MEZAVANT XL 1200MG GASTRO-RESISTANT PROLONGED RELEASE TABLETS

Active substance: MESALAZINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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).

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.

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 non-cancerous 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

Pharmacotherapeutic group: Aminosalicylic acid and similar agents.
Mezavant XL gastro-resistant, prolonged release tablets contain 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

• Keep out of the reach and sight of children

• If you are allergic (hypersensitive) to a family of drugs known as salicylates (which include aspirin)

• Store below 25°C

• If you are allergic (hypersensitive) to mesalazine or any of the other ingredients of Mezavant XL listed in section 6 of this leaflet

• Store in the original package in order to protect from moisture

• If you have severe kidney or severe liver problems

• 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.

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)

6. FURTHER INFORMATION

• If you have had a previous allergic reaction to sulphasalazine (another medicine used to treat ulcerative colitis)

What Mezavant XL contains

• If you have narrowing or blockage of the stomach or the gut

The active substance is mesalazine 1200mg.
The other ingredients are: Carmellose sodium; Carnauba Wax; Stearic Acid; Silica, Colloidal Hydrated; Sodium Starch Glycolate (Type A);
Talc; Magnesium Stearate; Methacrylic Acid – Methyl Methacrylate Copolymer (1:1); Methacrylic Acid – Methyl Methacrylate Copolymer (1:2)
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 or 120 tablets. Not all pack sizes
may be marketed.
The red-brown tablets are oval shaped and stamped S476.

• 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 your blood to clot) e.g. warfarin

Marketing Authorisation Holder and Manufacturer

Tel:
Fax:
Email:

1. WHAT MEZAVANT XL IS AND WHAT IT IS USED FOR

2. BEFORE YOU TAKE MEZAVANT XL

5. HOW TO STORE MEZAVANT XL

Marketing Authorisation Holder
Shire Pharmaceutical Contracts Ltd
Hampshire International Business Park
Chineham, Basingstoke
Hampshire, RG24 8EP
United Kingdom

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

Taking Mezavant XL with food and drink

Manufacturer
Cosmo SpA
Via C. Colombo 1
20020 Lainate-Milan
Italy

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.

+44 (0) 1256 894000
+44 (0) 1256 894711
medinfo@uk.shire.com

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

By licence of Giuliani SpA, Milan, Italy

Mezavant XL is unlikely to have any effect on your ability to drive or use machines.

Representative for country: Shire Pharmaceutical Contracts Ltd, Hampshire International Business Park, Chineham, Basingstoke, Hampshire,
RG24 8EP, United Kingdom, Tel: +44 (0) 1256 894000, Fax: +44 (0) 1256 894711.

3. HOW TO TAKE MEZAVANT XL

This leaflet was last approved in 12/2011


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.
2660000/2
1827 (11081014421142)

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.

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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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