy Only

• If you take NRA-TOPIRAMATE during pregnancy, your baby has a higher risk for birth defects called cleft lip, cleft palate, and other malformations (e.g., anomalies involving various body systems including limbs and heart). 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.
• If you take NRA-TOPIRAMATE during pregnancy, your child may be at a higher risk for developing behaviourial or learning issues such as autism spectrum disorders or intellectual disabilities.
• Talk to your healthcare professional as there may be other medicines to treat your condition that have a lower chance of birth defects.
• If you are pregnant, able to get pregnant or think you are pregnant and are being treated for epilepsy, you should talk to your healthcare professional about using other possible treatments instead of NRA-TOPIRAMATE. If the decision is made to use NRA-TOPIRAMATE, you should use a highly effective birth control (contraception) during your treatment. You should talk to your healthcare professional about the best kind of birth control to use while you are taking NRA-TOPIRAMATE.
• Treatment with topiramate during pregnancy can cause metabolic acidosis that may have harmful effects on your baby. Talk to your healthcare professional if NRA-TOPIRAMATE has caused metabolic acidosis during your pregnancy.
• If you take NRA-TOPIRAMATE during pregnancy, you may have pre-term labour or your baby may be born early (premature delivery). Talk to your healthcare professional if you have questions about this risk during pregnancy.
• If you become pregnant while taking NRA-TOPIRAMATE, tell your healthcare professional right away. You and your healthcare professional should decide if you will continue to take NRA-TOPIRAMATE while you are pregnant.

Pregnancy Registry: If you become pregnant while taking NRA-TOPIRAMATE, talk to your healthcare professional about registering with the North American Antiepileptic Drug (NAAED) 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 following website http://www.aedpregnancyregistry.org/.

Migraine Prevention Only

• NRA-TOPIRAMATE is NOT to be used to prevent migraine headaches in pregnant women or women of childbearing potential who are not using a highly effective method of birth control.

Do not stop NRA-TOPIRAMATE without first talking to your healthcare professional. Stopping NRA-TOPIRAMATE suddenly can cause serious problems including seizures.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with NRA-TOPIRAMATE:

• medicines used to treat heart failure such as digoxin;
• central nervous system (CNS) depressants such as alcohol;
• medicines containing hormones used for birth control (hormonal contraceptives) including pills, implants, patches, or injections;
• medicines used to treat diabetes such as metformin, glyburide, or pioglitazone;
• medicines used to treat bipolar disorder such as lithium or risperidone;
• medicines used to treat depression such as amitriptyline;
• medicines used to treat high blood pressure such as diltiazem or hydrochlorothiazide;
• medicines such as blood thinners (anticoagulants);
• medicines that increase the risk of developing kidney stones such as acetazolamide;
• medicines used to treat epilepsy (seizures) such as phenytoin, valproic acid (valproate), or carbamazepine.

How to take NRA-TOPIRAMATE:

• NRA-TOPIRAMATE tablets is usually taken twice a day (in the morning and in the evening). However, your healthcare professional may tell you to take it once a day depending on your situation.

• NRA-TOPIRAMATE tablets can be taken with or without food.

• NRA-TOPIRAMATE tablets should be swallowed whole with plenty of water. Do not break or crush your tablets.
• Always check that you have enough NRA-TOPIRAMATE tablets and do not run out.
• Do not stop taking NRA-TOPIRAMATE or adjust the amount of NRA-TOPIRAMATE you/your child is/are taking without first checking with your healthcare professional.

Usual dose:

Your healthcare professional will determine the right dose for you/your child. Take NRA-TOPIRAMATE exactly as your healthcare professional has told you to. Your healthcare professional may start with a low dose and slowly adjust your dose as needed.

Epilepsy Only

NRA-TOPIRAMATE taken alone:

• Adults and children (6 years of age or older): The starting dose is 25 mg in the evening. The usual maintenance dose is 100 mg to 400 mg per day in two divided doses.

NRA-TOPIRAMATE taken with other antiepileptic drugs:

• Adults (17 years of age or older): The starting dose is 50 mg in the evening. The usual maintenance dose is 200 mg to 400 mg per day in two divided doses.

• Children (2 to 16 years of age): The starting dose is 25 mg in the evening (or less depending on weight). The healthcare professional will determine the appropriate maintenance dose based on weight.

Migraine Prevention Only

• Adults (18 years of age or older): The starting dose is 25 mg in the evening. The usual maintenance dose is 100 mg per day in two divided doses.

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.

Possible side effects from using NRA-TOPIRAMATE:

These are not all the possible side effects you may have when taking NRA-TOPIRAMATE. If you experience any side effects not listed here, tell your healthcare professional.

Side effects in adults include: co-ordination problems, slow thinking, and forgetfulness, dizziness, tiredness, tingling, headache, upper respiratory tract infection (e.g., colds, bronchitis), drowsiness, agitation, decrease in appetite, speech disorders (e.g., hesitancy or word-finding difficulty), depression, emotional lability, mood swings, nausea, taste changes, and weight loss.

Side effects in children include: forgetfulness, tiredness, drowsiness, nervousness, decrease in appetite, weight loss, upper respiratory tract infection (e.g., colds, bronchitis), headache, tingling and aggressive behaviour.

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

• Do not use this product after the expiry date written on the package.
• NRA-TOPIRAMATE tablets should be stored in tightly closed containers at room temperature (15°C to 30°C). Protect from moisture.
• Keep out of reach and sight of children.

If you want more information about NRA-TOPIRAMATE:

• Talk to your healthcare professional
• Find the full Product Monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html) or by calling Nora Pharma Inc. at