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This document outlines important safety information and warnings related to the use of mesalamine (Rowasa). Please read carefully and consult your healthcare provider if you have any questions or concerns.

• Severe Allergic Reactions and Skin Reactions: Mesalamine (Rowasa) may cause serious allergic responses, which can be life-threatening. Symptoms include difficulties breathing, chest constriction, and swelling of the face, lips, tongue, or eyes. Skin-related allergic reactions may manifest as hives, itching, skin pain, redness, blisters, or peeling. If you experience any of these symptoms, discontinue use immediately and seek emergency medical assistance. Risks include allergies to mesalamine or sulfites and a history of asthma.

• Kidney Concerns: If you have a history of kidney problems, inform your healthcare provider before beginning mesalamine (Rowasa). Since this drug is processed through the kidneys, any existing kidney damage can lead to drug accumulation and increased side effects, including potential kidney failure. Discuss the potential risks and benefits with your prescriber. Risks include a history of kidney issues, concurrent use of kidney-damaging drugs, or taking sulfasalazine (Azulfidine).

• Liver Considerations: Those with previous liver conditions may experience deteriorating liver function when using mesalamine (Rowasa). Notify your prescriber if you have any liver problems, so they can help evaluate the treatment's risks and benefits. Risk factors include a history of liver issues.

• Acute Intolerance Syndrome: Some individuals may experience acute intolerance syndrome in response to mesalamine (Rowasa). Symptoms may involve abdominal pain or cramps, bloody diarrhea, fever, headache, or rash, which can mimic an ulcerative colitis flare-up. Stop taking the medication and contact your healthcare team immediately if these symptoms worsen.

Contraindications

Do not use this medication if any of the following conditions apply, as they may pose significant health risks. Consult your healthcare provider for guidance.

• Allergy to sulfites
• Allergy to salicylates, including aspirin or bismuth subsalicylate (Pepto-Bismol)

Always ensure to follow medical advice and report any adverse effects promptly to your healthcare provider.

When taking this medication, you might experience some common side effects. These include mild stomach pain, cramps, headaches, gas, and nausea, which typically affect a small percentage of users. Additionally, flu-like symptoms may occur. These effects are generally not severe, but if they persist or worsen, consult your healthcare provider for guidance.

There are other side effects that some individuals may encounter, such as diarrhea, constipation, stomach bloating, and rectal discomfort, including pain or burning sensations. Some users report leg or joint pain, back pain, hemorrhoids, kidney stones, hair loss, dizziness, tiredness, cold-like symptoms, fever, itching, and skin rashes. While these are less common, it is important to monitor these symptoms and seek advice if they become bothersome.

In rare instances, serious side effects can occur that require immediate medical attention. These include symptoms of an allergic reaction, such as a red rash, shortness of breath, chest tightness, or swelling of the lips, tongue, face, or eyes. Severe skin reactions or acute intolerance syndrome, characterized by intense stomach pain, bloody diarrhea, nausea, fever, headache, and rash, are also serious and warrant prompt medical intervention. If you notice any unusual or severe symptoms, it is crucial to seek medical help right away.

Mesalamine (Rowasa) can interact with various medications and supplements. It's important to inform your doctor and pharmacist about all the medicines and supplements you are taking, whether they are prescription, over-the-counter, vitamins, or herbal products.

Certain medications may interact with Mesalamine, and while their combined use is generally not advised, your doctor might decide that both should be used together. In such cases, your doctor may adjust the dosage or frequency of one or both drugs. These medications include a wide range of nonsteroidal anti-inflammatory drugs (NSAIDs) and others such as Aceclofenac, Ibuprofen, Naproxen, and Sulfasalazine, among many others.

Additionally, using Mesalamine with Tamarind or Warfarin may elevate the risk of specific side effects. However, your healthcare provider might determine that the benefits outweigh the risks, and again, may alter the dosage or usage schedule as necessary.

Furthermore, this medication might affect certain laboratory tests, like urine normetanephrine levels, potentially leading to inaccurate results. Therefore, it's essential to inform lab personnel and all healthcare providers that you are using this medication.