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ASACOL 400MG MR TABLETS

Active substance(s): 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.
– 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.
In this leaflet:
1. W
 hat Asacol 400mg MR Tablets are and what they
are used for
2. Before you take Asacol 400mg MR Tablets
3. How to take Asacol 400mg MR Tablets
4. Possible side effects
5. How to store Asacol 400mg MR Tablets
6. Further information
1. WHAT ASACOL 400MG MR TABLETS ARE AND WHAT
THEY ARE USED FOR
Asacol 400mg MR Tablets contain the active substance
mesalazine (also known as 5-aminosalicylic acid) which is
an anti-inflammatory drug used in the treatment of:
•U
 lcerative colitis – a disease of the large bowel
(colon) and back passage (rectum) in which the lining
of the bowel becomes inflamed (red and swollen).
Symptoms can include rectal bleeding, frequent
diarrhoea and abdominal pain. Asacol 400mg MR
Tablets act locally in the colon to reduce inflammation
and can also prevent further episodes (flares) of
ulcerative colitis.
•C
 rohn’s ileo-colitis – a disease affecting the small
bowel (terminal ileum) and colon in which the lining of
the bowel becomes swollen and sore. This may lead to
the development of ulcers, abscesses and narrowing
(strictures) in the bowel. Asacol 400mg MR Tablets act
locally in the terminal ileum and colon to control the
disease and prevent further flares of Crohn’s ileocolitis.
2. BEFORE YOU TAKE ASACOL 400MG MR TABLETS
Do not take Asacol 400mg MR Tablets if you:
• are allergic (hypersensitive) to any of the ingredients
in the product (see Section 6 on ‘What Asacol 400mg
MR Tablets contain’)
• are allergic to aspirin or any other salicylate
• have had kidney problems or blood abnormalities
while taking other medicines such as sulphasalazine
• have severe kidney impairment.
DO NOT give the tablets to children under 2 years of age.
Take special care with Asacol 400mg MR Tablets
• Asacol should be used with extreme caution in patients
with confirmed mild to moderate kidney impairment.
• Asacol should be used with caution in the elderly.
Taking other medicines
Please tell your doctor if you are taking or have recently
taken any other medicines, including those obtained without
a prescription.

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.
Tests on your liver, kidney and blood
Before you start treatment with Asacol 400mg tablets you will
have a blood and urine test to check how well your kidneys
are working and what your blood is doing. During treatment
your doctor will check how well your liver, kidney and blood
is working by taking blood and urine sample periodically
during your treatment.
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. HOW TO TAKE ASACOL 400MG MR 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 water; do not
break, crush or chew them.
Whilst taking this medicine ensure you drink adequate fluids
to remain well hydrated, especially after severe or prolonged
episodes of vomiting and /or diarrhoea, high fever or heavy
sweating. This is to avoid problems with your kidneys.
The usual dose is:
•T
 reating ulcerative colitis – 6 tablets each day divided
throughout the day. For example:

– 2 tablets 3 times a day OR

– 3 tablets twice a day.
•P
 reventing further episodes of ulcerative colitis
– between 3 and 6 tablets once daily or divided
throughout the day. For example:

– a daily dosage of 3 tablets may be taken as
3 tablets once a day or 1 tablet 3 times a day

– a daily dosage of 6 tablets may be taken as
6 tablets once a day or 3 tablets twice a day.
•P
 reventing further episodes of Crohn’s ileo-colitis –
between 3 and 6 tablets divided throughout the day.
For example:

– a daily dosage of 3 tablets may be taken as
1 tablet 3 times a day

– a daily dosage of 6 tablets may be taken as
3 tablets twice a day.
DO NOT take more than 6 tablets a day.
Asacol 400mg MR Tablets are not recommended for
use in children.
Keep taking the tablets for as long as your doctor tells you.
Your symptoms may come back if you stop treatment too
early. Remember to get a repeat prescription at the right
time so that you do not miss a day of treatment.

