Consumer medicine information

Budenofalk Foam

Budesonide

BRAND INFORMATION

Brand name

Budenofalk Foam

Active ingredient

Budesonide

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Budenofalk Foam.

SUMMARY CMI

BUDENOFALK® foam

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 BUDENOFALK foam?

BUDENOFALK foam contains the active ingredient, budesonide. BUDENOFALK foam is used to treat ulcerative colitis (inflammation) of the rectum (back passage) and the lower part of the large bowel.

For more information, see Section 1. Why am I using BUDENOFALK foam? in the full CMI.

2. What should I know before I use BUDENOFALK foam?

Do not use if you have ever had an allergic reaction to BUDENOFALK foam 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 use BUDENOFALK foam? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with BUDENOFALK foam and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use BUDENOFALK foam?

The recommended dose is one actuation daily, corresponding to 2 mg budesonide. BUDENOFALK foam can be applied in the morning or evening.

This medicine may only be used rectally, so it has to be inserted through the anus. Do NOT take it by mouth.

More instructions can be found in Section 4. How do I use BUDENOFALK foam? in the full CMI.

5. What should I know while using BUDENOFALK foam?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using BUDENOFALK foam.
  • If you become pregnant while using this medicine, tell your doctor immediately.
Things you should not do
  • Do not use BUDENOFALK foam 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 using BUDENOFALK foam 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 foam in the original packaging until it is time to use it.
  • Keep your BUDENOFALK foam in a cool dry place where the temperature stays below 25°C.
  • Store the pack upright.
  • Do not refrigerate or freeze. Protect from direct sunlight.
  • Keep away from flames or sparks. Contains flammable gas.
  • Keep it where children cannot reach it.
  • Use within 4 weeks of first opening.
  • A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

For more information, see Section 5. What should I know while using BUDENOFALK foam? in the full CMI.

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 using BUDENOFALK foam are: Burning or pain in the rectum, indigestion, irritable stomach (dyspepsia), increased risk of infection, muscle and joint pain, muscle weakness, muscle twitching, brittle bones (osteoporosis), mood changes, such as depression, irritability or euphoria.

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.



FULL CMI

BUDENOFALK® foam

Active ingredient: budesonide

Consumer Medicine Information (CMI)

This leaflet provides important information about using BUDENOFALK foam. 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 BUDENOFALK foam.

Where to find information in this leaflet:

1. Why am I using BUDENOFALK foam?
2. What should I know before I use BUDENOFALK foam?
3. What if I am taking other medicines?
4. How do I use BUDENOFALK foam?
5. What should I know while using BUDENOFALK foam?
6. Are there any side effects?
7. Product details

1. Why am I using BUDENOFALK foam?

BUDENOFALK foam contains the active ingredient, budesonide. Budesonide belongs to a group of medications called corticosteroids.

BUDENOFALK foam is used to treat ulcerative colitis (inflammation) of the rectum (back passage) and the lower part of the large bowel.

2. What should I know before I use BUDENOFALK foam?

Warnings

Do not use BUDENOFALK foam 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 use this medicine if you suffer from a severe liver disease (liver cirrhosis).
  • Do not use this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering when it is dispensed to you.

Check with your doctor if you:

  • Tell 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 stresses
    - any other disease where use of corticosteroids may have unwanted effects.
  • you have an infection. The symptoms of some infections can be atypical or less pronounced.
  • have been exposed to chicken pox, measles or shingles infections. These illnesses may become more severe when you take BUDENOFALK.
  • have not yet had measles.
  • need to be vaccinated, please speak to your doctor first.
  • are due to have an operation, please tell your surgeon and anaesthetist that you are using BUDENOFALK foam.
  • have been treated with a systemically acting corticosteroid preparation (i.e. one which is absorbed into the blood circulation and acting outside the gastrointestinal tract) before starting treatment with BUDENOFALK foam, your symptoms may reappear when the medicine is changed. If this happens, contact your doctor.
  • experience blurred vision or other visual disturbances.

There is insufficient information to recommend BUDENOFALK foam for use in children or adolescents.

BUDENOFALK foam contains propylene glycol which may cause skin irritation in some people.

BUDENOFALK foam also contains cetyl alcohol and cetostearyl alcohol (component of emulsifying wax), which may cause local skin reactions (e.g. contact dermatitis).

