Ratio-Topiramate: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

• ratio-TOPIRAMATE has been prescribed to you/your child

  to control epilepsy.

• ratio-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:

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

When it should not be used:

• You/your child should not use ratio-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 ratio-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:

The tablets contain the following inactive ingredients: pregelatinzed starch, lactose monohydrate, colloidal silicon dioxide, sodium starch glycolate, microcrystalline cellulose and magnesium stereate, hydroxypropyl methylcellulose, titanium dioxide, polydextrose, triacetin and polyethylene glycol. The Colourants that are present in the tablets are as follows: 100 mg: yellow iron oxide and 200 mg: red iron oxide.

What dosage forms it comes in:

Tablets: 25 mg, 100 mg, 200 mg

WARNINGS AND PRECAUTIONS

BEFORE you use ratio-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 and allergies.
• you are breast-feeding (nursing).
• you/your child are/is taking medicines that slow down the nervous system (CNS depressants).
• you/your child are taking oral contraceptives and ratio-TOPIRAMATE Tablets, and tell your doctor about any changes in your bleeding patterns (breakthrough bleeding/spotting).
• 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 ratio-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 ratio-TOPIRAMATE. If the decision is made to use ratio-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 ratio-TOPIRAMATE.
• Metabolic acidosis may have harmful effects on your baby. Talk to your healthcare provider if ratio-TOPIRAMATE has caused metabolic acidosis during your pregnancy.

• Tell your doctor right away if you become pregnant while taking ratio-TOPIRAMATE. You and your doctor should decide if you will continue to take ratio-TOPIRAMATE while you are pregnant.

  Pregnancy Registry: If you become pregnant while taking ratio-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 ratio-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:

ratio-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.

ratio-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.

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 ratio-TOPIRAMATE without first talking to a healthcare provider. Stopping ratio-TOPIRAMATE suddenly can cause serious problems.

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

PROPER USE OF THIS MEDICATION

ratio-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 ratio-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 ratio-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:

ratio-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. ratio-TOPIRAMATE is usually taken twice a day.

ratio-TOPIRAMATE 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.

ratio-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. ratio-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.

ratio-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:

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.

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).

• Decreased sweating may occur while taking ratio-

  TOPIRAMATE. 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. Contact your doctor if you/your child are/is not sweating as usual or show/shows signs of increased body temperature.

• Side effects reported most often in adults are: co-ordination

  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 experience 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 between 15 - 30°C in tightly closed light resistance containers. Protect from humidity.
• Keep this and all medicines in a safe place away from children.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Teva Canada Limited at:

1-800-268-4127 ext. 5005

or druginfo@tevacanda.com

Teva Canada Limited

30 Novopharm Court

Toronto, Ontario

Canada, M1B 2K9

Last revised: July 16, 2012

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

• Report online at www.healthcanada.gc.ca/medeffect
• Call toll-free at 1-866-234-2345

• Complete a Canada Vigilance Reporting Form and:

  • Fax toll-free to 1-866-678-6789, or

  • Mail to: Canada Vigilance Program

    Health Canada

    Postal Locator 0701E

    Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^TM Canada Web site at

www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.