Asacol (Mesalazine) 400mg Tablets PIL - Warner Chilcott UK
item no: AAAH5767

dimensions: 180 x 300

print proof no: 5

pharmacode:

origination date: 15.01.15

min pt size: 10

colours/plates:
1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
revision date: 10.03.15

Technical Approval

revised by: S.Anson

date sent: n/a

supplier: IL/Catalent, Schorndorf,
Germany

technically app. date:

Non Printing Colours
1.
2.
3.

If you take more Asacol 400mg MR Tablets than
you should
Do not exceed the recommended dose. You should only
take as many tablets as your doctor has instructed on
the pharmacist’s label. If you take too much medicine, tell
your doctor immediately or go to your nearest Accident &
Emergency Department. Take the tablet pack with you if
possible.
If you forget to take Asacol 400mg MR Tablets
If you forget to take a dose at the required time, take it as
soon as you remember and continue taking your tablets as
before. DO NOT take more than two doses in one hour. If it
is almost time for your next dose, wait until then and carry on
as 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.
Allergic reactions 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.
Tell your doctor immediately if you experience any of the
following symptoms:
• fever, sore throat, mouth or lip ulcers, spots
underneath your skin anywhere on your body,
including the genital and anal regions, become very
pale, swollen ankles or have unusual bleeding
(e.g. unexpected nosebleeds or bleeding gums)
• skin rash with flaking, boils or sore lips or mouth
• bruising more easily or suspect blood abnormalities
• problems with kidney function
Common side effects (in more than 1 in 100 people but
less than 1 in 10 people):
• diarrhoea
• abdominal pain
• nausea (feeling sick)
• headache.
Rare side effects (in less than 1 in 1000 people):
• problems with heart, lung, liver or kidney function
• inflammation of the pancreas
• blood abnormalities
• numbness and tingling of the fingers and toes due to
damaged nerves
• hair loss
• fever
• skin rash.
Very rare side effects (in less than 1 in 10,000 people):
• worsening of symptoms of colitis
• Erythema multiforme and Stevens-Johnson syndrome
(skin and mucous membrane disease).

5. HOW TO STORE ASACOL 400MG MR TABLETS
Keep out of the sight and reach of children.
Store Asacol 400mg MR Tablets in their original pack below
25ºC (77ºF) in a dry place, protected from direct sunlight.
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.
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.
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
copolymer (1:2), dibutyl sebacate, ferric oxide yellow
(E172), ferric oxide red (E172) and macrogol 6000.
See also Section 2 on ‘Important information about some of
the ingredients of Asacol 400mg MR Tablets’.
What Asacol 400mg MR Tablets look like and contents
of the pack
Asacol 400mg MR Tablets are red-brown, coated and oblong
shaped. They are packed in a plastic bottle with a childresistant closure that contains a cotton/silica gel moisture
absorbing pouch.
Asacol 400mg MR Tablets are available in packs of 84, 90,
120 or 168 tablets. (not all pack sizes may be marketed).
Marketing Authorisation Holder
Warner Chilcott UK Limited, Old Belfast Road, Millbrook,
Larne, County Antrim, BT40 2SH, United Kingdom.
Manufacturer
Actavis Group PTC, Reykjavíkurvegi 76-78,
220 Hafnarfjörður (Iceland)
Getting more advice about ulcerative colitis or Crohn’s
ileo-colitis
In addition to advice and information available from your
doctor and pharmacist, you may wish to contact Crohn’s
and Colitis UK for Colitis and Crohn’s Disease which offers
information, advice and local support groups.
Crohn’s and Colitis UK, 4 Beaumont House, Sutton Road, St
Albans, Herts., AL1 5HH
Telephone Information Line: 0845 130 2233
(Monday to Friday 10am – 1pm)
Crohn’s and Colitis Support Line: 0845 130 3344
(Monday to Friday 1.00pm – 3.30pm / 6.30pm – 9pm)

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. 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

Large print, braille, audio format leaflet
To obtain this leaflet in large print, braille or audio format,
please call the following free-phone number: 0800 198 5000.

By reporting side effects you can help provide more
information on the safety of this medicine.

