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MEZAVANT XL 1200MG PROLONGED RELEASE TABLETS

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PACKAGED LEAFLET: INFORMATION FOR THE USER
MEZAVANT XL 1200mg GASTRO-RESISTANT PROLONGED RELEASE TABLETS
(mesalazine)
This medicine is available as above name but will be referred to as Mezavant XL throughout the
following leaflet.
Read all of this leaflet carefully before you start taking this medicine.

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. Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Mezavant XL is and what it is used for
2. Before you take Mezavant XL
3. How to take Mezavant XL
4. Possible side effects
5. How to store Mezavant XL
6. Further information
1. WHAT MEZAVANT XL IS AND WHAT IT IS USED FOR
Pharmacotherapeutic group: Aminosalicylic acid and similar agents.
Mezavant XL gastro-resistant, prolonged release tablets contain mesalazine, which is an antiinflammatory 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.
2. 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
aspirin)
• If you are allergic (hypersensitive) to mesalazine or any of the other ingredients of Mezavant
XL listed in section 6 of this leaflet
• If you have severe kidney or severe liver problems
Take special care with Mezavant XL: Before treatment with Mezavant XL, tell your doctor
• 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
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription, that contain:
• 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 you blood to clot
e.g. warfarin
Taking 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 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 XL.
Driving and using machines
Mezavant XL is unlikely to have any effect on your ability to drive or use machines.
3. HOW TO TAKE MEZAVANT XL
Always take Mezavant XL as your doctor has told you. 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 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.
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.
If you forget to take Mezavant XL
It is important to take your Mezavant XL tablets every day, even when you don’t have any
symptoms of ulcerative colitis. Always finish the prescribed course.

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.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Mezavant XL can cause side effects, although not everybody gets them.
Common side effects, occurring in less than 1 in 10 patients, are headache, changes in blood
pressure, flatulence (passing wind), nausea (feeling sick), bloated or painful stomach, diarrhoea,
indigestion, vomiting (being sick), abnormal liver function test, itching, rash, muscle and joint
pain, back pain, weakness and fever (high temperature).
Uncommon side effects, seen in less than 1 in 100 patients are: a reduction in blood platelets
which increases the risk of bleeding and bruising; dizziness; feeling sleepy or tired; trembling or
shaking; ear pain; racing heartbeat; changes in blood pressure; an inflamed pancreas or colon
(associated with pain in upper abdomen and back and feeling sick); rectal polyp (a noncancerous growth in the back passage causing symptoms such as constipation and bleeding);
acne; hair loss; itchy skin with or without a rash; hives; swollen face; fatigue (feeling extremely
tired).
The following side effects are associated with other medicines containing mesalazine. These
are: severe reduction in blood cells which can cause weakness, bruising or make infections more
likely, low blood cell counts; neuropathy (abnormal or damaged nerves giving a sensation of
numbness and tingling); inflammation of the heart and lining around the heart; inflammation of
the lung; difficulty in breathing or wheezing; gall stones; hepatitis (inflammation of the liver giving
rise to flu-like symptoms and jaundice); allergic swelling of tongue, lips and around eyes; skin
redness; muscular pain; kidney problems (such as inflammation and scarring of the kidney).
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.
Tell your doctor immediately
• If you experience symptoms such as cramping, severe stomach pain, bloody and excessive
stools (diarrhoea), fever, headache or rash. These symptoms could be a sign of Acute
Intolerance Syndrome which can happen during an acute episode of ulcerative colitis. This is
a serious condition which occurs rarely, but means your treatment would have to be stopped
immediately
• If you develop unexplained bruising (without injury), rash, anaemia (feeling tired, weak and
looking pale, especially on lips, nails and inside of eyelids), fever (high temperature), sore
throat or unusual bleeding (e.g. nose bleeds)
• If you develop allergic swelling of tongue, lips and around eyes
5. HOW TO STORE MEZAVANT XL
• Keep out of the reach and sight of children
• Do not store above 25°C.
• Store in the original package
• Do not use Mezavant XL after the expiry date which is stated on the box
• Medicines should not be disposed of via waste water or household waste. Ask your
pharmacist how to dispose of medicines you no longer require or medicines that have expired.
These measures will help to protect the environment.
• If the tablets become discoloured or show any other signs of deterioration, you should seek
the advice of your pharmacist who will tell you what to do.
6. FURTHER INFORMATION
What Mezavant XL contains
The active substance is mesalazine 1200mg.
The other ingredients are: Carmellose sodium; Carnauba Wax; Stearic Acid; Silica, Colloidal
Hydrated; Sodium Starch Glycolate; Talc; Magnesium Stearate; Methacrylic Acid Copolymer
Type A, Methacrylic Acid Copolymer Type B; Triethylcitrate; Titanium Dioxide (E171); Red Ferric
Oxide (E172); Macrogol 6000.
What Mezavant XL looks like and contents of the pack
Mezavant XL is supplied in foil blister strips which are contained in a cardboard box. The pack
contains 60 and 120 tablets.
The red-brown tablets are oval shaped marked ‘S476’ on one side and plain on reverse.
PL No: 15814/0996 Mezavant XL 1200mg Gastro-Resistant Prolonged Release Tablets

POM

This product is manufactured by Cosmo SpA, Via C. Colombo 120020 Lainate-Milan, Italy and is
procured from within the EU and repackaged by the Product Licence holder who is: OPD
Laboratories Ltd., Unit 6, Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (ref): 10.04.12

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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