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OCTASA 400MG MR TABLETS

Active substance(s): MESALAZINE

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Octasa 400 mg Modified Release Tablets
Active substance: mesalazine

Package leaflet:
Information for the user
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 ulcerative
colitis
— 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
have:
— ever had any problems with your liver or 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 mesalazine-induced
allergic reactions of your heart, then do not take
Octasa. Octasa can be taken with care if you have
had a previous allergic reaction of the heart even if
not caused by taking 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
medicine.
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
Patients who are intolerant to lactose should note that
Octasa contains a small amount of lactose. If your
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 medicine
must be swallowed whole preferably with some liquid.
Do not chew, crush or break the tablets before
swallowing them.
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 kidney.
The recommended dose is:
Adults (including the elderly): To treat ulcerative
colitis
Six tablets a day taken in divided doses.
To prevent Crohn’s ileo-colitis or ulcerative
colitis
Between 3 and 6 tablets a day taken in divided doses.
Follow your doctor’s instructions. Do not take more
than six tablets a day.
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: two to three tablets per day.
30-40 kg weight: two to four tablets per day in
divided doses. 40 kg weight: three to five tablets per
day in divided doses. The total dose should not
exceed 4 g/day.
— To prevent ulcerative colitis or Crohn’s ileo-colitis:
20-30 kg weight: one tablet per day.
30-40 kg weight: one to 2 tablets per day
40 kg weight: one to three 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 tablet, 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 Octasa 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:
Common:
— rash
— indigestion
Uncommon
— fever
— high number of white blood cells called eosinophil
granulocytes
— sensation of tingling, pricking and numbness
— hives, itching skin
— chest pain
Rare
— 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 or
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)

— hair loss
— muscle and joint pain
— kidney problems (such as inflammation and
scarring 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
— 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 Yellowcard.mhra.gov.uk. 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 protect
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 400 mg mesalazine
The other ingredients are: lactose monohydrate,
sodium starch glycolate (Type A), triethyl citrate, E553b,
methacrylic acide – methylmethacrylate copolymer
(1:2), povidone E1201, magnesium stearate (vegetable
origin), iron oxides E172, macrogol 6000
What Octasa looks like and contents of the pack
Octasa 400 mg Modified Release Tablets are redbrown, oblong, tablets.
They are available in pack sizes of 90 or 120 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
Lincolnhire, LN5 0HX
United Kingdom Tel: + 44 (0) 1522 813500
The manufacturer is:
Haupt Pharma Wülfing GmbH, D – 31028 Gronau,
Germany
Rottendorf Pharma GmbH, Ostenfelder Strasse 51 – 61,
59320 Ennigerloh, Germany
New advice website: Log on to
www.UCandme.co.uk for impartial information on
UC, living with it, helpful apps and links.
This information applies only to Tillotts Pharma UK Ltd.
Octasa 400 mg Modified Release Tablets. PL 36633/0002
This leaflet was last revised in February 2015

307979

Octasa 400 mg Modified Release Tablets
Active substance: mesalazine

Package leaflet:
Information for the user
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 ulcerative
colitis
— 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
have:
— ever had any problems with your liver or 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 mesalazine-induced
allergic reactions of your heart, then do not take
Octasa. Octasa can be taken with care if you have
had a previous allergic reaction of the heart even if
not caused by taking 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
medicine.
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
Patients who are intolerant to lactose should note that
Octasa contains a small amount of lactose. If your
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 medicine
must be swallowed whole preferably with some liquid.
Do not chew, crush or break the tablets before
swallowing them.
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 kidney.
The recommended dose is:
Adults (including the elderly): To treat ulcerative
colitis
Six tablets a day taken in divided doses.
To prevent Crohn’s ileo-colitis or ulcerative
colitis
Between 3 and 6 tablets a day taken in divided doses.
Follow your doctor’s instructions. Do not take more
than six tablets a day.
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: two to three tablets per day.
30-40 kg weight: two to four tablets per day in
divided doses. 40 kg weight: three to five tablets per
day in divided doses. The total dose should not
exceed 4 g/day.
— To prevent ulcerative colitis or Crohn’s ileo-colitis:
20-30 kg weight: one tablet per day.
30-40 kg weight: one to 2 tablets per day
40 kg weight: one to three 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 tablet, 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 Octasa 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:
Common:
— rash
— indigestion
Uncommon
— fever
— high number of white blood cells called eosinophil
granulocytes
— sensation of tingling, pricking and numbness
— hives, itching skin
— chest pain
Rare
— 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 or
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)

— hair loss
— muscle and joint pain
— kidney problems (such as inflammation and
scarring 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
— 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 Yellowcard.mhra.gov.uk. 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 protect
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 400 mg mesalazine
The other ingredients are: lactose monohydrate,
sodium starch glycolate (Type A), triethyl citrate, E553b,
methacrylic acide – methylmethacrylate copolymer
(1:2), povidone E1201, magnesium stearate (vegetable
origin), iron oxides E172, macrogol 6000
What Octasa looks like and contents of the pack
Octasa 400 mg Modified Release Tablets are redbrown, oblong, tablets.
They are available in pack sizes of 90 or 120 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
Lincolnhire, LN5 0HX
United Kingdom Tel: + 44 (0) 1522 813500
The manufacturer is:
Haupt Pharma Wülfing GmbH, D – 31028 Gronau,
Germany
Rottendorf Pharma GmbH, Ostenfelder Strasse 51 – 61,
59320 Ennigerloh, Germany
New advice website: Log on to
www.UCandme.co.uk for impartial information on
UC, living with it, helpful apps and links.
This information applies only to Tillotts Pharma UK Ltd.
Octasa 400 mg Modified Release Tablets. PL 36633/0002
This leaflet was last revised in February 2015

307979

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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