Olsalazine

WHY is this medicine prescribed?

Olsalazine is used to treat ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum) in adults when another medication (sulfasalazine) could not be tolerated. Olsalazine is in a class of medications called anti-inflammatory agents. Olsalazine reduces the bowel inflammation, diarrhea (stool frequency), rectal bleeding, and abdominal pain.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Olsalazine comes as a capsule to take by mouth. It usually is taken twice a day after meals or with food. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take olsalazine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Drink plenty of fluids while taking olsalazine.

What SPECIAL PRECAUTIONS should I follow?

Before taking olsalazine,

• tell your doctor and pharmacist if you are allergic to olsalazine, balsalazide (Colazal); mesalamine (Apriso, Pentasa, others); sulfasalazine (Azulfidine); salicylate pain relievers such as aspirin, choline magnesium trisalicylate, diflunisal, magnesium salicylate (Doan's, others); any other medications; or any of the ingredients in olsalazine capsules. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• The following nonprescription or herbal products may interact with olsalazine: aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn). Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking olsalazine. Do not start any of these medications while taking olsalazine without discussing with your healthcare provider

• tell your doctor if you have or have ever had a skin condition such as eczema (atopic dermatitis; a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes), kidney stones, kidney or liver disease, or any other medical condition.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking olsalazine, call your doctor.

• plan to avoid unnecessary or prolonged exposure to the sunlight and to wear protective clothing, sunglasses, and sunscreen. Olsalazine may make your skin sensitive to sunlight.

• you should know that olsalazine should not be taken by people who have received the varicella virus (chicken pox) vaccine in the past six weeks because of the risk of Reye's syndrome (a serious condition in which fat builds up on the brain, liver, and other body organs).

• you should know that olsalazine 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, or rash.

What should I do IF I FORGET to take a dose?

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.

What SIDE EFFECTS can this medicine cause?

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

• stomach upset
• nausea
• bloating
• loss of appetite
• headache
• muscle or joint pain
• dizziness
• difficulty falling or staying asleep

If you experience any of the following symptoms, or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately or get emergency medical treatment:

• rash, hives, itching or peeling or blistering skin
• fever
• swelling of the eyes, face, lips, tongue, mouth, or throat
• difficulty breathing or swallowing
• new or worsening cough
• shortness of breath
• chest pain
• diarrhea
• unusual bleeding or bruising
• extreme tiredness
• yellowing of the skin or eyes
• pain in the right upper part of the stomach
• pale stools
• difficult or painful urination or cloudy, discolored, or bloody urine
• back pain

Olsalazine may cause your urine to become discolored, reddish-brown when it comes in contact with any surface or water (e.g., in the toilet). Call your doctor if your urine is discolored.

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

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of 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 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

What should I do in case of OVERDOSE?

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.

Symptoms of overdose may include the following:

• nausea, vomiting, and abdominal pain
• rapid or shallow breathing
• ringing in ears
• headache
• dizziness
• confusion
• seizures

What OTHER INFORMATION should I know?

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.