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mesalamine (5-aminosalicylic acid) delayed-release tablet - oral, Asacol (cont.)

HOW TO USE: Take this medication by mouth with or without food, usually 3 times daily or as directed by your doctor. Dosage is based on your medical condition and response to treatment. Different brands of this medication deliver different amounts of medication. Do not switch brands without your doctor's permission and directions.Swallow this medication whole. Do not crush, chew, or break the tablets. Doing so can keep the drug from being released properly into the colon.Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day.Tell your doctor if your condition persists or worsens.

SIDE EFFECTS: Flu-like symptoms, vomiting, nausea, dizziness, weakness, headache, constipation, abdominal/back pain, upset stomach, diarrhea, or gas may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.You may sometimes see whole or partial tablets in your stool. If this occurs frequently, tell your doctor. You may not be absorbing enough of the medication.Remember that your doctor has prescribed this medication because the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Infrequently, this medication may make your symptoms worse rather than better (acute intolerance syndrome or sensitivity reaction). Tell your doctor immediately if you experience any of these unlikely but serious side effects: worsening stomach pain/cramping, worsening bloody diarrhea, fever, headache.Tell your doctor immediately if any of these unlikely but serious side effects occur: tingling hands/feet, painful straining during a bowel movement.Tell your doctor immediately if any of these rare but very serious side effects occur: dark urine, persistent nausea/vomiting, severe stomach/abdominal pain, yellowing eyes/skin, signs of infection (e.g., fever with persistent sore throat), easy bruising/bleeding, chest pain, shortness of breath, change in the amount of urine.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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.



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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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