2. What should I know before I use SALOFALK foam?
Do not use if you have ever had an allergic reaction to SALOFALK 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 SALOFALK foam? in the full CMI.
3. What if I am taking other medicines?
4. How do I use SALOFALK foam?
The usual dose is of SALOFALK foam is two applications once daily at bedtime, although
your doctor or pharmacist will tell you exactly how much to use and where to find
this information.
This medicine may only be used rectally, so it has to be inserted through the anus.
Do NOT take it by mouth.
5. What should I know while using SALOFALK foam?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using SALOFALK foam.
Remind them if any new medicines are about to be started.
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Things you should not do
|
Do not use SALOFALK foam to treat any complaint other than that directed by your doctor.
It may not be safe to use SALOFALK foam for another complaint.
Do not give SALOFALK foam to someone else even if their symptoms are the same. It
may not be safe for another person to use SALOFALK foam.
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Driving or using machines
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This medicine is not expected to affect your ability to drive a car or operate machinery.
However, you should still be careful before you drive or use any machines or tools
until you know how SALOFALK foam affects you. SALOFALK foam may cause dizziness in
some people.
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Looking after your medicine
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Keep SALOFALK foam in a cool dry place, protected from light, where the temperature
stays below 25°C.
Do not refrigerate or freeze.
Keep away from flames or sparks including cigarettes, SALOFALK foam contains flammable
gas. Heat and dampness can destroy some medicines including SALOFALK foam.
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.
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6. Are there any side effects?
All medicines can have side effects. If they do occur, they are usually mild and temporary.
The most common side effects using SALOFALK foam are: headache, mild stomach pains,
excessive gas in the stomach or bowel, increased number of bowel motions, diarrhoea,
nausea and vomiting, rash or itchy skin. 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: mesalazine
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using SALOFALK 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 SALOFALK foam.
Where to find information in this leaflet:
1. Why am I using SALOFALK foam?
SALOFALK foam contains the active ingredient mesalazine (5-aminosalicylic acid). Mesalazine is an anti-inflammatory agent used to treat inflammatory bowel disease.
SALOFALK foam is used to treat and prevent relapses of mild to moderate attacks of
ulcerative colitis (inflammation of the bowel).
Ask your doctor if you have any questions about why SALOFALK foam has been prescribed
for you.
Your doctor may have prescribed SALOFALK foam for another reason.
Do not give SALOFALK foam to a child below 12 years of age. The safety and effectiveness of SALOFALK foam in this group have not been established.
2. What should I know before I use SALOFALK foam?
Warnings
SALOFALK foam is not addictive.
Do not use SALOFALK foam if:
you are allergic to mesalazine, to salicylates such as acetylsalicylic acid (e.g.
Aspirin®) or any of the ingredients listed at the end of this leaflet. Signs of allergic
reactions may include itchy skin rash, shortness of breath and swelling of the face
or tongue.
you suffer from a severe kidney or liver problem.
the expiry date (EXP) printed on the pack has passed. If you use this medicine after
the expiry date has passed, it may not work as well.
the product package is torn or shows signs of tampering.
Always check the ingredients to make sure you can use this medicine. If unsure, speak
to your doctor or pharmacist.
Check with your doctor if you:
have any allergies to any other medicines, foods, preservatives or dyes.
have or have had any other medical conditions, especially lung or breathing problems
such as asthma. SALOFALK foam contains sulfite which may cause an allergic reaction
have kidney problems. Kidney stones may develop with use of mesalazine, the active
ingredient in SALOFALK foam. Symptoms may include pain in the side of abdomen and
blood in urine. Take care to drink sufficient amounts of liquid during treatment with
SALOFALK foam.
have liver problems.
have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores
after using mesalazine.
If you have not told your doctor about any of the above, tell them before you start
to use SALOFALK foam.
Serious skin reactions including drug reaction with eosinophilia and systemic symptoms
(DRESS), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) have been
reported in association with mesalazine treatment. Stop using SALOFALK foam and seek
medical attention immediately if you notice any of the symptoms related to these serious
skin reactions described in Side effects section below.
If you experience strong or recurrent headache, disturbed vision, or ringing or buzzing
in the ears contact your doctor immediately.
SALOFALK foam contains propylene glycol which may cause skin irritation in some people.
In addition, propylene glycol may cause drowsiness and confusion in people with kidney
problems.
SALOFALK foam also contains cetostearyl alcohol, which may cause local skin reactions
(e.g. contact dermatitis).
People who take medicines containing mesalazine, such as SALOFALK foam, may notice
red-brown discolouration in the toilet bowl. This is due to mesalazine in urine of
these people coming in contact with sodium hypochlorite bleach used to clean the toilet.
This is the result of a chemical reaction between mesalazine and bleach and is harmless.