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 using BUDENOFALK foam 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 foam 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 and rifampicin, medicines used to treat infections
  • ritonavir and cobicistat medicines used for treating HIV infections
  • carbamazepine, medicine used for treating epilepsy
  • rifampicin, medicine used to treat tuberculosis
  • contraceptive pill
  • cholestyramine, medicine used to reduce cholesterol level
  • cimetidine, medicine to reduce stomach acid.

These medicines may be affected by BUDENOFALK foam or they may affect how well BUDENOFALK foam works. You may need different doses of your medicines 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 using BUDENOFALK foam as this can alter its effects.

Your doctor or pharmacist have more information on medicines to be careful with or to avoid while using BUDENOFALK foam.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are using and if these affect BUDENOFALK foam.

4. How do I use BUDENOFALK foam?

How much to use

Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

Adults and the elderly: Apply one actuation daily, corresponding to 2 mg budesonide. BUDENOFALK foam can be used in the morning or evening.

One BUDENOFALK foam contains 14 doses (14 applications or “actuations”) or 2 weeks of dosing, based on a standard 2 mg/day dosing regimen.

In the product pack, the individual applicators are inserted into purpose-designed plastic tray. To remove an applicator, push down firmly on the tray with one hand, while pulling out the applicator with the other hand.

When to use

BUDENOFALK foam should be administered about the same time each day. Using it at the same time each day will have the best effect. It will help you remember when to use it.

How to use

Picture of the can

This medicine may only be used rectally, so it has to be inserted via the anus. Do NOT take it by mouth.

If possible, go to the toilet and empty your bowels before using the foam.

  1. Wash your hands thoroughly with soap and water.
  2. For your comfort, ensure that BUDENOFALK foam should always be stored at room temperature before use.
  3. Push the applicator firmly onto the spout of the spray can.

  1. Shake the can for 15 seconds to mix the contents.
  2. Each time you use a new can, remove the safety tab from under the pump dome.

  1. Twist the dome on top of the canister until the semi-circular gap underneath it is in line with the applicator.

The can is now ready for use.

  1. Place your forefinger on top of the pump dome. Turn the can upside down. Note that the can will only work properly when held with the pump dome pointing down and as vertically as possible.

  1. Place one foot on a stool or chair. Alternatively, lie on your side with the lower leg stretched out and the upper leg bent at an angle.
  2. Insert the applicator into the rectum as far as possible. Push down the pump dome fully once, hold and then release it very slowly. As soon as you release the pump dome, the foam will be actuated from the can. Leave the applicator in this position for 10 to 15 seconds before withdrawing it from your rectum to allow the full dose to be released.

This will ensure that the entire dose is delivered to the rectum and will also reduce the risk any irritation around your anus if the applicator is removed too quickly while the foam is still being released.

  1. After administering the foam remove the applicator from the spout of the can and dispose of it as domestic waste in the plastic bag provided.

  1. Wash your hands thoroughly and try not to empty your bowels again for as long as possible.
  2. Always use a new applicator for each dose.

You may experience a little discomfort and a feeling of urgency to empty your bowels immediately after foam insertion. This is normal and expected, especially when you first start using BUDENOFALK foam due to the inflammation present within the bowel related to your ulcerative colitis. Try to resist this urge to empty your bowels for as long as possible. This feeling will subside over the next few days as treatment continues and the inflammation decreases.

The following QR code links to a patient instructions for use video, which covers the same dosing procedure detailed above:

How long to use

The duration of treatment will be decided by your doctor. In general, the inflammation and associated symptoms should subside after 6 to 8 weeks.

BUDENOFALK helps control your condition but does not cure it. Therefore, you must continue to use BUDENOFALK for as long as your doctor tells you to.

If you forget to use

If you missed a dose and it is almost time for your next dose, skip the dose you missed and administer your next dose when you are meant to.

Otherwise, dose as soon as you can and then go back to taking your medicine at the time in the day you would normally administer it.

Do not use 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 use your medicine, ask your pharmacist for some hints.

If you use too much

To date, no cases of overdosage with budesonide are known. In view of the properties of budesonide contained in BUDENOFALK foam, an overdose resulting in toxic damage is extremely unlikely.

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5. What should I know while using BUDENOFALK foam?

