Patient Medication Information: uses, side effects, how to take - Mezera (Avir Pharma, 500 mg, 1 G)
What is MEZERA used for?
- Treatment of active ulcerative colitis (inflammation of the lining of the large bowel and rectum) in adults.
How does MEZERA work?
MEZERA is believed to work by interfering in the activity of certain chemicals in your body that cause inflammation (e.g., prostaglandins). This will help reduce the inflammation (swelling and pain) in the rectum and lower part of the large bowel.
What are the ingredients in MEZERA?
Medicinal ingredient: Mesalamine, also known as 5-aminosalicylic acid, 5-ASA or mesalazine.
Non-medicinal ingredients:
500 mg: Basic butylated methacrylate copolymer, calcium stearate, croscarmellose sodium, glycine, hypromellose, iron oxide yellow, macrogol, methacrylic acid/methyl methacrylate copolymer (1:1), microcrystalline cellulose, povidone, silica, sodium carbonate, talc and titanium dioxide.
1 g: Calcium stearate, croscarmellose sodium, hypromellose, iron oxide yellow, macrogol, methacrylic acid/methyl methacrylate copolymer (1:1), methacrylic acid/methyl methacrylate copolymer (1:2), microcrystalline cellulose, povidone, silica, talc and titanium dioxide.
MEZERA comes in the following dosage forms:
Delayed-release tablets: 500 mg and 1 g
Do not use MEZERA if you:
- have severe kidney disease.
- have severe liver disease.
- have ulcers of the stomach or small intestine.
- have a blockage along the urinary tract.
- are allergic to this drug or to any ingredient of MEZERA. See “What are the ingredients in MEZERA?”, above.
- are allergic to salicylates such as Aspirin® (acetylsalicylic acid).
- are unable to swallow the whole tablet, without breaking or chewing.
- are under 2 years old.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take MEZERA. Talk about any health conditions or problems you may have, including if you:
- have any kidney or liver problems.
- have lung or breathing problems such as asthma.
- have had previous inflammation of the heart. Talk to your doctor if you suspect that you are experiencing problems with your heart. See “Serious side effects and what to do about them” table, below.
- have pyloric stenosis (a narrowing of the outlet from the stomach that causes contents of the stomach to remain there for a longer period of time). Pyloric stenosis may keep MEZERA tablet from reaching the colon as quickly as it normally would.
- have a history of allergy to sulfasalazine.
- have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after using mesalamine.
Other warnings you should know about:
Urine discoloration: You may notice red-brown urine discoloration after using toilets treated with bleach products. This is because of a chemical reaction between mesalamine and bleach and is harmless.
Monitoring and Testing: During treatment your doctor may want to keep you under close medical supervision and you may need to have regular blood and urine tests.
Kidney Stones: Kidney stones may develop with use of mesalamine. Symptoms may include blood in urine, urinating more often and pain in your back, side, belly or groin. Be sure to drink enough liquids while you are taking MEZERA. Talk to your doctor about how much water or other liquids you should be drinking.
Serious Skin Reactions: Serious skin reactions including drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in association with mesalamine treatment. Stop using mesalamine and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in “Serious side effects and what to do about them” table.
Pregnancy and Breastfeeding: If you are pregnant, able to get pregnant or think you are pregnant, there are specific risks you should discuss with your doctor.
- Avoid becoming pregnant while you are taking MEZERA. It may harm your unborn baby.
- Tell your doctor right away if you become pregnant or think you are pregnant during treatment with MEZERA.
Taking MEZERA during pregnancy have been reported to cause
- Early labor
- Birth defects in babies. The baby may develop kidney and heart issues.
- MEZERA is passed into human breastmilk. Talk to your doctor about how to feed your baby.
- If you breastfeed your baby while taking MEZERA, your baby could develop / start to have diarrhea. It is important to monitor your baby’s stool and contact your doctor right away if they have diarrhea. Your doctor may advise you to stop breastfeeding your baby.
Sun Sensitivity: If you have conditions such as atopic dermatitis or eczema, you may be more sensitive to the sun while taking MEZERA. Your doctor may tell you to avoid sun exposure, wear protective clothing, or use a sunscreen while outdoors.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with MEZERA:
- Medicine used to prevent organ transplant rejection called azathioprine
- Medicines used to treat cancer such as 6-mercaptopurine, thioguanine and methotrexate
- Medicine used to treat ulcerative colitis such as aminosalicylates (including MEZERA)
- Medicine used to treat blood clots called warfarin
- Medicines used to treat gout such as probenecid and sulfinpyrazone
- Medicines used to treat high blood pressure such as spironolactone and furosemide
- Medicine used to treat bacterial infections called rifampicin
- Medicine used to treat inflammation called corticosteroids, for example prednisone
- Vaccine against chickenpox (varicella vaccine)
The use of mesalamine with drugs known to affect the kidney may increase the risk of kidney reactions. These drugs include some anti-inflammatory drugs (NSAIDs) and azathioprine.
How to take MEZERA:
Take tablets regularly for the treatment to keep working.
Swallow tablets whole, 1 hour before meals and with liquid in the morning, at midday, and in the evening.
Do not crush, chew or break the tablets. Do not take the tablets with alcohol.
Do not suddenly stop taking the tablets.
Usual dose:
Take two 500 mg MEZERA tablets or one 1 g MEZERA tablet, three times per day (total adult dose: 3 g/day).
Overdose:
| If you think you, or a person you are caring for, have taken too much MEZERA, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
|---|
Missed Dose:
If you miss a dose of MEZERA, take your dose as soon as possible, unless it is almost time for the next dose. Do not take two MEZERA doses at the same time to make up for a missed dose.
What are possible side effects from using MEZERA?
These are not all the possible side effects you may have when taking MEZERA. If you experience any side effects not listed here, tell your healthcare professional.
The most commonly reported side effects are: headache, nausea, vomiting, indigestion and increased enzymes (this will be monitored by laboratory tests and addressed by your doctor).
Worsening of ulcerative colitis may occur and may include the following symptoms: abdominal or stomach cramps or pain (severe) and diarrhea.
Other side effects reported with MEZERA include: difficulty swallowing, fatigue, hepatitis cholestatic, sinus infection, tendon pain, back pain, depression, difficulty sleeping, acne, rash, itching, bloating, feeling gassy dizziness, headache, hair loss, muscle or joint pain, lowered sperm count (reversible when MEZERA is discontinued), numbness in hands and feet, decreased platelet count in the blood, allergic and fibrotic lung reactions (including difficulty breathing, cough, bronchospasm (lung contraction), alveolitis (alveoli inflammation), pulmonary eosinophilia (lung inflammation from an increase of a type of white blood cells, eosinophils), lung infiltration, pneumonitis (lung inflammation)) and increased sensitivity of your skin to sun and ultraviolet light (photosensitivity).
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| UNCOMMON | |||
| Kidney stones (hard little pebbles that form in your kidneys): blood in urine, urinating more often and pain in your back, side, belly or groin. | ✓ | ||
| RARE | |||
| Myocarditis/ Pericarditis (inflammation of the heart muscle and lining around the heart): 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. | ✓ | ||
| VERY RARE | |||
| Acute Intolerance Syndrome: cramping, acute stomach pain, blood 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. | ✓ | ||
| Pancreatitis (inflamed or swollen pancreas): abdominal pain and feeling sick. | ✓ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Serious skin reactions including drug reactions with eosinophilia and systemic symptoms, Stevens-Johnson syndrome, toxic epidermal necrolysis: reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes, widespread rash, fever and enlarged nodes. These serious skin rashes can be preceded by fever and flu-like symptoms. | ✓ | ||
| Blood problems: unexplained bruising, unusual bleeding (for example, nose bleeds), anemia (feeling weak), fever, sore throat. | ✓ | ||
| Kidney problems (such as inflammation and scarring of the kidney or kidney failure): 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). | ✓ | ||
| Hepatitis including liver failure (inflammation of the liver): jaundice (yellowing of the skin and eyes) and flu-like symptoms. | ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Store MEZERA 500 mg tablets at room temperature between 15 and 25°C.
Store MEZERA 1 g tablets at room temperature between 15 and 30°C.
Keep out of reach and sight of children.
No other specific storage conditions are required.
If you want more information about MEZERA:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (www.avirpharma.com), or by calling 1-888-430-0436.
AVIR Pharma Inc.
660 Boul. Industriel
Blainville, Quebec
J7C 3V4
www.avirpharma.com
Last Revised: AUG 02, 2024
MEZERA® is a registered trade-mark of Dr. Falk Pharma GmbH, used under license by AVIR Pharma Inc.