SIDE EFFECTS: See also Warning section. Stomach upset, nausea, diarrhea, or drowsiness 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: numbness/tingling of arms/legs, easy bleeding/bruising, unusual tiredness, unusual weight loss, signs of liver problems (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine). Rarely, heart-related problems or stroke have occurred in people taking lesinurad in combination with allopurinol. However, it is not known if these medications caused these problems. Get medical help right away if you have any of these very serious side effects, including: weakness on one side of the body, sudden vision changes, trouble speaking, confusion, chest/jaw/left arm pain, shortness of breath, unusual sweating. This medication can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash. 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: fever, swollen lymph nodes, 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.

HOW TO USE: See also Warning section. 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 food as directed by your doctor, usually once daily in the morning with a full glass of water (8 ounces/240 milliliters). Drink plenty of fluids (at least 8 full glasses a day) while taking this medication to help it work better, unless otherwise directed by your doctor. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. If you are switching from taking lesinurad or allopurinol to this combination product, be sure to stop taking the other lesinurad or allopurinol product to avoid taking too much medication(s) and increasing the risk of side effects. You may have more gout attacks for several months after you start taking this medicine while your body gets rid of extra uric acid. Do not stop taking this medication if you have a gout flare/attack. This medication is not for treating gout attacks. Your doctor may prescribe other medication (including colchicine, NSAIDs such as ibuprofen, naproxen, or indomethacin) to prevent or treat a gout attack while you are taking this medication. Continue to take lesinurad/allopurinol and your prescribed medicines for gout attacks as directed by your doctor. Tell your doctor if your condition does not get better or if it gets worse.

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to lesinurad or allopurinol; or if you have any other allergies. This product may contain inactive ingredients, 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: kidney disease, liver problems, cancer treatment, a certain inherited disease (Lesch-Nyhan syndrome). This drug may make you drowsy. Alcohol or marijuana (cannabis) can make you more drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if lesinurad passes into breast milk. Allopurinol passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: 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. Some products that may interact with this drug are: capecitabine, didanosine, valproic acid, "blood thinners" (such as warfarin, dicoumarol). This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use reliable backup birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well. Aspirin can decrease the effects of this medication. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually 81-162 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

OVERDOSE: 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 their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.