Mezavant Xl 1200mg Gastro-Resistant Prolonged Release Tablets
1. What Mezavant XL is and what it is used for
2. What you need to know before you take Mezavant XL
3. How to take Mezavant XL
PACKAGE LEAFLET: INFORMATION FOR THE USER MEZAVANT® XL 1200MG GASTRO-RESISTANT PROLONGED RELEASE TABLETS
(mesalazine)
Your medicine is known as the above but will be referred to
as Mezavant XL throughout the remainder of this leaflet.
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Mezavant XL is and what it is used for
2. What you need to know before you take Mezavant XL
3. How to take Mezavant XL
4. Possible side effects
5. How to store Mezavant XL
6. Contents of the pack and other information
Pharmacotherapeutic group: Aminosalicylic acid and similar agents.
Mezavant XL gastro-resistant, prolonged release tablets contain the active substance mesalazine, which is an anti-inflammatory drug for the treatment of ulcerative colitis.
Ulcerative colitis is a disease of the colon (large bowel) and rectum (back passage), where the lining of the gut becomes red and swollen (inflamed) resulting in symptoms of frequent and bloody stools together with stomach cramps.
When given for an acute episode of ulcerative colitis, Mezavant XL acts through the entire colon and rectum to treat the inflammation and reduce symptoms. The tablets can also be taken to help prevent reoccurrence of ulcerative colitis.
Do not take Mezavant XL
- If you are allergic (hypersensitive) to a family of drugs known as salicylates (which include 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
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 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, 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.
Children and adolescents
Mezavant 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 does not interfere with the following antibiotics, used to treat infections: amoxicillin, metronidazole or sulfamethoxazole.
However, Mezavant may interact with some other medicines. Tell your doctor or pharmacist if you are taking or 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 aspirin, ibuprofen or diclofenac)
- Azathioprine or 6-mercaptopurine (known as 'immunosuppressant' medicines which reduce the activity of your body's immune system).
- 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, due care should be taken if using Mezavant XL in pregnancy or whilst breastfeeding.
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.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose for adults is 2.4g to 4.8g (two to four tablets) taken once a day for an acute episode of ulcerative colitis. If you are taking the highest daily dose of 4.8g/day, you should be evaluated after 8 weeks treatment. Once your symptoms have cleared and to help prevent reoccurrence of another episode, your doctor should direct you to take 2.4g (two tablets) once a day.
Remember to take your tablets at the same time each day with food. The tablets should be swallowed whole and must not be crushed or chewed.
Whilst taking this medicine ensure you drink fluids to remain well hydrated especially after severe or prolonged episodes of vomiting and/or diarrhoea, high fever or heavy sweating.
Mezavant XL is not recommended to be given to children under 18 years of age due to lack of data on safety and efficacy.
If you take more Mezavant XL than you should
If you take too much Mezavant XL you may have one or more of the following symptoms: tinnitus (ringing in ears), dizziness, headache, confusion, drowsiness, shortness of breath, excess loss of water (associated with sweating, diarrhoea and vomiting), low blood sugar (which can cause light-headedness), rapid breathing, changes in the blood chemistry and increased body temperature.
If you do take too many tablets, contact your doctor, pharmacist or hospital casualty department straight away. Take your tablet pack with you.
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