Mesalamine, 5-ASA rectal suspension

What is this medicine?

MESALAMINE (me SAL a meen) is used to treat the pain and inflammation caused by ulcerative colitis.

How should I use this medicine?

This medicine is for rectal use only. Do not take by mouth. Follow the directions on the prescription label. Wash your hands before and after use. Shake well before using. Lie on your left side, extend the left leg and pull the right leg up towards your chest or pull both knees toward the chest. Take off the applicator tip cover and place the applicator tip gently into the rectum. Pointing the tip toward your stomach, squeeze the bottle steadily. Stay in position for at least 30 minutes to allow the medication to spread inside. For best results, use this medicine before bedtime and after you have had a bowel movement. Try keeping the suspension in the rectum for 8 hours. Take your medicine at regular intervals. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• blood in the urine

• bloody diarrhea

• breathing problems

• chest pain

• pain in the lower back or side

• pain when urinating

• rash, fever, swollen lymph nodes

• signs and symptoms of infection like fever; chills; cough; sore throat; pain or trouble passing urine

• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin

• trouble passing urine or change in the amount of urine

• unusual bleeding or bruising

• unusual or severe stomach upset or pain

• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• gas

• headache

• mild hair loss

• nausea, vomiting

• rectal pain or discomfort

• stomach pain

What may interact with this medicine?

Interactions are not expected.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unopened, unused medicine after the expiration date.

Once the foil-wrapped unit of seven bottles is opened, any bottles remaining after 14 days should be thrown away. This medicine may darken after opening the foil pouch. Slight darkening is okay. However, any medicine with dark brown contents should be thrown away.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• kidney disease

• liver disease

• an unusual or allergic reaction to mesalamine, aspirin, sulfites, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Visit your health care professional for regular checks on your progress. Tell your health care professional if your symptoms do not start to get better or if they get worse. You may need blood work done while taking this medicine.

This medicine may stain clothing and other fabrics, flooring, painted surfaces, marble, granite, plastics, and enamel.

Ask how many glasses of fluid you need to drink a day. You must not get dehydrated.