Skip to Content

OCTASA 800MG MR TABLETS

Active substance(s): MESALAZINE

PDF options:  View Fullscreen   Download PDF

PDF Transcript

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.

Reading way (177)

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)

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 doses.
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.

20.10.2017 SBU

Kontur
Guides
Dimension

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.

PIL PRAC Update Photosensitivity
225 8535 4.indd 1

8,5 pt

The recommended dose is:

177

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.

Helvetica Neue LT W1G 45 Light, 46 Light Italic, 75 Bold; Tahoma Regular

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 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 mesalazine-induced
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

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.

170 x 300 mm

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

Always take this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not
sure.

225 8535 3

2. What you need to know before you take Octasa

3. How to take Octasa

225 8535 4

Octasa acts locally at the site of inflammation (colon,
rectum and terminal ileum) to reduce this inflammation.

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.

PIL Octasa 800mg (T) Tab
Pack GB

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.

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.

HPW

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).

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.

Pantone Red 032 C
Black

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.

Octasa with food, drink and alcohol
You may eat and drink normally (including alcohol), when
taking Octasa.

Tillotts Pharma AG

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.

• drugs that prevent the formation of blood clots
(anticoagulants, e.g., warfarin)

Reading way (177)

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

Pg. 1
20.10.17 13:35

Reading way (177)

The marketing authorisation holder is:

Kontur
Guides
Dimension

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
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 800 mg Modified Release Tablets. PL 36633/0001
This leaflet was last revised in November 2017

225 8535 4

PIL PRAC Update Photosensitivity
225 8535 4.indd 2

8,5 pt

Marketing Authorisation Holder and Manufacturer

Helvetica Neue LT W1G 45 Light, 46 Light Italic, 75 Bold; Tahoma Regular

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.

177

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 copolymer (1:2),
povidone E1201, magnesium stearate (vegetable origin),
iron oxides E172, macrogol 6000

170 x 300 mm

6. Contents of the pack and other information
Is this leaflet hard to see or read?
Telephone 0800 1985000 for help.

225 8535 3

– 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.

225 8535 4

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
• increased sensitivity of your skin to sun and ultraviolet
light (photosensitivity).
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 scarring of
the kidney), kidney failure, which may be reversible if
treatment is stopped early
• reversible decrease in sperm production

5. How to store Octasa

PIL Octasa 800mg (T) Tab
Pack GB

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).

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.

20.10.2017 SBU

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.

HPW

4. Possible side-effects

Reading way (177)

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.

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

Pantone Red 032 C
Black

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.

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

Tillotts Pharma AG

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.

Pg. 2
20.10.17 13:35

+ Expand Transcript

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