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I WILL understand Safety Information

Understanding Safety Information

Potential benefits and safety information

Whether you and your doctor are considering Lialda, or if you are already taking it, it is essential to learn about the potential benefits and safety information. If you’re taking Lialda and you have concerns or experience any side effects, be sure to talk to your doctor. There are a few important things you should be aware of before taking Lialda.

On this page, you’ll learn some important information to discuss with your doctor — and things to look for — before and during Lialda therapy.

For starters, here are 2 things you should always remember to do:

  1. Understand that Lialda has both potential benefits and side effects.
  2. Ask your doctor about what Lialda does, if it’s right for you, how it may help, and what kind of side effects may occur. (These questions (PDF) may help you have a more useful conversation.)

Please read the Important Safety Information. If you’re already taking Lialda, be sure to talk to your doctor if you have any questions or experience any side effects.

Use the links below to skip to the information you're looking for.

Before Starting

Lialda is a 5-aminosalicylic acid (or mesalamine, as it's also known), and it may be an appropriate option to help achieve remission of active, mild to moderate ulcerative colitis and to maintain ulcerative colitis (UC) remission.

What should I tell my doctor before taking Lialda (mesalamine)?

It’s important to tell the doctor if you:

  • Are allergic to any of the following:
    • Salicylates, such as aspirin, or other medications that contain aspirin
    • Aminosalicylates
    • Mesalamine or any of the ingredients in Lialda
    • Sulfasalazine
  • Have or have had any of the following conditions:
    • Kidney problems
    • Heart-related allergic reactions, such as inflammation of the heart muscle (myocarditis) or the lining of the heart (pericarditis)
    • Liver problems
    • Stomach blockage
  • Are pregnant, plan to become pregnant, or are breastfeeding

Tell the doctor about all of the medication you take, including prescription and non-prescription medication, vitamins, and herbal supplements. Especially let your doctor know if you are taking:

  • Non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or naproxen
  • Azathioprine or 6-mercaptopurine

What are the possible side effects of Lialda?

Lialda may cause serious side effects, including:

  • Kidney problems
  • A condition that may be hard to tell apart from a UC flare. Call your doctor right away if you experience any of the following symptoms: cramping, stomach ache, bloody diarrhea, fever, headache, and rash
  • Heart-related allergic reactions, such as inflammation of the heart muscle (myocarditis) or the lining of the heart (pericarditis)
  • Liver problems

The most common side effects reported in clinical studies of Lialda were:

  • Ulcerative colitis
  • Headache
  • Passing gas
  • Abnormal liver function test results
  • Stomach ache

In clinical studies of Lialda, inflammation of the pancreas also occurred. If this happens to you, your doctor may tell you to stop taking Lialda.

Other side effects may occur.

How should I take Lialda?

  • Take Lialda exactly as directed by the doctor
  • Take Lialda with food
  • Swallow Lialda tablets whole. Crushing or splitting the tablets could prevent Lialda from working properly

Taking Lialda

If you have been prescribed Lialda, taking it as your doctor directs is important when it comes to helping to get your active, mild to moderate UC into remission as shown in two 8-week clinical trials — and helping to keep it there, as shown in a 6-month study.

Here are a few things to know if you’ve started taking Lialda:

Once-daily dose
Depending on your condition, the recommended dose may be:

  • 2 or 4 tablets once a day with food to help achieve remission of active, mild to moderate UC
  • 2 tablets once a day with food to help maintain remission of UC

Take Lialda as prescribed by your doctor.

Be sure to tell the doctor about all of the medication you take, including:

  • Prescription and non-prescription medication, vitamins, and herbal supplements
  • Non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or naproxen
  • Azathioprine or 6-mercaptopurine

Lialda may cause serious side effects including:

  • Kidney problems
  • A condition that may be hard to tell apart from a UC flare. Call your doctor right away if you experience any of the following symptoms: cramping, stomach ache, bloody diarrhea, fever, headache, and rash.
  • Heart-related allergic reactions, such as inflammation of the heart muscle (myocarditis) or the lining of the heart (pericarditis)
  • Liver problems

Potential side effects to look out for
While taking Lialda, tell your doctor if you experience any side effects. In clinical trials, side effects with Lialda included:

  • Ulcerative colitis
  • Headache
  • Passing gas
  • Abnormal liver function test results
  • Stomach ache

In clinical studies of Lialda, inflammation of the pancreas also occurred. If this happens to you, your doctor may tell you to stop taking Lialda.

Other side effects may occur with Lialda.

Medications that contain mesalamine, such as Lialda, have been associated with a condition that may be hard to tell apart from a UC flare. Call your doctor right away if you experience any of the following symptoms: cramping, stomach ache, bloody diarrhea, fever, headache, and rash.

Potential benefits of taking Lialda
In 8-week clinical trials, patients with active, mild to moderate UC who took Lialda and achieved remission experienced the following:

  • No rectal bleeding
  • Less frequent bowel movements
  • Improvement to the inside lining of the colon

Lialda was not effective for everyone.

Please see additional Important Safety Information below and the Full Prescribing Information (PDF) and discuss it with your doctor.

Read about Lialda side effects

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