Things you should do

If you are about to start on any new medicine, remind your doctor and pharmacist that you are also using BUDENOFALK foam.

Tell any other doctors, dentists, and pharmacists who treat you that you are using this medicine.

If you are going to have surgery, tell the surgeon or anaesthetist that you are using BUDENOFALK foam.

It may affect other medicines used during surgery.

If you become pregnant while using this medicine, tell your doctor immediately.

Things you should not do

Do not use BUDENOFALK foam 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 using BUDENOFALK foam 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 foam in its original packaging until it is time to use it.

Keep your BUDENOFALK foam in a cool place where the temperature stays below 25°C.

Store the pack upright.

Do not refrigerate or freeze.

Protect from direct sunlight.

Keep away from flames or sparks. Contains flammable gas.

Use within 4 weeks of first opening.

Do not store BUDENOFALK foam or any other medicine in the bathroom or near a sink. Do not leave it on a windowsill 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 use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

Do not pierce or burn the can even when empty.

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

Less serious side effectsWhat to do
When using BUDENOFALK foam:
Common side effects:
  • burning or pain in the rectum
  • indigestion, irritable stomach (dyspepsia)
  • increased risk of infection
  • muscle and joint pain, muscle weakness, muscle twitching
  • brittle bones (osteoporosis)
  • mood changes, such as depression, irritability or euphoria
  • rash from hypersensitivity reactions, red spots from bleeding in the skin, delayed wound healing, local skin reactions such as contact dermatitis.
Uncommon side effects:
  • changes to the blood parameters (decreased red blood cells (anaemia), increase in erythrocyte sedimentation rate, increase in the number of white blood cells)
  • ulcers in the stomach or small intestine
  • headache
  • giddiness, disturbance of smell
  • urinary tract infections
  • sleeplessness, restlessness with increased physical activity, anxiety
  • nausea, abdominal pain, dyspepsia, wind, tingling in the abdomen, anal fissure, mouth rash, urgent need to empty the bowels, rectal bleeding,
  • changes in liver function tests
  • changes in pancreatic function, changes in adrenal hormones (e.g. cortisol)
  • acne, increased sweating
  • increase in appetite
  • weakness
  • increase in body weight
  • high blood pressure.
Rare side effects:
  • glaucoma, cataracts, blurred vision
  • inflammation of the pancreas
  • bone loss due to poor circulation of blood (osteonecrosis)
  • aggression
  • bruising.
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effect

Serious side effectsWhat to do
  • signs or symptoms of an infection
  • headache
  • changes in behaviour such as depression, irritability, euphoria, restlessness, anxiety or aggression.
Call your doctor or pharmacist immediately if you notice any of these symptoms.

The following side effects have been reported with medicines which are in the same class as BUENDOFALK foam (corticosteroids). These side effects are typical for systematically acting preparations (i.e. absorbed into the blood circulation and acting outside the gastrointestinal tract). As BUDENOFALK foam acts locally, the risk of these class effects occurring with this medicine is generally expected to be lower than with the systemically acting corticosteroids.

Possible class effects of systemically acting corticosteroids are:

  • Cushing's syndrome – e.g. with roundness of the face, weight gain, reduced glucose tolerance, high blood sugar, high blood pressure, fluid retention in the tissues (e.g. swollen legs), increased excretion of potassium (hypokalaemia), irregular periods in women, unwanted body hair in women, impotence, abnormal laboratory findings (reduced adrenal function), red stripes on the skin (stretch marks), acne.
  • increased risk of infection
  • mood changes such as depression, irritation or euphoria
  • Tiredness, malaise
  • 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.

Some of these unwanted effects were only reported after long-term use of oral budesonide.

These side effects are typical for systemic corticosteroids. Data shows that the frequency of systemic adverse reactions is lower with BUDENOFALK foam due to its local action.

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 using any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What BUDENOFALK foam contains

Active ingredient
(main ingredient)		Budesonide 2 mg
Other ingredients
(inactive ingredients)		emulsifying wax
cetyl alcohol
purified water
disodium edetate
steareth-10
propylene glycol
citric acid monohydrate,
butane, isobutane and propane as propellants.

Do not use this medicine if you are allergic to any of these ingredients.

