Patient
Information Leaflet on ‘Asacol’ (mesalazine) 400mg MR
Tablets
This leaflet
tells you about ‘Asacol’ 400mg MR Tablets. Please read
it before taking these tablets. If there is anything you
do not understand, or if you want to know more about
your tablets, ask your doctor or pharmacist (chemist).
Please keep this leaflet. You may
want to read it again.
What
is in ‘Asacol’ 400mg MR Tablets?
Your
modified release tablets contain the active
ingredient mesalazine (also known as
5-aminosalicylic acid). ‘Asacol’ 400mg MR Tablets
are available in one strength of 400 milligrammes
(mg). They are covered with a coating called
‘Eudragit S’ (also known as methacrylic acid
copolymer) which allows the tablets to pass through
the stomach without dissolving. The tablet coating
will break down in the bowel, where the active
mesalazine is released.
The
tablets also contain inactive ingredients. These are
lactose, sodium starch glycollate, magnesium
stearate (E572), talcum (E553b),
polyvinylpyrrolidone, methacrylic acid copolymer,
dibutylphthalate, polyethylene glycol, yellow iron
oxide (E172), red iron oxide (E172).
Your
tablets each contain 0.8 mg sodium.
Your
tablets are available in packs of 90 and 120.
What is
‘Asacol’?
‘Asacol’
contains mesalazine, which is an anti-inflammatory drug.
What is
‘Asacol’ used for?
Ulcerative
colitis is a disease of the large bowel (colon) and back
passage (rectum), in which the lining of the bowel
becomes inflamed (red and swollen). ‘Asacol’ 400mg MR
Tablets act locally in the colon and rectum to reduce
this inflammation. They can also be used to prevent
further episodes of ulcerative colitis.
Crohn’s ileo-colitis
is a disease affecting the small bowel (terminal ileum)
and large bowel (colon) in which the lining of the bowel
becomes swollen and sore. This may lead to the
development of ulcers, abscesses and narrowings
(strictures) in the bowel. ‘Asacol’ 400mg MR Tablets act
locally in the terminal ileum and colon. Once the
disease has been brought under control they can be used
to prevent further episodes of Crohn’s ileo-colitis.
BEFORE
TAKING YOUR TABLETS
If you
answer YES to any of the
following questions go back to your doctor and ask what
you should do. You may need to be given another medicine
or the dose may need to be changed.
- Are
you allergic to any of the ingredients, aspirin or
other salicylates?
- Have
you got any kidney problems?
- Have
you had kidney problems whilst taking another
medicine such as sulphasalazine?
- Have
you had problems with your blood whilst taking
another medicine such as sulphasalazine?
- Is
the patient a child under two years of age?
- Are
you pregnant or do you think you may be?
- Are
you breast-feeding?
- Are
you taking a medicine called lactulose for
constipation?
TAKING
YOUR TABLETS
The usual
adult dosage is:
- For
the treatment of ulcerative colitis, six tablets
each day divided out throughout the day. For
example, two tablets three times a day or three
tablets twice a day.
- To
prevent an episode of ulcerative colitis or Crohn’s
ileo-colitis, between three and six tablets divided
out throughout the day. For example, from one tablet
three times a day to two tablets three times a day.
- Do
not take more than six tablets per day.
Swallow the tablets whole, do not chew or crush
them.
Doctors
sometimes prescribe different doses to those given
in this leaflet, if this applies to you, discuss it
with your doctor if you have not already done so.
The
pharmacist’s label on your pack will tell you how
much your doctor would like you to take. Please read
the label carefully.
Do
not take more than your doctor has recommended.
‘Asacol’
400mg MR Tablets are not recommended for children.
How
long should you carry on using 'Asacol'?
Keep
taking your tablets for as long as the doctor has
instructed. Always finish the prescribed course.
Your symptoms may come back if you stop your
treatment too early.
What
if you have taken too much?
You
should only take as many tablets as your doctor or
pharmacist has told you. If you take too many tell
your doctor or hospital casualty department straight
away. Take your tablet pack with you.
What
if you miss a dose?
If you
forget to take a dose at the right time, take it as
soon as you remember. Then go on as before, but do
not take two doses within one hour or so of each
other.
What
unwanted effects might your tablets cause?
The most
common unwanted effects with mesalazine (e.g. ‘Asacol’)
are nausea (feeling sick), headache, diarrhoea and
stomach pain.
Blood
disorders, inflammation of the pancreas, heart, liver or
kidney and other kidney problems, hair loss and damage
to peripheral nerves giving rise to numbness and
tingling can also occur rarely as unwanted effects. Your
doctor may want to take blood or urine samples
occasionally to ensure that your kidneys are functioning
properly.
Tell your
doctor if you start to bruise easily or if you get any
of the following symptoms: fever, sore throat, spots
under your skin, swollen ankles or unusual bleeding
(e.g. unexplained nosebleeds).
You should
also check with your doctor immediately if you
experience a rash on your skin combined with flaking,
boils or sore lips or mouth.
Allergic
reactions to mesalazine can occur. Tell your doctor if
you get a rash (with or without itching), any shortness
of breath, palpitations (rapid heart beat) or chest
pain. These effects will usually disappear when the
mesalazine is stopped.
Very rarely,
symptoms of colitis can worsen in patients taking
mesalazine.
Tell your doctor or pharmacist if you
notice any of these effects or any other unwanted
effects not mentioned above.
STORING
YOUR TABLETS
Your tablets
will have an expiry date on the pack. You should not use
your tablets after this date.
The tablets
should be stored in a dry place below room temperature
(25ºC or 77ºF) and protected from light, preferably in
their original pack.
Keep all medicines out of the reach
of children - preferably in a locked cupboard or
medicine cabinet.
Remember this medicine has
been prescribed just for you. Never offer your medicine
to other people. It may not be suitable for them even if
their symptoms seem the same as yours.
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