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Package leaflet: Information for the user

Octasa 800 mg Modified Release Tablets
Active substance: 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, please 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 you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
What is in this leaflet:
1. What Octasa is and what it is used for
2. What you need to know before you take Octasa
3. How to take Octasa
4. Possible side-effects
5. How to store Octasa
6. Contents of the pack and other information
1. What Octasa is and what it is used for

Octasa contains the active substance mesalazine.
This is an anti-inflammatory medicine used to treat
ulcerative colitis and Crohn’s ileo-colitis.
Octasa is used:
•• to treat and prevent further episodes of u­ lcerative
•• to prevent further episodes of Crohn’s i­leo-colitis
once the disease has been brought under control.
Ulcerative colitis is a disease of the large bowel
(colon) or back passage (rectum), in which the lining
of the bowel becomes inflamed (red and swollen).
Crohn’s ileo-colitis is a disease that affects the small
bowel (terminal ileum) and the large bowel (colon) in
which the lining of the bowel becomes inflamed.
This can lead to ulcers, abscesses and narrowing
(strictures) in the bowel.
Octasa acts locally at the site of inflammation (colon,
rectum and terminal ileum) to reduce this inflammation.
2. What you need to know before you take Octasa

Do not take Octasa
•• If you are allergic to mesalazine or any of the
other ingredients of this medication (listed in
­section 6)
•• If you are allergic to salicylates (e. g. aspirin)
•• If you have severe kidney problems
•• If you have severe liver problems
Warnings and precautions
Talk to your doctor before taking Octasa if you have
any medical conditions or illnesses, particularly if you
•• ever had any problems with your kidneys. This is
especially important if you are elderly.
•• any lung problems, e. g. asthma.
•• suffered an allergy to sulfasalazine in the past.
•• ever had allergic reactions of your heart such as
inflammation of the heart muscle or heart sac.
If you have had previous suspected mesalazineinduced allergic reactions of your heart, then
Octasa must not be taken. Octasa can be taken
with care if you have had a previous allergic
­reaction of the heart not caused by mesalazine.
•• If you have an ulcer of the stomach or intestine,
you may take Octasa with care
Test for your liver, kidney and blood
Before and while you are taking Octasa, your doctor
may want to monitor you from time to time, to check
that your liver, kidneys, blood and lungs are all right.
There have been a few reports of intact tablets in the
stool. What appear to be intact tablets may sometimes be the remains of the tablet coating. If you
often observe tablets or tablet shells in the stool, you
should consult your doctor.
Children and adolescents
Octasa is only recommended for use in children
6 years and older.

Other medicines and Octasa
Tell your doctor or pharmacist if you are taking or
have recently taken or might take any other ­medicines
such as:
•• drugs affecting the immune system (e. g. azathioprine, or 6-mercaptopurine or t­hioguanine)
•• drugs that prevent the formation of blood clots
(anticoagulants, e.g., warfarin)
Octasa with food, drink and alcohol
You may eat and drink normally (including alcohol),
when taking Octasa.
Pregnancy and breast-feeding and fertility
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this
Driving and using machines
Octasa is not expected to affect your ability to drive
or operate machinery. However, if you are affected in
anyway do not drive or operate machinery.
Important information about some of the
ingredients of Octasa
People who are intolerant to lactose should note
that Octasa contains a small amount of lactose.
If you doctor has told you that you have intolerance
to some sugars, contact your doctor before taking
this medicine.
3. How to take Octasa

Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you
are not sure.
Octasa should be taken before meals. This medication must be swallowed whole preferably with some
liquid. Do not chew, crush or break the tablets before
swallowing them.
Whilst taking this medication 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 kidney.
The recommended dose is:
Adults (including the elderly)
To treat acute phases of ulcerative colitis your daily
dose is 3 to 6 tablets. 3 tablets may be taken once
daily or in divided doses (as advised by your doctor).
Above 3 tablets a day should be taken in divided
To prevent ulcerative colitis or Crohn’s ileo-colitis
your daily dose is 2 to 3 tablets once daily or in
divided doses. Do not take more than 6 tablets per
day, and do not take more than 3 tablets together at
the same time.
Use in children and adolescents
Octasa is only recommended for use in children
6 years and older. The daily dose depends on the
child’s weight.
•• To treat acute phases of ulcerative colitis:
20-30 kg weight: one tablet per day.

30-40 kg weight: one to two tablets per day in
divided doses. Above 40 kg weight: two to three
tablets per day in divided doses. The total dose
should not exceed 4 g/day.
•• To prevent ulcerative colitis or Crohn’s ileo-colitis:
30-40 kg weight: one tablet per day.