Marketing Authorisation Number: PL 10947/0011

Asacol® is a Trademark

This leaflet was last approved in March 2015

Asacol (Mesalazine) 400mg Tablets PIL - Warner Chilcott UK
item no: AAAH5767

dimensions: 180 x 300

print proof no: 5

pharmacode:

origination date: 15.01.15

min pt size: 10

416997
AAAH5767

colours/plates:
1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
revision date: 10.03.15

Technical Approval

revised by: S.Anson

date sent: n/a

supplier: IL/Catalent, Schorndorf,
Germany

technically app. date:

Non Printing Colours
1.
2.
3.

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.
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 copolymer (1:2),
dibutyl sebacate, ferric oxide
yellow (E172), ferric oxide red
(E172) and macrogol 6000.
See also Section 2 on ‘Important
information about some of the
ingredients of Asacol 400mg
MR tablets’.
What Asacol 400mg
MR tablets look like and
contents of the pack
Asacol 400mg MR tablets are
red-brown, coated and oblong
shaped. They are packed in
a plastic bottle with a childresistant closure that contains
a cotton/silica gel moisture
absorbing pouch.
Asacol 400mg MR tablets are
available in packs of 84, 90, 120
or 168 tablets (not all pack sizes
may be marketed).
Marketing Authorisation
Holder
Warner Chilcott UK Limited, Old
Belfast Road, Millbrook, Larne,
County Antrim, BT40 2SH,
United Kingdom.
50819874

Manufacturer
Actavis, Barnstaple,
EX32 8NS, UK.

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

Getting more advice about
ulcerative colitis or Crohn’s
ileo-colitis
In addition to advice and
information available from your
doctor and pharmacist, you
may wish to contact Crohn’s
and Colitis UK for Colitis and
Crohn’s Disease which offers
information, advice and local
support groups.
Crohn’s and Colitis UK,
4 Beaumont House, Sutton
Road, St Albans, Herts.,
AL1 5HH
Telephone Information Line:
0845 130 2233 (Monday to
Friday 10am – 1pm)
Crohn’s and Colitis Support Line:
0845 130 3344
(Monday to Friday 1.00pm3.30pm / 6.30pm – 9pm)
Large print, braille, audio
format leaflet
To obtain this leaflet in large
print, braille or audio format,
please call the following freephone number: 0800 198 5000.
Asacol® is a Trademark
Marketing Authorisation Number:
PL 10947/0011
This leaflet was last approved in
March 2015

AAAH2308

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.
In this leaflet:
1. What Asacol 400mg
MR tablets are and what they
are used for
2. Before you take Asacol
400mg MR tablets
3. How to take Asacol 400mg
MR tablets
4. Possible side effects
5. How to store Asacol 400mg
MR tablets
6. Further information

colon to reduce inflammation
and can also prevent further
episodes (flares) of ulcerative
colitis.
•C
 rohn’s ileo-colitis – a
disease affecting the small
bowel (terminal ileum) and
colon in which the lining of
the bowel becomes swollen
and sore. This may lead to
the development of ulcers,
abscesses and narrowing
(strictures) in the bowel. Asacol
400mg MR tablets act locally in
the terminal ileum and colon to
control the disease and prevent
further flares of Crohn’s ileocolitis.
2. BEFORE YOU TAKE
ASACOL 400MG
MR TABLETS
Do not take Asacol 400mg
MR tablets if you:
• are allergic (hypersensitive)
to any of the ingredients in
the product (see Section
6 on ‘What Asacol 400mg
MR tablets contain’)
• are allergic to aspirin or any
other salicylate
• have had kidney problems
or blood abnormalities while
taking other medicines such as
sulphasalazine
• have severe kidney impairment.
DO NOT give the tablets to
children under 2 years of age.

