Rowasa Enema

Rowasa Enema is used for:

Treating mild to moderate inflammation of the colon or rectum.

Rowasa Enema is a 5-aminosalicylic acid (5-ASA). It works by preventing the production of substances that cause the inflammation of the colon.

Do NOT use Rowasa Enema if:

• you are allergic to any ingredient in Rowasa Enema, 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 chicken pox
• you are taking probenecid or sulfinpyrazone

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

Before using Rowasa Enema:

Some medical conditions may interact with Rowasa Enema. 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, foods, or other substances
• if you have had a stroke, bleeding in the brain, or an aneurysm
• if you have Kawasaki syndrome, the flu, chicken pox, or a rheumatic (inflammatory) disease (eg, osteoarthritis)

Some MEDICINES MAY INTERACT with Rowasa Enema. Tell your health care provider if you are taking any other medicines, especially any of the following:

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

This may not be a complete list of all interactions that may occur. Ask your health care provider if Rowasa Enema 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 Rowasa Enema:

Use Rowasa Enema as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Best results are achieved if the bowel is emptied immediately before using Rowasa Enema.
• Use Rowasa Enema at bedtime, unless otherwise directed by your doctor.
• Shake the bottle well. Remove the protective sheath from the applicator tip.
• Holding the bottle at the neck will not allow the medicine to be discharged. The position most often used is to lay on the left side, with the lower leg extended and the upper right leg flexed forward for balance. An alternative is the knee-chest position.
• Gently insert the applicator tip in the rectum, pointing toward the naval. Grasp the bottle firmly, then tilt slightly so that the nozzle is aimed toward the back. Squeeze slowly to instill the medicine. Steady hand pressure will discharge most of the medicine. After using, withdraw the bottle and throw it away.
• Remain in this position for at least 30 minutes after using Rowasa Enema to allow complete distribution of the medicine in the body. Stay in the same position all night if possible.
• Rowasa Enema will stain direct contact surfaces, including, fabrics, flooring, painted surfaces, marble, granite, vinyl, and enamel. Choose a suitable location when using of Rowasa Enema.
• If you miss a dose of Rowasa Enema and you are using 1 dose daily at bedtime, skip the missed dose. Do not use the dose in the morning. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Rowasa Enema.

Important safety information:

• Rowasa Enema may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Rowasa Enema with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Rowasa Enema may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Rowasa Enema. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
• Some of these products contain sulfites. Sulfites may cause an allergic reaction in some patients (eg, asthma patients). If you have ever had an allergic reaction to sulfites, ask your pharmacist if your product has sulfites in it.
• Salicylates have been linked to a serious illness called Reye syndrome. Do not give Rowasa Enema to a child or teenager who has the flu, chickenpox, or a viral infection. Contact your doctor with any questions or concerns.
• Rowasa Enema should be used with extreme caution in CHILDREN; safety and effectiveness in 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 Rowasa Enema while you are pregnant. Rowasa Enema is found in breast milk. If you are or will be breast-feeding while you use Rowasa Enema, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Rowasa Enema:

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:

Back or joint pain; bloating; flu-like symptoms; gas; hair loss; hemorrhoids; increased sensitivity to sunlight; mild headache; mild stomach discomfort or pain; nausea; rectal pain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody diarrhea; bloody or coffee ground-like vomit; cramps; fever, chills, or sore throat; severe headache; sudden or severe stomach pain.

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; dehydration; diarrhea; dizziness; drowsiness; fever; headache; quick and short breathing; ringing in the ears; sweating; vomiting.

Store Rowasa Enema between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. After the foil-wrapped unit of 7 bottles is opened, use all enemas promptly. The contents of the enemas may darken with time. Slight darkening will not affect the strength of Rowasa Enema. Throw away enemas with dark brown contents. Keep Rowasa Enema out of the reach of children and away from pets.

General information:

• If you have any questions about Rowasa Enema, please talk with your doctor, pharmacist, or other health care provider.
• Rowasa Enema is 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 Rowasa Enema. 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.

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