Qysimia (Phentermine /topiramate):
Full medication information can be found by visiting their website at:
https://qsymia.com/?utm_source=google&utm_medium=cpc&gad_so
urce=1&gclid=CjwKCAjwhIS0BhBqEiwADAUhc3ZFsIV6NrEkjPcmJG-3
dI8tDsw4qLqOiYqf_4u1FHTM2MtQ8MejIxoCqcsQAvD_BwE
Important Safety Information
Do not take Qsymia if you are pregnant, planning to become pregnant, or become
pregnant during Qsymia treatment; have glaucoma; have thyroid problems
(hyperthyroidism); are taking certain medicines called monoamine oxidase inhibitors
(MAOIs) or have taken MAOIs in the past 14 days; are allergic to topiramate,
sympathomimetic amines such as phentermine, or any of the ingredients in Qsymia.
See the end of the Medication Guide for a complete list of ingredients in 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. Patients who are pregnant must not take Qsymia. Patients who can become pregnant should have a pregnancy test before taking Qsymia and every month while taking Qsymia and 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.
Qsymia may slow the increase in height in children 12 years and older.
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.
Visual field defects (independent of elevated intraocular pressure) have been reported
in clinical trials and in postmarketing experience in patients receiving topiramate. In
clinical trials, most of these events were reversible after topiramate discontinuation. If
visual problems occur at any time during treatment, consider discontinuing 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: thoughts about suicide or dying; attempts to commit suicide; new or worse depression; new or worse anxiety; feeling agitated or restless; panic attacks; trouble sleeping (insomnia); new or worse irritability; acting aggressive, being angry, or violent; acting on dangerous impulses; an extreme increase in activity or talking (mania); other unusual changes in behavior or mood.
Serious eye problems, which include any sudden decrease in vision, with or without eye
pain and redness or 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.
Qsymia may cause a severe rash with blisters and peeling skin, especially around the
mouth, nose, eyes, and genitals (Stevens-Johnson Syndrome). Qsymia may also cause
a rash with blisters and peeling skin over much of the body that may be life threatening
(Toxic Epidermal Necrolysis). Call your healthcare provider right away if you develop a
skin rash or blisters.
COMMON SIDE EFFECTS OF QSYMIA IN ADULTS INCLUDE:
Numbness or tingling in the hands, arms, feet, or face (paraesthesia); dizziness;
changes in the way foods taste or loss of taste (dysgeusia); trouble sleeping (insomnia); constipation; and dry mouth.
COMMON SIDE EFFECTS OF QSYMIA IN CHILDREN 12 YEARS OLD AND OLDER INCLUDE:
Depression, dizziness, joint pain, fever, flu, and ankle sprain.
POSSIBLE SIDE EFFECTS OF QSYMIA INCLUDE:
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, or 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.
High blood pressure medicines. If you are taking medicines for your blood pressure,
your doctor may need to adjust these medicines while taking Qsymia.
Central Nervous System (CNS) side effects. The use of prescription sleep aids, anxiety
medicines, or drinking alcohol with Qsymia may cause an increase in CNS symptoms
such as dizziness and light-headedness. Do not drink alcohol with 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. Drink 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.
Qsymia capsules contain the inactive ingredient FD&C Yellow No. 5 (tartrazine) which
can cause allergic-type reactions (including bronchial asthma) in certain people,
especially people who also have an allergy to aspirin.
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.
By signing below I am acknowledging I have read the above information regarding risks and side effects related to this medication. I also state that I am not pregnant and do not plan to become pregnant.