Phentermine; Topiramate extended-release capsules

What is this medication?

Phentermine; Topiramate (FEN ter meen; Toe PYRE a mate) is a combination of two drugs that decrease appetite and help you lose weight. This product is used with a reduced calorie diet and exercise. This product can also help you maintain weight loss.

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:

• bone problems
• depression or other mental illness
• diabetes
• diarrhea
• glaucoma
• having surgery
• heart disease
• high blood pressure
• history of drug abuse or alcohol abuse problem
• history of heart attack or stroke
• history of irregular heartbeat
• kidney disease or stones
• liver disease
• low levels of potassium in the blood
• lung or breathing disease, like asthma
• metabolic acidosis
• on a ketogenic diet
• seizures
• suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member
• taken an MAOI like Carbex, Eldepryl, Marplan, Nardil, or Parnate in last 14 days
• thyroid disease
• an unusual or allergic reaction to phentermine, topiramate, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not crush or chew. This medicine is usually taken with or without food once per day in the morning. Avoid taking this medicine in the evening. It may interfere with sleep. Take your doses at regular intervals. Do not take your medicine 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 health care provider about the use of this medicine 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 medicine with any of the following medications:

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

This medicine may also interact with the following medications:

• acetazolamide
• alcohol
• antihistamines for allergy, cough and cold
• atropine
• birth control pills
• carbamazepine
• certain medicines for bladder problems like oxybutynin, tolterodine
• certain medicines for depression, anxiety, or psychotic disturbances
• certain medicines for high blood pressure
• certain medicines for Parkinson's disease like benztropine, trihexyphenidyl
• certain medicines for sleep
• certain medicines for stomach problems like dicyclomine, hyoscyamine
• certain medicines for travel sickness like scopolamine
• dichlorphenamide
• digoxin
• diuretics
• linezolid
• medicines for colds or breathing difficulties like pseudoephedrine or phenylephrine
• medicines for diabetes
• methazolamide
• narcotic medicines for pain
• phenytoin
• sibutramine
• stimulant medicines 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 doctor or health care provider for regular checks on your progress.

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

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

Avoid extreme heat. This medicine 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 medicine. 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 medicine 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 medicine may affect blood sugar levels. Ask your healthcare provider if changes in diet or medicines are needed if you have diabetes.

Check with your health care professional 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 medicine.

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

Patients and their families should watch out for new or worsening depression or thoughts of suicide. Also watch out for sudden changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. If this happens, especially at the beginning of treatment or after a change in dose, call your healthcare professional.

This medicine may cause serious skin reactions. They can happen weeks to months after starting the medicine. Contact your health care provider 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 medicine. Talk to your health care professional about using an extra method of birth control.

Women should inform their health care provider if they wish to become pregnant or think they 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 health care provider for more information.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• anxious
• breathing problems
• changes in vision
• chest pain or chest tightness
• depressed mood or other mood changes
• fast, irregular heartbeat
• increased blood pressure
• irritable
• pain, tingling, numbness in the hands or feet
• redness, blistering, peeling or loosening of the skin, including inside the mouth
• restlessness
• seizures
• signs and symptoms of increased acid in the body like breathing fast; fast heartbeat; headache; confusion; unusually weak or tired; nausea, vomiting
• signs and symptoms of kidney stones like blood in urine; pain in the lower back or side; pain when urinating
• signs and symptoms of a stroke like changes in vision; confusion; trouble speaking or understanding; severe headaches; sudden numbness or weakness of the face, arm or leg; trouble walking; dizziness; loss of balance or coordination
• suicidal thoughts
• trouble passing urine or change in the amount of urine

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

• changes in taste
• constipation
• dizziness
• dry mouth
• headache
• 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. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law.

This medicine may cause harm and death if it is taken by other adults, children, or pets. Return medicine that has not been used to an official disposal site. Contact the DEA at 1-800-882-9539 or your city/county government to find a site. If you cannot return the medicine, mix any unused medicine with a substance like cat litter or coffee grounds. Then throw the medicine away in a sealed container like a sealed bag or coffee can with a lid. Do not use the medicine after the expiration date.

Store at room temperature between 15 and 25 degrees C (59 and 77 degrees F).

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.