Dosage form:

Extended-release capsule 500 mg

Extended-release granules 1g, 2 g,4g

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):

• Tell your doctor or pharmacist if you have an allergy to mesalazine or any other part of this drug.
• Tell your doctor or pharmacist if you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• 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):

• Tell all of your health care 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 health care providers and lab workers that you take this drug.
• 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.
• If you are 65 or older, use this drug with care. You could have more side effects.
• 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.

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;
• Chest pain or pressure;
• 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 very bad belly pain or cramps, bloody stools, fever, headache, or rash;
• 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, feeling tired, not hungry, 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.

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:

• Stomach pain or diarrhea;
• Upset stomach or throwing up;
• Heartburn;
• Constipation;
• Gas;
• Burping;
• Nose or throat irritation;
• Headache;
• Dizziness;
• 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 the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose.

Do not take extra medicine to make up the missed dose.

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.