Colesevelam Hydrochloride, Oral

________________________________________________________________________

KEY POINTS

• This medicine is taken by mouth, along with diet and exercise, to lower cholesterol levels or to help control blood sugar in adults with type 2 diabetes. Take it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• 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.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: bile acid sequestrant; cholesterol-lowering

Generic and brand names: colesevelam hydrochloride, oral; Welchol

What is this medicine used for?

This medicine is taken by mouth, along with diet and exercise, to:

• Lower cholesterol levels
• Help control blood sugar in adults with type 2 diabetes

It may be used alone or with other medicines.

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:

• An allergy to any medicine
• Constipation, hemorrhoids, or a blockage in the intestines
• High triglycerides
• Pancreatitis
• Phenylketonuria (some forms of this medicine contain phenylalanine.)
• Thyroid problems
• Trouble swallowing
• Type 1 diabetes
• Ulcers
• Vitamin A, D, E, or K deficiency

Also tell your healthcare provider if you have had major abdominal surgery.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not stop taking this medicine without your healthcare provider's approval. This medicine will work only when taken regularly.

Check with your healthcare provider before using this medicine in children under 10 years of age.

This medicine comes in tablet and powder forms. Take this medicine with meals. If you have the tablet form of this medicine, take it with a full glass of water. If you have trouble swallowing the tablet, you may be able to take the powder form instead. Talk with your healthcare provider about this.

If you have the powder form of medicine, carefully follow the directions for mixing it with liquid. Do not take this medicine in its dry form. One powder packet should be mixed in 4 to 8 ounces of water, fruit juice, or diet soda. Stir well and drink. Do not breathe in any of the powder form of this medicine.

Take other medicines at least 4 hours before taking this medicine. Talk with your provider about this.

Drink more liquid while you take this medicine to help prevent constipation. Talk to your healthcare provider about this.

What if I miss a dose?

If you miss a dose, take it with a meal as soon as you remember unless it is almost time for the next scheduled dose. In that case, 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: stomach pain, severe constipation, gas.

What should I watch out for?

This medicine may keep your body from absorbing certain vitamins and folic acid. Your healthcare provider may recommend that you take a vitamin supplement with folic acid.

This medicine is part of a complete program that includes diet and exercise. Follow the diet and exercise program your healthcare provider recommends.

You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

If you are taking this medicine for diabetes, test your blood sugar on the schedule your provider recommends and keep track of it. Low blood sugar can happen if you miss or delay meals, drink too much alcohol, take too much medicine, or exercise more than usual. Symptoms of low blood sugar include confusion, shaking, weakness, strong hunger, cold sweats, headache, nausea, vision problems, and feeling faint. Treat the condition quickly by eating or drinking something with sugar in it such as candy, juice, or nondiet soda. Taking glucose tablets or glucose gel (available in drug stores) is another quick way to treat hypoglycemia. If you have low blood sugar often, contact your healthcare provider to find out if you need a dosage adjustment.

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 reactions (hives, itching, rash, tightness in your chest, trouble breathing).

Serious (Report these to your healthcare provider right away.): Symptoms of low blood sugar (confusion, trouble concentrating, shaking, weakness, strong hunger, sweating, headache, nausea, vision problems, slurred speech, unusual tingling, and feeling faint); trouble swallowing; severe stomach pain; severe nausea and vomiting; severe constipation.

Other: Constipation, gas, heartburn, nausea, loss of appetite, muscle aches or pain, sore throat, runny nose.

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:

• Amiodarone (Cordarone, Pacerone)
• Antibiotics such as doxycycline (Doryx, Monodox, Vibramycin), minocycline (Dynacin, Minocin, Solodyn), penicillin, and tetracycline
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenobarbital, and phenytoin (Dilantin, Phenytek)
• Bexarotene (Targretin)
• Corticosteroids such as dexamethasone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), and prednisone (Prednisone Intensol)
• Diabetes medicines such as glimepiride (Amaryl), glipizide/metformin (Metaglip), glyburide (Glynase), linagliptin/metformin (Jentadueto), metformin (Fortamet, Glucophage, Riomet), pioglitazone/metformin (Actoplus Met), rosiglitazone/metformin (Avandamet), saxagliptin/metformin (Kombiglyze), and sitagliptin/metformin (Janumet)
• Diuretics (water pills) such as bumetanide, chlorthalidone, furosemide (Lasix), hydrochlorothiazide (Microzide), and torsemide (Demadex)
• Hormonal birth control implants, IUDs, patches, pills, shots, and vaginal rings, and estrogen hormones such as Cenestin, Estinyl, Estratab, FemPatch, and Premarin
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune) and mycophenolate (CellCept, Myfortic)
• Leflunomide (Arava)
• Methotrexate (Otrexup, Rasuvo, Rheumatrex, Trexall)
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as diclofenac (Cambia, Voltaren, Zipsor), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Olmesartan (Benicar)
• Other cholesterol-lowering medicines such as atorvastatin (Lipitor), ezetimibe (Zetia), lomitapide (Juxtapid), and pravastatin (Pravachol)
• Phosphate supplements
• Propranolol (Hemangeol, Inderal, InnoPran)
• Raloxifene (Evista)
• Retinoid medicines such as acitretin (Soriatane), isotretinoin (Absorica, Amnesteem, Claravis, Myorisan, Zenatane), and tretinoin (Atralin, Renova, Retin-A)
• Teriflunomide (Aubagio)
• Thyroid medicines such as levothyroxine (Levo-T, Levothroid, Levoxyl, Synthroid, Unithroid), liothyronine (Cytomel, Triostat), liotrix (Thyrolar), and thyroid USP (Armour Thyroid, Nature-Throid)
• Ursodiol (Actigall, Urso Forte)
• Vitamins A, D, E, and K
• Warfarin (Coumadin)

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.

---

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.