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Table of Contents

1. Metformin
2. Bupropion
3. Topiramate

Metformin

Metformin is approved by the FDA as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Healthcare providers have the discretion to prescribe a medication for other uses as part of the practice of medicine.

Important Safety Information

Metformin is a prescription medicine that is FDA approved to treat Type 2 diabetes mellitus when hyperglycemia cannot be managed with diet and exercise alone.

When prescribed off-label Metformin may help some adults with overweight or obesity lose weight and keep the weight off.

What is the most important information I should know about Metformin tablets?

Serious side effects can happen in people taking Metformin tablets, including:

Lactic Acidosis. Metformin, the medicine in Metformin tablets, can cause a rare, but serious, side effect called lactic acidosis (a build-up of lactic acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital.

Stop taking Metformin tablets and call your healthcare provider right away if you get any of the following symptoms of lactic acidosis:

• Feel very weak and tired

• Have unusual (not normal) muscle pain

• Have trouble breathing

• Have unusual sleepiness or sleep longer than usual

• Have unexplained stomach or intestinal problems with nausea and vomiting, or diarrhea

• Feel cold, especially in your arms and legs

• Feel dizzy or lightheaded

• Have a slow or irregular heartbeat

You have a higher chance of getting lactic acidosis if you:

• Have kidney problems. People whose kidneys are not working properly should not take Metformin tablets.

• Have liver problems.

• Have congestive heart failure that requires treatment with medicines.

• Drink a lot of alcohol (very often or short-term "binge" drinking).

• Get dehydrated (lose a large amount of body fluids). This can happen if you are sick with a fever, vomiting, or diarrhea. Dehydration can also happen when you sweat a lot with activity or exercise and do not drink enough fluids.

• Have certain x-ray tests with injectable dyes or contrast agents.

• Have surgery.

• Have a heart attack, severe infection, or stroke.

• Are 80 years of age or older and have not had your kidney function tested.

Do not take Metformin tablets if you:

• Have kidney problems

• Have an abnormal creatinine level (not to exceed 500mg daily)

• Are allergic to the metformin in Metformin tablets or any of the ingredients in Metformin tablets. See the medication guide for the full list of ingredients.

• Are going to get an injection of dye or contrast agents for an x-ray procedure or if you are going to have surgery and not able to eat or drink much. In these situations, Metformin tablets will need to be stopped for a short time. Talk to your healthcare provider about when you should stop Metformin tablets and when you should start Metformin tablets again.

What should I tell my healthcare provider before taking Metformin tablets?

Before taking Metformin tablets, tell your healthcare provider if you:

• Have type 1 diabetes. Metformin tablets should not be used to treat people with type 1 diabetes.

• Have a history or risk for diabetic ketoacidosis (high levels of certain acids, known as ketones, in the blood or urine). Metformin tablets should not be used for the treatment of diabetic ketoacidosis.

• Have kidney problems.

• Have an abnormal creatinine level

• Have liver problems.

• Have heart problems, including congestive heart failure.

• Are older than 80 years. If you are over 80 years old you should not take Metformin tablets unless your kidneys have been checked and they are normal.

• Drink alcohol very often, or drink a lot of alcohol in short-term "binge" drinking.

• Are taking insulin.

• Have any other medical conditions.

• Are pregnant or plan to become pregnant. It is not known if metformin will harm your unborn baby. If you are pregnant, talk with your healthcare provider about the best way to control your blood sugar while you are pregnant.

• Are breast-feeding or plan to breast-feed. It is not known if metformin passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby while you take Metformin tablets.

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

• Metformin tablets may affect the way other medicines work, and other medicines may affect how Metformin tablets work.

Common side effects of Metformin tablets include diarrhea, nausea, and upset stomach. These side effects generally go away after you take the medicine for a while. Taking your medicine with meals can help reduce these side effects. Tell your healthcare provider if the side effects bother you a lot, last for more than a few weeks, come back after they've gone away, or start later in therapy. You may need a lower dose or need to stop taking the medicine for a short period or for good.

About 3 out of every 100 people who take Metformin tablets have an unpleasant metallic taste when they start taking the medicine. It lasts for a short time.

Metformin tablets rarely cause hypoglycemia (low blood sugar) by themselves. However, hypoglycemia can happen if you do not eat enough, if you drink alcohol, or if you take other medicines to lower blood sugar.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

The above health information is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient. The product information provided is intended only for residents of the United States. The products discussed herein may have different product labeling in different countries.

Bupropion

Bupropion is approved by the FDA for the treatment of major depressive disorder. Healthcare providers have the discretion to prescribe a medication for other uses as part of the practice of medicine.

Important Safety Information

Bupropion is a prescription medicine that is FDA approved to treat adults with a certain type of depression called major depressive disorder, and for the prevention of autumn-winter seasonal depression (seasonal affective disorder). When prescribed off-label Bupropion may help some adults with overweight and obesity lose weight and keep the weight off.

What is the most important information I should know about Bupropion tablets?

Serious side effects can happen in people taking Bupropion tablets, including:

Seizures. Bupropion can cause seizures, which can be serious and life-threatening. The risk of seizures is dose-related and increases with higher doses of Bupropion.

Stop taking Bupropion tablets and call your healthcare provider right away if you experience:

• Seizures

• Severe confusion or hallucinations

• Unusual changes in mood or behavior

• Severe allergic reactions such as rash, itching, swelling, or difficulty breathing

You have a higher chance of getting seizures if you:

• Have a history of seizures

• Have a brain injury

• Have a brain tumor

• Have a history of eating disorders, such as anorexia or bulimia

• Drink alcohol or use sedatives excessively

• Use other medications that lower the seizure threshold

• Have diabetes treated with insulin or other medications

Do not take Bupropion tablets if you:

• Have a seizure disorder

• Have a history of eating disorders

• Are abruptly stopping the use of alcohol or sedatives

• Are allergic to bupropion or any of the ingredients in Bupropion tablets. See the medication guide for the full list of ingredients.

