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ASACOL 800MG MR TABLETS

Active substance(s): MESALAZINE

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Insert - Asacol® 800mg - UK - MoH Submission

PACKAGE LEAFLET:
INFORMATION FOR THE USER
Asacol® 800mg 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 800mg MR
tablets are and what they are
used for
2. Before you take Asacol
800mg MR tablets
3. How to take Asacol 800mg
MR tablets
4. Possible side effects
5. How to store Asacol 800mg
MR tablets
6. Further information
1. WHAT ASACOL 800MG MR
TABLETS ARE AND WHAT
THEY ARE USED FOR
Asacol 800mg 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 800mg
MR tablets act locally in the
colon to reduce inflammation

Artwork created at 100%
Drop keylines and notes before printing
Part number: 79997MD118G
Drawing number: 438850

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
800mg MR tablets act locally
in the terminal ileum and
colon to control the disease
and prevent further flares of
Crohn’s ileo-colitis.
2. BEFORE YOU TAKE
ASACOL 800MG MR
TABLETS
Do not take the Asacol 800mg
MR tablets if you:
•a
 re allergic (hypersensitive)
to any of the ingredients in
the product (see Section 6 
on “What Asacol 800mg MR
tablets contain”).
•a
 re allergic to aspirin or any
other salicylate
•h
 ad kidney problems or blood
abnormalities while taking
other medicines such as
sulphasalazine
•h
 ave confirmed severe kidney
or liver impairment
•h
 ave stomach ulcers, with or
without bleeding.
DO NOT give the tablets to
children unless directed by a 
doctor.
Take special care with Asacol
800mg MR tablets
•A
 sacol should be used with
extreme caution in patients
with confirmed mild to
moderate kidney impairment
• Asacol should be used with
caution in the elderly, and in
patients who ever had any
blood disorder, especially
while taking medicines such as
sulphasalazines.
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 800mg 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 800mg 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 800mg 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 800mg MR tablets are
not expected to affect your
ability to drive or operate
machinery.
Important information about
some of the ingredients of
Asacol 800mg 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
800MG MR TABLETS
Always take Asacol 800mg 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 without
breaking, crushing or chewing
the tablet. You can take them
at any time of the day, with or
without meals.
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 - up
to 6 tablets each day divided
throughout the day (as advised
by your doctor).
• Preventing a flare of ulcerative
colitis - up to 3 tablets each
day once daily or divided
throughout the day (as advised
by your doctor).
• Preventing a flare of Crohn’s 
ileo-colitis - up to 3 tablets
each day divided throughout
the day (as advised by your
doctor).
DO NOT take more than 6 
tablets a day.
Asacol 800mg MR tablets are
not recommended for use in
children.
If you stop taking Asacol
800mg MR tablets
Keep taking the 800mg MR
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
800mg 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
800mg 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 two doses
together. 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
800mg 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
• vomiting
• nausea (feeling sick)
• wind
• headache
• joint and muscular pain
• indigestion
• rectal disorder.

Rare side effects (in less than 1 
in 1,000 people):
• problems with heart, liver, lung
or kidney function
• inflammation of the liver or kidney
• inflammation of the pancreas
• blood abnormalities
• nerve ending damage, vertigo
or dizziness
• chest pain or chest infections
• sinusitis (inflammation of
lining of sinuses) or rhinitis
(inflammation of lining of nose)
• skin rashes
• hair loss
• unexplained wheezing or
shortness of breath
• cough
• fever
• flu like symptoms.
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
800MG MR TABLETS
Keep out of the sight and reach
of children.
Please keep the moisture
absorbing pouch in 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 800mg 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 800mg MR
tablets contain
The active substance is
mesalazine (also known
as 5-aminosalicylic acid).
Each tablet contains 800mg
mesalazine.
The other ingredients are
Core: lactose monohydrate,
sodium starch glycolate, talc,
povidone, magnesium stearate,
colloidal anhydrous silica.
Coating: methacrylic acid methyl methacrylate copolymer
(1:2), talc, dibutyl sebacate,
ferric oxide red (E172),
methacrylic acid - methyl
methacrylate copolymer (1:1),
ferric oxide yellow (E172),
macrogol.
Black ink containing: propylene
glycol, ferric oxide black (E172),
ammonium hydroxide, shellac.
See also end of Section 2 on
‘Important information about
some of the ingredients of
Asacol 800mg MR tablets’.
What Asacol 800mg MR
tablets look like and contents
of the pack
Asacol 800mg MR tablets are
red-brown, coated, and oblong
shaped, marked with WC 800. 
They are packed in a plastic
bottle with a child- resistant
closure that contains cotton/
silica gel moisture absorbing
pouches.
Asacol 800mg MR tablets are
available in packs of 12, 36, 84 
or 180 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
Inflammatory Bowel Disease
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 10947/0012
This leaflet was last approved in
November 2015

438850
79997MD118G

PACKAGE LEAFLET: INFORMATION FOR THE USER

Asacol® 800mg 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 800mg MR tablets are and what they are
used for
2. Before you take Asacol 800mg MR tablets
3. How to take Asacol 800mg MR tablets
4. Possible side effects
5. How to store Asacol 800mg MR tablets
6. Further information
1. WHAT ASACOL 800MG MR TABLETS ARE AND WHAT
THEY ARE USED FOR
Asacol 800mg 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 800mg 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 800mg MR tablets act
locally in the terminal ileum and colon to control the
disease and prevent further flares of Crohn’s ileo-colitis.
2. BEFORE YOU TAKE ASACOL 800MG MR TABLETS
Do not take the Asacol 800mg MR tablets if you:
• are allergic (hypersensitive) to any of the ingredients in
the product (see Section 6 on “What Asacol 800mg MR
tablets contain”).
• are allergic to aspirin or any other salicylate
• had kidney problems or blood abnormalities while taking
other medicines such as sulphasalazine
• have confirmed severe kidney or liver impairment
• have stomach ulcers, with or without bleeding.
DO NOT give the tablets to children unless directed by a
doctor.
Take special care with Asacol 800mg 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, and
in patients who ever had any blood disorder, especially
while taking medicines such as sulphasalazines.
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 800mg 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 800mg 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 800mg 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 800mg MR tablets are not expected to affect your
ability to drive or operate machinery.
Important information about some of the ingredients of
Asacol 800mg 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 800MG MR TABLETS
Always take Asacol 800mg 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 without
breaking, crushing or chewing the tablet. You can take them
at any time of the day, with or without meals.
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 – up to 6 tablets each day
divided throughout the day (as advised by your doctor).
• Preventing a flare of ulcerative colitis – up to 3 tablets
each day once daily or divided throughout the day (as
advised by your doctor).
• Preventing a flare of Crohn’s ileo-colitis – up to
3 tablets each day divided throughout the day (as
advised by your doctor).
DO NOT take more than 6 tablets a day.
Asacol 800mg MR tablets are not recommended for use in
children.
If you stop taking Asacol 800mg MR tablets
Keep taking the 800mg MR 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 800mg 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 800mg 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 two doses together. 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.

Asacol (Mesalazine) 800 mg PIL Warner Chilcott UK

MOCK UP
ONLY

1. black

item no:

AAAH7972

dimensions: 180 x 300

print proof no:

6

pharmacode:

origination date: 25.3.15
approved for print/date

colours/plates:

min pt size:

2.
3.
4.

10 pt

originated by:

db

revision date:

4.6.15

Technical Approval

revised by:

db

date sent:

n/a

supplier:

IL/Catalent

approved:

n/a

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

4. POSSIBLE SIDE EFFECTS

6. FURTHER INFORMATION

Like all medicines, Asacol 800mg MR tablets can cause side
effects, although not everybody gets them.

What Asacol 800mg MR tablets contain
The active substance is mesalazine (also known as
5-aminosalicylic acid). Each tablet contains 800mg
mesalazine.
The other ingredients are
Core: lactose monohydrate, sodium starch glycolate, talc,
povidone, magnesium stearate, colloidal anhydrous silica.
Coating: methacrylic acid – methyl methacrylate
copolymer (1:2), talc, dibutyl sebacate, ferric oxide
red (E172), methacrylic acid – methyl methacrylate
copolymer (1:1), ferric oxide yellow (E172), macrogol.
Black ink containing: propylene glycol, ferric oxide
black (E172), ammonium hydroxide, shellac.
See also end of Section 2 on ‘Important information about
some of the ingredients of Asacol 800mg MR tablets’.

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
• vomiting
• nausea (feeling sick)
• wind
• headache
• joint and muscular pain
• indigestion
• rectal disorder.
Rare side effects (in less than 1 in 1,000 people):
• problems with heart, liver, lung or kidney function
• inflammation of the liver or kidney
• inflammation of the pancreas
• blood abnormalities
• nerve ending damage, vertigo or dizziness
• chest pain or chest infections
• sinusitis (inflammation of lining of sinuses) or rhinitis
(inflammation of lining of nose)
• skin rashes
• hair loss
• unexplained wheezing or shortness of breath
• cough
• fever
• flu like symptoms.
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

What Asacol 800mg MR tablets look like and contents of
the pack
Asacol 800mg MR tablets are red-brown, coated, and oblong
shaped, marked with WC 800. They are packed in a plastic
bottle with a child- resistant closure that contains cotton/
silica gel moisture absorbing pouches.
Asacol 800mg MR tablets are available in packs of 12, 36,
84 or 180 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 Inflammatory Bowel Disease
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)
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.
Asacol® is a Trademark
Marketing Authorisation Number: PL 10947/0012
This leaflet was last approved in May 2015

By reporting side effects you can help provide more
information on the safety of this medicine.
5. HOW TO STORE ASACOL 800MG MR TABLETS
Keep out of the sight and reach of children.
Please keep the moisture absorbing pouch in 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 800mg 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.

AAAH7972

Asacol (Mesalazine) 800 mg PIL Warner Chilcott UK

MOCK UP
ONLY

1. black

item no:

AAAH7972

dimensions: 180 x 300

print proof no:

6

pharmacode:

origination date: 25.3.15
approved for print/date

colours/plates:

min pt size:

2.
3.
4.

10 pt

originated by:

db

revision date:

4.6.15

Technical Approval

revised by:

db

date sent:

n/a

supplier:

IL/Catalent

approved:

n/a

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

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 800mg MR
tablets contain
The active substance is
mesalazine (also known
as 5-aminosalicylic acid).
Each tablet contains 800mg
mesalazine.
The other ingredients are
Core: lactose monohydrate,
sodium starch glycolate, talc,
povidone, magnesium stearate,
colloidal anhydrous silica.
Coating: methacrylic acid –
methyl methacrylate copolymer
(1:2), talc, dibutyl sebacate,
ferric oxide red (E172),
methacrylic acid – methyl
methacrylate copolymer (1:1),
ferric oxide yellow (E172),
macrogol.
Black ink containing: propylene
glycol, ferric oxide black (E172),
ammonium hydroxide, shellac.
See also end of Section 2 on
‘Important information about
some of the ingredients of
Asacol 800mg MR tablets’.
What Asacol 800mg MR
tablets look like and contents
of the pack
Asacol 800mg MR tablets are
red-brown, coated, and oblong
shaped, marked with WC 800.
They are packed in a plastic
bottle with a child- resistant
closure that contains cotton/
silica gel moisture absorbing
pouches.
Asacol 800mg MR tablets are
available in packs of 12, 36, 84
or 180 tablets (not all pack sizes
may be marketed).

50819938

Marketing Authorisation
Holder
Warner Chilcott UK Limited, Old
Belfast Road, Millbrook, Larne,
County Antrim, BT40 2SH,
United Kingdom.
Manufacturer
Actavis, Barnstaple,
EX32 8NS, UK.
Getting more advice about
Inflammatory Bowel Disease
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 10947/0012
This leaflet was last approved in
May 2015

AAAH2329

PACKAGE LEAFLET:
INFORMATION FOR THE USER

and can also prevent further
episodes (flares) of ulcerative
colitis.
Asacol® 800mg MR tablets
•C
 rohn’s ileo-colitis – a
(mesalazine)
disease affecting the small
bowel (terminal ileum) and
colon in which the lining of
Read all of this leaflet carefully
the bowel becomes swollen
before you start taking this
and sore. This may lead to
medicine.
the development of ulcers,
– Keep this leaflet. You may
abscesses and narrowing
need to read it again.
(strictures) in the bowel. Asacol
– If you have any further
800mg MR tablets act locally
questions, ask your doctor or
in the terminal ileum and
pharmacist.
colon to control the disease
– This medicine has been
and prevent further flares of
prescribed for you. Do not
Crohn’s ileo-colitis.
pass it on to others. It may
harm them, even if their
2. BEFORE YOU TAKE
symptoms are the same as
ASACOL 800MG MR
yours.
TABLETS
– If any of the side effects gets
Do not take the Asacol 800mg
serious, or if you notice any
MR tablets if you:
side effects not listed in this
• are allergic (hypersensitive)
leaflet, please tell your doctor
to any of the ingredients in
or pharmacist.
the product (see Section 6
In this leaflet:
on “What Asacol 800mg MR
1. What Asacol 800mg MR
tablets contain”).
tablets are and what they are • are allergic to aspirin or any
used for
other salicylate
2. Before you take Asacol
• had kidney problems or blood
800mg MR tablets
abnormalities while taking
3. How to take Asacol 800mg
other medicines such as
MR tablets
sulphasalazine
4. Possible side effects
• have confirmed severe kidney
5. How to store Asacol 800mg
or liver impairment
MR tablets
• have stomach ulcers, with or
6. Further information
without bleeding.
1. WHAT ASACOL 800MG MR
DO NOT give the tablets to
TABLETS ARE AND WHAT
children unless directed by a
THEY ARE USED FOR
doctor.
Asacol 800mg MR tablets
Take special care with Asacol
contain the active substance
800mg MR tablets
mesalazine (also known as
• Asacol should be used with
5-aminosalicylic acid) which is
extreme caution in patients
an anti-inflammatory drug used
with confirmed mild to
in the treatment of:
moderate kidney impairment
•U
 lcerative colitis – a disease
• Asacol should be used with
of the large bowel (colon)
caution in the elderly, and in
and back passage (rectum)
patients who ever had any
in which the lining of the
blood disorder, especially
bowel becomes inflamed
while taking medicines such as
(red and swollen). Symptoms
sulphasalazines.
can include rectal bleeding,
Taking other medicines
frequent diarrhoea and
abdominal pain. Asacol 800mg Please tell your doctor if you are
taking or have recently taken
MR tablets act locally in the
any other medicines, including
colon to reduce inflammation

page 4

page 1

260x210 Leaflet Reel Fed Bi Fold Profile (BST)

Asacol 800mg MR Tablets (DBS)
BST QP (UK)
JDE No.:

Asacol (Mesalazine) 800 mg Tablets PIL Warner Chilcott UK

50819938

item no:

AAAH2329

dimensions: 260 x 210

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

print proof no:

10

pharmacode:

Pharmacode: 8219

originated by:

db

revision date:

4.6.15

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: 17.9.14
approved for print/date

min pt size:

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

9.6 pt

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

those obtained without a
prescription.
Asacol 800mg 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 800mg 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 800mg 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 800mg MR tablets are
not expected to affect your
ability to drive or operate
machinery.
Important information about
some of the ingredients of
Asacol 800mg 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
800MG MR TABLETS
Always take Asacol 800mg 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 without
breaking, crushing or chewing
the tablet. You can take them
at any time of the day, with or
without meals.
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 – up
to 6 tablets each day divided
throughout the day (as advised
by your doctor).
•P
 reventing a flare of ulcerative
colitis – up to 3 tablets each
day once daily or divided
throughout the day (as advised
by your doctor).
•P
 reventing a flare of Crohn’s
ileo-colitis – up to 3 tablets
each day divided throughout
the day (as advised by your
doctor).
DO NOT take more than 6
tablets a day.
Asacol 800mg MR tablets are
not recommended for use in
children.
If you stop taking Asacol
800mg MR tablets
Keep taking the 800mg MR
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
800mg 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
800mg 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 two doses
together. 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
800mg 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
• vomiting
• nausea (feeling sick)
• wind
• headache
• joint and muscular pain
• indigestion
• rectal disorder.

page 2

Rare side effects (in less than 1
in 1,000 people):
• problems with heart, liver, lung
or kidney function
• inflammation of the liver or
kidney
• inflammation of the pancreas
• blood abnormalities
• nerve ending damage, vertigo
or dizziness
• chest pain or chest infections
• sinusitis (inflammation of
lining of sinuses) or rhinitis
(inflammation of lining of nose)
• skin rashes
• hair loss
• unexplained wheezing or
shortness of breath
• cough
• fever
• flu like symptoms.
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
800MG MR TABLETS
Keep out of the sight and reach
of children.
Please keep the moisture
absorbing pouch in 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 800mg MR
tablets after the expiry date
which is stated on the pack after
‘Exp’. The expiry date refers to

page3

260x210 Leaflet Reel Fed Bi Fold Profile (BST)

Asacol 800mg MR Tablets (DBS)
BST QP (UK)
JDE No.:

Asacol (Mesalazine) 800 mg Tablets PIL Warner Chilcott UK

50819938

item no:

AAAH2329

dimensions: 260 x 210

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

print proof no:

10

pharmacode:

Pharmacode: 8219

originated by:

db

revision date:

4.6.15

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: 17.9.14
approved for print/date

min pt size:

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

9.6 pt

5.
6.
Non Printing Colours
1. profile
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.

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