2. What should I know before I take BUDENOFALK Capsules?
Do not take if you have ever had an allergic reaction to BUDENOFALK capsules 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.
For more information, see Section
2. What should I know before I take BUDENOFALK Capsules? in the full CMI.
3. What if I am taking other medicines?
4. How do I take BUDENOFALK Capsules?
The recommended dose is one BUDENOFALK capsule three times a day (morning, midday
and evening), or three BUDENOFALK capsules once daily in the morning.
This medicine may only be used orally.
5. What should I know while taking BUDENOFALK Capsules?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are taking BUDENOFALK
capsules.
If you become pregnant while taking this medicine, tell your doctor immediately.
|
|
Things you should not do
|
Do not take BUDENOFALK capsules to treat any other complaints unless your doctor tells
you to.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Do not stop taking BUDENOFALK capsules or change the dosage without checking with
your doctor.
|
|
Driving or using machines
|
This medicine is not expected to affect your ability to drive a car or operate machinery.
|
|
Looking after your medicine
|
Keep BUDENOFALK capsules in their original packaging until it is time to take them.
Keep your capsules in a cool and dry place where the temperature stays below 30C.
Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
|
6. Are there any side effects?
All medicines can have side effects. If they do occur, they are usually minor and
temporary. The most common side effects taking BUDENOFALK capsules are: abdominal
pain, pain in the upper middle part of the abdomen, diarrhoea / soft stools, high
blood pressure, acne, tiredness, general feeling of being ill. 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 BUDENOFALK capsules. 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 BUDENOFALK capsules.
Where to find information in this leaflet:
1. Why am I taking BUDENOFALK capsules?
BUDENOFALK capsules contain the active ingredient, budesonide distributed within enteric-coated
(gastric resistant) granules. Budesonide belongs to a group of medications called
corticosteroids.
BUDENOFALK capsules are used to treat
Crohn’s disease affecting the ileum and/or the ascending colon (inflammation of the
last section of the small bowel and/or the first section of the large bowel) for 8
weeks.
2. What should I know before I take BUDENOFALK capsules?
Warnings
Do not take BUDENOFALK capsules if:
you are allergic to budesonide, or any of the ingredients listed at the end of this
leaflet.
Always check the ingredients to make sure you can use this medicine.
Do not take this medicine if you suffer from a severe liver disease (liver cirrhosis).
Do not take this medicine after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering.
Check with your doctor if you:
have any other conditions and taking medicines
liver disease
lung disease (tuberculosis)
high blood pressure
diabetes, when the level of sugar in the blood is too high
disease which causes bones to become less dense, gradually making them weaker, more
brittle and likely to break (osteoporosis)
ulcer in stomach or duodenum
glaucoma (high pressure in the eye)
cataracts
family history of diabetes or glaucoma
any infections
any stresses
intolerance to sugars
any other disease where use of steroids may have unwanted effects.
have an infection. The symptoms of some infections can be atypical or less pronounced.
have been exposed to chicken pox, measles and shingles infections. These illnesses
may become more severe when you take BUDENOFALK capsules.
have not yet had measles.
need to be vaccinated, please speak to your doctor first.
know you are due to have an operation, please tell your doctor that you are taking
BUDENOFALK capsules.
have been treated with a stronger corticosteroid preparation before starting treatment
with BUDENOFALK capsules, your symptoms may reappear when the medicine is changed.
If this happens, contact your doctor.
experience blurred vision or other visual disturbances.
BUDENOFALK capsules are not recommended for use in children or adolescents.
BUDENOFALK capsules contain lactose and sucrose. This may cause a problem if you have
intolerance to some sugars.
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.
Your doctor will discuss the risks and benefits of taking BUDENOFALK capsules if you
are pregnant or breastfeeding.
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 BUDENOFALK capsules and affect how it works.
cardiac glycosides such as digoxin, medicines used to treat heart conditions
diuretics, medicines used to treat excess fluid in your body
ketoconazole and itraconazole, medicines used to treat fungal infections
antibiotics such as clarithromycin, medicines used to treat infections
ritonavir and cobicistat medicines used to treat HIV infections
carbamazepine, medicine used to treat epilepsy
rifampicin, medicine used to treat tuberculosis
contraceptive pill
cholestyramine, medicine used to reduce cholesterol level
cimetidine, medicine used to reduce stomach acid.
These medicines may be affected by BUDENOFALK capsules or they may affect how well
BUDENOFALK capsules work. You may need different doses of your medicine(s) or you
may need to take different medicines. Your doctor or pharmacist will advise you if
this is required.
Avoid drinking grapefruit juice while you are taking BUDENOFALK capsules as this can
alter its effects.
Your doctor or pharmacist have more information on medicines to be careful with or
to avoid while taking BUDENOFALK capsules.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect BUDENOFALK capsules.
4. How do I take BUDENOFALK capsules?
Follow all directions given to you by your doctor or pharmacist carefully.
