SfRowasa (rectal)

sfRowasa is used to treat ulcerative colitis, proctitis, and proctosigmoiditis in adults.

sfRowasa may also be used for other reasons not mentioned in this medication guide.

Call your doctor right away if you have severe stomach pain, cramping, and bloody diarrhea (this may happen with fever, headache, and skin rash).

You should not use sfRowasa if you are allergic to sfRowasa, aspirin, sulfasalazine, or salicylates (such as Disalcid, Doans Pills, Dolobid, Kaopectate, Nuprin Backache, Pepto-Bismol, Tricosal, Trilisate, and others).

Tell your doctor if you have ever had:

• a skin condition such as eczema;
• a kidney stone or kidney disease;
• asthma or sulfite allergy; or
• liver disease.

If you are breastfeeding, tell your doctor if you see diarrhea in the nursing baby.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

SfRowasa may cause serious side effects. Stop using sfRowasa and call your doctor right away if you have:

• severe stomach pain, cramping, bloody diarrhea;
• fever, headache, general ill feeling;
• rash, itching, eye redness;
• low white blood cell counts--fever, chills, mouth sores, skin sores, sore throat, cough, feeling light-headed, trouble breathing;
• signs of a kidney stone--severe pain in your side and back, frequent need to urinate, foul-smelling urine, dark or cloudy urine; or
• kidney problems--increased or decreased urination, swelling, weight gain.

Low white blood cell counts may be more likely in older adults.

Common side effects of sfRowasa may include:

• fever;
• dizziness;
• rectal pain, colitis;
• rash; or
• acne.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Do not take a rectal suppository or enema by mouth. Use it only in your rectum.

For best results, use sfRowasa at bedtime. Try to empty your bowel and bladder before using rectal medicine. Read and carefully follow any Instructions for Use provided with your medicine.

Wash your hands before and after using rectal medicine.

Remove the wrapper before inserting the suppository. Avoid handling the suppository too long or it will melt. Lie on your back with your knees up toward your chest. Gently insert the suppository into your rectum about 1 inch, pointed tip first.

Stay lying down for a few minutes while the suppository melts. You should feel little or no discomfort. Avoid using the bathroom for 1 to 3 hours or longer, if possible.

Shake the rectal enema liquid well just before each use.

Drink plenty of liquids while you are using sfRowasa.

To use the enema, lie on your left side with your left leg extended and your right leg slightly bent. Remove the cap from the applicator tip and gently insert the tip into your rectum. Slowly squeeze the bottle to empty the contents into the rectum.

After using the enema, lie down on your left side for at least 30 minutes to allow the liquid to distribute throughout your intestines. Avoid using the bathroom, and hold in the enema at least 8 hours, or all night, if possible.

Drink plenty of water each day.

It may take up to 3 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

You may need frequent blood tests to check your blood cells or kidney function.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using sfRowasa.

Store at cool room temperature away from moisture and heat.

The enema liquid may darken in color after it has been removed from the foil pouch. This should not affect the medicine. However, throw away any enema liquid that has turned dark brown.

Skip the missed dose and wait until your next bedtime to take the medicine. Do not use two doses at one time.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222.

Avoid getting sfRowasa on clothing, flooring, painted surfaces, vinyl, marble, granite, and other surfaces. sfRowasa products may stain surfaces.

If you have a skin condition like eczema, sfRowasa could make you more likely to get sunburned. Stay out of sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outside.

sfRowasa can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis, organ transplant rejection, bowel disorders, high blood pressure, or pain or arthritis (including Advil, Motrin, and Aleve).

Tell your doctor about all your other medicines, especially:

• azathioprine or 6-mercaptopurine; or

This list is not complete. Other drugs may affect sfRowasa, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.