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MEZAVANT XL 1200 MG GASTRO-RESISTANT PROLONGED RELEASE TABLETS

Active substance(s): MESALAZINE

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T05703

Mezavant® XL 1200 mg
gastro-resistant, prolonged release tablets
(mesalazine)

Patient Information Leaflet
The name of your medicine is Mezavant XL
1200 mg gastro-resistant, prolonged release
tablets but will be referred to as Mezavant XL
throughout the 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

1. What Mezavant XL is and what it is used
for
Pharmacotherapeutic group:
acid and similar agents.

Aminosalicylic

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 reccurrence of ulcerative
colitis.

2. 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 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
breast-feeding.
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.

3. How to take Mezavant XL
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.
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 medicine, ask your doctor or pharmacist.

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4. Possible side effects
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

6. Contents of the pack and other
information
What Mezavant XL contains
Each tablet contains 1200 mg mesalazine.
The other ingredients are: Carmellose sodium;
Carnauba Wax; Stearic Acid; Silica, Colloidal
Hydrated;
Sodium
Starch
Glycolate;
Magnesium Stearate; Copolymer Type A and
Type B methacrylic acid; Triethyl citrate;
Titanium Dioxide (E171); Iron Oxide Red
(E172); Macrogol 6000.
What Mezavant XL looks like and contents of
the pack
Mezavant XL is available in blister covered with
aluminum content in a cardboard box.
The pack contains 60 or 120 tablets. Not all
pack sizes may be marketed.

Like all medicines, this medicine can cause side
effects, although not everybody gets them.

The tablets are red-brown oval-shaped and
bear the engraved initials S476.

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,
inflammation which causes abdominal pain or
diarrhoea; diarrhoea, indigestion, vomiting
(being sick), abnormal liver function test,
itching, rash, joint pain, back pain, weakness,
fatigue (feeling extremely tired); fever (high
temperature).

Manufacturer and Product Licence Holder:
This medicine is manufactured by Cosmo
S.p.A, Via C. Colombo 1, 20020 Lainate (MI),
Italy. It is procured from within the EU by the
Product Licence Holder: Swinghope Ltd.,
Marlowe Way, Croydon CR0 4XS UK and
repackaged by Interport Ltd, Marlowe Way,
Croydon CR0 4XS UK.

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; throat pain; 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;
muscle pain; hives; swollen face;

PL No: 10380/1453

POM

Leaflet Revision Date: 03/07/2015
Mezavant® is a registered trademark of Giuliani
International Limited, Ireland.

Rare side effects, seen in less than 1 in 1000
patients are: kidney failure; severe reduction in
the number of white blood cells that makes
infection more likely.
The following side effects have been
reported but it is not known exactly how
often they occur:
Severe reduction in blood cells which can cause
weakness or bruising; low blood cell counts;
allergic reaction (hypersensitivity); serious
allergic reaction which causes difficulty in
breathing or dizziness; serious illness with
blistering of the skin, mouth, eyes and genitals;
allergic reaction which causes skin rash, fever
and inflammation of internal organs; 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 you get any side effects talk to your doctor.
This includes any possible any side effects not
listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Mezavant XL
• Keep out of the sight and reach 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.

T05703

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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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