Mesalover® (Mesalazine)

Dosage form:

• Extended-release capsule 500 mg
• Extended-release granules 1g, 2 g,4g
• Extended-release tablet 1200 mg

What is Mesalazine (Mesalover®) used for?

• It is used to treat ulcerative colitis.
• It is used to help keep ulcerative colitis flares from coming back.
• It is used to treat mild to moderate disease at the far end of the colon.
• It may be given to you for other reasons. Talk with the doctor.

Important notes before taking Mesalazine (Mesalover®):

• If you are allergic to this drug; any part of this drug; 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: kidney disease or liver disease.
• If you have a stomach or bowel ulcer.
• If you have a narrowing of your stomach valve or other type of stomach block.
• If you have a blockage in your urinary tract, talk with your health care provider.
• This drug may interact with other drugs or health problems.
• 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 drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Important notes while taking Mesalazine (Mesalover®):

All products:

• Tell all of your healthcare providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This drug may affect certain lab tests. Tell all of your healthcare providers and lab workers that you take this drug.
• Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.
• If you are allergic to sulfites, talk with your doctor. Some products have sulfites.
• If you have phenylketonuria (PKU), talk with your doctor. Some products have phenylalanine.
• While taking this drug, your urine may turn reddish-brown when it comes in contact with surfaces or water that have been treated with bleach (like in the toilet). If you notice that your urine is reddish-brown, watch your urine flow. Call the doctor only if your urine is reddish-brown when it leaves the body before it comes into contact with any surfaces or water that may have been treated with bleach.
• You may get sunburned more easily. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
• If you are 65 or older, use this drug with care. You could have more side effects.
• Not all products are meant for use in all children. Talk with the doctor before giving this drug to a child.
• Do not give to children and teenagers who have or are getting better from flu signs, chickenpox, or other viral infections due to the chance of Reye’s syndrome. Reye’s syndrome causes very bad problems to the brain and liver.
• 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.

Tablets:

• You may see parts of this drug in your stool. If this happens a lot, talk with your doctor. 

Mesalazine side effects:

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 kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain;
• Back pain, belly pain, or blood in the urine. May be signs of a kidney stone.
• Chest pain or pressure; a fast or abnormal heartbeat;
• Fever, chills, or sore throat; any unexplained bruising or bleeding; or feeling very tired or weak;
• Some people may have a reaction to this drug that looks like the signs of ulcerative colitis. Call your doctor right away if you have new or worsening stomach pain or cramps, bloody stools, fever, headache, itching, rash, red or pink eyes, or are not feeling well.
• Liver problems have rarely happened with this drug. Sometimes, this has been deadly. Call your doctor right away if you have signs of liver problems like dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Some heart problems have rarely happened with this drug. Sometimes, this has been deadly. Call your doctor right away if you have shortness of breath, a big weight gain, or swelling in the arms or legs.
• Severe skin reactions may happen with this drug. These include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions. Sometimes, body organs may also be affected. These reactions can be deadly. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or any areas of skin; fever; chills; body aches; shortness of breath; or swollen glands.

What are some other side effects of this drug?

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:

• Constipation, diarrhea, stomach pain, upset stomach, or throwing up.
• Nose or throat irritation.
• Dizziness or headache.
• Back pain.

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.

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.

How do I store and/or throw out this drug?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Do not use this drug after expiry date. 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.