Lesinurad; Allopurinol oral tablets

What is this medicine?

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.

How should I use this medicine?

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.

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

What side effects may I notice from receiving this medicine?

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

• fever with rash, swollen lymph nodes, or swelling of the face

• joint pain

• muscle pain

• 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

What may interact with this medicine?

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

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.

Where should I keep my medicine?

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.

What should I tell my health care provider before I take this medicine?

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

What should I watch for while using this medicine?

Tell your doctor or health care professional 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 health care professional may give you other medicines to help prevent your gout flares.

Drink 2 liters (68 ounces) of fluid each day to stay hydrated. Check with your doctor or health care professional 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.