How much to take
Adults and the elderly:
One BUDENOFALK capsule three times a day (morning, midday and evening), or three BUDENOFALK
capsules once daily in the morning.
BUDENOFALK capsules treatment should be terminated by gradual reduction of your dose
over the last two weeks. The dosage should be reduced to two capsules daily (one in
the morning and one in the evening) for one week. In the last week, only one capsule
should be taken in the morning.
Once you have started taking BUDENOFALK capsules, do not stop taking it abruptly.
When to take
Take BUDENOFALK capsules about 30 minutes before a meal.
Take your medicine at about the same time each day.
Taking it at the same time each day will have the best effect. It will also help you
remember when to take it.
How to take
Swallow the capsules whole with a glass of water. Do not chew or crush the capsules.
If you have difficulty swallowing the capsules, open the capsule and take the granules
with plenty of liquid. Do not chew or crush the granules.
Due to the gastro-resistant coating being on the granules rather than the capsules,
there is no change in how the medicine works by swallowing the capsules whole versus
opening the capsules and swallowing the granules directly.
How long to take
Your doctor will decide how long you need to continue the treatment with this medicine.
This will depend on your condition. BUDENOFALK capsules may be used for up to 8 weeks
for each episode of Crohn’s disease.
If you forget to take
Take your dose as soon as you remember and continue to take it as you would normally.
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 that you missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering when to take your medicine, ask your pharmacist for
some hints.
If you take too much
If you think that you have taken too many BUDENOFALK capsules no emergency treatment
is required. If you have any concerns, you should
contact your doctor, or
phone the Poisons Information Centre
(by calling 13 11 26)
5. What should I know while taking BUDENOFALK capsules?
Things you should do
If you are about to start on any new medicine, remind your doctor and pharmacist that
you are taking BUDENOFALK capsules.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking
BUDENOFALK capsules.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
BUDENOFALK capsules.
It may affect other medicines used during surgery.
If you become pregnant while taking BUDENOFALK capsules, tell your doctor immediately.
Things you should not do
Do not take BUDENOFALK capsules to treat any other complaints unless your doctor tells
you to.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Do not stop taking BUDENOFALK capsules or change the dosage without checking with
your doctor.
Driving or using machines
This medicine is not expected to affect your ability to drive a car or operate machinery.
Looking after your medicine
Keep BUDENOFALK capsules in their original packaging until it is time to take them.
Keep your BUDENOFALK capsules in a cool and dry place where the temperature stays
below 30°C.
Do not store it or any other medicine in the bathroom or near a sink. Do not leave
it on a window sill or in the car.
Heat and dampness can destroy some medicines.
Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
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, speak to your doctor or pharmacist
if you have any further questions about side effects.
Less serious side effects
Serious side effects
The following side effects have been reported with medicines which are in the same
class as BUDENOFALK capsules (corticosteroids). These side effects listed below depend
on the dose, the period of treatment, whether there has been prior or accompanying
treatment with other corticosteroid preparations and on the individual sensitivity.
Possible class effects are:
Cushing Syndrome: roundness of the face, weight gain, increased risk of high blood
sugar, fluid retention, reduced growth
increased risk of infection
irregular periods in women, male hair growth patterns in women, impotence
mood changes such as depression, irritation or euphoria
blurred vision (e.g. glaucoma and cataract)
increased risk of blood clotting, disease of the blood vessels (associated with stopping
steroid use after long term therapy)
stomach complaints, gastric ulcers, pancreatitis and constipation
muscle pain and bone weakness (osteoporosis), loss of bone and cartilage (aseptic
bone necrosis)
rash from hypersensitivity reactions (allergic exanthema), formation of red stripes
(striations) and bleeding in the skin, delayed wound healing, local skin reactions
(such as contact dermatitis)
isolated cases: increased brain pressure with possible additional swelling of the
optic disk in adolescents.
These side effects are typical for systemic corticosteroids, such as prednisolone.
Data shows that the frequency of systemic adverse reactions is lower with BUDENOFALK
capsules.
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 that 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 BUDENOFALK capsules contain
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Active ingredient
(main ingredient)
|
Budesonide 3 mg
|
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Other ingredients
(inactive ingredients)
|
lactose monohydrate
sugar spheres (sucrose)
triethyl citrate
purified talc
povidone
methacrylic acid copolymer
ammonio methacrylate copolymer
gelatin
sodium lauryl sulphate
titanium dioxide
iron oxide red
iron oxide black
erythrosine.
|
Do not take this medicine if you are allergic to any of these ingredients.
What BUDENOFALK capsules looks like
BUDENOFALK capsules are pink opaque capsules containing round white pellets.
BUDENOFALK capsules are approved in blister packs of 9 and 10 (starter packs), 50
and 90.
Who distributes BUDENOFALK capsules
Dr Falk Pharma Australia Pty Ltd,
9 Help Street
Chatswood NSW 2067
Australian Registration Number: AUST R 179566
BUDENOFALK is a registered trademark of Dr. Falk Pharma GmbH, Germany.
This leaflet was revised in March 2026.
