What SALOFALK is used for
SALOFALK contains an ingredient called mesalazine (5-aminosalicylic acid), which is used to treat, and prevent relapse 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 not expected to affect your ability to drive a car or operate machinery.
SALOFALK is only available on a doctor's prescription.

Before you take SALOFALK
When you must not take it
Do not take SALOFALK if:
• You are allergic to mesalazine or aspirin-like medicines, 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 and under. The safety and effectiveness of Salofalk in this group have not been established.
Before you start to take it
Tell your doctor if:
1. You have any allergies.
2. You are pregnant or intend to become pregnant or are breastfeeding or wish to breastfeed.
Your doctor will discuss the risks and benefits of taking SALOFALK if you are pregnant or breastfeeding.
3. You have or have had any medical conditions, especially the following:
• Lung or breathing problems such as asthma.
• Phenylketonuria. Salofalk granules contain aspartame.
If you have not told your doctor about any of the above, tell him/her before you take 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, medicine used to treat tuberculosis.
• Azathioprine, medicine used to suppress the immune system.
• Mercaptopurine, 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 taking SALOFALK. Your doctor or pharmacist will advise you.

How to take SALOFALK
How much to take
For acute ulcerative colitis, the recommended SALOFALK dose is one 500 mg or 1 g granule sachet three times a day
For long term treatment of ulcerative colitis, the recommended SALOFALK dose is one 500 mg granule sachet three times a day.
For some conditions, your doctor may prescribe a different dose.
How to take it
Tear open the sachet along the end with the triangular mark.
Pour contents of sachet onto tongue.
Swallow the SALOFALK granules whole without chewing or crushing.
Drink some water to wash down the granules.
How long to take it
SALOFALK helps control your condition but does not cure it.
Therefore, you must take SALOFALK for as long as your doctor tells you to.
If you forget to take SALOFALK
If you forget to take SALOFALK, leave out that dose completely. Take your next dose at the normal time it is due. Do not take a double dose to make up for the dose that you missed.
If you have trouble remembering when to take 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 taken too many SALOFALK granules, even if there are no signs of discomfort or poisoning.
Possible symptoms may include feeling sick, vomiting and diarrhoea.
While you are taking SALOFALK
Things you must do
Make sure that all of your doctors and pharmacists know you are taking SALOFALK. Remind them if any new medicines are about to be started.
Things that you must not do
Do not take 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 taken 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 take SALOFALK.

Side Effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking 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 taking 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 taking SALOFALK
Storage
• Keep SALOFALK granules in their original package until it is time to take them. If you take them out of their packaging, they may not keep well.
• 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.
Disposal
If your doctor tells you to stop taking SALOFALK, ask your pharmacist what to do with any granules that are left over.