Apriso Extended-Release Capsules

Generic Name: Mesalamine (me-SAL-a-meen)Brand Name: Apriso

Apriso Extended-Release Capsules are used for:

Maintaining remission of ulcerative colitis (inflammation of the colon). It may also be used for other conditions as determined by your doctor.

Apriso Extended-Release Capsules are a 5-aminosalicylic acid (5-ASA). It works by preventing the production of substances that cause inflammation of the colon.

Do NOT use Apriso Extended-Release Capsules if:

  • you are allergic to any ingredient in Apriso Extended-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 chickenpox or you have received a live vaccine (eg, varicella, influenza) within the past 6 weeks
  • you are taking probenecid or sulfinpyrazone

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

Before using Apriso Extended-Release Capsules:

Some medical conditions may interact with Apriso Extended-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 (eg, sulfasalazine, aspirin), foods, or other substances
  • if you have had a stroke, bleeding in the brain, or an aneurysm
  • if you have a history of liver or kidney problems, certain stomach problems (pyloric stenosis), pancreas problems (eg, pancreatitis), Kawasaki syndrome, or a rheumatic (inflammatory) disease (eg, rheumatoid arthritis)
  • if you have a history of heart problems (eg, inflammation of the sac around your heart)
  • if you have the flu or chickenpox or if you have recently received a live vaccine (eg, varicella, influenza)

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

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

This may not be a complete list of all interactions that may occur. Ask your health care provider if Apriso Extended-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 Apriso Extended-Release Capsules:

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

  • Take Apriso Extended-Release Capsules by mouth with or without food. If stomach upset occurs, take with food or milk to reduce stomach irritation.
  • Swallow Apriso Extended-Release Capsules whole. Do not break, crush, or chew before swallowing.
  • Do not take an antacid within 1 hour before or 2 hours after you take Apriso Extended-Release Capsules.
  • If you miss a dose of Apriso Extended-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 Apriso Extended-Release Capsules.

Important safety information:

  • Apriso Extended-Release Capsules may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Apriso Extended-Release Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • This product contains phenylalanine. If you must have a diet that is low in phenylalanine, contact your doctor.
  • Apriso Extended-Release Capsules may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Apriso Extended-Release Capsules. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
  • Some patients may experience an intolerance reaction to Apriso Extended-Release Capsules. Signs of intolerance are very similar to symptoms of inflammatory bowel disease. They may include severe or persistent stomach pain or cramping, bloody diarrhea, fever, headache or rash. If you experience any of these symptoms, contact your doctor right away.
  • Salicylates have been linked to a serious illness called Reye syndrome. Do not give Apriso Extended-Release Capsules 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, liver function, or complete blood cell counts, may be performed while you use Apriso Extended-Release Capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Apriso Extended-Release Capsules with caution in the ELDERLY; they may be more sensitive to its effects.
  • Apriso Extended-Release Capsules should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these 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 Apriso Extended-Release Capsules while you are pregnant. Apriso Extended-Release Capsules are found in breast milk. If you are or will be breast-feeding while you use Apriso Extended-Release Capsules, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Apriso Extended-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:

Diarrhea; headache; mild abdominal discomfort or pain; nausea; runny or stuffy nose.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; bloody diarrhea; bloody or coffee ground-like vomit; change in amount of urine; chest pain; dark urine; fever, chills, or persistent sore throat; severe or persistent headache; severe or sudden stomach pain or cramping; sudden 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; diarrhea; dizziness; drowsiness; fast or difficult breathing; fever; headache; hearing loss; ringing in the ears; seizures; sweating; vomiting of blood; weakness.

Proper storage of Apriso Extended-Release Capsules:

Store Apriso Extended-Release Capsules at room temperature, between 68 to 77 degrees F (20 to 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Apriso Extended-Release Capsules out of the reach of children and away from pets.

General information:

  • If you have any questions about Apriso Extended-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.
  • Apriso Extended-Release Capsules are 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 Apriso Extended-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.