Olsalazine is used to treat ulcerative colitis in adults.

Olsalazine may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

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

Olsalazine is usually taken twice per day.

Always take this medicine with food.

Drink plenty of liquids while you are taking olsalazine to keep your kidneys working properly.

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

Call your doctor if your ulcerative colitis symptoms get worse, or if you also have a fever, headache, or rash.

Store olsalazine at room temperature away from moisture and heat.

Usual Adult Dose for Ulcerative Colitis -- Maintenance:

500 mg orally 2 times a day

Use: Maintenance of remission of ulcerative colitis in patients who are intolerant of sulfasalazine

You should not use olsalazine if you are allergic to olsalazine, balsalazide, mesalamine, or sulfasalazine, or to salicylates such as aspirin, Novasal, Doan's Extra Strength, Salflex, Tricosal, and others.

Your treatment with olsalazine may be delayed if you have received a chickenpox vaccine (varicella, Varivax) within the past 6 weeks.

Tell your doctor if you have ever had:

• liver disease;

• kidney disease; or

• a skin disorder such as eczema or atopic dermatitis.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

You should not breastfeed while using olsalazine.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

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

Overdose symptoms may include nausea, vomiting, stomach pain, diarrhea, rapid breathing, ringing in your ears, headache, dizziness, confusion, seizures.

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 and moisture (not in the bathroom).

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.

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

If you have eczema or other skin problems, olsalazine could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Stop using olsalazine and seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Olsalazine may cause serious side effects. Stop using olsalazine and call your doctor at once if you have:

• worsening colitis (fever, stomach pain, cramping, or bloody diarrhea).

Also call your doctor at once if you have:

• severe or ongoing diarrhea;

• chest pain, shortness of breath, fast or pounding heartbeats;

• low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed;

• liver problems--loss of appetite, stomach pain (upper right side), itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• kidney problems--swelling, urinating less, feeling short of breath; or

• signs of a kidney stone--pain in your side or lower back, blood in your urine, painful or difficult urination.

Common side effects of olsalazine may include:

• diarrhea, stomach pain; or

• rash, itching.

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.

Olsalazine 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;

• thioguanine; or

• a blood thinner--heparin, warfarin, Coumadin, Jantoven.

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

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your response to olsalazine. Before you have any laboratory tests, tell the laboratory personnel that you take olsalazine, as this medication may interfere with some laboratory tests.

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.