Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using MESALAZINE 1.2 TAKEDA?
MESALAZINE 1.2 TAKEDA contains the active ingredient mesalazine. MESALAZINE 1.2 TAKEDA
is used for the treatment of ulcerative colitis.
2. What should I know before I use MESALAZINE 1.2 TAKEDA?
Do not use if you have ever had an allergic reaction to MESALAZINE 1.2 TAKEDA or any
of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with MESALAZINE 1.2 TAKEDA and affect how it works.
4. How do I use MESALAZINE 1.2 TAKEDA?
Your doctor will tell you what dose to take each day.
Take your tablets with or without food at the same time each day. The tablets must
be swallowed whole and must not be crushed or chewed. Follow all directions given
to you by your pharmacist or doctor carefully.
5. What should I know while using MESALAZINE 1.2 TAKEDA?
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Things you should do
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Remind any doctor or dentist you visit that you are using MESALAZINE 1.2 TAKEDA. If
you are pregnant or intend to become pregnant while using this medicine, tell the
doctor immediately.
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Things you should not do
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Do not stop using this medicine suddenly or change the dosage without checking with
your doctor.
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Driving or using machines
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MESALAZINE 1.2 TAKEDA is unlikely to have any effect on your ability to drive or use
machines.
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Looking after your medicine
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Store MESALAZINE 1.2 TAKEDA in a cool dry place where the temperature is below 25°C.
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6. Are there any side effects?
Common side effects include headache, tiredness, indigestion, mild stomach pains,
excessive gas in the stomach or bowel, increased number of bowel motions, nausea,
vomiting, rash or itchy skin, fever, loss of strength, muscle or joint or back pain.
Serious side effects include: Acute intolerance syndrome symptoms such as cramping,
severe stomach pain, bloody and excessive stools (diarrhoea), fever, headache or rash.
Unexplained bruising, rash, anaemia, sore throat, unusual bleeding. Allergic reaction.
Severe pain in the back, side or stomach. Trouble urinating, pain or burning during
urination. Increased blood pressure.
Active ingredient(s): mesalazine
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using MESALAZINE 1.2 TAKEDA. It
does not take the place of talking to your doctor or pharmacist.
You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using MESALAZINE 1.2 TAKEDA. The information in this leaflet was last updated on the date listed on the final
page. More recent information on the medicine may be available. You should ensure
that you speak to your pharmacist or doctor to obtain the most up to date information
on this medicine. You can also download the most up to date leaflet from
www.takeda.com/en-au . Those updates may contain important information about the medicine and its use of
which you should be aware.
Where to find information in this leaflet:
1. Why am I using MESALAZINE 1.2 TAKEDA?
MESALAZINE 1.2 TAKEDA contains the active ingredient mesalazine (also called 5-aminosalicylic
acid or 5-ASA).
MESALAZINE 1.2 TAKEDA is an anti-inflammatory drug used for the treatment of ulcerative
colitis. When MESALAZINE 1.2 TAKEDA is taken for a flare up of ulcerative colitis,
it acts through the entire colon and rectum to treat the inflammation and reduce symptoms.
MESALAZINE 1.2 TAKEDA can also be taken to help prevent re-occurrence of ulcerative
colitis.
2. What should I know before I use MESALAZINE 1.2 TAKEDA?
Warnings
Do not use MESALAZINE 1.2 TAKEDA if:
1. you are allergic to mesalazine, or any of the ingredients listed at the end of this
leaflet.
2. you are allergic to a family of drugs known as salicylates (which include aspirin).
3. Always check the ingredients to make sure you can use this medicine.
Check with your doctor if you:
have any kidney problems
have previously had inflammation of the heart (which may be the result of an infection
in the heart)
have had a previous allergic reaction to MESALAZINE 1.2 TAKEDA or other medicines
containing mesalazine or sulphasalazine (other medicines taken for treatment of ulcerative
colitis)
have narrowing or blockage of the stomach or the gut
have skin conditions such as atopic dermatitis or atopic eczema
have ever developed severe skin rash or skin peeling, blistering and/or mouth sores
have any other medical conditions or take any medicines for any other condition
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with MESALAZINE 1.2 TAKEDA and affect how it works.
These include:
mesalazine or sulphasalazine (taken for treatment of ulcerative colitis)
non-steroidal anti-inflammatory drugs (for example medicines containing aspirin, ibuprofen
or diclofenac)
azathioprine or 6-mercaptopurine (known as 'immunosuppressant' medicines).
warfarin (taken to prevent blood clots) or other coumarin-type anticoagulants
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect MESALAZINE 1.2 TAKEDA.
4. How do I use MESALAZINE 1.2 TAKEDA?
How much to take
Adults and the elderly:
The usual daily dose for adults and the elderly is 2.4g to 4.8g (two to four tablets)
taken once a day for an acute episode of ulcerative colitis. If you are taking the
highest daily dose of 4.8g/day, you should be evaluated after 8 weeks of treatment.
