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|Asacol Delayed-Release Tablets

Asacol Delayed-Release Tablets

Asacol Delayed-Release Tablets is used for:

Treating and causing remission of various forms of mild to moderate ulcerative colitis (inflammation of the colon). Asacol Delayed-Release Tablets may also be used to treat other conditions as determined by your doctor.

Asacol 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 Asacol Delayed-Release Tablets if:

• you are allergic to any ingredient in Asacol 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 Asacol Delayed-Release Tablets:

Some medical conditions may interact with Asacol 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 Asacol 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 the effectiveness of Asacol Delayed-Release Tablets may be decreased
• 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 actions and side effects of these medicines may be increased
• Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), anticoagulants (eg, warfarin), beta-blockers (eg, propranolol), probenecid, or sulfinpyrazone because the effectiveness of these medicines may be decreased

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

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

• Asacol Delayed-Release Tablets may be taken with or without food. If stomach upset occurs, take with food or milk.
• Swallow whole. Do not break, crush, or chew tablets.
• Continue to use Asacol Delayed-Release Tablets even if you feel well. Do not miss any doses.
• If a dose is missed, 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 Asacol Delayed-Release Tablets.

Important safety information:

• Asacol Delayed-Release Tablets may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Asacol Delayed-Release Tablets. Using Asacol Delayed-Release Tablets alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
• Asacol Delayed-Release Tablets may cause increased sensitivity to sunlight. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Asacol Delayed-Release Tablets. Use sunscreen or protective clothing if you must be outside for a prolonged period.
• Intact or partially intact tablets may be seen in the stool. If this occurs repeatedly, contact your doctor.
• Asacol Delayed-Release Tablets contains aspirin, which has been linked to Reye syndrome. Do not give Asacol Delayed-Release Tablets to children or teenagers during or after chickenpox, flu, or other viral infections without checking with your doctor or pharmacist.
• LAB TESTS, including kidney function and complete blood cell counts, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Use Asacol Delayed-Release Tablets with caution in the ELDERLY because they may be more sensitive to its effects, especially blood problems.
• Use Asacol Delayed-Release Tablets with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Asacol Delayed-Release Tablets during pregnancy. Asacol Delayed-Release Tablets is excreted in breast milk. If you are or will be breast-feeding while using Asacol Delayed-Release Tablets, contact your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Asacol 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; 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 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/findyour.htm), 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 Asacol 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 Asacol Delayed-Release Tablets out of the reach of children and away from pets.

General information:

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