After administration of 14 spray actuations (14 daily doses), a residual amount of foam will remain in the can. This is present in the can to ensure that 2 mg of budesonide is contained in all 14 doses. Throw away the can with any residual contents after application of the 14 daily doses.

What BUDENOFALK foam looks like

BUDENOFALK foam available in the following packs:

  • Two pressurised containers (14 daily doses each can), with 28 applicators and 28 plastic bags.

Who distributes BUDENOFALK foam

Dr Falk Pharma Australia Pty Ltd,
9 Help Street
Chatswood, NSW 2067

Australian Registration Number: AUST R 179575

BUDENOFALK® is a registered trademark of Dr. Falk Pharma GmbH, Germany.

This leaflet was prepared in February 2025.

Published by MIMS May 2025

BRAND INFORMATION

Brand name

Budenofalk Foam

Active ingredient

Budesonide

Schedule

S4

 

1 Name of Medicine

Budenofalk foam.

Budesonide.

2 Qualitative and Quantitative Composition

Budenofalk foam contains budesonide 2 mg/application as the active ingredient budesonide.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Foam.

4 Clinical Particulars

4.1 Therapeutic Indications

Budenofalk foam is indicated in the treatment of active rectal and rectosigmoid disease in ulcerative colitis.

4.2 Dose and Method of Administration

For adults aged > 18 years of age.

Apply one actuation of 2 mg budesonide daily. Budenofalk 2 mg foam can be applied in the morning or evening.
Budenofalk 2 mg foam should be in room temperature when applied.
The canister is first fitted with an applicator and then shaken for about 15 seconds before the applicator is inserted into the rectum as far as comfortable. Note that the dose is only sufficiently accurate when the pump dome is held downwards as vertically as possible. To administer a dose of Budenofalk 2 mg foam, the pump dome is fully pushed down and very slowly released. Following the activation the applicator should be held in position for 10-15 seconds before being withdrawn from the rectum.
The best results are obtained when the intestine is evacuated prior to administration of Budenofalk 2 mg foam.
The attending physician determines the duration of use. An acute episode generally subsides after 6 to 8 weeks.
Treatment may be continued in patients showing progressive improvement, but it should not be persisted with if the response has been inadequate. Continuous treatment beyond 8 weeks has not been assessed. Budenofalk 2 mg foam should not be used after this time.
Topical steroids including Budenofalk have not been shown to be effective in the maintenance of remission of ulcerative colitis.
Do not use Budenofalk foam after 4 weeks of first opening the container.

4.3 Contraindications

Budenofalk foam is contraindicated in patients with the following:
hypersensitivity to budesonide or any of the ingredients;
hepatic cirrhosis.

4.4 Special Warnings and Precautions for Use

Identified precautions.

Topical steroids have not been demonstrated to maintain remission in ulcerative colitis. Budenofalk should only be used for treatment of active ulcerative colitis. Treatment should not continue beyond 8 weeks.
Treatment with Budenofalk foam results in lower steroid levels than systematically acting glucocorticoids. Particular care is needed in patients who are transferred from systemically acting glucocorticoid treatment, with a higher systemic effect, to Budenofalk foam. These patients may have adrenocortical suppression at the time of the initiation of treatment with Budenofalk foam. Therefore, monitoring of adrenocortical function may be considered in these patients and their dose of the preceding systemically acting glucocorticoid should be reduced cautiously.
Caution is required in patients with tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma, cataracts, family history of diabetes, family history of glaucoma, or any other condition in which glucocorticoids may have undesirable effects.
Systemic effects of glucocorticoids may occur, particularly when prescribed at high doses, for prolonged periods and for those agents which are highly absorbed systemically. Such effects may include Cushing's syndrome, adrenal suppression, growth retardation, decreased bone mineral density, cataract, glaucoma and a wide range of psychiatric/ behavioural effects (see Section 4.8 Adverse Effects (Undesirable Effects)).
Glucocorticoids may cause suppression of the HPA axis and reduce the stress response. When patients are subject to surgery or other stresses, supplementary systemic glucocorticoid treatment is recommended.
As with all glucocorticoids, some degree of adrenal suppression may occur in particularly sensitive patients, therefore, monitoring of haematological and adrenal function is strongly advised.

Infection.

