Rowasa (Mesalamine)

(me sal' a meen)

Mesalamine is used to treat ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum) and also to maintain improvement of ulcerative colitis symptoms. Mesalamine is in a class of medications called anti-inflammatory agents. It works by stopping the body from producing a certain substance that may cause inflammation.

Mesalamine comes as a delayed-release (releases the medication in the intestine where its effects are needed) tablet, a delayed-release (releases the medication in the intestine where its effects are needed) capsule, a controlled-release (releases the medication throughout the digestive system) capsule, and as an extended-release (long-acting) capsule to take by mouth. Your doctor will tell you how often to take your medication, depending on your condition and how well your symptoms are controlled. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take mesalamine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Swallow the delayed-release tablets and delayed-release capsules whole; do not split, chew, or crush them. Be careful not to break the protective coating on the delayed-release tablets. Continue to take mesalamine until you finish your prescription, even if you feel better at the beginning of your treatment. Do not stop taking mesalamine without talking to your doctor.

Before taking mesalamine,
• tell your doctor and pharmacist if you are allergic to mesalamine, balsalazide (Colazal, Giazo); olsalazine (Dipentum); salicylate pain relievers such as aspirin, choline magnesium trisalicylate, diflunisal, magnesium salicylate (Doan's, others); sulfasalazine (Azulfidine), any other medications, or any of the ingredients found in mesalamine. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antacids such as aluminum hydroxide and magnesium hydroxide (Maalox), calcium carbonate (Tums), or calcium carbonate and magnesium (Rolaids); aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); azathioprine (Azasan, Imuran); or mercaptopurine (Purinethol). Your doctor may need to change the doses of your medications or monitor you more carefully for side effects.
• tell your doctor if you have or have ever had myocarditis (swelling of the heart muscle), pericarditis (swelling of the sac around the heart), or liver or kidney disease. If you will be taking the delayed-release tablets or capsules, tell your doctor if you have or have ever had a gastrointestinal obstruction (a blockage in your stomach or intestine).
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking mesalamine, call your doctor.
• you should know that mesalamine may cause a serious reaction. Many of the symptoms of this reaction are similar to the symptoms of ulcerative colitis, so it may be difficult to tell if you are experiencing a reaction to the medication or a flare (episode of symptoms) of your disease. Call your doctor if you experience some or all of the following symptoms: stomach pain or cramping, bloody diarrhea, fever, headache, weakness, or rash.
• if you have phenylketonuria (PKU, an inherited condition in which a special diet must be followed to prevent mental retardation), you should know that the extended release capsules contains aspartame that forms phenylalanine.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Mesalamine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• muscle or joint pain, aching, tightness or stiffness
• back pain
• nausea
• vomiting
• heartburn
• burping
• constipation
• gas
• dry mouth
• itching
• dizziness
• sweating
• acne
• slight hair loss
• decreased appetite

Some side effects can be serious. If you experience any of the following symptoms or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately:

• chest pain
• shortness of breath
• black or tarry stools
• bloody vomit
• vomiting material that looks like coffee grounds
• swelling of any part of the body

Mesalamine may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat, light, and moisture (not in the bathroom). It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

If you are taking mesalamine delayed-release tablets, you may notice the tablet shell or part of the tablet shell in your stool. Tell your doctor if this happens frequently. Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests before and during your treatment. Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking mesalamine. Do not let anyone else take your medicine. Ask your pharmacist any questions you have about refilling your prescription. It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.