Patient Medication Information: uses, side effects, how to take - Topiramate (Cobalt Pharmaceuticals)
ABOUT THIS MEDICATION
What the medication is used for:
- TOPIRAMATE has been prescribed to you/your child to control epilepsy.
- 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 no |
t
| responding to acute treatment. |
What it does:
| TOPIRAMATE affects chemicals in the brain that are involved | ||
| in sending signals to the nerves. TOPIRAMATE belongs to | ||
a
| group of medicines used to treat epilepsy. |
When it should not be used:
You/your child should not use 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 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, 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, | ||
polyethylene glycol 400, polysorbate 80, iron oxide yellow, iron oxide red and titanium dioxide.
What dosage forms it comes in:
25, 100, and 200 mg tablets
WARNINGS AND PRECAUTIONS
| BEFORE you use 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).
- you/your child are/is taking medicines that slow down the nervous system (CNS depressants).
- you/your child are taking oral contraceptives and TOPIRAMATE, and 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 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 TOPIRAMATE. If the decision is made to use 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 TOPIRAMATE.
- Metabolic acidosis may have harmful effects on your baby. Talk to your healthcare provider if TOPIRAMATE has caused metabolic acidosis during your pregnancy.
- Tell your doctor right away if you become pregnant while taking TOPIRAMATE. You and your doctor should decide if you will continue to take TOPIRAMATEwhile you are pregnant.
Pregnancy Registry: If you become pregnant while taking TOPIRAMATE, talk to your doctor 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 website http://www.massgeneral.org/aed/.
MIGRAINE PROPHYLAXIS
TOPIRAMATE is not to be used to prevent migraine headaches in pregnant women or women of child bearing potential who are not using an effective method of birth control.
Other Precautions:
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 | |
.
| TOPIRAMATE may reduce the efficacy of oral contraceptive |
s
| even in the absence of breakthrough bleeding. Therefore, ora |
l
| contraceptives containing not less than 30 µg of estrogen should | ||
| be used. | ||
A very small number of people may have thoughts of suicide.
TOPIRAMATE can increase the level of acid in your blood (metabolic acidosis). If 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 TOPIRAMATE.
| Rarely, blood tests have shown a slight increase in acidity. In | |
| many cases, there are no symptoms from this increased acidit |
y
| but some people may experience symptoms such as rapid | |
| breathing, persistent lack of energy and loss of appetite. Som | |
e people may experience more serious symptoms such as heart problems, confused thinking or reduced consciousness.
Do not stop TOPIRAMATE without first talking to a
healthcare provider. Stopping 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, or any other | ||
| antiepileptic drugs, such as phenytoin, valproic acid o | ||
r
| carbamazepine. |
PROPER USE OF THIS MEDICATION
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 TOPIRAMATE you are taking unless your doctor tells you to.
| Swallow the Tablets and take with plenty of water. You/you |
r
| 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 checkin |
g
| with your doctor. |
| EPILEPSY | ||
| It is important that you take TOPIRAMATE exactly as your | ||
| doctor has instructed. Your doctor will start with a low dose an | ||
d
| slowly increase the dose to the lowest amount needed to control |
your/your child’s epilepsy.
Usual dose:
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. TOPIRAMATE is usually taken twice | ||
| a day. | ||
| 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 | |
.
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 migrain | |
e
| headache. Your doctor will start treatment with a dose of 25 mg |
| to be taken at night. Your doctor will then increase your dose t |
o
| the lowest amount needed to prevent migraine headaches |
.
Usual dose:
| The usual adult dose is 100 mg per day. 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. | |||
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 whethe | |||
r
| listed o |
r 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).
| 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 righ | ||||
t
| away if you/your child have/ has a fever or decreased | ||
| sweating. | ||
|
,
| slow your alertness, make you feel tired, or cause vomiting. |
- Taking TOPIRAMATE when you/your child are/is also
| taking calproic acid can cause a drop in body temperature to | ||
| less than 35°C (95°F), a feeling of tiredness, confusion, or | ||
| coma. | ||
Drink plenty of fluids when taking TOPIRAMATE to
decrease your chances of getting kidney stones.
- 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) an |
d
| 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) | |
.
| ||||
| 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. | ||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist right away | Seek urgent medical attention | ||
Only if severe | In all cases | |||
| Rare | Kidney stones (blood in the urine or pain in the lower back or genital area) | ✓ | ||
Sudden worsening of vision, blurred vision with painful/red eye(s), loss of part of the field of vision | ✓ | |||
| Decreased sweating and increased body temperature (fever) | ✓ | |||
| Very Rare | Metabolic Acidosis (unexplained tiredness, loss of appetite, irregular heartbeat, and impaired consciousness) | ✓ | ||
Confusion, problems with concentration, attention, memory, and/or speech | ✓ | |||
| Thoughts of suicide or hurting yourself | ✓ | |||
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||||||||||
Symptom / effect High blood ammonia (This happens when taken with medicine called valproic acid.) (decreased alertness, tiredness or fatigue, vomiting) Allergic Reaction (red skin, hives, itching, swelling of the lips, face, tongue, throat, trouble breathing, wheezing, shortness of breath, skin rashes, blisters of the skin, sore mouth or eyes) | Talk with your doctor or pharmacist right away | Seek urgent medical attention | |||||||||
| ✓ | |||||||||||
| ✓ | |||||||||||
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 TOPIRAMATE, contact your doctor or pharmacist.
HOW TO STORE IT
•
| Do not use this product after the expiry date written on the | |||
| package. | |||
•
| Store in a tightly closed container at room temperature | ||
| (between 15 - 30°C) in a dry place. | ||
•
| Keep this and all medicines in a safe place away from | ||
| children. | ||
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:
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- 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, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ 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.
MORE INFORMATION
| This document plus the full product monograph, prepared for | ||
| health professionals can be found by contacting the sponsor, | ||
| Cobalt Pharmaceuticals Company, at: 1-866-254-6111 | ||
| Cobalt Pharmaceuticals Company | ||||
| 6733 Mississauga Road, Unit 400 | ||||
| Mississauga, ON | ||||
| Canada, L5N 6J5 | ||||
| Last revised: | ||||
August 27, 2014