Phentermine/Topiramate, Oral

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KEY POINTS

• This medicine is taken by mouth to help overweight and obese adults lose weight. Take it exactly as directed.
• You will need regular checkups to see how this medicine affects you. Keep all appointments.
• This medicine may increase suicidal thoughts or actions in some people.
• If taken by a pregnant woman, this medicine may increase the risk that the baby will be born with a cleft lip or cleft palate. You must use effective birth control.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: appetite suppressant/antiseizure

Generic and brand names: phentermine/topiramate, oral; Qsymia

What is this medicine used for?

This medicine is taken by mouth to help obese adults or overweight adults who also have weight related health problems lose weight and keep the weight off. This medicine should be used with a reduced calorie diet and increased physical activity.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A stroke or transient ischemic attack (TIA)
• Diabetes
• Glaucoma
• Heart problems, fast or irregular heartbeat, or high blood pressure
• Kidney disease or kidney stones
• Liver disease
• Low levels of potassium in your blood
• Lung disease
• Mental health problems such as anxiety, bipolar disorder, or depression
• Metabolic acidosis (too much acid in the blood)
• Osteoporosis
• Problems with alcohol or drug abuse
• Seizures
• Thyroid problems

Do not take this medicine if you have taken MAO inhibitors within the past 2 weeks. Talk with your healthcare provider about this.

Females of childbearing age: Do not take this medicine if you are pregnant. This medicine has been reported to cause birth defects. You must have a negative pregnancy test before you start this medicine and every month while you are taking this medicine. Talk with your healthcare provider about effective forms of birth control while taking this medicine. Do not become pregnant during treatment with this medicine. Stop taking this medicine at the first sign that you may be pregnant and contact your healthcare provider right away. Do not breast-feed while you are taking this medicine.

How do I take it?

This medicine will be mailed to you from a certified pharmacy. It is not available through local pharmacies. Talk with your healthcare provider about this.

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not increase the dosage without your healthcare provider's approval. It may be habit-forming. If you take this medicine for a long time, do not stop taking this medicine without your healthcare provider's approval. You may have to reduce your dose gradually.

Check with your healthcare provider before using this medicine in children under age 18.

Take this medicine in the morning, with or without food. Swallow the capsules whole. Do not open, chew, or crush the capsules.

What if I miss a dose?

If you miss a dose, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: aggressiveness, blurred vision, confusion, diarrhea, dizziness, drowsiness, fainting, fast breathing, fever, hallucinations, irregular heartbeat, lightheadedness, loss of balance, nausea, panic, restlessness, seizures, stomach cramps, tremors, trouble talking, vomiting.

What should I watch out for?

You will need regular checkups to see how this medicine affects you. Keep all appointments. Follow your healthcare provider's advice about diet, eating habits, and exercise to maintain weight loss.

This medicine may increase suicidal thoughts or actions in some people. Call your healthcare provider right away if you have new or increased thoughts of suicide.

If taken by a pregnant woman, this medicine may increase the risk that the baby will be born with a cleft lip or cleft palate. You must use effective birth control. If you use hormonal birth control, you may have spotting while taking this medicine. Talk with your provider about birth control. Tell your provider if you have changes in your menstrual period while taking this medicine.

If you develop eye pain and blurred vision, contact your healthcare provider right away. If this condition is not treated properly, it can lead to vision loss.

This medicine may cause you to sweat less and get a fever that can be dangerous. Be careful when you exercise or are outside in hot weather.

Drink plenty of fluids while you are taking this medicine to help prevent kidney stones. Ask your healthcare provider about this.

This medicine may cause drowsiness, dizziness, confusion, or trouble concentrating. Do not drive or operate machinery until you are fully alert.

This medicine is a controlled substance. It is illegal for you to give it to anyone else.

If you have diabetes: This medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; severe rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Blurred vision or double vision; chest pain; confusion or memory problems; new or worsening depression or anxiety; thoughts of suicide; severe dizziness; severe drowsiness; eye pain; fainting; fast or irregular heartbeat; unusual tiredness; fever; hallucinations (seeing or hearing things that are not there); trouble talking; trouble urinating; painful urination; blood in the urine; severe stomach, back or side pain; yellowing of the eyes or skin; trouble walking; sudden or worsening breathing problems; unusual tiredness or weakness; swelling in the lower legs; decreased sweating; red, itchy or or peeling skin.

