Qysmia Medication Guide

This medication guide will be given to every Qysmia patient.  This first page covers all the potential adverse side effects.  In other words, "good luck"--especially if you're an obese woman of child-bearing age.

MEDICATION GUIDE

QSYMIA™ (Kyoo sim ee’ uh)
(phentermine and topiramate extended-release)
Capsules
Read this Medication Guide before you start taking Qsymia and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. If you have any questions about Qsymia, talk to your healthcare provider or pharmacist.
What is the most important information I should know about Qsymia?
(For other side effects, also see “What are the possible side effects of Qsymia?”)
Qsymia can cause serious side effects, including:
• Birth defects (cleft lip/cleft palate). If you take Qsymia 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.
Women who are pregnant must not take Qsymia.
Women who can become pregnant should:
1. Have a negative pregnancy test before taking Qsymia and every month while taking Qsymia.
2. Use effective birth control (contraception) consistently while taking Qsymia. Talk to your healthcare provider about how to prevent pregnancy.
If you become pregnant while taking Qsymia, stop taking Qsymia immediately, and tell your healthcare provider right away. Healthcare providers and patients should report all cases of pregnancy to:
 FDA MedWatch at 1-800-FDA-1088, and
 The Qsymia Pregnancy Surveillance Program at 1-888-998-4887
• Increases in heart rate. Qsymia can increase your heart rate at rest. Your healthcare provider should check your heart rate while you take Qsymia. Tell your healthcare provider if you experience, while at rest, a racing or pounding feeling in your chest lasting several minutes when taking Qsymia.
• Suicidal thoughts or actions. Topiramate, an ingredient in Qsymia, may cause you to have suicidal thoughts or actions. Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
o thoughts about suicide or dying
o attempts to commit suicide
o new or worse depression
o new or worse anxiety
o feeling agitated or restless
o panic attacks
o trouble sleeping (insomnia)
o new or worse irritability
o acting aggressive, being angry, or violent
o acting on dangerous impulses
o an extreme increase in activity and talking (mania)
o other unusual changes in behavior or mood
• Serious eye problems which include:
o any sudden decrease in vision, with or without eye pain and redness,
o a blockage of fluid in the eye causing increased pressure in the eye
(secondary angle closure glaucoma).
These problems can lead to permanent vision loss if not treated. Tell your healthcare provider right away if you have any new eye symptoms.
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It is not known if Qsymia changes your risk of heart problems or stroke or of death due to heart problems or stroke.
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• Do not stop taking Qsymia without talking to your healthcare provider. Stopping Qsymia suddenly can cause serious problems, such as seizures. Your healthcare provider will tell you how to stop taking Qsymia slowly.
(snip)What should I avoid while taking Qsymia?
• Do not get pregnant while taking Qsymia. See “What is the most important information I should know about QSYMIA.”
• Do not drink alcohol while taking Qsymia. Qsymia and alcohol can affect each other causing side effects such as sleepiness or dizziness.
• Do not drive a car or operate heavy machinery, or do other dangerous activities until you know how Qsymia affects you. Qsymia can slow your thinking and motor skills, and may affect vision.
What are the possible side effects of Qsymia?
• See “What is the most important information I should know about Qsymia?” at the beginning of this Medication Guide
• Mood changes and trouble sleeping. Qsymia may cause depression or mood problems, and trouble sleeping. Tell your healthcare provider if symptoms occur.
• Concentration, memory, and speech difficulties. Qsymia may affect how you think and cause confusion, problems with concentration, attention, memory or speech. Tell your healthcare provider if symptoms occur.
• Increases of acid in bloodstream (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 Qsymia.
• Low blood sugar (hypoglycemia) in people with type 2 diabetes mellitus who also take medicines used to treat type 2 diabetes mellitus. Weight loss can cause low blood sugar in people with type 2 diabetes mellitus who also take medicines used to treat type 2 diabetes mellitus (such as insulin or sulfonylureas). You should check your blood sugar before you start taking Qsymia and while you take Qsymia.
• Possible seizures if you stop taking Qsymia too fast. Seizures may happen in people who may or may not have had seizures in the past if you stop Qsymia too fast. Your healthcare provider will tell you how to stop taking Qsymia slowly.
• Kidney stones. Drinking plenty of fluids when taking Qsymia to help decrease your chances of getting kidney stones. If you get severe side or back pain, and/or blood in your urine, call your healthcare provider.
• Decreased sweating and increased body temperature (fever). People should be watched for signs of decreased sweating and fever, especially in hot temperatures. Some people may need to be hospitalized for this condition.
Common side effects of Qsymia include:
• numbness or tingling in the hands, arms, feet, or face (paresthesia)
• dizziness
• change in the way foods taste or loss of taste (dysgeusia)
• trouble sleeping (insomnia)
• constipation
• dry mouth
Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of Qsymia. For more information, ask your healthcare provider or pharmacist.