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IPOCOL 400MG MR TABLETS

Active substance(s): MESALAZINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ00000LT000

IPOCOL 400 mg 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 Ipocol MR Tablets are and what they
are used for
2. Before you take Ipocol MR Tablets
3. How to take Ipocol MR Tablets
4. Possible side effects
5. How to store Ipocol MR Tablets
6. Further information

1

What Ipocol MR Tablets are and
what they are used for

Ipocol 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. Ipocol
MR Tablets act locally in the colon to reduce
inflammation and can also prevent further
episodes (flares) of ulcerative colitis.
Ipocol MR Tablets can also be used to prevent
further attacks of ulcerative colitis.

2

This medicine is sometimes prescribed for other
purposes and you should consult your doctor for
Before ifyou
take Ipocol MR
more information
necessary.

Tablets

DO NOT take Ipocol MR Tablets if you:
• are allergic (hypersensitive) to mesalazine or
any of the other ingredients of Ipocol MR
Tablets (see section 6 – What Ipocol 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.
Take special care with Ipocol MR Tablets
• Ipocol MR Tablets should be used with
extreme caution in patients with confirmed
mild to moderate kidney impairment
• Ipocol MR Tablets should be used with
extreme caution in the elderly
• If you become dehydrated (lose too much
water), it is important to replace your fluid as
soon as possible, contact your doctor or
pharmacist for advice.

Taking other medicines
Please tell your doctor if you are taking or have
recently taken any other medicines, including
those obtained without a prescription.
Ipocol MR Tablets should NOT be taken with
lactulose or similar medicines to treat
constipation.

Use of non-steroidal anti-inflammatory drugs
(NSAIDs such as ibuprofen, aspirin, Cox-II
inhibitors) and azathioprine (used for organ
transplant therapy) in particular may increase
the risk of kidney reactions.
Pregnancy and breast-feeding
Women who are pregnant or breast-feeding
should not take Ipocol MR Tablets unless
advised otherwise by their doctor.

Ask you doctor or pharmacist for advice before
taking any medicine.

Driving and using machines
This medicine can cause you to feel sick
(nausea). If this happens, do not drive, operate
machinery or do anything that requires full
alertness.

3

How to take Ipocol MR Tablets

Always take Ipocol MR Tablets exactly as the
doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
The tablets should be swallowed whole with
water; do not break, crush or chew them.
The usual dose is:

Adults and the elderly:
• 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 – between 3 and 6 tablets each day
divided throughout the day, e.g.
- 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.

Your doctor will need to monitor your kidney
function prior to starting Ipocol MR Tablets,
every three months for the first year, then 6
monthly for the next four years and annually
after that.

Children 6 – 18 years of age:
• To treat anaemia: Starting with
30-50 mg/kg/day in divided doses. Maximum
dose 75 mg/kg/day the total dose should not
exceed 4 g/day
• Maintenance dose: Starting at
15-30 mg/kg/day in divided doses. The total
dose should not exceed 2 g/day.

Artwork Proof Box
A healthy decision
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR,
United Kingdom.
T: 01276 698020
F: 01276 698324
W: www.uk.sandoz.com
E: sandoz.artwork@me.com

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Date prepared:
31/07/2012

Prepared by:
TB

RA Approved?
Yes

Date approved:
31/07/2012

Approved by:
RC
Fonts:
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Colours:
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Dimensions: 130 x 295 mm

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It is recommended that half the adult dose may
be given to children up to a body weight of
40 kg; and the normal adult dose to those above
40 kg.
Your doctor may decide to change your dose, it
is always important to follow your doctorʼs
directions about when and how to take your
medicine. Remember to get a repeat
prescription at the right time so that you do not
miss a day of treatment.

