Sevelamer HCL 400mg Tablets

IMPORTANT: 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.

SEVELAMER - ORAL

(seh-VELL-uh-mer)

COMMON BRAND NAME(S): Renagel, Renvela

USES: Sevelamer is used to lower high blood phosphorus (phosphate) levels in patients who are on dialysis due to severe kidney disease. Dialysis removes some phosphate from your blood, but it is difficult to remove enough to keep your phosphate levels balanced. Decreasing blood phosphate levels can help keep your bones strong, prevent unsafe buildup of minerals in your body, and possibly decrease the risk of heart disease and strokes that can result from high phosphate levels. Sevelamer works by holding onto phosphate from the diet so that it can pass out of your body.

HOW TO USE: Take this medication by mouth as directed by your doctor, usually 3 times daily with meals. Swallow the tablet whole. Do not crush, chew, or split the tablet. The dosage is based on your medical condition, any other medications you take to lower your phosphate levels, and your response to treatment. In children, the dosage is also based on body size. If you are taking the powder form of this medication, check the manufacturer package directions for mixing with water, beverage, or food and taking it within 30 minutes. Follow the directions for the proper amount of water to use for your dose. Stir the mixture well and drink all of it. If the powder settles to the bottom of the cup, stir again right before drinking. You may also mix the powder with a small amount of food or beverage to take as part of a meal. If mixing with food or beverage, do not heat the powder or add to heated foods or liquids. Take this medication regularly in order to get the most benefit from it. Remember to take it 3 times a day with meals, or on the schedule given to you by your doctor.

SIDE EFFECTS: Headache, diarrhea, stomach upset, nausea, vomiting, cough, gas, or constipation may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she 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: problems with your dialysis access site, severe constipation/inability to have a bowel movement, stomach/abdominal pain or swelling. Get medical help right away if you have any very serious side effects, including: trouble breathing, chest pain, pain/redness/swelling in the lower legs. 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.

PRECAUTIONS: Before taking sevelamer, tell your doctor or pharmacist if you are allergic to it; 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: low blood phosphorus levels, stomach/intestinal problems (such as blockage, constipation), stomach/intestinal surgeries, swallowing problems (dysphagia). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is unknown if this medication 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. Sevelamer may interfere with the effectiveness of some drugs (including ciprofloxacin, mycophenolate, thyroid medications such as levothyroxine, among others) by making it more difficult for them to be absorbed by the stomach. Ask your pharmacist about the best times to take your other medications.

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.

NOTES: Your doctor may direct you to follow a special diet to help lower your blood phosphate levels. Follow the diet closely. Do not share this medication with others. Laboratory and/or medical tests (such as blood phosphate, calcium, bicarbonate and chloride levels) should be performed regularly to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, skip the missed dose unless you have just eaten. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

STORAGE: 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.

Information last revised July 2018. Copyright(c) 2018 First Databank, Inc.