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. SALOFALK foam
should not be used during breastfeeding as there is no experience using it in breastfeeding
women.
Your doctor will discuss the risks and benefits of using SALOFALK 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.
SALOFALK foam may interfere with the action of the following types of medicines:
anticoagulants which are medicines used to stop blood clots, e.g. warfarin.
Some medicines may interfere with SALOFALK and affect how it works.
glucocorticoids which are medicines used to treat inflammation or swelling, e.g. prednisolone
sulphonylureas which are medicines used to lower blood sugar
methotrexate which is a medicine used to treat some types of cancer and arthritis.
probenecid/sulphinpyrazone which are medicines used to treat gout
spironolactone/frusemide which are medicines which lower blood pressure or increase
volume of urine
rifampicin which is a medicine used to treat tuberculosis
azathioprine which is a medicine used to suppress the immune system
mercaptopurine or thioguanine which are medicines used to treat leukaemia.
You may need to use different amounts of the above medicines, or you may need to take
different medicines when you are using SALOFALK foam. Your doctor or pharmacist will
advise you.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect SALOFALK foam.
4. How do I use SALOFALK foam?
How much to use
Follow all directions given to you by your doctor or your pharmacist carefully.
They may differ from the information contained in this leaflet.
The usual dose of SALOFALK foam is two applications once daily at bedtime, although
the doctor or pharmacist will tell you exactly how much to use and where to find this
information.
Each SALOFALK foam can contains 80 g of foam which delivers a total of 14 applications,
with each application delivering 1g of mesalazine. If your doctor prescribed a dose
of 1g/day, you will need to administer one (1) application each day. Alternatively,
if your doctor prescribed a dose of 2g/day, you will need to administer two (2) applications
each day.
When to use SALOFALK foam
SALOFALK foam should be used each evening at bedtime.
How to use SALOFALK foam
If possible, go to the toilet and empty your bowels before using SALOFALK foam.
Store and use SALOFALK foam at room temperature, 20 - 25°C (see also section on storage).
1. Wash your hands thoroughly with soap and water.
2. Push the applicator firmly onto the spout of the aerosol can.
3. Shake the can for 15 seconds each time before use.
4. Each time you use a new can, remove the safety tab from under the pump dome at the
top of the aerosol can.
5. Each time you use a new can, twist the pump dome in a clockwise direction until the
semi-circular gap underneath it is in line with the nozzle. It is now ready to use.
6. Place your forefinger on top of the pump dome. Turn the aerosol can upside down and
keep it upright with the pump dome pointing down for it to work properly.
7. Stand with one foot on the floor and raise the other foot onto a chair or stool.
8. Insert the applicator into the rectum as far as is comfortable. To administer SALOFALK
foam, push the pump dome in fully once with your index finger and hold for 5 seconds,
to prime the aerosol can and then very slowly lift your finger off the pump dome.
The foam containing 1 g of mesalazine is now being delivered and you must wait 15
seconds for the dosing to be completed.If you doctor has prescribed 2 g of mesalazine/day, keep the applicator in place and
repeat the above process.
9. Wait a further 15 seconds before slowly withdrawing the applicator from the rectum
to allow any residual foam to be released. This is important to reduce the risk of
local irritation around your anus.
10. Remove the applicator from the spout of the aerosol can and dispose of it in the plastic
bag provided as domestic waste.
11. Wash your hands thoroughly and try not to empty your bowels again until the next morning.
You may experience a little discomfort and a feeling of urgency to empty your bowels
immediately after the foam insertion. This is normal and expected due to the inflammation
present within the bowel. Try to resist this urge to empty your bowels for as long
as possible. This feeling will subside 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 SALOFALK foam
Continue using your SALOFALK foam for as long as your doctor tells you.
This medicine helps control your condition but does not cure it. It is important to
keep using your SALOFALK foam for as long as your doctor tells you, even if you feel
well.
If you forget to use SALOFALK foam
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 are not sure what to do, ask your doctor or pharmacist.
If you use too much SALOFALK foam
If you think that you have used too much SALOFALK foam, you may need urgent medical
attention.
You should immediately:
phone the Poisons Information Centre
(by calling 13 11 26) for advice, or
contact your doctor, or
go to the Accident & Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
Possible symptoms of overdose may include feeling sick, vomiting and diarrhoea.
5. What should I know while using SALOFALK foam?
Things you should do
Make sure that all of your doctors and pharmacists who are treating you know you are
using SALOFALK foam. Remind them if any new medicines are about to be started.
Tell your doctor immediately if you become pregnant or if you wish to breastfeed while
using SALOFALK foam.
Things you should not do
Do not use SALOFALK foam to treat any complaint other than that directed by your doctor.
