Mesalamine Controlled-Release Capsules

Mesalamine Controlled-Release Capsules is used for:

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Treating and causing remission of various forms of mild to moderate ulcerative colitis (inflammation of the colon). Mesalamine Controlled-Release Capsules may also be used for other conditions as determined by your doctor.

Mesalamine Controlled-Release Capsules is a 5-aminosalicylic acid (5-ASA). It works by preventing the production of substances that cause the inflammation of the colon.

Do NOT use Mesalamine Controlled-Release Capsules if:

• you are allergic to any ingredient in Mesalamine Controlled-Release Capsules, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, naproxen), or salicylates (eg, aspirin)
• you are younger than 18 years of age and you have the flu or chicken pox
• you are taking probenecid or sulfinpyrazone

Contact your doctor or health care provider right away if any of these apply to you.

Before using Mesalamine Controlled-Release Capsules:

Some medical conditions may interact with Mesalamine Controlled-Release Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have had a stroke, bleeding in the brain, or an aneurysm
• if you have liver or kidney problems, Kawasaki syndrome, the flu, chicken pox, or a rheumatic (inflammatory) disease (eg, osteoarthritis)

Some MEDICINES MAY INTERACT with Mesalamine Controlled-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Carbonic anhydrase inhibitors (eg, acetazolamide) because they may decrease Mesalamine Controlled-Release Capsules's effectiveness
• Gingko biloba extract because side effects, such as increased bleeding, may occur
• Insulin, meglitinide antidiabetics (eg, repaglinide), sulfonylureas (eg, glipizide), or valproic acid because the risk of their side effects may be increased by Mesalamine Controlled-Release Capsules
• Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), anticoagulants (eg, warfarin), beta-blockers (eg, propranolol), probenecid, or sulfinpyrazone because their effectiveness may be decreased by Mesalamine Controlled-Release Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Mesalamine Controlled-Release Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Mesalamine Controlled-Release Capsules:

Use Mesalamine Controlled-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Mesalamine Controlled-Release Capsules by mouth with or without food. If stomach upset occurs, take with food or milk to reduce stomach irritation.
• Swallow Mesalamine Controlled-Release Capsules whole. Do not break, crush, or chew before swallowing.
• If you miss a dose of Mesalamine Controlled-Release Capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Mesalamine Controlled-Release Capsules.

Important safety information:

• Mesalamine Controlled-Release Capsules may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Mesalamine Controlled-Release Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Mesalamine Controlled-Release Capsules may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Mesalamine Controlled-Release Capsules. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
• Salicylates have been linked to a serious illness called Reye syndrome. Do not give Mesalamine Controlled-Release Capsules to a child or teenager who has the flu, chickenpox, or a viral infection. Contact your doctor with any questions or concerns.
• Mesalamine Controlled-Release Capsules should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Mesalamine Controlled-Release Capsules while you are pregnant. Mesalamine Controlled-Release Capsules is found in breast milk. If you are or will be breast-feeding while you use Mesalamine Controlled-Release Capsules, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Mesalamine Controlled-Release Capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Acne; back or joint pain; diarrhea; dizziness; gas; hair loss; headache; heartburn; increased sensitivity to sunlight; loss of appetite; mild abdominal discomfort or pain; nausea; runny or stuffy nose; sneezing.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody diarrhea; bloody or coffee ground-like vomit; fever, chills, or sore throat; severe cramping; severe headache; severe or sudden stomach pain.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http: / / www.aapcc.org / dnn / Resources / FindLocalPoisonCenters / tabid / 130 / Default.aspx), or emergency room immediately. Symptoms may include confusion; dehydration; diarrhea; dizziness; drowsiness; fever; headache; quick and short breathing; ringing in the ears; sweating; vomiting.

Store Mesalamine Controlled-Release Capsules at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Mesalamine Controlled-Release Capsules out of the reach of children and away from pets.

General information:

• If you have any questions about Mesalamine Controlled-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.
• Mesalamine Controlled-Release Capsules is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Mesalamine Controlled-Release Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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