• Are taking other forms of bupropion

What should I tell my healthcare provider before taking Bupropion tablets? Before taking Bupropion tablets, tell your healthcare provider if you:

• Have a history of depression or other mental health conditions

• Have a history of seizures or epilepsy

• Have a history of head injury or brain tumor

• Have an eating disorder

• Have diabetes

• Drink alcohol or use sedatives regularly

• Are pregnant or plan to become pregnant. It is not known if bupropion will harm your unborn baby. If you are pregnant, talk with your healthcare provider about the best way to manage your depression or quit smoking while you are pregnant.

• Are breastfeeding or plan to breastfeed. It is not known if bupropion passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby while you take Bupropion tablets.

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Bupropion tablets may affect the way other medicines work, and other medicines may affect how Bupropion tablets work.

Common side effects of Bupropion tablets include dry mouth, sweating, tremor, anxiety, dizziness, insomnia, and changes in appetite. These side effects generally go away after you take the medicine for a while. Taking your medicine with meals can help reduce these side effects. Tell your healthcare provider if the side effects bother you a lot, last for more than a few weeks, come back after they've gone away, or start later in therapy. You may need a lower dose or need to stop taking the medicine for a short period or for good.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

The above health information is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient. The product information provided is intended only for residents of the United States. The products discussed herein may have different product labeling in different countries.

Topiramate

Topiramate is FDA approved

• to treat certain types of seizures (partial-onset seizures and primary generalized tonic-clonic seizures) in adults and children 2 years and older.

• with other medicines to treat certain types of seizures (partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome) in adults and children 2 years and older.

• to prevent migraine headaches in adults and adolescents 12 years and older.

Topiramate is prescribed off-label and may help some adults with overweight and obesity lose weight and keep the weight off.

Important Safety Information

What is the most important information I should know about Topiramate?

Topiramate may cause eye problems. Serious eye problems include:

• Any sudden decrease in vision with or without eye pain and redness.

• A blockage of fluid in the eye causing increased pressure in the eye (secondary angle closure glaucoma).

These eye problems can lead to permanent loss of vision if not treated.

You should call your healthcare provider right away if you have any new eye symptoms, including any new problems with your vision.

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. If a high fever, a fever that does not go away, or decreased sweating develops, call your healthcare provider right away.

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 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

Your healthcare provider should do a blood test to measure the level of acid in your blood before and during your treatment with Topiramate. If you are pregnant, you should talk to your healthcare provider about whether you have metabolic acidosis.

Like other antiepileptic drugs, Topiramate may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call 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 may lower bone mineral density. TOPIRAMATE may decrease the density of bones when used over a long period.

Topiramate may have negative effects on growth in children TOPIRAMATE may slow height increases and weight gain in children and adolescents when used over a long period.

Do not stop Topiramate without first talking to a healthcare provider.

• Stopping Topiramate 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 suddenly, you may have seizures that do not stop. Your healthcare provider will tell you how to stop taking Topiramate slowly.

• If you miss a single dose of Topiramate, 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 and skip the missed dose. Do not double your dose. If you have missed more than one dose, you should call 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 can harm your unborn baby.

• 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 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.

• Tell your healthcare provider right away if you become pregnant while taking Topiramate. You and your healthcare provider should decide if you will continue to take Topiramate while you are pregnant.

• If you take Topiramate 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 has caused metabolic acidosis during your pregnancy.

• Pregnancy Registry: If you become pregnant while taking Topiramate, 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 and other antiepileptic drugs during pregnancy.

Before taking Topiramate, 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 passes into breast milk. Breastfed babies may be sleepy or have diarrhea. It is not known if the Topiramate 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.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Topiramate 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 may make your birth control less effective. Tell your healthcare provider if your menstrual bleeding changes while you are using birth control and Topiramate.

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.

What are the possible side effects of Topiramate?

Topiramate may cause serious side effects including:

• See “What is the most important information I should know about Topiramate?”

• High blood ammonia levels. High ammonia in the blood can affect your mental activities, slow your alertness, make you feel tired, or cause vomiting. This has happened when Topiramate is taken with a medicine called valproic acid (Depakene® or Depakote®).

• Effects on thinking and alertness. Topiramate may affect how you think and cause confusion, problems with concentration, attention, memory, or speech. TOPIRAMATE may cause depression or mood problems, tiredness, and sleepiness.

• Dizziness or loss of muscle coordination.

• Serious skin reactions. Topiramate may cause a severe rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome). Topiramate may also cause a rash with blisters and peeling skin over much of the body that may cause death (toxic epidermal necrolysis). Call your healthcare provider right away if you develop a skin rash or blisters.

• Kidney stones. Drink plenty of fluids when taking Topiramate to decrease your chances of getting kidney stones.

• Low body temperature. Taking Topiramate when you are also taking valproic acid can cause a drop in body temperature to less than 95°F, feeling tired, confusion, or coma.

Call your healthcare provider right away if you have any of the symptoms above.

The most common side effects of Topiramate include:

• Tingling of the arms and legs (paresthesia)

• Not feeling hungry

• Nausea

• A change in the way foods taste

• Diarrhea

• Weight loss

• Nervousness

• Upper respiratory tract infection

• Speech problems

• Tiredness

• Dizziness

• Sleepiness/drowsiness

• Slow reactions

• Difficulty with memory

• Pain in the abdomen

• Fever

• Abnormal vision

• Decreased feeling or sensitivity, especially in the skin

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

The above health information is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient. The product information provided is intended only for residents of the United States. The products discussed herein may have different product labeling in different countries.