Other: changes in sexual ability or desire; constipation; diarrhea; mild dizziness; dry mouth; headache; irritability; itching; nausea; numbness or tingling in hands, arms, feet, or face; tremors; change in taste; trouble sleeping.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Alpha blockers such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), silodosin (Rapaflo), and terazosin
• Antianxiety medicines such as alprazolam (Xanax), chlordiazepoxide, clonazepam (Klonopin), clorazepate (Gen-Xene, Tranxene), diazepam (Valium), lorazepam (Ativan), and oxazepam
• Antidepressants such as amitriptyline, citalopram (Celexa), clomipramine, desipramine (Norpramin), desvenlafaxine (Pristiq), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), trazodone, and venlafaxine (Effexor)
• Antipsychotic medicines such as aripiprazole (Abilify), asenapine (Saphris), chlorpromazine, clozapine (Clozaril, FazaClo), fluphenazine, haloperidol (Haldol), iloperidone (Fanapt), olanzapine (Zyprexa), paliperidone (Invega), perphenazine, pimozide (Orap), prochlorperazine (Compro), quetiapine (Seroquel), risperidone (Risperdal), thioridazine, trifluoperazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenobarbital, phenytoin (Dilantin, Phenytek), primidone (Mysoline), topiramate (Qudexy, Topamax, Trokendi), valproic acid (Depacon, Depakene, Depakote), and zonisamide (Zonegran)
• Azelastine (Astelin, Astepro)
• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), bisoprolol (Zebeta), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), nebivolol (Bystolic), pindolol, and sotalol (Betapace, Sorine)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Caffeine in food, drinks, or medicines
• Calcium channel blockers such as amlodipine (Norvasc), amlodipine/atorvastatin (Caduet), diltiazem (Cardizem, Cartia, Tiazac), felodipine, isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), nisoldipine (Sular), and verapamil (Calan, Covera, Verelan)
• Carbonic anhydrase inhibitors such as acetazolamide (Diamox), dorzolamide (Cosopt, Trusopt), and methazolamide (Neptazane)
• Decongestants such as oxymetazoline (Afrin, Dristan), phenylephrine (Neo-Synephrine, Sudafed PE), and pseudoephedrine (Sudafed)
• Diabetes medicines such as glimepiride (Amaryl), glipizide (Glucotrol), glyburide (Glynase), insulin, metformin (Fortamet, Glucophage, Riomet), nateglinide (Starlix), pioglitazone (Actos), repaglinide (Prandin), and rosiglitazone (Avandia)
• Digoxin (Lanoxin)
• Diuretics (water pills) such as bumetanide, chlorothiazide (Diuril), chlorthalidone, furosemide (Lasix), hydrochlorothiazide (Microzide), and torsemide (Demadex)
• Doxepin (Silenor)
• Hormonal birth control implants, IUDs, patches, pills, shots, and vaginal rings (Talk to your healthcare provider if you need birth control.)
• Linezolid (Zyvox)
• Lithium (Lithobid)
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Medicines to treat breathing or lung problems such as albuterol (ProAir, Proventil, Ventolin), arformoterol (Brovana), fluticasone/salmeterol (Advair), fluticasone/vilanterol (Breo Ellipta), formoterol (Perforomist), metaproterenol, mometasone/formoterol (Dulera), salmeterol (Serevent), terbutaline (Brethine), theophylline, and umeclidinium/vilanterol (Anoro Ellipta)
• Mefloquine
• Memantine (Namenda)
• Milnacipran (Savella)
• Muscle relaxants such as baclofen (Gablofen, Lioresal), carisoprodol (Soma), cyclobenzaprine (Amrix), dantrolene (Dantrium), methocarbamol (Robaxin), and tizanidine (Zanaflex)
• Natural remedies such as evening primrose oil, gingko biloba, gotu kola, green tea, guarana, kava, St. John's wort, and valerian
• Pain medicines such as codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone/acetaminophen (Norco, Vicodin), hydromorphone (Dilaudid, Exalgo), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), oxycodone/acetaminophen (Percocet, Roxicet), tapentadol (Nucynta), and tramadol (ConZip, Ultram)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Procarbazine (Matulane)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Sleeping pills such as butabarbital (Butisol), flurazepam, pentobarbital (Nembutal), temazepam (Restoril), triazolam (Halcion), zaleplon (Sonata), and zolpidem (Ambien, Edluar, Intermezzo)
• Stimulants such as amphetamine/dextroamphetamine (Adderall), armodafinil (Nuvigil), atomoxetine (Strattera), dexmethylphenidate (Focalin), dextroamphetamine (Dexedrine), methamphetamine (Desoxyn), methylphenidate (Concerta, Daytrana, Metadate, Ritalin), and modafinil (Provigil)
• Thalidomide (Thalomid)

Do not drink alcohol while taking this medicine unless your healthcare provider approves.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.