1. WHAT ASACOL 400MG
MR TABLETS ARE AND
Take special care with Asacol
WHAT THEY ARE USED FOR 400mg MR tablets
• Asacol should be used with
Asacol 400mg MR tablets
extreme caution in patients
contain the active substance
with confirmed mild to
mesalazine (also known as
moderate kidney impairment.
5-aminosalicylic acid) which is
• Asacol should be used with
an anti-inflammatory drug used
caution in the elderly.
in the treatment of:
•U
 lcerative colitis – a disease
Taking other medicines
of the large bowel (colon)
Please tell your doctor if you are
and back passage (rectum)
taking or have recently taken any
in which the lining of the
other medicines, including those
bowel becomes inflamed
obtained without a prescription.
(red and swollen). Symptoms
Asacol 400mg MR tablets should
can include rectal bleeding,
NOT be taken with Lactulose (a
frequent diarrhoea and
medicine for constipation).
abdominal pain. Asacol 400mg Use of non-steroidal antiMR tablets act locally in the
inflammatory drugs (NSAIDs

page 4

page 1

260x210 Leaflet Reel Fed Bi Fold Profile (BST)

Asacol 400mg MR Tablets (DBS)
BST QP (UK)
JDE No.:

Asacol (Mesalazine) 400 mg Tablets PIL Warner Chilcott UK

50819874

item no:

AAAH2308

dimensions: 260 x 210

Dimensions: 260x210 (Reel Fed)
Component: Leaflet for Bottle

print proof no:

9

pharmacode:

Pharmacode: 5952

originated by:

db

revision date:

27.2.15

Technical Approval

revised by:

db

date sent:

n/a

supplier:

Actavis UK

approved:

n/a

Date Sent:
12/08/14
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

origination date: 15.9.14
approved for print/date

min pt size:

colours/plates:
1. black
2.
3.
4.

9.5 pt

5.
6.
Non Printing Colours
1. profile
2.
3.

such as ibuprofen, aspirin, Cox-II
inhibitors) and azathioprine in
particular may increase the risk
of kidney reactions.

prolonged episodes of vomiting
and /or diarrhoea, high fever or
heavy sweating. This is to avoid
problems with your kidneys.

Pregnancy and breast-feeding The usual dose is:
Women who are pregnant or
•T
 reating ulcerative colitis –
breast-feeding should not take
6 tablets each day divided
Asacol 400mg MR tablets unless
throughout the day. For
advised otherwise by their
example:
doctor.
– 2 tablets 3 times a day OR
– 3 tablets twice a day.
Ask your doctor or pharmacist
•P
 reventing further episodes of
for advice before taking any
ulcerative colitis
medicine.
– between 3 and 6 tablets once
daily or divided throughout the
Tests on your liver, kidney and
day. For example:
blood
– a daily dosage of 3 tablets may
Before you start treatment with
be taken as 3 tablets once a
Asacol 400mg tablets you will
day or 1 tablet 3 times a day
have a blood and urine test to
– a daily dosage of 6 tablets may
check how well your kidneys are
be taken as 6 tablets once a
working and what your blood
day or 3 tablets twice a day.
is doing. During treatment
•P
 reventing further episodes of
your doctor will check how well
Crohn’s ileo-colitis – between
your liver, kidney and blood is
3 and 6 tablets divided
working by taking blood and
throughout the day. For
urine sample periodically during
example:
your treatment.
– a daily dosage of 3 tablets may
be taken as 1 tablet 3 times a
Driving and using machines
day
Asacol 400mg MR tablets are
– a daily dosage of 6 tablets may
not expected to affect your
be taken as 3 tablets twice a
ability to drive or operate
day.
machinery.
DO NOT take more than
Important information about
6 tablets a day.
some of the ingredients of
Asacol 400mg MR tablets
Asacol 400mg MR tablets are
Lactose – if you know you have
not recommended for use in
an intolerance to some sugars,
children.
contact your doctor before
taking this medicine.
If you stop taking Ascol 400mg
MR tablets
3. HOW TO TAKE ASACOL
Keep taking the tablets for as
400MG MR TABLETS
long as your doctor tells you.
Your symptoms may come
Always take Asacol 400mg
back if you stop treatment too
MR tablets exactly as your
early. Remember to get a repeat
doctor has told you. You should prescription at the right time so
check with your doctor if you are that you do not miss a day of
not sure.
treatment.
The tablets should be swallowed If you take more Asacol 400mg
whole with water; do not break,
MR tablets than you should
crush or chew them.
Do not exceed the
recommended dose. You should
Whilst taking this medicine
only take as many tablets as
ensure you drink adequate
your doctor has instructed on
fluids to remain well hydrated,
the pharmacist’s label. If you
especially after severe or

take too much medicine, tell
your doctor immediately or
go to your nearest Accident &
Emergency Department. Take
the tablet pack with you if
possible.