Suppression of the inflammatory response and immune function increases the susceptibility to infections and their severity. The risk of deterioration of bacterial, fungal, amoebic and viral infections during glucocorticoid treatment should be carefully considered. The clinical presentation may often be atypical and serious infections such as septicaemia and tuberculosis may be masked, and therefore may reach an advanced stage before being recognised.

Chickenpox.

Chickenpox is of particular concern since this normally minor illness may be fatal in immunosuppressed patients. Patients without a definite history of chickenpox should be advised to avoid close personal contact with chickenpox or herpes zoster and if exposed they should seek urgent medical attention. If the patient is a child, parents must be given the above advice. Passive immunisation with varicella zoster immunoglobulin (VZIG) is needed by exposed nonimmune patients who are receiving systemic glucocorticoids or who have used them within the previous 3 months; this should be given within 10 days of exposure to chickenpox. If a diagnosis of chickenpox is confirmed, the illness warrants specialist care and urgent treatment. Glucocorticoids should not be stopped and the dose may need to be increased.

Measles.

Patients with compromised immunity who have come into contact with measles should, wherever possible, receive normal immunoglobulin as soon as possible after exposure.

Live vaccines.

Live vaccines should not be given to individuals with chronic glucocorticoid use. The antibody response to other vaccines may be diminished.

Visual disturbance.

Visual disturbance may be reported with systemic and topical glucocorticoid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical glucocorticoids.
Concomitant treatment with ketoconazole or other CYP3A4 inhibitors should be avoided (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

Use in hepatic impairment.

While a reduced first pass effect in the liver for the budesonide is anticipated due to the rectal administration of the Budenofalk foam, based on the experience with oral preparations of budesonide in patients suffering from late stage primary biliary cirrhosis (PBC) with hepatic cirrhosis an increased systemic availability of budesonide in all patients with severely impaired hepatic function is to be expected. However, in patients with liver disease without hepatic cirrhosis oral budesonide in daily doses of 3 mg TID was safe and well tolerated. There is no evidence that a specific dose recommendation for patients with noncirrhotic liver diseases or only slightly impaired liver function is necessary. As the plasma levels of budesonide appear to be generally slightly higher with rectal budesonide, Budenofalk foam should be used only with caution in patients with hepatic impairment.

Use in the elderly.

The experience in elderly with Budenofalk foam is limited.

Paediatric use.

Budenofalk foam is not recommended for use in children or adolescents. Long term effects, including on height and bone density have not been assessed.

Effects on laboratory tests.

Because adrenal function may be suppressed by treatment with budesonide, an ACTH stimulation test for diagnosing pituitary insufficiency might show false results (low values).

Excipients with known effect.

This medicinal product contains 600.3 mg propylene glycol in each actuation of Budenofalk foam. Propylene glycol may cause skin irritation.
Cetyl alcohol and cetostearyl alcohol (component of emulsifying wax) may cause local skin reactions (e.g. contact dermatitis).

4.5 Interactions with Other Medicines and Other Forms of Interactions

Pharmacodynamic interactions.

Cardiac glycosides.

The action of the glycoside can be potentiated by potassium deficiency.

Saluretics.

Potassium excretion can be enhanced.

Pharmacokinetic interactions.

Cytochrome P450. Orally administered budesonide undergoes first pass metabolism involving the cytochrome P450 system in the liver and the intestinal wall. For Budenofalk foam, a reduced first pass effect in the liver is anticipated, relative to orally administered budesonide, due to the administration of the product in the rectum. Caution should still be exercised due to the absence of relevant clinical experience with Budenofalk foam with the concomitant administration of inhibitors, inducers or substrates for CYP34A enzymes, as detailed in the following.

CYP3A4 inhibitors.

Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic glucocorticoid side-effects, in which case patients should be monitored for systemic glucocorticoid side-effects. Ketoconazole 200 mg orally once daily increased the plasma concentrations of an orally administered single dose (3 mg) of budesonide approximately 6-fold during concomitant administration. When ketoconazole was administered 12 hours after budesonide, the concentrations increased approximately 3-fold. As there are not enough data to give dose recommendations, the combination should be avoided.
Other potent inhibitors of CYP3A4 such as ritonavir, itraconazole, clarithromycin, and grapefruit juice are also likely to cause a marked increase of the plasma concentrations of budesonide. Therefore, concomitant application of budesonide should be avoided.

CYP3A4 inducers.

