Uses

Mesalamine (also known as 5-aminosalicylic acid) is used to treat certain types of bowel disease (distal ulcerative colitis, proctosigmoiditis, proctitis). It does not cure these conditions, but it may relieve mild-to-moderate pain and decrease the frequency of diarrhea/bloody stools caused by irritation/swelling in the colon/rectum. Mesalamine is an aminosalicylate anti-inflammatory drug. It is believed to work by blocking the production of certain natural chemicals that may cause pain and swelling.

Other Uses

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used for Crohn's disease.

How To Use

Read the Patient Information Leaflet if available from your pharmacist before you start using mesalamine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Use this medication rectally as directed by your doctor, usually once daily at bedtime. The dosage is based on your medical condition and response to treatment.

Drink plenty of fluids during treatment with this medication unless otherwise directed by your doctor. This will help prevent kidney stones.

Visually inspect the contents of the bottle before use. The contents should be off-white to tan in color. A slight darkening of the medication is expected, but any enemas that turn dark brown should be discarded.

This medication works best if you have a bowel movement before using it. Shake the bottle well. Holding the bottle at the neck, remove the cover from the applicator tip. Lie on your left side with your right knee bent. Insert the tip of the bottle into the rectum, pointing toward the navel. Gently and steadily squeeze out the entire contents of the bottle. Remove the bottle. Remain in position for 30 minutes. Throw away the empty bottle. Try to keep the medication in the rectum for 8 hours.

This medication may stain surfaces that it touches (such as clothing, floor, and counter surfaces).

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time each day.

Tell your doctor if your condition lasts or gets worse.

Side Effects

Rectal pain, pain while inserting the bottle tip, gas, and joint/leg pain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Rarely, this medication may make symptoms of your condition worse rather than better (acute intolerance syndrome or sensitivity reaction). Tell your doctor right away if you experience any of these unlikely but serious side effects:

• worsening stomach pain/cramping
• worsening bloody diarrhea
• severe/prolonged headache

Tell your doctor right away if you have any serious side effects, including:

• chest pain
• shortness of breath
• severe stomach/abdominal pain (especially if spreading to the back)
• yellowing eyes/skin
• dark urine
• signs of kidney problems (such as change in the amount of urine, blood in the urine)

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• fever
• swollen lymph nodes
• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using mesalamine, tell your doctor or pharmacist if you are allergic to it; or to other aminosalicylates (such as balsalazide, olsalazine); or to salicylates (such as aspirin, salsalate); or to sulfasalazine; or if you have any other allergies. This product may contain inactive ingredients (such as sulfites), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• asthma
• kidney problems
• liver disease
• pancreas problems (pancreatitis)
• inflammation of the sac around the heart (pericarditis)

This medication may make you more sensitive to the sun, especially if you have skin problems (such as atopic dermatitis, eczema). Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication is similar to aspirin. Children and teenagers younger than 18 years should not take aspirin or aspirin-related medications (such as salicylates) if they have chickenpox, flu, or any undiagnosed illness, or if they have just been given a live virus vaccine (such as varicella vaccine), without first consulting a doctor about Reye's syndrome, a rare but serious illness.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medication may interfere with certain lab tests (such as urine normetanephrine levels), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

Overdose

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as liver/kidney function) may be done before you start using this medication and while you are using it. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Once the foil-wrapped unit of bottles is opened, use all enemas promptly as directed by your physician. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.