Skip to Content

ASACOL 400MG MR TABLETS

Active substance: MESALAZINE

View full screen / Print PDF » Download PDF ⇩
Transcript
absorbing pouch.
Asacol 400mg MR tablets are
available in packs of 84, 90,
120 or 168 tablets (not all pack
sizes may be marketed).

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.

Marketing Authorisation
Holder
Warner Chilcott UK Limited,
Old Belfast Road, Millbrook,
Larne, County Antrim,
BT40 2SH, United Kingdom.

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.

Manufacturer
Actavis, Barnstaple,
EX32 8NS, UK

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 acidmethyl 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
50819874

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 January 2015

AAAH2308

page 4

260x210 Leaflet Reel Fed Bi Fold Profile (BST)

PACKAGE LEAFLET:
INFORMATION FOR THE
USER

Asacol® 400mg MR tablets
(mesalazine)

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.
• Crohn’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 ileo-colitis.

Read all of this leaflet
carefully before you start
taking this medicine.
–  eep this leaflet. You may
K
need to read it again.
– f you have any further
I
questions, ask your doctor or
pharmacist.
–  his medicine has been
T
prescribed for you. 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
I
serious, or if you notice any
2.  EFORE YOU TAKE
B
side effects not listed in this
ASACOL 400MG
leaflet, please tell your doctor
MR TABLETS
or pharmacist.
Do not take Asacol 400mg
In this leaflet:
MR tablets if you:
1.  hat Asacol 400mg
W
•  re allergic (hypersensitive)
a
MR tablets are and what
to any of the ingredients in
they are used for
the product (see Section
2.  efore you take Asacol
B
6 on ‘What Asacol 400mg
400mg MR tablets
MR tablets contain’)
3.  ow to take Asacol 400mg
H
•  re allergic to aspirin or any
a
MR tablets
other salicylate
4.  ossible side effects
P
•  ave had kidney problems
h
5.  ow to store Asacol 400mg
H
or blood abnormalities while
MR tablets
taking other medicines such
6.  urther information
F
as sulphasalazine
•  ave severe kidney
h
1.  HAT ASACOL 400MG
W
impairment.
MR TABLETS ARE AND
DO NOT give the tablets to
WHAT THEY ARE USED
children under 2 years of age.
FOR
Take special care with
Asacol 400mg MR tablets
Asacol 400mg MR tablets
contain the active substance
•  sacol should be used with
A
mesalazine (also known as
extreme caution in patients
5-aminosalicylic acid) which is
with confirmed mild to
an anti-inflammatory drug used
moderate kidney impairment.
in the treatment of:
A
• Ulcerative colitis – a disease •  sacol should be used with

caution in the elderly.
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,
page 1

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 breastfeeding
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.

The usual dose is:
• Treating ulcerative colitis –

6 tablets each day divided
throughout the day. For
example:
–   tablets 3 times a day OR
2
–   tablets twice a day.
3
• Preventing further episodes

of ulcerative colitis
–  etween 3 and 6 tablets once
b
daily or divided throughout
the day. For example:
–  daily dosage of 3 tablets
a
may be taken as 3 tablets
once a day or 1 tablet 3
times a day
–  daily dosage of 6 tablets
a
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:
–  daily dosage of 3 tablets
a
may be taken as 1 tablet 3
times a day
–  daily dosage of 6 tablets
a
may be taken as 3 tablets
twice a day.
DO NOT take more than
6 tablets a day.

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
H
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.

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

page 2

260x210 Leaflet Reel Fed Bi Fold Profile (BST)

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:
•  rash with or without itching,
a
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:
• ever, sore throat, mouth or
f
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)
•  kin rash with flaking, boils or
s
sore lips or mouth
•  ruising more easily or
b
suspect blood abnormalities
•  roblems with kidney function
p

Common side effects (in more
than 1 in 100 people but less
than 1 in 10 people):
•  iarrhoea
d
•  bdominal pain
a
•  ausea (feeling sick)
n
•  eadache.
h
Rare side effects (in less than
1 in 1000 people):
•  roblems with heart, lung,
p
liver or kidney function
• nflammation of the pancreas
i
•  lood abnormalities
b
• 
numbness and tingling of
the fingers and toes due to
damaged nerves
•  air loss
h
• ever
f
•  kin rash.
s
Very rare side effects (in less
than 1 in 10,000 people):
•  orsening of symptoms of
w
colitis
•  rythema multiforme and
E
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.  OW TO STORE ASACOL
H
400MG MR TABLETS
Keep out of the reach and
sight of children.
Store Asacol 400mg
MR tablets in their original
pack below 25ºC (77ºF) in
a dry place, protected from
direct sunlight.

page3

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.
–  his medicine has been prescribed for you. Do not
T
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 notice
I
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.  HAT ASACOL 400MG MR TABLETS ARE AND WHAT
W
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 colon to reduce inflammation
and can also prevent further episodes (flares) of
ulcerative colitis.
• Crohn’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:
•  re allergic (hypersensitive) to any of the ingredients
a
in the product (see Section 6 on ‘What Asacol 400mg
MR Tablets contain’)
• are allergic to aspirin or any other salicylate
•  ave had kidney problems or blood abnormalities
h
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
•  sacol should be used with extreme caution in patients
A
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:
• 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:

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

–  daily dosage of 6 tablets may be taken as
a
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:

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

–  daily dosage of 6 tablets may be taken as
a
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:
•  rash (with or without itching), any shortness of breath,
a
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:
• ever, sore throat, mouth or lip ulcers, spots
f
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
•  umbness and tingling of the fingers and toes due to
n
damaged nerves
• hair loss
• fever
• skin rash.
Very rare side effects (in less than 1 in 10,000 people):
• worsening of symptoms of colitis
•  rythema multiforme and Stevens-Johnson syndrome
E
(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.

Expand view ⇕

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.

Hide