Ava-Topiramate: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

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

Ava-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:

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

When it should not be used:

You/your child should not use Ava-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.

Ava-Topiramate 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:

For the 25 mg, 100 mg and 200 mg tablets: colloidal silicon dioxide, copovidone, lactose, magnesium stearate, polyethylene glycol, sodium starch glycolate and titanium dioxide.

The 25 mg tablets also contain: hydroxypropyl methylcellulose, polydextrose and triethyl citrate. The 100 mg tablets also contain: polyvinyl alcohol, talc and iron oxide yellow.

The 200 mg tablets also contain: polyvinyl alcohol, talc and iron oxide red.

What dosage forms it comes in: Tablets: 25 mg, 100 mg, 200 mg

WARNINGS AND PRECAUTIONS

BEFORE you use Ava-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.

• if 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 you are taking this medicine.
• you/your child have or have had liver disease
• any medical problems and any allergies you/your child have or have had in the past.

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

• you are breast-feeding (nursing).
• you/your child are taking medicines that slow down the nervous system (CNS depressants).
• you/your child are taking oral contraceptives and Ava-Topiramate Tablets, 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.

Other Precautions

Ava-Topiramate may cause some people to be less alert than normal. Make sure you know how you/your child are affected by this medication before you drive, use machines, or do anything else that could be dangerous if you are not alert.

Ava-Topiramate may reduce the efficacy of oral contraceptives even in the absence of breakthrough bleeding. Therefore, oral contraceptives containing not less than 30 :g 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 using. It is especially important that your doctor know if you/your child are taking digoxin, oral contraceptives, glyburide, lithium, risperidone, diltiazem or any other antiepileptic drugs, such as phenytoin, valproate or carbamazepine.

PROPER USE OF THIS MEDICATION

Ava-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 Ava-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 Ava-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 you/your child’s epilepsy.

Usual Dose:

Ava-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. Ava-Topiramate is usually taken twice a day.

Ava-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.

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. Ava-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.

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 Ava-Topiramate, 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 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(s) sudden worsening of vision, blurred vision or painful/red eye(s).

• Decreased sweating may occur while taking pms-topiramate.

• 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 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 10 reports 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 15-30EC in a dry place.
• Keep this and all medicines in a safe place away from children.

REPORTING SIDE EFFECTS

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be obtained by contacting Avanstra Inc., at

1-888-550-6060

Avanstra Inc.

Calgary, Alberta

T3N 0A4

Last revised August 8, 2011