Uses of Sulfasalazine Tablets:

• It is used to treat ulcerative colitis.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Sulfasalazine Tablets?

• If you have an allergy to sulfasalazine or any other part of this medicine (sulfasalazine tablets).
• If you have a sulfa allergy.
• If you are allergic to this medicine (sulfasalazine tablets); any part of this medicine (sulfasalazine tablets); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Bowel block, porphyria, or trouble passing urine.

This is not a list of all drugs or health problems that interact with this medicine (sulfasalazine tablets).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (sulfasalazine tablets) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Sulfasalazine Tablets?

• Tell all of your health care providers that you take this medicine (sulfasalazine tablets). This includes your doctors, nurses, pharmacists, and dentists.
• If you have asthma, talk with your doctor. You may be more sensitive to this medicine (sulfasalazine tablets).
• Be careful if you have G6PD deficiency. Anemia may happen.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Have your urine checked as you have been told by your doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine (sulfasalazine tablets).
• This medicine may change the color of urine or skin to a yellow or orange color. This is not harmful.
• Very bad and sometimes deadly allergic reactions, infections, heart problems, kidney problems, liver problems, lung problems, and blood problems have happened with this medicine (sulfasalazine tablets). Nerve or muscle problems that have not gone away have also happened with this medicine (sulfasalazine tablets). Talk with the doctor.
• Some males have had sperm problems while taking this medicine (sulfasalazine tablets). This may affect being able to father a child. This may go back to normal after the drug is stopped. Talk with the doctor.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is this medicine (Sulfasalazine Tablets) best taken?

Use this medicine (sulfasalazine tablets) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take after meals.
• Keep taking this medicine (sulfasalazine tablets) as you have been told by your doctor or other health care provider, even if you feel well.
• Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Feeling very tired or weak.
• Pale skin.
• Any unexplained bruising or bleeding.
• Swollen gland.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

What are some other side effects of Sulfasalazine Tablets?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Stomach pain or heartburn.
• Upset stomach or throwing up.
• Not hungry.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Sulfasalazine Tablets?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine (sulfasalazine tablets), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.