Compounds or drugs such as carbamazepine and rifampicin, which induce CYP3A4, might reduce the systemic but also the local exposure of budesonide at the gut mucosa. An adjustment of the budesonide dose might be necessary.

CYP3A4 substrates.

Compounds or drugs which are metabolized by CYP3A4 might be in competition with budesonide. This might lead to an increased budesonide plasma concentration if the competing substance has a stronger affinity to CYP3A4, or, if budesonide binds stronger to CYP3A4, the competing substance might be increased in plasma and a dose adaption/ reduction of this drug might be required.
Elevated plasma concentrations and enhanced effects of glucocorticoids have been reported in women also receiving oestrogens or oral contraceptives, but this has not been observed with oral low dose combination contraceptives.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

There are no data on the effect of budesonide on human fertility. Subcutaneous administration of budesonide to rats at doses up to 20 microgram/kg/day did not affect fertility.
(Category B3)
Administration during pregnancy should be avoided unless there are compelling reasons for therapy with Budenofalk foam.
There are no data on pregnancy outcomes after rectal administration of budesonide in humans. Although data on the use of inhaled budesonide in a large number of exposed pregnancies indicate no adverse effects, the maximal concentration of budesonide in plasma is expected to be higher with rectal budesonide compared to inhaled budesonide.
In pregnant animals, administration of budesonide, like other glucocorticoids, has been shown to cause foetal death and abnormalities of foetal development (reductions in foetal/ pup growth and litter size, skeletal and visceral abnormalities). The relevance of these findings to humans has not been established.
 Budesonide is excreted in human milk. However, only minor effects on the breastfed infant are anticipated after the administration of Budenofalk foam within the therapeutic range. A decision should be made whether to discontinue breastfeeding or to discontinue Budenofalk foam taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

In clinical trial BUF-6/UCA involving a total of 120 patients, Budenofalk foam, was well tolerated. Table 1 shows the adverse events:
Undesirable effects were reported in 14% of patients in clinical trials with Budenofalk foam. Burning in the rectum or pain were common, and nausea, headache and an increase in liver enzymes were uncommon.

Post-marketing adverse effects.

The following suspect adverse drug reactions presented by body system have been spontaneously reported in international postmarketing surveillance as well as in clinical trials of different Budenofalk preparations, including the enteric capsules and the foam.
The assessment of undesirable effects is based on the following frequencies: very common: (≥ 1/10); common: (≥ 1/100 to < 1/10); uncommon: (≥ 1/1,000 to < 1/100); rare: (≥ 1/10,000 to < 1/1,000); very rare: (< 1/10,000), including isolated reports.
Adverse drug reactions by frequency and system organ class (SOC).

Infections and parasitic diseases.

Uncommon: urinary tract infections.

Blood and lymphatic system disorders.

Uncommon: anaemia, increase in erythrocyte sedimentation rate, leukocytosis.

Metabolism and nutrition disorders.

Uncommon: increased appetite.

Psychiatric disorders.

Common: Depression, irritability, euphoria.
Uncommon: insomnia, psychomotor hyperactivity, anxiety.
Rare: aggression.

Musculoskeletal and connective tissue disorders.

Common: Muscle and joint pain, muscle weakness and twitching, osteoporosis.
Rare: Osteonecrosis.

Eye disorders.

Rare: Glaucoma, cataract, blurred vision.

Nervous system disorders.

Uncommon: headache, dizziness, disturbances of smell.

Vascular disorders.

Uncommon: hypertension.

Gastrointestinal disorders.

Common: dyspepsia.
Uncommon: nausea, abdominal pain, flatulence, abdominal complaints, anal fissure, aphthous stomatitis, frequent urge to defecate, haemorrhoids, rectal bleeding, duodenal and gastric ulcer.
Rare: pancreatitis.

Hepatobiliary disorders.

Uncommon: increase in transaminases (ALT, AST), increase in parameters of cholestasis (GGT, AP).

Skin and subcutaneous tissue disorders.

Uncommon: acne, increased sweating.
Rare: ecchymosis.

Investigations.

Uncommon: increase in amylase, change in cortisol.

General disorders and administration site conditions.

Common: burning in the rectum and pain.
Uncommon: asthenia, increase in body weight.

Systemically acting glucocorticoids.