Once your symptoms have cleared and to help prevent re-occurrence of another episode,
your doctor may direct you to take 2.4g (two tablets) once a day.
Children and Adolescents:
MESALAZINE 1.2 TAKEDA is not recommended to be given to children under 18 years of
age due to lack of data on safety and efficacy.
Follow the instructions provided and use MESALAZINE 1.2 TAKEDA until your doctor tells
you to stop.
When to take MESALAZINE 1.2 TAKEDA
Take MESALAZINE 1.2 TAKEDA at the same time each day. It is important to take MESALAZINE
1.2 TAKEDA every day for as long as your doctor tells you to, even when you don't
have any symptoms of ulcerative colitis.
How to take MESALAZINE 1.2 TAKEDA
MESALAZINE 1.2 TAKEDA can be taken with or without food. The tablets must be swallowed
whole and must not be crushed or chewed.
If you forget to use MESALAZINE 1.2 TAKEDA
MESALAZINE 1.2 TAKEDA should be used regularly at the same time each day. If you miss
your dose at the usual time, then take them as usual the next day.
Do not take a double dose to make up for the dose you missed.
If you use too much MESALAZINE 1.2 TAKEDA
If you think that you have used too much MESALAZINE 1.2 TAKEDA, you may need urgent
medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using MESALAZINE 1.2 TAKEDA?
Things you should do
make sure that all of your doctors, dentists, and pharmacists know you are taking
MESALAZINE 1.2 TAKEDA. Remind them if any new medicines are about to be started.
ensure adequate fluid intake during treatment.
Things you should not do
do not stop using this medicine suddenly or change the dosage without checking with
your doctor.
do not give to children under 18 years of age. MESALAZINE 1.2 TAKEDA is not suitable
for children under 18 years of age as there is not enough information on its effects
in children.
do not give MESALAZINE 1.2 TAKEDA to anyone else, even if they have the same condition
as you. It may not be safe for another person to take MESALAZINE 1.2 TAKEDA.
do not take MESALAZINE 1.2 TAKEDA to treat any other complaints unless your doctor
tells you to. It may not be safe to use MESALAZINE 1.2 TAKEDA for another complaint.
Driving or using machines
MESALAZINE 1.2 TAKEDA is unlikely to have any effect on your ability to drive or use
machines.
Looking after your medicine
Keep MESALAZINE 1.2 TAKEDA tablets in the pack until it is time to take them. Store
MESALAZINE 1.2 TAKEDA in a cool dry place where the temperature stays below 25°C.
Do not store it in the bathroom or near a sink, or in the car or on windowsill.
Do not use this medicine after the expiry date.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
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Less serious side effects
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What to do
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headache
tiredness
indigestion
mild stomach pains
bloating or passing wind
excessive gas in the stomach or bowel
increased number of bowel motions
nausea
vomiting
rash or itchy skin
fever
loss of strength
muscle, joint or back pain
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
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Serious side effects
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What to do
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if you experience symptoms such as cramping, severe stomach pain, bloody and excessive
stools (diarrhoea), fever, headache or rash. These symptoms could be a sign of Acute
Intolerance Syndrome which can happen during an acute episode of ulcerative colitis.
This is a serious condition which occurs rarely, but means your treatment would have
to be stopped immediately
if you develop unexplained bruising (without injury), rash, 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)
if you develop allergic swelling of face, eyes, lips, mouth, tongue or throat which
may cause difficulty in swallowing or breathing.
widespread rash with blistering of the skin, particularly around the mouth, eyes and
genitals
allergic skin rash with fever
severe pain in the back, side or stomach. Trouble urinating, pain or burning during
urination. These could be symptoms of kidney stones
increased blood pressure
If you notice reddish non-elevated, target-like or circular patches on the trunk,
often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals
and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms.
Your treatment will need to be stopped immediately if you experience these serious
conditions.
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What MESALAZINE 1.2 TAKEDA contains
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Active ingredient
(main ingredient)
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Mesalazine
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Other ingredients
(inactive ingredients)
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Carmellose sodium, carnauba wax, stearic acid, silicon dioxide, sodium starch glycollate,
talc-purified, magnesium stearate, methacrylic acid copolymer, triethyl citrate, titanium
dioxide (E171), iron oxide red (CI77491), Macrogol 6000
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Do not take this medicine if you are allergic to any of these ingredients.
What MESALAZINE 1.2 TAKEDA looks like
MESALAZINE 1.2 TAKEDA 1.2 g tablet (AUST R 316122): Oval shaped red-brown tablets
which are stamped with S476.
MESALAZINE 1.2 TAKEDA is supplied as a 60 tablets pack size.
Who distributes MESALAZINE 1.2 TAKEDA
Takeda Pharmaceuticals Australia Pty Ltd
Level 39, 225 George Street
Sydney NSW 2000
Australia
Phone: 1800 012 612
www.takeda.com/en-au
This leaflet was prepared in June 2021.
TAKEDA® and the TAKEDA® Logo are registered trademarks of Takeda Pharmaceutical Company
Limited.