Pill Identifier App

ASACOL 400MG MR TABLETS

Active substance: MESALAZINE

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

Asacol 400mg MR Tablets
®

(mesalazine)

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

Read all of this leaflet carefully before you start taking this
medicine.

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.

– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor or pharmacist.

Driving and using machines

– 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.

Asacol 400mg MR Tablets are not expected to affect your ability to drive
or operate machinery.

– 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.

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.

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

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.

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 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.

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, e.g.
– 2 tablets 3 times a day or
– 3 tablets twice a day.
• Preventing further episodes of ulcerative colitis or 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.

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.

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).

DO NOT give the tablets to children under 2 years of age.
If you forget to take Asacol 400mg MR Tablets
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).

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

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

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.

The other ingredients are

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

The active substance is mesalazine (also known as 5-aminosalicylic
acid). Each tablet contains 400mg mesalazine.
Core: lactose monohydrate, sodium starch glycollate, magnesium
stearate, talc, povidone.
Coating: methacrylic acid-methyl methacrylate copolymer (1:2),
dibutylphthalate, 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 child-resistant 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.

• nausea (feeling sick)
• headache.
Rare side effects (in less than 1 in 1000 people):

Manufacturer
Warner Chilcott Deutschland GmbH, Dr.-Otto-Röhm Strasse 2–4,
D-64331 Weiterstadt, Germany

• problems with heart, lung, liver or kidney function
• inflammation of the pancreas

Getting more advice about ulcerative colitis or Crohn’s ileo-colitis

• blood abnormalities

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:

• 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).

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

If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor.

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

5. HOW TO STORE ASACOL 400MG MR TABLETS

Asacol® is a Trademark

Keep out of the reach and sight of children.

Marketing Authorisation Number: PL 10947/0011

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 03/2012

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.
354705
10000173

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
(web5)