Phentermine; Topiramate Extended-Release Capsules

What is this medication?

Phentermine; Topiramate (FEN ter meen; Toe PYRE a mate) promotes weight loss. It may also be used to maintain weight loss. It works by decreasing appetite. Changes to diet and exercise are often combined with this medication.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Qsymia

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Depression or other mental health conditions
• Diabetes
• Diarrhea
• Glaucoma
• Having surgery
• High thyroid levels
• History of substance use disorder
• Kidney disease
• Kidney stones
• Liver disease
• Low levels of potassium in the blood
• Lung disease
• Metabolic acidosis
• On a ketogenic diet
• Osteoporosis, weak bones
• Seizures
• Suicidal thoughts, plans, or attempt by you or a family member
• Taken an MAOI, such as Marplan, Nardil, or Parnate in the last 14 days
• Trouble sleeping
• An unusual or allergic reaction to phentermine, topiramate, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with a glass of water. Follow the directions on the prescription label. Do not crush or chew. This medication is usually taken with or without food once per day in the morning. Avoid taking this medication in the evening. It may interfere with sleep. Take your doses at regular intervals. Do not take your medication more often than directed.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 12 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, skip it. Take your next dose at the normal time. Do not take extra or 2 doses at the same time to make up for the missed dose.

What may interact with this medication?

Do not take this medication with any of the following:

• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

This medication may also interact with the following:

• Acetazolamide
• Alcohol
• Antihistamines for allergy, cough and cold
• Atropine
• Birth control pills
• Carbamazepine
• Certain medications for bladder problems like oxybutynin, tolterodine
• Certain medications for depression, anxiety, or psychotic disturbances
• Certain medications for high blood pressure
• Certain medications for Parkinson disease like benztropine, trihexyphenidyl
• Certain medications for sleep
• Certain medications for stomach problems like dicyclomine, hyoscyamine
• Certain medications for travel sickness like scopolamine
• Dichlorphenamide
• Digoxin
• Diuretics
• Linezolid
• Medications for colds or breathing difficulties like pseudoephedrine or phenylephrine
• Medications for diabetes
• Methazolamide
• Narcotic medications for pain
• Phenytoin
• Sibutramine
• Stimulant medications for attention disorders, weight loss, or to stay awake
• Valproic acid
• Zonisamide

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress.

Do not stop taking this medication except on your care team's advice. You may develop a severe reaction. Your care team will tell you how much medication to take.

Do not take this medication close to bedtime. It may prevent you from sleeping.

Avoid extreme heat. This medication can cause you to sweat less than normal. Your body temperature could increase to dangerous levels, which may lead to heat stroke.

You should drink plenty of fluids while taking this medication. If you have had kidney stones in the past, this will help to reduce your chances of forming kidney stones.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medication affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may increase dizziness and drowsiness. Avoid alcoholic drinks.

This medication may affect blood sugar levels. Ask your care team if changes in diet or medications are needed if you have diabetes.

Check with your care team if you have severe diarrhea, nausea, and vomiting, or if you sweat a lot. The loss of too much body fluid may make it dangerous for you to take this medication.

Tell your care team right away if you have any change in your eyesight.

Watch for new or worsening thoughts of suicide or depression. This includes sudden changes in mood, behaviors, or thoughts. These changes can happen at any time but are more common in the beginning of treatment or after a change in dose. Call your care team right away if you experience these thoughts or worsening depression.

This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Contact your care team right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips or lymph nodes in your neck or under your arms.

Birth control may not work properly while you are taking this medication. Talk to your care team about using an extra method of birth control.

Tell your care team if you wish to become pregnant or think you might be pregnant. There is a potential for serious side effects and harm to an unborn child. Losing weight while pregnant is not advised and may cause harm to the unborn child. Talk to your care team for more information.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Difficulty with paying attention, memory, or speech
• Fast or irregular heartbeat
• Fever that does not go away, decreased sweating
• High acid level—trouble breathing, unusual weakness or fatigue, confusion, headache, fast or irregular heartbeat, nausea, vomiting
• High ammonia level—unusual weakness or fatigue, confusion, loss of appetite, nausea, vomiting, seizures
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Kidney stones—blood in the urine, pain or trouble passing urine, pain in the lower back or sides
• Low potassium level—muscle pain or cramps, unusual weakness or fatigue, fast or irregular heartbeat, constipation
• Mood and behavior changes—anxiety, nervousness, confusion, hallucinations, irritability, hostility, thoughts of suicide or self-harm, worsening mood, feelings of depression
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Burning or tingling sensation in hands or feet
• Change in taste
• Constipation
• Dizziness
• Dry mouth
• Trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets. This medication can be abused. Keep it in a safe place to protect it from theft. Do not share it with anyone. It is only for you. Selling or giving away this medication is dangerous and against the law.

Store at room temperature between 15 and 25 degrees C (59 and 77 degrees F). Protect from moisture. Keep the container tightly closed.

This medication may cause harm and death if it is taken by other adults, children, or pets. It is important to get rid of the medication as soon as you no longer need it, or if it is expired. You can do this in two ways:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.