ASACOL 400MG MR TABLETS

Active substance: MESALAZINE

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PACKAGE LEAFLET: INFORMATION FOR THE
USER
Asacol® 400mg MR Tablets
(mesalazine)

Read all of this leaflet carefully before you
start taking this medicine.
–  eep this leaflet. You may need to read it
K
again.
– f you have any further questions, ask your
I
doctor or pharmacist.
–  his medicine has been prescribed for you.
T
Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
– f any of the side effects gets serious, or if you
I
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1.  hat Asacol 400mg MR Tablets are and
W
what they are used for
2.  efore you take Asacol 400mg MR Tablets
B
3.  ow to take Asacol 400mg MR Tablets
H
4.  ossible side effects
P
5.  ow to store Asacol 400mg MR Tablets
H
6. Further information

1.  HAT ASACOL 400MG MR TABLETS ARE
W
AND WHAT THEY ARE USED FOR

Asacol 400mg MR Tablets should NOT be taken
with Lactulose (a medicine for constipation).
Use of non-steroidal anti-inflammatory drugs
(NSAIDs such as ibuprofen, aspirin, Cox-II
inhibitors) and azathioprine in particular may
increase the risk of kidney reactions.

Pregnancy and breast-feeding
Women who are pregnant or breast-feeding
should not take Asacol 400mg MR Tablets unless
advised otherwise by their doctor.
Ask your doctor or pharmacist for advice before
taking any medicine.
Driving and using machines
Asacol 400mg MR Tablets are not expected to
affect your ability to drive or operate machinery.

Important information about some of the
ingredients of Asacol 400mg MR Tablets
Lactose – if you know you have an intolerance to
some sugars, contact your doctor before taking
this medicine.
3.  OW TO TAKE ASACOL 400MG MR
H
TABLETS

Always take Asacol 400mg MR Tablets exactly as
your doctor has told you. You should check with
your doctor if you are not sure.

The tablets should be swallowed whole with
Asacol 400mg MR Tablets contain the
water; do not break, crush or chew them.
active substance mesalazine (also known
as 5-aminosalicylic acid) which is an antiThe usual dose is:
inflammatory drug used in the treatment of:
• Treating ulcerative colitis – 6 tablets each day

• Ulcerative colitis – a disease of the large

divided throughout the day. For example:
bowel (colon) and back passage (rectum)
– 2 tablets 3 times a day OR
in which the lining of the bowel becomes
– 3 tablets twice a day.
inflamed (red and swollen). Symptoms can
• Preventing further episodes of ulcerative

include rectal bleeding, frequent diarrhoea and
colitis – between 3 and 6 tablets once daily or
abdominal pain. Asacol 400mg MR Tablets
divided throughout the day. For example:
act locally in the colon to reduce inflammation
–  daily dosage of 3 tablets may be taken as
a
and can also prevent further episodes (flares)
3 tablets once a day or 1 tablet 3 times a
of ulcerative colitis.
day
• Crohn’s ileo-colitis – a disease affecting

–  daily dosage of 6 tablets may be taken as
a
the small bowel (terminal ileum) and colon in
6 tablets once a day or 3 tablets twice a day.
which the lining of the bowel becomes swollen
• Preventing further episodes of Crohn’s

and sore. This may lead to the development
ileo-colitis – between 3 and 6 tablets divided
of ulcers, abscesses and narrowing (strictures)
throughout the day. For example:
in the bowel. Asacol 400mg MR Tablets act
–  daily dosage of 3 tablets may be taken as
a
locally in the terminal ileum and colon to
1 tablet 3 times a day
control the disease and prevent further flares
–  daily dosage of 6 tablets may be taken as
a
of Crohn’s ileo-colitis.
3 tablets twice a day.
2.  EFORE YOU TAKE ASACOL 400MG MR
B
DO NOT take more than 6 tablets a day.
TABLETS
Asacol 400mg MR Tablets are not
Do not take Asacol 400mg MR Tablets if you:
recommended for use in children.
•  re allergic (hypersensitive) to any of the
a
Keep taking the tablets for as long as your doctor
ingredients in the product (see Section 6 on
tells you. Your symptoms may come back if you
‘What Asacol 400mg MR Tablets contain’)
stop treatment too early. Remember to get a
•  re allergic to aspirin or any other salicylate
a
repeat prescription at the right time so that you
•  ave had kidney problems or blood
h
do not miss a day of treatment.
abnormalities while taking other medicines
If you take more Asacol 400mg MR Tablets
such as sulphasalazine
than you should
•  ave severe kidney impairment.
h
Do not exceed the recommended dose. You
DO NOT give the tablets to children under 2
should only take as many tablets as your doctor
years of age.
has instructed on the pharmacist’s label. If
you take too much medicine, tell your doctor
Take special care with Asacol 400mg MR
immediately or go to your nearest Accident &
Tablets
Emergency Department (take the tablet pack with
•  sacol should be used with extreme caution
A
you if possible).
in patients with confirmed mild to moderate
kidney impairment.
If you forget to take Asacol 400mg MR Tablets
•  sacol should be used with caution in the
A
If you forget to take a dose at the required time,
elderly.
take it as soon as you remember and continue
Taking other medicines
taking your tablets as before. DO NOT take more
Please tell your doctor if you are taking or have
than two doses in one hour. If it is almost time for
recently taken any other medicines, including
your next dose, wait until then and carry on as
those obtained without a prescription.
before.

If you have any further questions on the use of
this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS

Like all medicines, Asacol 400mg MR Tablets can
cause side effects, although not everybody gets
them.

Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.
6. FURTHER INFORMATION

What Asacol 400mg MR Tablets contain
The active substance is mesalazine (also known
as 5-aminosalicylic acid). Each tablet contains
400mg mesalazine.
The other ingredients are
Core: lactose monohydrate, sodium starch
glycollate, magnesium stearate, talc, povidone.
Coating: methacrylic acid-methyl methacrylate
Tell your doctor IMMEDIATELY if you experience
copolymer (1:2), dibutyl sebacate, ferric oxide
any of the following symptoms:
yellow (E172), ferric oxide red (E172) and
• ever, sore throat, mouth or lip ulcers, spots
f
macrogol 6000.
underneath your skin anywhere on your
See also Section 2 on ‘Important information
body, including the genital and anal regions,
about some of the ingredients of Asacol 400mg
become very pale, swollen ankles or have
unusual bleeding (e.g. unexpected nosebleeds MR Tablets’.
or bleeding gums)
What Asacol 400mg MR Tablets look like and
•  kin rash with flaking, boils or sore lips or
s
contents of the pack
mouth
Asacol 400mg MR Tablets are red-brown, coated
•  ruising more easily or suspect blood
b
and oblong shaped. They are packed in a plastic
abnormalities
bottle with a child-resistant closure that contains
•  roblems with kidney function
p
a cotton/silica gel moisture absorbing pouch.
Asacol 400mg MR Tablets are available in packs
Common side effects (in more than 1 in 100
of 90 or 120 tablets (not all pack sizes may be
people but less than 1 in 10 people):
marketed).
•  iarrhoea
d
•  bdominal pain
a
Marketing Authorisation Holder
•  ausea (feeling sick)
n
Warner Chilcott UK Limited, Old Belfast Road,
•  eadache.
h
Millbrook, Larne, County Antrim, BT40 2SH,
Rare side effects (in less than 1 in 1000 people): United Kingdom.
•  roblems with heart, lung, liver or kidney
p
Manufacturer
function
Actavis UK Limited
• nflammation of the pancreas
i
Whiddon Valley,
•  lood abnormalities
b
Barnstaple,
•  umbness and tingling of the fingers and toes North Devon,
n
due to damaged nerves
EX32 8NS
•  air loss
h
United Kingdom
• ever
f
•  kin rash.
s
Getting more advice about ulcerative colitis or
Crohn’s ileo-colitis
Very rare side effects (in less than 1 in 10,000
In addition to advice and information available
people):
from your doctor and pharmacist, you may wish
•  orsening of symptoms of colitis
w
to contact the National Association for Colitis and
•  rythema multiforme and Stevens-Johnson
E
Crohn’s Disease which offers information, advice
syndrome (skin and mucous membrane
and local support groups:
disease).
National Association for Colitis and Crohn’s
Reporting of side effects
Disease
If you get any side effects, talk to your doctor,
PO Box 205, St. Albans, Hertfordshire, AL1 5ZN
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also Telephone information line: 0845 130 3344
(Monday to Thursday 10am – 1pm)
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard
NACC-in-Contact Support Line: 0845 130 2233
(Monday to Thursday 6.30pm – 9pm)
By reporting side effects you can help provide
more information on the safety of this medicine.
Large print, braille, audio format leaflet
To obtain this leaflet in large print, braille or audio
5.  OW TO STORE ASACOL 400MG MR
H
format, please call the following free-phone
TABLETS
number: 0800 198 5000.
Keep out of the reach and sight of children.
Asacol® is a Trademark
Store Asacol 400mg MR Tablets in their original
pack below 25°C (77ºF) in a dry place, protected Marketing Authorisation Number: PL 10947/0011
from direct sunlight.
This leaflet was last approved in October 2014
Do not remove the moisture absorbing pouch
from the bottle.
The pouch is not part of your medicine and is
marked DO NOT EAT. Keep the bottle tightly
closed.
Allergic reactions to the tablets 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 you stop taking
the medicine.

Do not use Asacol 400mg MR Tablets after the
expiry date which is stated on the pack after
‘Exp’. The expiry date refers to the last day of
that month.

416997
AAAH1241

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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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