• nausea (feeling sick)
• headache.

Rare side effects (in less than 1
in 1000 people):
• problems with heart, lung, liver
or kidney function
If you forget to take Asacol
• inflammation of the pancreas
400mg MR tablets
• blood abnormalities
If you forget to take a dose at
• numbness and tingling of
the required time, take it as soon
the fingers and toes due to
as you remember and continue
damaged nerves
taking your tablets as before. DO • hair loss
NOT take more than two doses
• fever
in one hour. If it is almost time
• skin rash.
for your next dose, wait until
Very rare side effects (in less
then and carry on as before.
than 1 in 10,000 people):
If you have any further questions • worsening of symptoms of
on the use of this product, ask
colitis
your doctor or pharmacist.
• Erythema multiforme and
Stevens-Johnson syndrome
4. POSSIBLE SIDE EFFECTS
(skin and mucous membrane
disease).
Like all medicines, Asacol
400mg MR tablets can cause
Reporting of side effects
side effects, although not
If you get any side effects, talk
everybody gets them.
to your doctor, pharmacist or
nurse. This includes any possible
Allergic reactions can occur. Tell side effects not listed in this
your doctor if you get:
leaflet. You can also report side
• a rash with or without itching,
effects directly via the Yellow
any shortness of breath,
Card Scheme at: www.mhra.gov.
palpitations (rapid heart beat)
uk/yellowcard
or chest pain. These effects will
usually disappear when you
By reporting side effects you can
stop taking the medicine.
help provide more information
on the safety of this medicine.
Tell your doctor immediately
if you experience any of the
following symptoms:
5. HOW TO STORE ASACOL
• fever, sore throat, mouth or lip
400MG MR TABLETS
ulcers, spots underneath your
Keep out of the sight and reach
skin anywhere on your body,
of children.
including the genital and anal
Store Asacol 400mg MR tablets
regions, become very pale,
swollen ankles or have unusual in their original pack below 25ºC
(77ºF) in a dry place, protected
bleeding (e.g. unexpected
from direct sunlight.
nosebleeds or bleeding gums)
• skin rash with flaking, boils or
Do not remove the moisture
sore lips or mouth
• bruising more easily or suspect absorbing pouch from the bottle.
The pouch is not part of your
blood abnormalities
medicine and is marked DO
• problems with kidney function
NOT EAT. Keep the bottle tightly
Common side effects (in more
closed.
than 1 in 100 people but less
than 1 in 10 people):
• diarrhoea
• abdominal pain

page 2

page3

260x210 Leaflet Reel Fed Bi Fold Profile (BST)

Asacol 400mg MR Tablets (DBS)
BST QP (UK)
JDE No.:

Asacol (Mesalazine) 400 mg Tablets PIL Warner Chilcott UK

50819874

item no:

AAAH2308

dimensions: 260 x 210

Dimensions: 260x210 (Reel Fed)
Component: Leaflet for Bottle

print proof no:

9

pharmacode:

Pharmacode: 5952

originated by:

db

revision date:

27.2.15

Technical Approval

revised by:

db

date sent:

n/a

supplier:

Actavis UK

approved:

n/a

Date Sent:
12/08/14
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

origination date: 15.9.14
approved for print/date

min pt size:

colours/plates:
1. black
2.
3.
4.

9.5 pt

5.
6.
Non Printing Colours
1. profile
2.
3.

