When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to mesalamine or salicylates (such as aspirin). Do not use the rectal suppository if you are allergic to saturated vegetable fat, such as shortening.

How to Use This Medicine:
Enema, Suppository

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Enema:
  
  • Use the enema at bedtime, unless your doctor tells you otherwise. Shake the bottle and then remove the cap.
  • Wash your hands with soap and water before and after using this medicine.
  • Lie on your left side with your left leg straight or slightly bent, and your right knee bent upward. Insert the applicator tip into your rectum about an inch. Gently squeeze the bottom of the bottle to release the enema.
  • Remove the bottle and throw it away.
  • You may need to hold the liquid in your rectum for several minutes or hours. This may be difficult or feel uncomfortable. It should become easier to do as you continue to use the medicine.
• Suppository:
  
  • Never take rectal suppositories by mouth.
  • Use this medicine at bedtime, unless your doctor tells you otherwise.
  • Before you insert a suppository, go to the bathroom and empty your bladder and, if possible, have a bowel movement.
  • This medicine will stain any surface it touches (such as clothing, bedsheets, floors, and countertops). To protect your clothing, consider wearing a sanitary napkin or adult undergarment such as Depend®. Protect your sheets by placing a waterproof pad on your bed.
  • Wash your hands with soap and water before and after using this medicine. Remove the foil or wrapper from the suppository before inserting it. Do not keep the suppository in your hand too long or it will begin to melt.
  • To make the suppository easier to insert, you may use a lubricating gel such as K-Y® Jelly, but do not use petroleum jelly (Vaseline®).
  • Lie on your left side with your left leg straight or slightly bent, and your right knee bent upward. Gently push the pointed end of the suppository into the rectum about 1 inch.
  • The medicine needs to remain in your body for 1 to 3 hours or longer. Try not to use the bathroom for at least that length of time after inserting the suppository.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• You may store the suppositories in the refrigerator, but do not freeze them. Store the enema at room temperature. Keep it away from heat, moisture, or direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how mesalamine works. Tell your doctor if you are also taking mesalamine by mouth, azathioprine, mercaptopurine, or an NSAID pain or arthritis medicine (such as aspirin, diclofenac, ibuprofen, naproxen).

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, or a history of heart disease (such as myocarditis or pericarditis). Tell your doctor if you have had an allergic reaction to sulfasalazine.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bloody diarrhea, severe cramping, stomach pain, possibly with fever, headache, rash
• Change in how much or how often you urinate
• Chest pain, trouble breathing
• Fast, slow, or pounding heartbeat

If you notice these less serious side effects, talk with your doctor:

• Mild headache or dizziness
• Mild stomach discomfort, nausea, diarrhea, gas

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088