Mezavant - Consumer Medicine Information
|Condition:||Crohn's Disease, Maintenance, Crohn's Disease, Inflammatory Bowel Disease, Ulcerative Colitis, Ulcerative Colitis, Active, Ulcerative Colitis, Maintenance, Ulcerative Proctitis|
|Ingredients:||mesalamine, carnauba wax, magnesium stearate, methacrylic acid – methyl methacrylate copolymer (1:1), methacrylic acid – methyl methacrylate copolymer (1:2), red ferric oxide (E172), polyethylene glycol (macrogol) 6000, silica (colloidal hydrated), sodium carboxymethylcellulose, sodium starch glycolate (type A), stearic acid, talc, titanium dioxide (E171) and triethylcitrate|
mesalamine Delayed- and Extended-Release Tablets
About This Medication
What the Medication is Used For
MEZAVANT tablets contain mesalamine, which is an anti-inflammatory drug for the treatment of a flare-up of ulcerative colitis and/or to help maintain remission (mucosal healing) in patients with ulcerative colitis. Ulcerative colitis is a disease of the large bowel (colon) and back passage (rectum), where the lining of the gut becomes red and swollen (inflamed) resulting in symptoms of frequent and bloody stools together with stomach cramps.
What It Does
MEZAVANT is believed to block the production and action of certain substances (cyclooxygenase, prostaglandins and others) involved in producing inflammation. MEZAVANT tablets use a technology called MMX, designed to delay and deliver effective concentrations of medicine for an extended period of time throughout the colon and rectum to treat the inflammation and reduce symptoms, such as bloody stools and diarrhea.
When It Should not be Used
- If you are allergic to this drug or its ingredients or components of the container (see What the nonmedicinal ingredients are)
- If you are allergic to a family of drugs known as salicylates [which includes acetylsalicylic acid (i.e., Aspirin†)]
- If you have severe liver problems
- If you have severe kidney problems.
† Aspirin is a registered trade-mark of Bayer Aktiengesellschaft
What the Medicinal Ingredient Is
What the Nonmedicinal Ingredients Are
carnauba wax, magnesium stearate, methacrylic acid – methyl methacrylate copolymer (1:1), methacrylic acid – methyl methacrylate copolymer (1:2), red ferric oxide (E172), polyethylene glycol (macrogol) 6000, silica (colloidal hydrated), sodium carboxymethylcellulose, sodium starch glycolate (type A), stearic acid, talc, titanium dioxide (E171) and triethylcitrate.
MEZAVANT tablets do not contain gluten, lactose or phthalates.
What Dosage Forms It Comes In
MEZAVANT 1.2g delayed- and extended-release tablets are available as red-brown, oval-shaped, film-coated tablets marked on one side with “S476”.
Warnings and Precautions
BEFORE you use MEZAVANT, talk to your doctor or pharmacist if:
- You have a narrowing or blockage of the upper digestive tube (e.g., pyloric stenosis).
- You have any kidney or liver problems.
- You have chronic lung disease such as asthma or others.
- You have digestive (peptic) or duodenal ulcers.
- You have urinary tract obstructions.
- You have previously had inflammation of the heart (which may be the results of an infection of the heart).
- Since mesalamine crosses the placenta in pregnancy and is excreted in breast milk in small quantities, due care should be taken if using MEZAVANT in pregnancy or while breast-feeding. If you are pregnant, think you might be pregnant or are breast-feeding you should ask your doctor for advice about taking MEZAVANT.
- You have had previous allergy (hypersensitivity reaction) to sulfasalazine (an ingredient in other medicines used to treat ulcerative colitis).
- You have had any allergies to this drug or its ingredients or components of the container.
Interactions With This Medication
The concomitant use of mesalamine with drugs known to affect the kidney, including some anti- inflammatory drugs (NSAIDs) and azathioprine may increase the risk of renal (kidney) reactions.
In patients receiving azathioprine or 6-mercaptopurine, concurrent use of mesalamine can increase the possibility of having abnormal blood components.
Proper Use of This Medication
Usual Adult Dose
Always take MEZAVANT as your doctor has told you. This can help bring your symptoms of ulcerative colitis under control and can also reduce the risk of symptoms reappearing. You should check with your doctor or pharmacist if you are not sure.
The usual daily dose for adults is 2.4g to 4.8g (two to four tablets) taken once a day for a flare-up of ulcerative colitis.
