Olsalazine, Oral

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KEY POINTS

• This medicine is taken by mouth to treat ulcerative colitis. Take it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: anti-inflammatory

Generic and brand names: olsalazine, oral; Dipentum

What is this medicine used for?

This medicine is taken by mouth to treat ulcerative colitis (a bowel disease), especially when you cannot tolerate other medicine.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Asthma or severe allergies
• Kidney or liver disease

Tell your healthcare provider if you have had the varicella (chickenpox) vaccine within the past 6 weeks.

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Check the label on the medicine for directions about your specific dose. Take it exactly as directed by your healthcare provider in evenly spaced doses every day. Do not take more of it or take it longer than prescribed. Do not stop taking this medicine without your healthcare provider's approval.

Check with your healthcare provider before using this medicine in children under age 18.

Take this medicine with food.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: slow movements, muscle weakness, nausea, vomiting, diarrhea, decreased urination.

What should I watch out for?

Report any changes in bowel movements, especially bloody diarrhea, to your healthcare provider.

You will need to have lab tests regularly to see how this medicine affects you. Keep all appointments for these tests.

This medicine may make you feel dizzy or lightheaded. Do not drive or operate machinery unless you are fully alert.

Do not get a varicella (chickenpox) vaccine within 6 weeks of taking this medicine.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Severe or bloody diarrhea, severe stomach pain, severe nausea or vomiting, unexplained fever or sore throat, unusual tiredness or weakness, yellowing of your skin or eyes, light-colored bowel movements, dark urine, chest pain, fast or irregular heartbeat, unusual bruising or bleeding.

Other: Headache, heartburn, mild nausea, stomach cramps, trouble sleeping, mild tiredness, dizziness, muscle or joint aches, loss of appetite, depression.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Aspirin and other salicylates
• Azathioprine (Azasan, Imuran)
• Cancer medicines such as mercaptopurine (Purinethol) and thioguanine (Tabloid)
• Digoxin (Lanoxin)
• Medicines to treat or prevent blood clots such as dalteparin (Fragmin), enoxaparin (Lovenox), heparin and warfarin (Coumadin)
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as diclofenac (Cambia, Voltaren, Zipsor), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Varicella (chickenpox) vaccine or varicella zoster (shingles) vaccine

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.