Topamax (Janssen, 50 mg, 300 mg, 400 mg): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

TOPAMAX has been prescribed to you/your child to control epilepsy.

$TOPAMAX 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:

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

When it should not be used:

You/your child should not use TOPAMAX 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.

TOPAMAX should not be used for:

• the prevention of other types of headaches that are

  different from migraine attacks.

• the acute treatment of migraine headache.

What the medicinal ingredient is:

topiramate

What the nonmedicinal ingredients are:

Tablets: carnauba wax, hypromellose (hydroxypropyl methylcellulose), lactose monohydrate, magnesium stearate, pregelatinized starch, microcrystalline cellulose, polyethylene glycol, polysorbate 80, purified water, sodium starch glycolate, titanium dioxide, and may contain synthetic iron oxide.

Sprinkle Capsules: black pharmaceutical ink, cellulose acetate, gelatin, povidone, silicon dioxide, sodium lauryl sulfate, sugar spheres (sucrose and starch), titanium dioxide.

What dosage forms it comes in:

Tablets: 25 mg, 50 mg, 100 mg, 200 mg, 300 mg, 400 mg Sprinkle Capsules: 15 mg, 25 mg, 50 mg

WARNINGS AND PRECAUTIONS

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 ③ any medical problems and any allergies you/your child has or has had in the past.

• you are pregnant, or you are planning to become pregnant.

• 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

  TOPAMAX Tablets or Sprinkle Capsules, and tell your doctor about any changes in your bleeding patterns (breakthrough bleeding/spotting). ③ you are taking a ketogenic diet (a diet high in fat and low in protein and sugar).

• you consume alcohol regularly.

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.

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 discontinue this medication without talking to your doctor first.

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, valproate or carbamazepine.

PROPER USE OF THIS MEDICATION

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 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/day.

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

MIGRAINE

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.

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

Overdose:

If you/your child accidentally take(s) an overdose of TOPAMAX, contact your doctor or the nearest hospital or Emergency Room, even though you/your child may not feel sick.

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

  TOPAMAX. 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 were: 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 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.

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

Rare side effects – from 1 to less than 1 report 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 between 15 – 30ºC in a dry place.
• Keep this and all medicines in a safe place away from children.

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:

toll-free telephone:

toll-free fax:

By email:

866-234-2345

866-678-6789

cadrmp@hc-sc.gc.ca By regular mail:

Canadian Adverse Drug Reaction Monitoring Program (CADRMP)

Health Canada

Address Locator: 0701C

Ottawa, ON K1A 0K9

NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.

MORE INFORMATION

This document plus the full Product Monograph, prepared for health professionals, can be found at: http://www.janssen-ortho.com

or by contacting the sponsor, Janssen-Ortho Inc., at: 1-800-567-3331

Janssen-Ortho Inc.

Toronto, Ontario M3C 1L9

Last revised: September 21, 2006

(Component #)

© 2006 JANSSEN-ORTHO Inc.

^*All trademark rights used under license

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