Occasionally side effects may occur which are typical for glucocorticoids, especially those which are systemically acting. These side effects, listed below, depend on the degree of systemic absorption, the dosage, the period of treatment and the concomitant or previous treatment with other glucocorticoids and the individual sensitivity.
Due to its local action, the risk of systemic adverse reactions of Budenofalk foam is generally lower than with systemically acting glucocorticoids. (See Section 5.2 Pharmacokinetic Properties).

Immune system disorders.

Interference with the immune response (e.g. increase in risk of infections).
An exacerbation or the reappearance of extraintestinal manifestations (especially affecting skin and joints) can occur on switching a patient from a systemically acting glucocorticoid to the locally acting budesonide.

Metabolism and nutrition disorders.

Cushing's syndrome: moon face, truncal obesity, reduced glucose tolerance, diabetes mellitus, sodium retention with oedema formation, increased excretion of potassium, inactivity or atrophy of the adrenal cortex, growth retardation in children, disturbance of sex hormone secretion (e.g. amenorrhoea, hirsutism, impotence).

Psychiatric disorders.

Depression, irritability, euphoria.
In addition, a wide range of other psychiatric/behavioural effects may occur.

Eye disorders.

Glaucoma, cataract.

Nervous system disorders.

Pseudotumor cerebri (including papilloedema) in adolescents.

Vascular disorders.

Hypertension, increased risk of thrombosis, vasculitis (withdrawal syndrome after long-term therapy).

Gastrointestinal disorders.

Stomach complaints, duodenal ulcer, pancreatitis, constipation.

Skin and subcutaneous tissue disorders.

Allergic exanthema, red striae, petechiae, ecchymoses, steroid acne, delayed wound healing. Local skin reactions such as contact dermatitis may occur.

Musculoskeletal, connective tissue and bone disorders.

Aseptic bone necrosis (femur and head of the humerus), diffuse muscle pain and weakness, osteoporosis.

General disorders.

Tiredness, malaise.
Some of these undesired effects were reported after long-term use of orally administered budesonide.
There are no data on the long term use of Budenofalk foam in patients with ulcerative colitis and long term use is not recommended.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

To date, no cases of overdosage with budesonide are known. In view of the properties of budesonide contained in Budenofalk 2 mg foam, an overdose resulting in toxic damage is extremely unlikely. For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Pharmacodynamic properties.

The exact mechanism of action of budesonide in the treatment of ulcerative colitis/ procto-sigmoiditis is not fully understood. Data from clinical pharmacology studies and controlled clinical trials strongly indicate that the mode of action of budesonide is predominantly based on a local action in the gut, consistent with its low bioavailability. Budesonide is a glucocorticoid with a high local anti-inflammatory effect.
At twice the recommended daily dose (4 mg), the administration of Budenofalk foam showed virtually no effect on the basal plasma cortisol levels, consistent with a lack of suppression of the hypothalamus-hypophysis-adrenal cortex axis by the topically acting budesonide.

Clinical trials.

Study BUF-6/UCA was an active controlled, multicentre, open label, parallel group trial involving 251 patients with proctitis or proctosigmoiditis were randomised to receive Budenofalk foam (2 mg budesonide once daily) or Colifoam (hydrocortisone acetate 100 mg foam once daily), both of which were administered rectally.
The primary efficacy parameter for this study was clinical remission, defined as Disease Activity Index (DAI) ≤ 3 at the end of the 8 week treatment. DAI is calculated as the sum of the scores of four parameters: weekly stool frequency, weekly rectal bleeding, mucosal appearance and physician's rating of disease activity (see Table 2).
This study was designed to demonstrate equivalence between the two treatments, confirmed if the 95% CI for the between group difference in the clinical remission rate was no more than 15% for the intent-to-treat population, which was subsequently confirmed.

5.2 Pharmacokinetic Properties

Absorption.

After oral administration, the systemic availability of budesonide is about 10%. After rectal administration the AUC is about 1.5-fold higher than in historical controls considering the identical oral budesonide dose. Peak levels are obtained after an average of 2-3 hours after administering Budenofalk 2 mg foam.

Distribution.

Budesonide has a high volume of distribution (about 3 L/kg). Plasma protein binding averages 85-90%.

Metabolism.