Insert - Asacol® 400mg- UK - MoH Submission

PACKAGE LEAFLET:
INFORMATION FOR THE USER
Asacol® 400mg MR tablets
(mesalazine)
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.
In this leaflet:
1. What Asacol 400mg
MR tablets are and what they
are used for
2. Before you take Asacol
400mg MR tablets
3. How to take Asacol 400mg
MR tablets
4. Possible side effects
5. How to store Asacol 400mg
MR tablets
6. Further information
1. WHAT ASACOL 400MG
MR TABLETS ARE AND
WHAT THEY ARE USED FOR
Asacol 400mg MR tablets
contain the active substance
mesalazine (also known as
5-aminosalicylic acid) which is
an anti-inflammatory drug used
in the treatment of:
• Ulcerative colitis - a disease
of the large bowel (colon)
and back passage (rectum)
in which the lining of the
bowel becomes inflamed
(red and swollen). Symptoms
can include rectal bleeding,
frequent diarrhoea and
abdominal pain. Asacol 400mg
MR tablets act locally in the

Artwork created at 100%
Drop keylines and notes before printing
Part number: 79998MD117G
Drawing number: 438846

colon to reduce inflammation
and can also prevent further
episodes (flares) of ulcerative
colitis.
•C
 rohn’s ileo-colitis - a
disease affecting the small
bowel (terminal ileum) and
colon in which the lining of
the bowel becomes swollen
and sore. This may lead to
the development of ulcers,
abscesses and narrowing
(strictures) in the bowel. Asacol
400mg MR tablets act locally in
the terminal ileum and colon to
control the disease and prevent
further flares of Crohn’s ileocolitis.
2. BEFORE YOU TAKE
ASACOL 400MG
MR TABLETS
Do not take Asacol 400mg
MR tablets if you:
•a
 re allergic (hypersensitive)
to any of the ingredients in
the product (see Section 
6 on ‘What Asacol 400mg
MR tablets contain’)
•a
 re allergic to aspirin or any
other salicylate
•h
 ave had kidney problems
or blood abnormalities while
taking other medicines such as
sulphasalazine
•h
 ave severe kidney impairment.
DO NOT give the tablets to
children under 2 years of age.
Take special care with Asacol
400mg MR tablets
•A
 sacol should be used with
extreme caution in patients
with confirmed mild to
moderate kidney impairment.
•A
 sacol should be used with
caution in the elderly.
Taking other medicines
Please tell your doctor if you are
taking or have recently taken any
other medicines, including those
obtained without a prescription.
Asacol 400mg MR tablets should
NOT be taken with Lactulose (a 
medicine for constipation).
Use of non-steroidal antiinflammatory 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.
Tests on your liver, kidney and
blood
Before you start treatment with
Asacol 400mg tablets you will
have a blood and urine test to
check how well your kidneys are
working and what your blood
is doing. During treatment
your doctor will check how well
your liver, kidney and blood is
working by taking blood and
urine sample periodically during
your treatment.
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. HOW TO TAKE ASACOL
400MG MR 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 water; do not break,
crush or chew them.
Whilst taking this medicine
ensure you drink adequate
fluids to remain well hydrated,
especially after severe or

prolonged episodes of vomiting
and /or diarrhoea, high fever or
heavy sweating. This is to avoid
problems with your kidneys.
The usual dose is:
• Treating ulcerative colitis 6 tablets each day divided
throughout the day. For
example:
- 2 tablets 3 times a day OR
- 3 tablets twice a day.
• Preventing further episodes of
ulcerative colitis
- between 3 and 6 tablets once
daily or divided throughout the
day. For example:
- a daily dosage of 3 tablets may
be taken as 3 tablets once a 
day or 1 tablet 3 times a day
- a daily dosage of 6 tablets may
be taken as 6 tablets once a 
day or 3 tablets twice a day.
• Preventing further episodes of
Crohn’s ileo-colitis - between
3 and 6 tablets divided
throughout the day. For
example:
- a daily dosage of 3 tablets may
be taken as 1 tablet 3 times a 
day
- a daily dosage of 6 tablets may
be taken as 3 tablets twice a 
day.
DO NOT take more than
6 tablets a day.
Asacol 400mg MR tablets are
not recommended for use in
children.
If you stop taking Ascol 400mg
MR tablets
Keep taking the tablets for as
long as your doctor tells you.
Your symptoms may come
back if you stop treatment too
early. Remember to get a repeat
prescription at the right time so
that you do not miss a day of
treatment.
If you take more Asacol 400mg
MR tablets than you should
Do not exceed the
recommended dose. You should
only take as many tablets as
your doctor has instructed on the
pharmacist’s label. If you

take too much medicine, tell
your doctor immediately or
go to your nearest Accident &
Emergency Department. Take
the tablet pack with you if
possible.
If you forget to take Asacol
400mg MR tablets
If you forget to take a dose at
the required time, take it as soon
as you remember and continue
taking your tablets as before. DO
NOT take more than two doses
in one hour. If it is almost time
for your next dose, wait until
then and carry on as 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.
Allergic reactions 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.
Tell your doctor immediately
if you experience any of the
following symptoms:
• fever, sore throat, mouth or lip
ulcers, spots underneath your
skin anywhere on your body,
including the genital and anal
regions, become very pale,
swollen ankles or have unusual
bleeding (e.g. unexpected
nosebleeds or bleeding gums)
• skin rash with flaking, boils or
sore lips or mouth
• bruising more easily or suspect
blood abnormalities
• problems with kidney function
Common side effects (in more
than 1 in 100 people but less
than 1 in 10 people):
• diarrhoea
• abdominal pain

• nausea (feeling sick)
• headache.
Rare side effects (in less than 1 
in 1000 people):
• problems with heart, lung, liver
or kidney function
• inflammation of the pancreas
• blood abnormalities
• numbness and tingling of
the fingers and toes due to
damaged nerves
• hair loss
• fever
• skin rash.
Very rare side effects (in less
than 1 in 10,000 people):
• worsening of symptoms of
colitis
• Erythema multiforme and
Stevens-Johnson syndrome
(skin and mucous membrane
disease).
Reporting of side effects
If you get any side effects, talk
to your doctor, pharmacist or
nurse. 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 ASACOL
400MG MR TABLETS
Keep out of the sight and reach
of children.
Store Asacol 400mg MR tablets
in their original pack below 25°C
(77°F) in a dry place, protected
from direct sunlight.
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.

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.
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 copolymer (1:2),
dibutyl sebacate, ferric oxide
yellow (E172), ferric oxide red
(E172) and macrogol 6000.
See also Section 2 on ‘Important
information about some of the
ingredients of Asacol 400mg
MR tablets’.
What Asacol 400mg
MR tablets look like and
contents of the pack
Asacol 400mg MR tablets are
red-brown, coated and oblong
shaped. They are packed in
a plastic bottle with a childresistant closure that contains
a cotton/silica gel moisture
absorbing pouch.
Asacol 400mg MR tablets are
available in packs of 84, 90, 120 
or 168 tablets (not all pack sizes
may be marketed).
Marketing Authorisation
Holder
Warner Chilcott UK Limited, Old
Belfast Road, Millbrook, Larne,
County Antrim, BT40 2SH,
United Kingdom.

Manufacturer
Warner Chilcott
Deutschland GmbH
Dr.-Otto-Röhm-Straße 2-4
64331 Weiterstadt, Germany.
Getting more advice about
ulcerative colitis or Crohn’s
ileo-colitis
In addition to advice and
information available from your
doctor and pharmacist, you
may wish to contact Crohn’s 
and Colitis UK for Colitis and
Crohn’s Disease which offers
information, advice and local
support groups.
Crohn’s and Colitis UK,
4 Beaumont House, Sutton
Road, St Albans, Herts.,
AL1 5HH
Telephone Information Line:
0845 130 2233 (Monday to
Friday 10am - 1pm)
Crohn’s and Colitis Support Line:
0845 130 3344
(Monday to Friday 1.00pm3.30pm / 6.30pm - 9pm)
Large print, braille, audio
format leaflet
To obtain this leaflet in large
print, braille or audio format,
please call the following freephone number: 0800 198 5000.
Asacol® is a Trademark
Marketing Authorisation Number:
PL 10947/0011
This leaflet was last approved in
November 2015

438846
79998MD117G

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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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