Above 40 kg weight: one to two tablets per day in
divided doses. The total dose should not exceed
2 g/day.
It is generally recommended that half the adult dose
may be given to children up to 40 kg weight; and the
normal adult dose to those above 40 kg.
If you take more Octasa than you should
You should not take a higher dose than your doctor
has prescribed for you. Contact your nearest ­hospital
casualty department or a doctor for advice if you or
anyone else has swallowed too many ­tablets or if you
think a child has swallowed any. Take this leaflet, and
any tablets that you still have to show the doctor.
If you forget to take Octasa
If you forget to take a dose at the right time, take one
as soon as you remember, unless it is nearly time to
take the next one. Do not take a double dose to
make up for a forgotten dose.
If you stop taking Octasa
Do not stop taking Octasa without talking to your
doctor first even if you feel better. If you have any
­further questions on the use of this product, ask your
doctor or pharmacist.
4. Possible side-effects

Like all medicines, this medicine can cause side
effects, although not everybody gets them. Organ
specific side effects affecting the heart, lungs, liver,
kidneys, pancreas, skin and subcutaneous tissue
have been reported.
Stop taking the medicine and seek urgent
medical advice immediately
If you develop unexplained bruising (without injury),
bleeding under your skin, purple spots or patches
under your skin, anaemia (feeling tired, weak and
looking pale, especially on lips, nails and inside of
eyelids), fever (high temperature), sore throat or
­unusual bleeding (e.g. nose bleeds).
The following side effects have been reported at the
approximate frequencies shown:
•• rash
•• indigestion
•• fever
•• high number of white blood cells called e­ osinophil
•• sensation of tingling, pricking and numbness
•• hives, itching skin
•• chest pain
•• headache
•• dizziness
•• inflammation of the heart with signs like chest
pains or palpitations
•• diarrhoea, stomach pain, wind (flatulence), f­eeling
of unease and discomfort in the stomach with an
urge to vomit and vomiting
Very rare
•• severe reduction in blood cells which can cause
weakness, bruising or make infections more likely,
low blood cell counts; reduction in blood platelets
which increases the risk of bleeding
•• allergic reactions such as rash or skin eruption
•• fever that occurs while taking the medicine and
which disappears when the medicine is stopped
(drug fever)
•• immune system disease that can involve organs
and joints
•• ulcerative colitis involving the entire large i­ntestine
•• abnormal or damaged nerves giving a sensation
of numbness or tingling
•• lung disease (scarring of lung tissue, allergic
­reaction) resulting in difficulty in breathing,
cough, wheezing and collection of fluid in
the lungs, pneumonia
•• inflamed pancreas (associated with pain in upper
abdomen and back and feeling sick)
•• abnormal liver function tests, hepatitis
­(inflammation of the liver giving rise to flu-like
symptoms and jaundice)

•• muscle or joint pain
•• hair loss
•• kidney problems (such as inflammation and

s­ carring of the kidney), kidney failure, which may
be reversible if treatment is stopped early
•• reversible decrease in sperm production
Not known
•• disorder of the immune system (lupus-like
­syndrome) which can cause inflammation of the
heart sac or membranes around the lungs and
heart, rash and /or joint pain
•• inflammation of the membranes of the pleural
cavity sourrounding the lungs (pleurisy)
•• intolerance to mesalazine sometimes with
­worsening symptoms of underlying disease
•• weight loss
•• laboratory test results out of normal range
Evaluation of the side effects is based on the following
frequencies: Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Not known: frequency cannot be estimated from the
available data
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
any side effects directly via the Yellow Card Scheme
at By reporting side effects
you can help provide more information on the safety
of this medicine.
5. How to store Octasa

– Keep out of the reach and sight of children.
– Do not store above 25 °C.
– Keep the tablets in the original package to p
­ rotect
them from moisture.
Do not use this medicine after the expiry date which
is stated on the outer packaging. Do not throw away
any medicines via wastewater or household waste.
Ask your pharmacist how to throw away any medicines you no longer use. These measures will help
protect the environment.
6. Contents of the pack and other information

Is this leaflet hard to see or read?
Telephone 0800 1985000 for help.
What Octasa contains
The active substance is mesalazine. Each tablet contains 800 mg mesalazine
The other ingredients are lactose monohydrate,
sodium starch glycolate (Type A), triethyl citrate, talc
E553b, methacrylic acide – methylmethacrylate co­
polymer (1:2), povidone E1201, magnesium stearate
(vegetable origin), iron oxides E172, m
­ acrogol 6000
What Octasa looks like and contents of the pack
Octasa 800 mg Modified Release Tablets are
­red-brown, oblong, tablets.
They are available in pack sizes of 90 or 180 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder is:
Tillotts Pharma UK Ltd,
Wellingore Hall, Wellingore
Lincolnshire, LN5 0HX
United Kingdom Tel: + 44 (0) 1522 813500
The manufacturer is:
Haupt Pharma Wülfing GmbH,
D – 31028 Gronau, Germany
Rottendorf Pharma GmbH,
D – 59320 Ennigerloh, Germany
New advice website: Log on to for impartial information
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This information applies only to
Tillotts Pharma UK Ltd. Octasa 800 mg
Modified Release Tablets. PL 36633/0001
This leaflet was last revised in

225 8535 3

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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.