Qsymia 3.75 mg-23 mg capsule, extended release

Generic name:
Phentermine/topiramate extended-release capsule - oral

Pronunciation
(FEN-ter-meen/toe-PYRE-a-mate)

Brand name(s)
Qsymia

To receive phentermine/topiramate in the United States, you must understand, agree to, and carefully follow the requirements of the REMS Program for this medication. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.

This medication is used with a doctor-approved exercise, behavior change, and reduced-calorie diet program to help you lose weight. It is used in adults and children 12 years or older who are obese. It is also used in certain overweight people, such as those who have weight-related medical problems. Losing weight and keeping it off can lessen the many health risks that come with obesity, including heart disease, diabetes, high blood pressure, and a shorter life.

It is not known how this medication helps people to lose weight. It may work by decreasing your appetite, by increasing the amount of energy used by your body, or by affecting certain parts of the brain. This medication is a combination of phentermine and topiramate. Phentermine is an appetite suppressant and belongs to a class of drugs called sympathomimetic amines. Topiramate is known as an anticonvulsant or antiepileptic drug.

Read the Medication Guide provided by your pharmacist before you start taking this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily in the morning. Taking this medication late in the day may cause trouble sleeping (insomnia). Swallow the capsules whole. Do not crush or chew the capsules. Doing so can release all of the drug at once, increasing the risk of side effects.

The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.

To prevent kidney stones from forming, drink plenty of liquids while taking this medication unless your doctor instructs you otherwise.

If you suddenly stop using this medication, you may have withdrawal symptoms (such as seizures). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used this medication for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.

Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Do not increase your dose, take it more often, or use it for a longer time than prescribed. Your condition will not improve any faster, and your risk of side effects will increase. Take this medication exactly as prescribed to lower the risk of addiction.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication.

When this medication is used for several weeks, it may not work as well. Talk with your doctor if this medication stops working well. Your doctor may direct you to stop taking this medication.

Dizziness, drowsiness, dry mouth, difficulty sleeping, tiredness, tingling of the hands/feet, joint pain, constipation, or metallic taste may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• signs of kidney stones (such as painful urination, fever, chills, pink/bloody urine)
• bone pain
• change in sexual ability/interest
• unusual bleeding/bruising
• confusion
• difficulty concentrating
• memory loss

A small number of people who take anticonvulsants for any reason (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor right away if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.

Rarely, topiramate may cause a very serious eye problem, usually within 1 month of starting treatment. This eye problem can lead to permanent blindness. Get medical help right away if any of these side effects occur:

• sudden vision changes (such as decreased vision, blurred vision)
• eye pain/redness

This medication can rarely cause a serious metabolic problem (high amount of ammonia in the blood), especially if you are also taking valproic acid. Tell your doctor right away if you experience sudden/unexplained tiredness, vomiting, or mental changes (such as decreased alertness).

Get medical help right away if you have any very serious side effects, including:

• rapid breathing
• fast/slow/irregular heartbeat
• severe headache
• trouble speaking
• seizure
• weakness on one side of the body

This drug may rarely cause serious (sometimes fatal) lung or heart problems (pulmonary hypertension, heart valve problems). The risk may increase with longer use of this medication and use of other appetite-suppressant drugs/herbal products along with this drug. Stop taking this medication and get medical help right away if you have any very serious side effects, including:

• chest pain
• difficulty breathing with exercise/decreased ability to exercise
• fainting
• swelling of the legs/ankles/feet

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to any other sympathomimetic amines (including decongestants such as pseudoephedrine, stimulants such as amphetamine, appetite suppressants such as diethylpropion); or if you have any other allergies. This product may contain inactive ingredients (such as tartrazine), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• high blood pressure
• glaucoma
• personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol)
• heart disease (such as chest pain, heart attack, heart murmur, fast/irregular heartbeat, heart valve problems)
• mental/mood problems (such as depression, thoughts of suicide, severe anxiety/agitation)
• high blood pressure in the lungs (pulmonary hypertension)
• stroke
• overactive thyroid (hyperthyroidism)
• seizures
• kidney disease (including kidney stones)
• liver disease
• a certain metabolic imbalance (metabolic acidosis)
• a diet high in fat and low in carbohydrates (ketogenic diet)

This drug may make you dizzy or drowsy or blur your vision. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

This medication may make you sweat less, making you more likely to get heat stroke. Avoid doing things that may cause you to overheat, such as hard work or exercise in hot weather, or using hot tubs. When the weather is hot, drink a lot of fluids and dress lightly. If you overheat, quickly look for a place to cool down and rest. Get medical help right away if you have a fever that does not go away, mental/mood changes, headache, or dizziness.

If you have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication during treatment with this medication.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially dizziness and high blood pressure. Dizziness can increase the risk of falling.

Children may be more sensitive to the side effects of this drug, especially weakened bones, slowed growth rate, and decreased sweating. Consult your doctor or pharmacist for more details.

This medication must not be used during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control with your doctor. If you become pregnant or think you may be pregnant, tell your doctor right away. You will need to have a negative pregnancy test before starting this medication. You will also need to take a pregnancy test every month while on this medication.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication.

Topiramate passes into breast milk. It is unknown if phentermine passes into breast milk. However, similar drugs pass into breast milk. This medication may have undesirable effects on a nursing infant. Breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication.

This drug should not be used with certain medications because very serious interactions may occur. If you are taking or have taken other appetite-suppressant drugs in the past year (such as diethylpropion, ephedra/ma huang), tell your doctor or pharmacist before starting this medication.

Some products that may interact with this drug include:

• orlistat
• other stimulants (including amphetamines, methylphenidate, street drugs such as cocaine or MDMA/"ecstasy")

Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, marijuana (cannabis), antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and opioid pain relievers (such as codeine).

Some products have ingredients that could raise your heart rate or blood pressure. Tell your pharmacist what products you are using, and ask how to use them safely (especially cough-and-cold products or diet aids).

If you are taking hormonal birth control (such as pills, patch, or ring) with this medication, tell your doctor if you have any new spotting or breakthrough bleeding.

Caffeine can increase the side effects of this medication. Avoid drinking large amounts of beverages containing caffeine (coffee, tea, colas), eating large amounts of chocolate, or taking nonprescription products that contain caffeine.

This medication may interfere with certain medical/lab tests (such as brain scan for Parkinson's disease), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: rapid breathing, unusual restlessness, fast/slow/irregular heartbeat, chest pain, hallucinations, seizures, loss of consciousness, severe drowsiness.

Do not share this medication with others. Sharing it is against the law.

Lab and/or medical tests (such as blood pressure, heart rate, heart tests, eye exams, kidney function, blood sugar, potassium and bicarbonate blood levels) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.