Salofalk Enema Foam Can 80g 4


Drug Name: mesalazine
Private Price $322.96
PBS $37.30
Concession $5.20
Safety Net $0.00

S8 Note - This prescription item is Schedule 8 and can only be supplied on a script from a registered doctor in Queensland. Any prescriptions from any other state cannot be filled and will be returned in the mail

Note: Private, PBS and our prices are available to the general public. Concession and Safety Net prices are only available to people with the appropriate concession or Safety Net cards. See Prescriptions for more details.


This prescription item requires a pre approved authority from the Government in order to get this item at the quoted price. Authority prescriptions need to be applied for by the doctor writing the script and can include reasons such as increased quantities due to dosage, increased repeats, use for a pre determined specified use, or the nature of the medication itself requiring specialist interaction. In the event that an authority is not granted on the script, the price will revert to the private price quoted for that item


This item contains more than one pack of a prescription product. Before this can be dispensed the doctor has to give approval. The prescription must be written for the total quantity or the prescription must be endorsed by your doctor "Regulation 24" otherwise we will be unable to dispense the increased amount. If you proceed with the order without approval, we will only send out one pack at the single pack price and refund the difference. Eg If your prescription is written out for 30 Tablets with 5 repeats and it does not have “Regulation 24 “ written on the script, the ONLY quantity we can dispense is 30 at one time. Further dispensing of this product could only occur after an appropriate length of time - usually 21 days but depends on dosage. In this example if you would like to obtain 180 Tablets then the doctor must endorse the prescription “Regulation 24” or the quantity must be written out for 180 and not 30. NB Conditions apply on the writing of a Regulation 24 prescription. Ask your doctor or pharmacist for details.

We can no longer accept signed authority forms from your doctor as permission to dispense more than one pack. Please contact our pharmacist for more information.

If you order this item as Private, NO PBS stickers will be issued. Once any prescription order has been sent the product cannot be returned for a refund even if your doctor changes your medication or you have an adverse reaction.

Salofalk Enema Foam Can 80g 4

Salofalk Enema Foam Can 80g 4

Product ID: 56555

Pharmacist Only Medicine

This product is a Pharmacist Only Medicine and requires pharmacist advice before we can dispatch this product. You must first place the order and then contact our pharmacists within 48 hours on 1300 367 283. The pharmacist will determine if this product is appropriate for you and if so, approve the order. In the event that you do not do this, the product will be deleted from your order and the balance of your order will be dispatched. This is not required if you have a doctor's prescription.


General Information

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about SALOFALK. It does not contain all of the available information. Reading this leaflet does not take the place of talking to your doctor or pharmacist.

Please read this leaflet before you start using SALOFALK. If you are helping someone else use SALOFALK, please read the leaflet before you give the first dose.

All medicines have risks and benefits. Your doctor has weighed the possible risks of using SALOFALK against the expected benefits.

If you have any concerns about using SALOFALK, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may want to read it again.

What SALOFALK is used for

SALOFALK contains an ingredient called mesalazine (5-aminosalicylic acid), which is used to treat, and prevent relapses of, mild to moderate attacks of ulcerative colitis (inflammation of the large bowel).

Your doctor may have prescribed SALOFALK for another use. Ask your doctor if you have any questions about why SALOFALK has been prescribed for you.

SALOFALK is not addictive.

SALOFALK is only available on a doctor's prescription.

Before you use SALOFALK

When you must not use it

Do not use SALOFALK if:
You are allergic to mesalazine or aspirin-like medicines, sulfites 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.
You have or have had stomach or duodenal ulcer.
You have or have had problems with the clotting of your blood or you tend to bleed easily.
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 package is torn or shows signs of tampering.

Do not give SALOFALK to a child 12 years old or under. The safety and effectiveness of SALOFALK in this age group have not been established.

Before you start to use it

Tell your doctor if:
1. You have any allergies.
2. You are pregnant or intend to become pregnant. Your doctor will discuss the risks and benefits of using SALOFALK if you are pregnant. If using SALOFALK, it should be discontinued in the last 2-4 weeks of pregnancy.
3. You are breastfeeding or wish to breastfeed. SALOFALK should not be used during breastfeeding as there is no experience with SALOFALK enemas in breastfeeding women. Women using SALOFALK and who are breastfeeding or wish to breastfeed should discuss this with their doctor.

Your doctor will discuss the risks and benefits of using SALOFALK if you are pregnant or breastfeeding.
4. You have or have had any medical conditions, especially:
Lung or breathing problems such as asthma. SALOFALK contains a sulfite which may cause an allergic reaction and propylene glycol which may cause skin irritation. In addition, SALOFALK contains propylene glycol, which may cause drowsiness and confusion in people with kidney problems.

If you have not told your doctor about any of the above, tell him/her before you use SALOFALK.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

SALOFALK may interfere with the action of the following types of medicines:
Anticoagulants - medicines used to stop blood clots
Glucocorticoids - medicines used to treat inflammation or swelling, (eg. prednisolone)
Sulphonylureas - medicines used to lower blood sugar
Methotrexate - medicine used to treat some types of cancer and arthritis.
Probenecid/sulphinpyrazone - medicines used to treat gout
Spironolactone/frusemide - medicines which lower blood pressure or increase volume of urine
Rifampicin - a medicine used to treat tuberculosis
Azathioprine - a medicine used to suppress the immune system
Mercaptopurine - a medicine used to treat leukaemia

You may need to use different amounts of these medicines, or you may need to take different medicines when you are using SALOFALK. Your doctor or pharmacist will advise you about this.

