Warnings
IMPORTANT SAFETY INFORMATION
Who should not take Topiramate + Vitamin B12?
Do not take Topiramate + Vitamin B12 if you:
Are allergic to Topiramate + Vitamin B12 or any of the inactive ingredients in Topiramate + Vitamin B12. Inactive ingredients include: magnesium stearate, maltodextrin, dextrose, sucralose, FD&C Yellow #5/Tartrazine, green color, silicon dioxide, microcrystalline cellulose, silica.
These eye problems can lead to permanent loss of vision if not treated.
Should you notice any new eye symptoms, including any new problems with your vision, immediately discontinue use of Topiramate and seek urgent in-person evaluation. Please also message your provider team as soon as you are able.
Topiramate + Vitamin B12 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. If a high fever, a fever that does not go away, or decreased sweating develops, call your healthcare provider right away.
Topiramate + Vitamin B12 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 may possibly harm your baby if you are pregnant. Metabolic acidosis can happen with or without symptoms. Sometimes people with metabolic acidosis will:
Feel tired
Not feel hungry (loss of appetite)
Feel changes in heartbeat
Have trouble thinking clearly
While not a standard of care for healthcare providers who specialize in weight loss, a blood test to measure the level of acid in your blood before your treatment with Topiramate + Vitamin B12, can be considered. Should you wish to have this testing completed please inform a member of our care team. If you are pregnant, you should talk to your healthcare provider about whether you have metabolic acidosis.
Like other antiepileptic drugs, Topiramate + Vitamin B12 may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Message a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
Thoughts about suicide or dying
Attempts to commit suicide
New or worse depression
New or worse anxiety
Panic attacks
An extreme increase in activity and talking (mania)
Feeling agitated or restless
Trouble sleeping (insomnia)
New or worse irritability
Acting aggressive, being angry or violent
Acting on dangerous impulses
Other unusual changes in behavior or mood
Topiramate + Vitamin B12 may lower bone mineral density. Topiramate + Vitamin B12 may decrease the density of bones when used over a long period.
Topiramate + Vitamin B12 may have negative effects on growth in children. Topiramate + Vitamin B12 may slow height increases and weight gain in children and adolescents when used over a long period
Your compounded medication contains Vitamin B12. Please use caution when taking additional over-the-counter vitamins or supplements and ensure that your total daily intake does not exceed recommended limits.
Do not stop Topiramate + Vitamin B12 without first talking to a healthcare provider.
Stopping Topiramate + Vitamin B12 suddenly can cause serious problems.
Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.
If you have epilepsy and you stop taking Topiramate + Vitamin B12 suddenly, you may have seizures that do not stop. Your healthcare provider will tell you how to stop taking Topiramate + Vitamin B12 slowly.
If you miss a single dose of Topiramate + Vitamin B12, take it as soon as you can. However, if you are within 6 hours of taking your next scheduled dose, wait until then to take your usual dose of Topiramate + Vitamin B12 and skip the missed dose. Do not double your dose. If you have missed more than one dose, you should message your healthcare provider for advice.
How can I watch for early symptoms of suicidal thoughts and actions?
Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
Keep all follow-up visits with your healthcare provider as scheduled.
Call your healthcare provider between visits as needed, especially if you are worried about symptoms.
Topiramate + Vitamin B12 can harm your unborn baby.
If you take Topiramate + Vitamin B12 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 should talk to their healthcare providers about using other possible treatments instead of Topiramate + Vitamin B12. If the decision is made to use Topiramate + Vitamin B12, 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 + Vitamin B12.
Tell your healthcare provider right away if you become pregnant while taking Topiramate + Vitamin B12. You and your healthcare provider should decide if you will continue to take Topiramate + Vitamin B12 while you are pregnant.
If you take Topiramate + Vitamin B12 during pregnancy, your baby may be smaller than expected at birth. The long-term effects of this are not known. Talk to your healthcare provider if you have questions about this risk during pregnancy.
Metabolic acidosis may have harmful effects on your baby. Talk to your healthcare provider if Topiramate + Vitamin B12 has caused metabolic acidosis during your pregnancy.
Pregnancy Registry: If you become pregnant while taking Topiramate + Vitamin B12, talk to your healthcare provider 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 Topiramate + Vitamin B12 and other antiepileptic drugs during pregnancy.
Before taking Topiramate + Vitamin B12, tell your healthcare provider about all of your medical conditions, including if you:
Have or have had depression, mood problems, or suicidal thoughts or behavior
Have kidney problems, have kidney stones, or are getting kidney dialysis
Have a history of metabolic acidosis (too much acid in the blood)
Have liver problems
Have weak, brittle, or soft bones (osteomalacia, osteoporosis, osteopenia, or decreased bone density)
Have lung or breathing problems
Have eye problems, especially glaucoma
Have diarrhea
Have a growth problem
Are on a diet high in fat and low in carbohydrates, which is called a ketogenic diet
Are having surgery
Are pregnant or plan to become pregnant
Are breastfeeding or plan to breastfeed? Topiramate + Vitamin B12 passes into breast milk. Breastfed babies may be sleepy or have diarrhea. It is not known if the Topiramate + Vitamin B12 that passes into breast milk can cause serious harm to your baby. Talk to your healthcare provider about the best way to feed your baby if you take Topiramate + Vitamin B12.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Topiramate + Vitamin B12 and other medicines may affect each other causing side effects. Especially tell your healthcare provider if you take:
Valproic acid (such as Depakene® or Depakote®).
Any medicines that impair or decrease your thinking, concentration, or muscle coordination.
Birth control that contains hormones (such as pills, implants, patches or injections). Topiramate + Vitamin B12 may make your birth control less effective. Tell your healthcare provider if your menstrual bleeding changes while you are using birth control and Topiramate + Vitamin B12.
Ask your healthcare provider if you are not sure if your medicine is listed above. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine. Do not start a new medicine without talking with your healthcare provider.
Medication disposal
If you no longer need your medication, the best way to dispose of most types of old, unused, unwanted, or expired medicines (both prescription and over the counter) is to drop off the medicine at a drug take back site, location, or program immediately. You can use the DEA DIVERSION CONTROL DIVISION LOOKUP to find your nearest drug disposal site.
If no drug take back sites, locations, or programs are available in your area, and there are no specific disposal instructions (such as flushing) in the medication guide or package insert, you can visit FDA- Disposal of Unused Medicines for more information or follow these simple steps to dispose of most medicines in your trash at home:
Mix medicines (liquid or pills; do not crush tablets or capsules) with an unappealing substance such as dirt, cat litter, or used coffee grounds;
Place the mixture in a container such as a sealed plastic bag;
Throw away the container in your trash at home; and
Delete all personal information on the prescription label of empty medicine bottles or medicine packaging, then trash or recycle the empty bottle or packaging.
This is only a summary of the most important information about Topiramate + Vitamin B12.
Need more information?
Ask your healthcare provider or pharmacist.
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