It may not be safe to use SALOFALK foam for another complaint.
Do not give SALOFALK foam to someone else even if their symptoms are the same. It
may not be safe for another person to use SALOFALK foam.
Do not 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.
However, you should be careful before you drive or use any machines or tools until
you know how SALOFALK foam affects you.
SALOFALK foam may cause dizziness in some people.
Looking after your medicine
Keep SALOFALK foam in a cool dry place, protected from light, where the temperature
stays below 25°C.
Do not refrigerate or freeze.
Keep away from flames or sparks including cigarettes, SALOFALK foam contains flammable
gas. Heat and dampness can destroy some medicines including SALOFALK foam.
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 window sills.
Keep it where young children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
When to discard your medicine
Use SALOFALK foam within 12 weeks of first opening.
Getting rid of any unwanted medicine
Do not pierce or burn the SALOFALK foam can even when empty.
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.
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
Serious side effects
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Serious side effects
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What to do
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general allergic reaction such as skin rash, fever, joint pain and/or breathing difficulties or a general inflammation
of your large bowel (causing severe diarrhoea and abdominal pain)
marked reduction of general health, especially if accompanied by fever and/or sore
throat or mouth. Very rarely this can be due to a low white blood cell count (agranulocytosis), which may increase the risk of developing a serious infection. Other blood cells
may also be affected (e.g. platelets or red cells causing aplastic anaemia or thrombocytopenia) with symptoms which may include unexplained bleeding, purple spots or patches under
your skin especially on lips and nails, anaemia (feeling tired, weak and looking pale,).
A blood test can confirm whether your symptoms are due to this medicine. These reactions
are very rare.
Serious skin rashes with 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,
widespread rash, fever and enlarged lymph nodes. These can be preceded by fever and
flu-like symptoms. These reactions occur in an unknown number of patients (frequency
not known).
Strong or recurrent headache, disturbed vision, or ringing or buzzing in ears. These could be symptoms of increased pressure within your skull (idiopatic intracranial
hypertension). These reactions occur in an unknown number of patients (frequency not
known (cannot be estimated from available data)).
Shortness of breath, chest pain or irregular heartbeat, or swollen limbs which may
be indicative of cardiac hypersensitivity reactions. These reactions are rare.
Problems with your kidney function (can occur very rarely), e.g. a change in the colour or amount of urine produced
and swollen limbs or a sudden flank pain (caused by a kidney stone) (occur in an unknown
number of patients (frequency not known)). As a precaution, your doctor may have your
blood, liver and kidney tested regularly during treatment with this medicine.
Other rare events, which have been reported with mesalazine include:
changes in liver function tests
liver disease with nausea, vomiting, loss of appetite, feeling generally unwell, abdominal
pain, fever, itching, yellowing of the skin and eyes, and dark coloured urine
allergic, inflammatory or other lung conditions
shortness of breath, difficulty breathing, cough, wheezing, chest pain that worsens
when breathing, lung shadow on x-ray due to allergic and/or inflammatory lung conditions.
increased sensitivity of the skin to sun and ultraviolet light (photosensitivity)
reversible decrease in semen production (oligospermia)
hair loss and the development of baldness (alopecia)
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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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As a precaution, your doctor may have your blood, liver and kidney tested regularly
during treatment with SALOFALK foam.
Tell your doctor or pharmacist if you notice anything which is unusual, including
anything else that may be making you feel unwell.
Other side effects not listed here may occur in some people.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
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/using any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What SALOFALK foam contains
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Active ingredient
(main ingredient)
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1 g mesalazine in each application
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Other ingredients
(inactive ingredients)
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Sodium metabisulfite
polysorbate 60
cetostearyl alcohol
disodium edetate
propylene glycol
propane
butane
isobutane.
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Do not take this medicine if you are allergic to any of these ingredients.
What SALOFALK foam looks like
SALOFALK foam is a greyish white to slightly reddish violet, creamy firm foam.
SALOFALK foam carton includes one (1) aerosol can, containing 80 g of foam, 14 applicators
for the administration of the foam and 14 plastic bags to dispose of each applicator.
This provides flexibility based on your doctor’s prescription. If the prescribed dose
is 1g/day, you will use all 14 applicators (a new one each day) over 2 weeks. If the
prescribed dose is 2g/day, you will need to administer two (2) doses with one applicator
each day. Therefore, you would only need 7 applicators and you can discard the 7 unused
applicators with the used can.
Who distributes SALOFALK foam
Dr Falk Pharma Australia Pty Ltd
9 Help Street
Chatswood, NSW 2067
Australia
Australian Registration Number: AUST R 95960
SALOFALK® is a registered trademark of Dr. Falk Pharma GmbH, Germany.
This leaflet was prepared in March 2025.
