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MEZAVANT XL 1200 MG GASTRO-RESISTANT PROLONGED RELEASE TABLETS

Active substance(s): MESALAZINE

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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 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 recurrence 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 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.
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 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.

4. Possible side effects

5. How to store Mezavant XL

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
- If you develop increased pressure in brain
causing headache which may originate
behind your eyes and worsen with eye
movements, with blurred or dimmed vision,
double vision, seeing light flashes, difficulty
seeing to the side, and brief or permanent
vision loss. These may be associated with
dizziness, nausea, vomiting, ringing in ears

• Keep this medicine out of the sight and reach
of children
• Do not store above 25°C
• Store in the original package
• Do not use this medicine after the expiry date
which is stated on the box after “EXP”. The
expiry date refers to the last day of the month
• If the medicine becomes discoloured or
shows any other signs of deterioration, you
should seek the advice of your pharmacist
who will tell you what to do
• Do not throw away any medicines via waste
water or household waste. Ask your
pharmacist how to throw away medicines you
no longer use. These measures will help to
protect the environment.

Like all medicines, this medicine 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;
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).
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;
throat pain; an inflamed pancreas (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.
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;
skin rash typically on face, skin sensitivity to
sunlight along with joint pain, arthritis, fatigue
and overall feeling sickness; kidney problems
(such as inflammation and scarring of the
kidney).

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.
The tablets are red-brown oval-shaped and
bear the engraved initials S476.
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 Limited
and repackaged by YMD Pharma Limited, both
at Commerce Way, Edenbridge TN8 6ED, UK.
POM

PL No: 10380/1453

Leaflet Revision Date: 12/01/2018
Mezavant® is a registered trademark of Giuliani
International Limited, Ireland.

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If you get any side effects, talk to your doctor.
This includes any possible 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 national
reporting system: Yellow Card Scheme
Website: http://www.mhra.gov.uk/yellowcard or
search for MHRA Yellow Card in the Google
Play or Apple App Store. By reporting side
effects you can help provide more information
on the safety of this medicine.

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