Mesalamine Delayed-Release Tablets

Mesalamine Delayed-Release Tablets 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 Delayed-Release Tablets may also be used for other conditions as determined by your doctor.

Mesalamine Delayed-Release Tablets 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 Delayed-Release Tablets if:

• you are allergic to any ingredient in Mesalamine Delayed-Release Tablets, 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 chickenpox
• 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 Delayed-Release Tablets:

Some medical conditions may interact with Mesalamine Delayed-Release Tablets. 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, certain stomach problems (pyloric stenosis), Kawasaki syndrome, the flu, chickenpox, or a rheumatic (inflammatory) disease (eg, rheumatoid arthritis)

Some MEDICINES MAY INTERACT with Mesalamine Delayed-Release Tablets. 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 Delayed-Release Tablets'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 Delayed-Release Tablets
• 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 Delayed-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Mesalamine Delayed-Release Tablets 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 Delayed-Release Tablets:

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

• Take Mesalamine Delayed-Release Tablets by mouth with or without food. If stomach upset occurs, take with food or milk to reduce stomach irritation.
• Swallow Mesalamine Delayed-Release Tablets whole. Do not break, crush, or chew before swallowing.
• Continue to take Mesalamine Delayed-Release Tablets even if you feel well. Do not miss any doses.
• If you miss a dose of Mesalamine Delayed-Release Tablets, 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 Delayed-Release Tablets.

Important safety information:

• Mesalamine Delayed-Release Tablets may cause dizziness. This effects may be worse if you take it with alcohol or certain medicines. Use Mesalamine Delayed-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Mesalamine Delayed-Release Tablets may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Mesalamine Delayed-Release Tablets. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
• You may notice undissolved parts of Mesalamine Delayed-Release Tablets in your stool with some brands of Mesalamine Delayed-Release Tablets. If this occurs repeatedly, contact your doctor.
• Salicylates have been linked to a serious illness called Reye syndrome. Do not give Mesalamine Delayed-Release Tablets to a child or teenager who has the flu, chickenpox, or a viral infection. Contact your doctor with any questions or concerns.
• Lab tests, including kidney function and complete blood cell counts, may be performed while you use Mesalamine Delayed-Release Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Mesalamine Delayed-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially blood problems.
• Mesalamine Delayed-Release Tablets 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 Delayed-Release Tablets while you are pregnant. Mesalamine Delayed-Release Tablets is found in breast milk. If you are or will be breast-feeding while you use Mesalamine Delayed-Release Tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Mesalamine Delayed-Release Tablets:

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; constipation; diarrhea; dizziness; gas; general feeling of being unwell; hair loss; headache; heartburn; increased sensitivity to sunlight; loss of appetite; mild abdominal discomfort or pain; nausea; runny or stuffy nose; sneezing; vomiting.

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; dark urine; decreased or increased urination; eye redness or discharge; fever, chills, or sore throat; mental or mood changes; severe cramping; severe headache; severe or sudden stomach pain; shortness of breath; unusual bruising or bleeding; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects 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), 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 Delayed-Release Tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Mesalamine Delayed-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Mesalamine Delayed-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
• Mesalamine Delayed-Release Tablets 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 Delayed-Release Tablets. 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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