Salofalk Enema Foam Can 80g 4

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.

Overdose

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:
Headache
Mild stomach pains
Excessive gas in the stomach or bowel
Increased number of bowel motions
Nausea (feeling sick)
Rash or itchy skin
Dizziness
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

Storage
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.

Disposal

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.

Ingredients

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).

Manufacturer/Supplier

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
Berwick
Victoria 3806
www.orphan.com.au

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.