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You should always consult with your healthcare provider before
introducing any changes to your diet or level of physical activity.

Living Well : Nutrition

Learning From Your Food Planner and Tracker

Use the information you store in your tracker to increase your awareness of the calories you consume

WHY USE A FOOD PLANNER AND TRACKER?

A food planner and tracker lets you record information about the foods you eat and your eating patterns. The better you understand these patterns, the easier it can be to establish new ones. After logging meals and snacks in a food planner and tracker for a while, you'll have a better idea of how many meals you eat each day and the types of food you enjoy. You should also know when you are most hungry and where you are most likely to eat. Your job now is to look at your eating habits, consult with your healthcare provider, and try to correct the troublesome ones.

Carefully reviewing your food planner and tracker will help you discover your unique eating patterns.

Let’s look at an example of automatic eating with someone we’ll call Ginny. She loved ice cream and ate a bowl every night. With instruction, she began counting her bites and noting the pleasure in each one; she averaged 16 bites. Ginny found that the first 4 bites were delicious and then there were about 10 bites where she paid little attention to what she was eating (automatic eating). The final few bites were good because she was nearly finished. With her increased awareness, Ginny decided that the middle 10 bites were needless calories.

UNDERSTANDING YOUR EATING PATTERNS

As you try to uncover eating patterns, pay careful attention to the following topics:

  • Time. Look for times of day when you are likely to eat. A typical pattern shows little eating at breakfast and lunch, but much eating and snacking at dinner and afterwards. Do you crave a snack just before bed? Do you always have something to eat in the mid-afternoon? Are your meals irregular? Do you skip meals? Make sure you account for the foods you eat, especially in places other than your kitchen or dining room, such as the den, the office, or your car.
  • Amount. Look over the amount and calories of the food you eat. One key is to enjoy what you eat so you do not waste calories. Are there foods that you could eat less of or avoid completely? Could you reduce your portion size? Do you eat specific amounts each time without thinking about how much you need and want?
  • Foods. Pay close attention to the foods you eat. Can you find patterns in the foods you choose? The “hearts” option may help you with that. Which foods contribute most to your calories? Can you think of substitutes for high-calorie foods?

Remember to review your the entries you've logged in your food planner and tracker with your healthcare provider, who is in the best position to suggest changes that are best for you.

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INDICATION

Qsymia should be used together with a reduced-calorie diet and increased physical activity for chronic weight management in:

  • Adults with an initial body mass index (BMI) of:
    • 30 kg/m2 or greater (obese) or
    • 27 kg/m2 or greater (overweight) in the presence of at least one weight-related medical condition such as high blood pressure, type 2 diabetes, or high cholesterol
  • Pediatric patients aged 12 years and older with an initial BMI in the 95th percentile or greater standardized for age and sex

LIMITATIONS OF USE:

  • It is not known if Qsymia changes your risk of heart problems or stroke or of death due to heart problems or stroke
  • It is not known if Qsymia is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products

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.

Call your doctor for medical advice about side effects. You may report side effects to VIVUS LLC at 1-888-998-4887 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please read the Qsymia Medication Guide, Full Prescribing Information and Risk of Birth Defects with Qsymia Patient Brochure.

The Q and Me® Patient Support Program is based on the LEARN® Program provided under copyright license (September 15, 2010). All rights reserved.

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.

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