Details for: AG-TOPIRAMATE
Company: ANGITA PHARMA INC.
DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
---|---|---|---|---|---|
02475936 | AG-TOPIRAMATE | TOPIRAMATE | 25 MG | TABLET | ORAL |
02475944 | AG-TOPIRAMATE | TOPIRAMATE | 100 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
- AG-Topiramate has been prescribed to you/your child to control epilepsy.
- AG-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
AG-Topiramate affects chemicals in the brain that are involved in sending signals to the nerves. AG-Topiramate belongs to a group of medicines used to treat epilepsy.
When it should not be used
- You/your child should not use AG-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 AG-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 non-medicinal ingredients are
Lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, pregelatinized starch, colloidal silicon dioxide, magnesium stearate, titanium dioxide, macrogol, carnauba wax, polysorbate 80. Additionally 100 mg has iron oxide yellow and 200 mg has iron oxide red.
What dosage form it comes in
25 mg, 100 mg, 200 mg
Warnings and precautions
BEFORE you use AG-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/your child has had a rash or other skin reaction while taking AG-Topiramate or another medication (see table of Serious Side Effects below).
- you are breast-feeding (nursing).AG-Topiramate passes into breast milk and can harm your baby. You and your doctor should decide whether you should take AG-Topiramate or breast-feed, but not both.
- you/your child are/is taking medicines that slow down the nervous system (CNS depressants).
- you/your child are taking oral contraceptives and AG-Topiramate Tablets, 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 AG-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 AG-Topiramate. If the decision is made to use AG-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 AG-Topiramate.
- Metabolic acidosis may have harmful effects on your baby. Talk to your healthcare provider if AGTopiramate has caused metabolic acidosis during your pregnancy.
- If you take AG-Topiramate during pregnancy, your baby may be born early. Talk to your healthcare provider if you have questions about this risk during pregnancy.
- Tell your doctor right away if you become pregnant
while taking AG-Topiramate. You and your doctor
should decide if you will continue to take AGTopiramate while you are pregnant.
Pregnancy Registry: If you become pregnant while taking AG-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.aedpregnancyregistry.org/.
MIGRAINE PROPHYLAXIS
AG-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
AG-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.
AG-Topiramate may reduce the efficacy of oral contraceptives even in the absence of breakthrough bleeding. Therefore, oral contraceptives containing not less than 30 mcg of estrogen should be used.
A very small number of people may have thoughts of suicide.
AG-Topiramate can increase the level of acid in your
blood (metabolic acidosis). If left 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 AG-Topiramate.
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.
If an allergic reaction happens such as fever, rash or skin blistering, even if mild, tell your doctor immediately or go to the emergency department at your nearest hospital. In very rare cases this could signal a serious skin reaction (see table of Serious Side Effects below)
Do not stop AG-Topiramate without first talking to a healthcare provider. Stopping AG-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, blood thinners, or any other antiepileptic drugs, such as phenytoin, valproic acid or carbamazepine.
Proper use of this medication
AG-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 AG-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 AG-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
AG-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. AG-Topiramate is usually
taken twice a day.
AG-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.
AG-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. AG-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.
AG-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).
- AG-Topiramate 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 right away if you/your child have/has a fever or decreased sweating.
- High ammonia in the blood can affect your mental activities, slow your alertness, make you feel tired, or cause vomiting.
- Taking AG-Topiramate when you/your child are/is also taking valproic acid can cause a drop in body temperature to less than 35ºC (95ºF), a feeling of tiredness, confusion, or coma.
- Drink plenty of fluids when taking AG-Topiramate to decrease your chances of getting kidney stones.
- Side effects reported most often in adults are: coordination 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.
Symptom / effect | Talk with your doctor or pharmacist right away Only if severe | Talk with your doctor or pharmacist right away In all cases | Seek urgent medical attention |
---|---|---|---|
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 | ✔ | ||
High blood ammonia (decreased alertness, tiredness or fatigue, vomiting, low body temperature ˂35°C (95°F) | ✔ | ||
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 | ✔ | ||
Allergic reaction including serious skin reaction (red skin, hives, itching, swelling of the lips, face, tongue, throat, trouble breathing, wheezing, shortness of breath, skin rashes, blistering, peeling skin, (particularly around the mouth, eyes, nose or genitals), sore mouth or eyes) | ✔ |
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 this drug, contact your doctor or pharmacist.
How to store
- Do not use this product after the expiry date written on the package.
- Store between 15 ºC –30ºC in a dry place.
- Keep this and all medicines in a safe place away from children.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
- Talk to your healthcare professional
- You may want to read this leaflet again. Please Do Not Throw It Away until you have finished your medicine
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://healthproducts.canada.ca/dpd-bdpp/index-eng.jsp ); the manufacturer’s website (www.angitapharma.in), or by calling 450-449-9272
This leaflet was prepared by
Angita Pharma Inc.
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Date of Revision: December 14, 2020