Lesinurad; Allopurinol oral tablets

What is this medication?

LESINURAD (le SIN ure ad) and ALLOPURINOL (al oh PURE i nole) work together to reduce the amount of uric acid in the body. They are used together in patients with gout, when allopurinol alone has not worked well enough.

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

COMMON BRAND NAME(S): DUZALLO

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

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

• an inherited condition that causes too much uric acid in the blood (Lesch-Nyhan syndrome)
• cancer
• dehydration
• have received a kidney transplant
• kidney disease
• liver disease
• on dialysis
• an unusual or allergic reaction to lesinurad, allopurinol, 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. Take this medicine with food. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

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 pediatrician regarding the use of this medicine in children. Special care may be needed.

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 your dose in the morning, do not take it later in the day. Wait and take your next dose the following morning. Do not take double or extra doses.

What may interact with this medication?

Do not take this medicine with the following medication:

• didanosine, ddI

This medicine may also interact with the following medications:

• aspirin
• certain antibiotics like amoxicillin, ampicillin, and rifampin
• certain medicines for blood pressure, heart disease, irregular heart beat like amiodarone, amlodipine
• certain medicines for cancer
• certain medicines for cholesterol like atorvastatin
• certain medicines for fungal infections, like fluconazole
• certain medicines for immunosuppression like azathioprine, cyclosporine, mercaptopurine
• certain medicines for seizures like carbamazepine, valproic acid
• certain medicines that treat or prevent blood clots like warfarin
• chlorpropamide
• female hormones, like estrogens and progestins and birth control pills, patches, rings, or injections
• sildenafil
• thiazide diuretics, like hydrochlorothiazide

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?

Tell your doctor or healthcare provider if your symptoms do not start to get better or if they get worse. Your gout may get worse (flare up) when you first start this medicine. Do not stop taking this medicine even if you have a flare. Your doctor or healthcare provider may give you other medicines to help prevent your gout flares.

This medicine may cause serious skin reactions. They can happen weeks to months after starting the medicine. Contact your healthcare 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.

Drink 2 liters (68 ounces) of fluid each day to stay hydrated. Check with your doctor or healthcare provider if you get an attack of severe diarrhea, nausea and vomiting, or if you sweat a lot.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this drug 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 can make you more drowsy and dizzy. Alcohol can also increase the chance of stomach problems and increase the amount of uric acid in your blood. Avoid alcoholic drinks.

You may need blood work done while you are taking this medicine.

Birth control pills, injections, patches, or implants may not work properly while you are taking this medicine. Talk to your doctor about using an extra method of birth control.

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
• breathing problems
• joint pain
• muscle pain
• rash, fever, and swollen lymph nodes
• redness, blistering, peeling, or loosening of the skin, including inside the mouth
• signs and symptoms of a heart attack like breathing problems; chest pain or discomfort; feeling faint or lightheaded, falls; nausea, vomiting; back or jaw pain
• signs and symptoms of infection like fever or chills; cough; sore throat
• signs and symptoms of kidney injury like trouble passing urine or change in the amount of urine, flank pain
• 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
• tingling, numbness in the hands or feet
• unusual bleeding or bruising
• unusually weak or tired

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

• changes in taste
• diarrhea
• drowsiness
• general ill feeling or flu-like symptoms
• headache
• nausea, vomiting
• upset stomach

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.

Store between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

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.