The usual daily dose for adults to help maintain remission (mucosal healing) is 2.4g (two tablets) taken once a day.
MEZAVANT should be taken with food. The tablets should be swallowed whole with liquid and should not be chewed or crushed.
|In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.|
If you forget to take your tablets then take them as usual the next day. Do not take a double dose to make up for a forgotten tablet.
Side Effects and What to Do About Them
Like all medicines, MEZAVANT can cause side effects, although not everybody gets them. The most frequently reported adverse events within clinical studies were inflamed colon, headache, abdominal pain (stomach pain), liver function tests abnormal, loose / frequent stools (diarrhea) and nausea (feeling sick).
Other commonly reported adverse reactions or side effects (≥1% to <10%) are: painful or bloated stomach, indigestion, gas, vomiting, weakness, fever, joint pain, back pain, allergic reactions (including hives, rash and swollen face), high blood pressure, feeling sleepy or tired.
Other less common side effects (seen in less than 1 in 100 patients) are: reduced number of platelets (a blood clotting cell), exacerbation of ulcerative colitis, dizziness, rectal polyp (a non-cancerous growth in the back passage causing symptoms such as constipation and bleeding), trembling or shaking, ear or throat pain, racing heartbeat, acne, fatigue (feeling extremely tired), an inflamed pancreas (associated with pain in upper abdomen and back and feeling sick), hair loss, low blood pressure.
The following side effects have been identified with post-marketing use of MEZAVANT: low white blood cell counts, inflammation of the heart muscle and lining around the heart, inflammation of the liver, kidney problems (such as inflammation and scarring of the kidney), inflammation of lungs due to allergic reaction, muscle pain, allergic swelling of skin or body parts.
The following additional side effects are associated with other medicines containing mesalamine. These are: low blood cell counts (red blood cells, white blood cells or platelets), neuropathy (abnormal or damaged nerves giving a sensation of numbness and tingling), difficulty in breathing, gall stones, skin redness.
If any of the side effects become serious or persist, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Serious Side Effects, how Often They Happen and What to Do About Them
|Symptom / effect||Talk with|
your doctor or
|Common||Allergic reaction - symptoms include hives, rash, swollen face.||✓|
|Unknown||Other allergic reaction - symptoms include swelling of the mouth, throat, difficulty in breathing and worsening asthma.||✓|
|Common||Acute Intolerance Syndrome - symptoms include cramping, acute stomach pain, bloody and excessive stools (diarrhea), fever, headache and rash. These symptoms could be a sign of a serious condition which occurs rarely but means your treatment would have to be stopped immediately.||✓|
|Uncommon||Blood problems and symptoms such as unexplained bruising, unusual bleeding (for example, nose bleeds), fever, sore throat.||✓|
|Uncommon||Pancreatitis (inflamed or swollen pancreas) and symptoms such as abdominal pain and feeling sick.||✓|
|Rare||Kidney problems (such as inflammation and scarring of the kidney or kidney failure) - symptoms include blood in the urine, fever, increased or decreased urine output, mental status changes (drowsiness, confusion, coma), nausea, vomiting, rash, swelling of the body, weight gain (from retaining fluid)||✓|
|Unknown frequency||Hepatitis (inflammation of the liver) - symptoms include jaundice (yellowing of the skin and eyes) and flu-like symptoms.||✓|
|Unknown frequency||Myocarditis/Pericarditis (inflammation of the heart muscle and lining around the heart) - symptoms include abnormal heartbeat, chest pain that may resemble a heart attack, fatigue, fever and other signs of infection including headache, muscle aches, sore throat, diarrhea, or rashes, joint pain or swelling, leg swelling, shortness of breath.||✓|
|Unknown frequency||Hypersensitivity pneumonitis (inflammation of lungs due to an allergic reaction) - symptoms include fever, cough, chills, and shortness of breath.||✓|
|Unknown frequency||Serious Skin Conditions (Stevens-Johnson syndrome, Drug Reaction with Eosinophilia and Systemic Symptoms) : Swelling of the skin or serious skin rash seen as severe blisters of the skin and mucous membranes||✓|
This is not a complete list of side effects. For any unexpected effects while taking MEZAVANT, contact your doctor or pharmacist.
How to Store It
Store at room temperature (15°C to 25°C).
Keep out of the reach and sight of children.
Reporting Suspected Side Effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Postal Locator 0701E
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
If you want more information about MEZAVANT: