ASACOL 400MG MR TABLETS

Active substance: MESALAZINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Asacol® 400mg MR Tablets
(mesalazine)
Read all of this leaflet carefully before you start taking
this medicine.
– Keep this leaflet. You may need to read it again.
– f you have any further questions, ask your doctor or
I
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.  hat Asacol 400mg MR Tablets are and what they
W
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 in
a
the product (see Section 6 on ‘What Asacol 400mg MR
T
ablets 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.
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.
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.
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.

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.

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

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.

4. POSSIBLE SIDE EFFECTS

6. FURTHER INFORMATION

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

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
 ore: lactose monohydrate, sodium starch glycollate,
C
magnesium stearate, talc, povidone.
 oating: methacrylic acid-methyl methacrylate
C
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 T
ablets’.

Allergic reactions to the tablets can occur. Tell your
doctor if you get a rash (with or without itching), any
shortness of breath, palpitations (rapid heart beat) or
chest pain. These effects will usually disappear when
you stop taking the medicine.
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).
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 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 90 or
120 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 the National
Association for Colitis and Crohn’s Disease which offers
information, advice and local support groups:
National Association for Colitis and Crohn’s Disease
PO Box 205, St. Albans, Hertfordshire, AL1 5ZN
Telephone information line: 0845 130 3344
(Monday to Thursday 10am – 1pm)
NACC-in-Contact Support Line: 0845 130 2233
(Monday to Thursday 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.

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

Asacol® is a Trademark

5. HOW TO STORE ASACOL 400MG MR TABLETS

Marketing Authorisation Number: PL 10947/0011

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.

This leaflet was last approved in October 2014

Do not remove the moisture absorbing pouch from the bottle.
The pouch is not part of your medicine and is marked
DO NOT EAT. Keep the bottle tightly closed.

416997
AAAH1241

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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