Budesonide undergoes extensive first pass biotransformation in the liver (approximately 90%) to metabolites of low glucocorticoid activity. The glucocorticoid activity of the major metabolites, 6β-hydroxybudesonide and 16α-hydroxyprednisolone, is less than 1% of that of budesonide.

Excretion.

The average elimination half-life is about 3-4 hours. The mean clearance rate is about 10-15 L/min for budesonide, determined by HPLC based methods.

Specific patient populations (liver disease).

Compromised hepatic function has an influence on the pharmacokinetics of budesonide with a reduced elimination rate and increased oral systemic availability, based on studies with orally administered budesonide.

Budenofalk foam.

The systemic bioavailability was calculated to be 15.3% and 13.8% after single and multiple dosing, respectively. Comparison of data after single and multiple dosing reveals no indication for a potential accumulation of budesonide in serum.
Pharmacokinetic data are summarised in Table 3 for Budenofalk 2 mg foam after single dose and steady state dosing in 18 healthy subjects:
Scintigraphic study of a single rectal dose of 99mTc labelled budesonide 2 mg (Budenofalk) foam in 12 patients showed that the spread of the budesonide foam ranged between 11 and 40 cm (mean of 25.4 ± 10.3 cm) from the anal verge, depending on the individual patient (this range includes extending to the distal half of the sigmoid colon, and to the proximal third of the descending colon). The maximal spread was reached between 2 and 6 hours (mean of 4 hours) after dosing, depending on the individual patient and remained relatively stable for between 4 hours and 6 hours. The distal half of the sigmoid colon was reached in all patients approximately after 2 hours after dosing and accounted for 27.4% of the administered radiolabelled budesonide foam.
This study maximised conditions for spread of the budesonide containing within the colon by having study subjects undergo a prestudy colonoscopy including a standard bowel preparation, as well as having them lie down for 4 hours after administration. It is anticipated that in clinical practice, the spread would be somewhat less than was demonstrated in this study.

5.3 Preclinical Safety Data

Genotoxicity.

Budesonide had no genotoxic effects in a battery of in vitro and in vivo tests.

Carcinogenicity.

The carcinogenic potential of budesonide has been assessed in mice and rats at respective oral doses up to 200 and 50 microgram/kg/day. No oncogenic effect was noted in mice. One study showed an increased incidence of malignant gliomas in male Sprague-Dawley rats given budesonide 50 microgram/kg/day; however this was not confirmed in further studies in male Sprague-Dawley and Fischer rats. In male rats dosed with 10, 25 and 50 microgram/kg/day, those receiving 25 and 50 microgram/kg/day showed an increased incidence of primary hepatocellular tumours; however this was also observed in rats treated with prednisolone and triamcinolone acetonide, thus indicating a class effect of glucocorticoids in rats.

6 Pharmaceutical Particulars

6.1 List of Excipients

Budenofalk foam contains the following excipients: cetyl alcohol, emulsifying wax, purified water, disodium edetate, steareth-10, propylene glycol, citric acid monohydrate and butane, isobutane and propane as propellants.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25˚C. Do not refrigerate or freeze. Store in an upright position.
After administration of 14 spray actuations (14 daily doses), a residual amount of foam will remain in the can. This is present in the can to ensure that 2 mg of budesonide is consistently delivered in all 14 spray actuations. Throw away the can with any residual contents after application of the 14 actuations.
This is a pressurised container, containing flammable propellant.
Do not expose to temperature higher than 50°C, protect from direct sunlight.
Do not pierce or burn even when empty.

6.5 Nature and Contents of Container

Budenofalk foam is supplied in aluminium pressurised container with metering valve together with 14 PVC applicators coated with white soft paraffin and liquid paraffin for administration of the foam and 14 plastic bags for hygienic disposal of the applicators.
Pack sizes: Original pack with 1 pressurised container, contains 14 doses of 1.2 g foam each.*
Original pack with 2 pressurised containers, contain 2 x 14 doses of 1.2 g foam each.
(*Currently not marketed.)

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.


Chemical name: 16α,17α-butylidene dioxy-11β, 21-dihydroxy-1,4-pregnadiene-3, 20-dione C25H34O6 = 430.5.
Budesonide is a white or almost white, crystalline powder. It is practically insoluble in water, freely soluble in methylene chloride, sparingly soluble in alcohol.

CAS number.

51333-22-3.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes