Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about taking this medicine,
speak to your doctor or pharmacist.
1. Why am I taking CORTIMENT?
CORTIMENT is used in adults for induction of remission in patients with mild to moderate
active ulcerative colitis (UC) where mesalazine (5-ASA) treatment is not enough or
not tolerated. It contains the active ingredient budesonide, which is a corticosteroid.
2. What should I know before I take CORTIMENT?
Do not take if you have ever had an allergic reaction to CORTIMENT 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 CORTIMENT and affect how it works.
4. How do I take CORTIMENT?
Swallow the tablet whole with a glass of water. Do not chew, crush or break the tablets.
CORTIMENT should be taken at the same time each day in the morning with or without
food.
5. What should I know while taking CORTIMENT?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are taking CORTIMENT.
Call your doctor straight away if you become pregnant
If you are about to have any blood tests, tell your doctor that you are taking this
medicine.
Keep all your doctor's appointments so that your progress can be checked.
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Things you should not do
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Do not stop taking this medicine or change your dose without talking to your doctor.
Do not give this medicine to anyone else, even if they have the same condition as
you.
Do not drink grapefruit juice.
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Looking after your medicine
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Store CORTIMENT in a cool dry place where the temperature stays below 30°C
Keep your tablets in the pack until it is time to take them.
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6. Are there any side effects?
All medicines can have side effects. Most of them are minor and temporary but some
may need medical attention.
Tell your doctor if you experience any side effects. Rash and/or itching or hives on the skin, swelling of the face, lips, tongue or other
parts of the body and shortness of breath, wheezing or difficulty breathing may be
a sign of an allergic reaction and you may require urgent medical attention in hospital.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient(s):
[budesonide]
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking CORTIMENT. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking CORTIMENT.
Where to find information in this leaflet:
1. Why am I taking CORTIMENT?
CORTIMENT is used in adults for induction of remission in patients with mild to moderate
active ulcerative colitis (UC) where mesalazine (5-ASA) treatment is not enough or
not tolerated. It belongs to a class of medicines called corticosteroids.
CORTIMENT contains the active ingredient budesonide.
CORTIMENT is used to help reduce inflammation. CORTIMENT is used to treat inflammation
of the large intestine (colon), which is an area commonly affected in UC. The tablets
release the active ingredient, budesonide, in a controlled manner along the colon.
2. What should I know before I take CORTIMENT?
Warnings
Do not take CORTIMENT if:
you are allergic to budesonide, peanut oil, soy or any of the ingredients listed at
the end of this leaflet.
Always check the ingredients to make sure you can take this medicine.
Check with your doctor if you:
have or have had any other medical conditions, especially the following:
infection (including viral, bacterial and/or fungal infections)
tuberculosis
high blood pressure
diabetes
osteoporosis
stomach ulcer
elevated eyeball pressure (glaucoma) or cataract
family history of diabetes or glaucoma
liver problems
mental health problems such as depression
scheduled to undergo surgery or are experiencing any other stresses.
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.
Chicken pox/Measles
Tell your doctor if you have NOT had chicken pox or measles or if you have been in
contact with people with chicken pox or measles.
These infections may be more serious if you get them while taking CORTIMENT. Your
doctor may want to vaccinate you for them before you start on CORTIMENT.
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 and CORTIMENT may interfere with each other and affect how they work.
CORTIMENT may
increase
the effect of medicines that include:
medicines used to treat heart failure (e.g. cardiac glycosides such as digoxin).
medicines used to treat high blood pressure and fluid build-up (e.g. diuretics).
Medicines that may
increase
the effect of CORTIMENT include:
medicines used to treat fungal infections (e.g. ketoconazole or itraconazole).
medicine used to treat HIV infections (e.g. HIV protease inhibitors).
some medicines that contain oestrogens, such as oral contraceptives or hormone replacement
therapies.
Medicines that may
reduce
the effect of CORTIMENT include:
medicine used to treat epilepsy (e.g. carbamazepine).
cholesterol-lowering medicines, antacids or medicines used to treat itch caused by
liver problems (e.g. cholestyramine).
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect CORTIMENT.
4. How do I take CORTIMENT?
How much to take
Usually, you will take one CORTIMENT 9 mg tablet daily.
Swallow the tablet whole with a glass of water. Do not chew, crush or break the tablets.
Follow the instructions provided and take CORTIMENT until your doctor tells you to
stop.
Usually, you will take this medicine daily for a maximum of eight weeks.
When to take CORTIMENT
CORTIMENT should be taken at the same time each day with or without food.
If you forget to take CORTIMENT
CORTIMENT should be taken regularly at the same time each day.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
If you take too much CORTIMENT
If you think that you have taken too much CORTIMENT, 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 taking CORTIMENT?
Things you should do
Call your doctor straight away if you:
become pregnant.
Remind any doctor, dentist or pharmacist you visit that you are taking CORTIMENT.
If you are about to have any blood tests, tell your doctor that you are taking this
medicine.
It may interfere with the results of some tests.
Keep all your doctor's appointments so that your progress can be checked.
Your doctor may do some tests from time to time to make sure the medicine is working
and to prevent unwanted side effects.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
this medicine.
Things you should not do
Do not stop taking this medicine or change your dose without talking to your doctor.
Do not give this medicine to anyone else, even if they have the same condition as
you.
Consuming grapefruit
Do not eat grapefruit or drink grapefruit juice while you are taking CORTIMENT.
Grapefruit juice, but no other fruit juices, can affect budesonide levels in the body.
This may increase the chances of getting unwanted side effects.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how CORTIMENT
affects you.
Looking after your medicine
Keep CORTIMENT in a cool dry place where the temperature stays below 30°C.
Keep your tablets in the pack until it is time to take them.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on windowsills.
Keep it where young children cannot reach it.
When to discard your medicine
Do not take this medicine after the expiry date.
Getting rid of any unwanted medicine
If you no longer need to take this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not take this medicine after the expiry date.
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.
Serious side effects
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Serious side effects
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What to do
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Allergic reaction:
rash, itching or hives on the skin
swelling of the face, lips, tongue or other parts of the body
shortness of breath, wheezing or difficulty breathing.
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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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Discuss with your doctor if you have experienced symptoms of psychological problems
while on CORTIMENT.
Psychological problems may develop when taking corticosteroids like CORTIMENT. In
very rare cases, psychological problems have developed when high doses of corticosteroids
were taken for a long time. This is particularly important if you are depressed and
may be thinking about committing suicide.
Medicines like CORTIMENT tablets (corticosteroids) may affect the normal production
of steroid hormones in your body. The effects include:
increased bone fragility (osteoporosis)
glaucoma (high eyeball pressure)
effect on the adrenal gland (small gland near the kidney).
Your doctor may also tell you to take additional oral corticosteroids during periods
of stress such as trauma and surgery.
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 CORTIMENT contains
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Active ingredient
(main ingredient)
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budesonide
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Other ingredients
(inactive ingredients)
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stearic acid [E570]
lecithin (of soya origin) [E322]
microcrystalline cellulose [E460]
hyprolose [E463]
lactose monohydrate
silicon dioxide [E551]
magnesium stearate [E470b].
methacrylic acid copolymer
talc - purified [E553b]
titanium dioxide [E171]
triethyl citrate
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Potential allergens
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Peanut oil
Soy
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Do not take this medicine if you are allergic to any of these ingredients.
What CORTIMENT looks like
CORTIMENT is a white to off-white, round, double convex tablet with a film coating,
and 'MX9' engraved on one side of the tablet. The tablets are supplied in blister
packs with aluminum press-through foil in a cardboard carton.
(AUST R 225849).
Who distributes CORTIMENT
CORTIMENT is distributed in Australia by:
Ferring Pharmaceuticals Pty Ltd
Suite 2, Level 1, Building 1
20 Bridge Street, Pymble, NSW 2073
This leaflet was prepared in March 2024.
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