If you take more Ipocol 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 pharmacistʼs label. If you
take too many tablets, or someone accidentally
swallows some, 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 Ipocol 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 are at all concerned about
this, consult your doctor or pharmacist.
If you stop taking Ipocol MR Tablets
If you suddenly stop taking this medicine your
symptoms may come back. You should not stop
taking your medicine unless you have been
advised to do so by your doctor.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4

Possible side effects

Like all medicines Ipocol MR Tablets can cause
side effects, although not everybody gets them,
If you experience any of the following serious
side effects stop taking this medicine and
contact your doctor or go to your nearest
hospitals casualty department immediately:

• allergic reaction. Symptoms include skin
rash, lumps or hives, swelling of the face,
lips, hands or feet, sudden wheeziness,
tightness of the chest or breathing problems
• liver problems. Symptoms include feeling
tired, feeling sick, pain below the right ribs,
your skin or the whites of your eyes turn
yellow
• changes in your blood. Symptoms include
unusual bleeding, bruising, rash, fever, sore
throat or excessive tiredness, or you become
susceptible to infection
Other side effects:
Common side effects you may experience
include:
• headaches
• feeling sick, being sick, diarrhoea, stomach
pains caused by inflammation (swelling,
redness and pain) in the intestines.

• muscle pain
• joint pain.

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.

5

How to store Ipocol MR
Tablets

Keep out of the reach and sight of children.

Store Ipocol MR Tablets at or below 25°C in a
dry place and protect from light.

Do not take Ipocol MR Tablets after the expiry
date shown on the label.

Do not take Ipocol MR Tablets if you notice any
visible signs of deterioration of these tablets
such as cracks in the coat, take them to your
pharmacist for advice.
Medicines should not be disposed of via
household waste. Ask your pharmacist how to
dispose of medicines you no longer require.
These measures will help to protect the
environment.

6

Further information

What Ipocol MR Tablets contain
Each tablet contains 400 mg of the active
ingredient mesalazine.
The other ingredients are microcrystalline
cellulose, sodium carboxymethyl starch,
corn starch, magnesium stearate, polyvinyl
pyrrolidone, mannitol, precipitated silica,
dimethylphthalate, methacrylic acid copolymer,
dimethicone, talc, titanium dioxide and red ferric
oxide.
What Ipocol MR Tablets look like and
contents of the pack
Ipocol MR Tablets are red-brown, coated and
round shaped.
The tablets are available in blister packs of 28,
30, 56, 60, 84, 90, 112, 120, 168 or 240 tablets
(not all pack sizes may be marketed).
Marketing Authorisation Holder
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey GU16 7SR, UK.

Manufacturer
Sofar Pharmaceuticals,
Via Firenze 40, 20069 Trezzano Rosa,
Milan, Italy.
Distributed by:
IXL Pharma Ltd,
Northampton Road, Brixworth,
Northamptonshire, NN6 9DQ

This leaflet was last revised in 07/2012.

More rarely you may suffer from:
• kidney problems
• inflammation in the lungs, which causes
severe cough or difficulty breathing
• inflammation of the pericardium (the sac that
surrounds the lungs) which can cause chest
pains
• inflammation of the pancreas, which causes
severe pain in the abdomen
• inflammation of the heart muscle, which can
cause chest pains, breathlessness or
irregular heartbeat
• lupus (a disease where the body attacks
internal organs such as lungs, heart, stomach
and joints). Symptoms include tiredness,
fever, joint pain
• a disorder of the nerves which can cause
weakness, tingling or numbness (peripheral
neuropathy)
• hair loss
• fever

SZ00000LT000

Artwork Proof Box
A healthy decision
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR,
United Kingdom.
T: 01276 698020
F: 01276 698324
W: www.uk.sandoz.com
E: sandoz.artwork@me.com

Ref: Brand alignment
Proof no.
004.0

Date prepared:
31/07/2012

Prepared by:
TB

RA Approved?
Yes

Date approved:
31/07/2012

Approved by:
RC
Fonts:
Helvetica

Colours:
Black
Black 20%
Dimensions: 130 x 295 mm

PROPOSED
MOCK UP

Artwork/RA Checklist:
Product name
Strength/dosage

Font size: 7pt
Pack size
PL number
Storage

Warnings
Excipients
Braille

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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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