How to use SALOFALK

How much to use

The usual dose is two applications a day at bedtime, although your doctor or pharmacist will tell you exactly how much to use and where to check this information.

Two applications is equivalent to 2 g mesalazine.

How to use it

If possible, go to the toilet and empty your bowels before using your enema.
1. Wash your hands thoroughly with soap and water.
2. Push the applicator firmly onto the spout of the spray can.
3. Shake the can for 15 seconds.
4. Remove the safety tab from under the pump dome.
5. Twist the dome on top of the canister until the semi-circular gap underneath it is in line with the nozzle.

The spray can is now ready for use.
6. Place your forefinger on top of the pump dome. Turn the spray can upside down. The pump dome must be pointing down.
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 comfortable. To administer a dose of SALOFALK foam, push the pump dome fully once and release it. Then push the pump dome fully a second time and release it slowly.
9. Wait 10-15 seconds before withdrawing the applicator.
10. Remove the applicator and dispose of it 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 enema 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.

How long to use it

SALOFALK helps control your condition but does not cure it.

Therefore, you must use SALOFALK for as long as your doctor tells you to.

If you forget to use SALOFALK

If you forget to use SALOFALK, leave out that dose completely. Use your next dose at the normal time it is due.

Do not use a double dose to make up for the dose that you missed.

If you have trouble remembering when to use SALOFALK, ask your pharmacist for some hints.


Telephone your doctor or Poisons Information Centre (13 11 26) or go to casualty at your nearest hospital immediately if you think that you or anyone else may have used too many SALOFALK foam enemas, even if there are no signs of discomfort or poisoning.

Possible symptoms may include feeling sick, vomiting and diarrhoea.

While you are using SALOFALK

Things you must do

Make sure that all of your doctors and pharmacists know you are using SALOFALK. Remind them if any new medicines are about to be started.

Things to be careful of

Be careful driving or operating machinery until you know how SALOFALK foam enema affects you. SALOFALK foam enema generally does not cause any problems with your ability to drive a car or operate machinery. However, as with many other medicines, SALOFALK may cause dizziness or light-headedness in some people. Make sure you know how you react to SALOFALK before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy or light-headed.

Things that you must not do

Do not use SALOFALK to treat any complaint other than that directed by your doctor. It may not be safe to use SALOFALK for another complaint.

SALOFALK should only be used by the person for whom it was prescribed. Do not give SALOFALK to someone else even if his/her symptoms are the same. It may not be safe for another person to use SALOFALK.

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using SALOFALK.

Like all medicines, SALOFALK may have some side effects. Most side effects are mild and may disappear without stopping SALOFALK. However, some may be serious and need medical attention.

Mild effects:

Tell your doctor or pharmacist if you notice any of the following that are troublesome or ongoing:
Mild stomach pains
Excessive gas in the stomach or bowel
Increased number of bowel motions
Nausea (feeling sick)
Rash or itchy skin
Common cold

More serious effects:

Tell your doctor immediately if you notice any of the following:
Fever, muscle aches and pains, painful joints and chest pain (sometimes spreading to the neck and shoulders, and sometimes fever)
Mild skin rash, itching or hives
Numbness or weakness of the arms and legs
Pain in the upper belly (may be due to inflammation of the pancreas)
Worsening of ulcerative colitis

Stop using SALOFALK and contact your doctor or go to the emergency department of your nearest hospital if any of the following happens:
Allergic reaction including swelling of limbs, face, lips, mouth or throat which may cause difficulty swallowing or breathing.

Other rare events, which have been reported with mesalazine, include:
Changes in kidney function and inflammation of the kidney
Changes in blood test results such as low white blood cell and/or platelet counts
Changes in liver function tests
Liver disease with nausea, vomiting, loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes, and dark coloured urine
Changes relating to your heart.

As a precaution, your doctor may have your blood, liver and kidney tested regularly during treatment with SALOFALK.

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell. Do not be alarmed by this list of possible side effects. You may not experience any of them.

After using SALOFALK

Keep SALOFALK in a cool dry place where the temperature stays below 25°C.
Do not store it or any other medicine in the bathroom or near a sink.
Do not leave it in the car on hot days. Heat and dampness can destroy some medicines.
Keep SALOFALK 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.
Protect from direct sunlight.
Do not refrigerate or freeze.
Contains FLAMMABLE gas - Keep away from flames or sparks including cigarettes.
Use container of SALOFALK within 12 weeks of first opening.


If your doctor tells you to stop using SALOFALK, ask your pharmacist what to do with any enemas that are left over.

Do not pierce or burn the can even when empty.

Product description

What it looks like

SALOFALK foam is presented as a greyish white to slightly reddish violet, creamy firm foam.


Each application of SALOFALK foam enema contains 1 g of the active ingredient, mesalazine.

SALOFALK foam enemas also contain the following inactive ingredients:
Sodium metabisulfite, polysorbate 60, cetostearyl alcohol, disodium edetate, propylene glycol, propane, n-butane and isobutane.

SALOFALK foam enemas are supplied in an aerosol can, containing 80 g of foam sufficient for 14 applications (1 g mesalazine/application).


SALOFALK foam enemas are made in Germany by:
Dr. Falk Pharma GmbH
Leinenweberstrasse. 5
D-79041 Freiburg, Germany

and are supplied in Australia by:
Orphan Australia Pty. Ltd.
48 Kangan Drive
Victoria 3806

This leaflet was prepared in November 2004.
Australian Registration Number:
SALOFALK foam enemas
1 g/application AUST R 95960

SALOFALK® is a registered trademark of Dr. Falk Pharma GmbH, used under licence by Orphan Australia Pty. Ltd.
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