Product Details

What you need to know before you take Mezavant XL

Do not take Mezavant XL − If you are allergic (hypersensitive) to a family of drugs known as salicylates (which include acetylsalicylic acid (Aspirin) − If you are allergic (hypersensitive) to mesalazine or any of the other ingredients of this medicine (listed in section 6 of this leaflet) − If you have severe kidney or severe liver problems Warnings and precautions Mesalazine may produce red-brown urine discoloration after contact with sodium hypochlorite bleach in the toilet water. It concerns a chemical reaction between mesalazine and bleach and is harmless. Talk to your doctor before using Mezavant XL − If you have any kidney or liver problems − If you have previously had inflammation of the heart (which may be the result of an infection in the heart) − If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after using Mezavant − If you have had a previous allergic reaction to sulphasalazine (another medicine used to treat ulcerative colitis) − If you have narrowing or blockage of the stomach or the gut − If you have lung problems Before and periodically during treatment with Mezavant XL, your doctor may take samples of your urine and blood to check that your kidneys and liver are working well and that your blood is healthy. Kidney stones may develop with the use of Mezavant XL. Symptoms may include pain in the sides of the abdomen and blood in the urine. Take care to drink a sufficient amount of liquid during treatment with Mezavant XL. Serious skin reactions including Drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), have been reported in association with Mezavant treatment. Stop using Mezavant and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4. Children and adolescents Mezavant XL is not recommended to be given to children under 18 years of age due to lack of data on safety and efficacy. Other medicines and Mezavant XL Studies have shown that Mezavant XL does not interfere with the following antibiotics, used to treat infections: amoxicillin, metronidazole or sulfamethoxazole. However, Mezavant XL may interact with some other medicines. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. − Mesalazine or sulphasalazine (taken for treatment of ulcerative colitis) − Non-steroidal anti-inflammatory drugs (for example medicines containing acetylsalicylic acid (Aspirin), ibuprofen or diclofenac) − Azathioprine or 6-mercaptopurine or other medicines known to affect how your bone marrow works (known as ‘immunosuppressant’ medicines which reduce the activity of your body’s immune system). Bone marrow is the material inside your bones that produces blood cells. − Coumarin-type anticoagulants (medicines which increase the time it takes for your blood to clot) e.g., warfarin Mezavant XL with food and drink Mezavant XL should be taken with food at the same time each day. The tablets should be swallowed whole and must not be crushed or chewed. Pregnancy and breast-feeding Since mesalazine crosses the placenta in pregnancy and is excreted in breast milk in small quantities, you should only use Mezavant XL during pregnancy or whilst breast-feeding if your doctor tells you to. Adverse outcomes [including low blood counts (white blood cells, red blood cells, and platelets)] were reported in infants born to mothers who took Mezavant XL during pregnancy. Diarrhoea has been reported in breastfed infants of mothers who took Mezavant XL. If you are pregnant or breast feeding, think you might be pregnant or are planning to have a baby, ask your doctor for advice about taking Mezavant XL. Interference with laboratory tests If you are undergoing urine tests, it is important to tell the doctor or nurse you are taking, or have recently taken this medicine as it can affect some results. Driving and using machines Mezavant XL is unlikely to have any effect on your ability to drive or use machines. Mezavant contains sodium This medicine contains less than 1 mmol sodium (23 mg) per the maximum recommended dose (4 tablets), that is to say essentially ‘sodium-free’.