"The U.S. Food and Drug Administration today approved a new use for Simponi (golimumab) injection to treat adults with moderate to severe ulcerative colitis.
Simponi works by blocking tumor necrosis factor (TNF), which plays an important"...
Apriso Consumer (continued)
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Infrequently, mesalamine can worsen ulcerative colitis. Tell your doctor right away if your symptoms worsen after starting this medication (such as increased abdominal pain/cramping, bloody diarrhea, fever).
Tell your doctor right away if you have any serious side effects, including: change in the amount of urine, dark urine, persistent nausea/vomiting, severe stomach/abdominal pain, yellowing eyes/skin, chest pain, shortness of breath.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Apriso (mesalamine extended-release capsules) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking mesalamine, tell your doctor or pharmacist if you are allergic to it; or to other aminosalicylates (such as balsalazide, olsalazine); or to salicylates (such as aspirin, salsalate); or to sulfasalazine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, stomach blockage (such as pyloric stenosis).
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
This medication may contain aspartame. If you have phenylketonuria (PKU) or any other condition that requires you to limit/avoid aspartame (or phenylalanine) in your diet, ask your doctor or pharmacist about using this medication safely.
This medication is similar to aspirin. Children and teenagers should not take aspirin or aspirin-related medications (such as salicylates) if they have chickenpox, flu, or any undiagnosed illness, or if they have recently received a vaccine. In these cases, taking aspirin increases the risk of Reye's syndrome, a rare but serious illness.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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