SALOFALK® modified release granules

mesalazine

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about SALOFALK modified release granules. It does not contain all of the available information.

All medicines have risks and benefits. Your doctor has weighed the possible risks of taking this medicine against the expected benefits.

Ask your doctor or pharmacist if you have any concerns about taking SALOFALK modified release granules.

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

What SALOFALK modified release granules is used for

SALOFALK modified release granules contain the active ingredient 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).

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

SALOFALK modified release granules are not addictive.

It is not expected to affect your ability to drive a car or operate machinery.

This medicine is only available on a doctor’s prescription.

Before you take it

When you must not take it

Do not take SALOFALK modified release granules 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
• 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 this medicine to a child below 6 years of age. The safety and effectiveness of this medicine in this group have not been established.

Before you start to take it

Tell your doctor if:

• you have any allergies
• 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 modified release granules if you are pregnant or breastfeeding.
• you have or have had any medical conditions, especially the following: 
  - lung or breathing problems such as asthma
  - phenylketonuria. SALOFALK modified release granules contain aspartame.

If you have not told your doctor about any of the above, tell them before you start to take it.

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.

This medicine may interfere with the action of the following types of medicines:

• anticoagulants, medicines used to stop blood clots, e.g. warfarin.
• glucocorticoids, medicines used to treat inflammation or swelling, e.g. 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 or thioguanine, medicines used to treat leukaemia
• lactulose or similar preparations, medicines which can change the acidity of the content of the bowels.

You may need to use different amounts of these medicines, or you may need to take different medicines when you are taking SALOFALK modified release granules. Your doctor or pharmacist will advise you.

How to take it

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

How much to take

Adults and the elderly: 
For acute ulcerative colitis, take 1.5 g to 3 g SALOFALK modified release granules once a day or in 2-3 divided doses.

For long term treatment of ulcerative colitis, take 1.5 g SALOFALK modified release granules once a day or in 2-3 divided doses.

Children over 6 years old: 
The dose of SALOFALK modified release granules for your child depends on disease severity and body weight. Your doctor will tell you how much your child should take.

For acute ulcerative colitis, the usual dose for a child is 30-50 mg SALOFALK modified release granules/kg/day in one single or 2-3 divided doses.

For long term treatment of ulcerative colitis, the usual dose for a child is 15-30 mg SALOFALK modified release granules/kg/day in one single or 2 divided doses.

For some conditions, your doctor may prescribe a different dose.

How to take it

1. Tear open the sachet along the end with the triangular mark.
2. Pour contents of sachet onto tongue.

1. Swallow the modified release granules whole without chewing or crushing.
2. Drink some water to wash down the medicine.

When to take it

Take SALOFALK modified release granules the same time each day. This will help you remember when to take it.

How long to take it

SALOFALK modified release granules helps control your condition but does not cure it. Therefore, you must continue to take your medicine for as long as your doctor tells you to.

If you forget to take it

If you forget to take a dose of SALOFALK modified release granules, 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 are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering when to take it, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much SALOFALK modified release granules. Do this even if there are no signs of discomfort or poisoning.

Possible symptoms of overdose may include feeling sick, vomiting and diarrhoea.

While you are taking it

Things you must do

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

Things that you must not do

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

Do not give your medicine to anyone else, even if they have the same condition as you. It may not be safe for another person to take it.

Do not stop taking your SALOFALK modified release granules or change the dosage without checking with your doctor.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking SALOFALK modified release granules.

Like all medicines, SALOFALK modified release granules may have some side effects. Most side effects are mild and may disappear without stopping it. 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 modified release granules and contact your doctor or go to Accident and Emergency at 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
• allergic, inflammatory or other lung conditions
• shortness of breath, difficulty breathing, cough, wheezing, chest pain that worsens when breathing.

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

Tell your doctor if you notice anything else that is making you feel unwell. Other side effects not listed above may also occur in some patients.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After taking it

Storage

Keep SALOFALK modified release granules in their original package until it is time to take them. If you take them out of their packaging, they may not keep as well.

Keep this medicine in a cool dry place, protected from light 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 on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep SALOFALK modified release granules where children cannot reach them. 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 this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

SALOFALK modified release granules are greyish-white cylindrical to round granules. This medicine is available in 4 different strengths, 500 mg, 1 g, 1.5 g and 3 g.

SALOFALK 500 mg modified release granules are available in packs of 100 sachets.

SALOFALK 1 g modified release granules are available in packs of 100 sachets.

SALOFALK 1.5 g modified release granules are available in packs of 60 sachets.

SALOFALK 3 g modified release granules are available in packs of 30 sachets.

Ingredients

Each SALOFALK sachet contains 500 mg, 1 g, 1.5 g or 3 g of the active ingredient, mesalazine.

They also contain the following inactive ingredients:

• microcrystalline cellulose
• hypromellose
• colloidal anhydrous silica
• methacrylic acid copolymer
• nonoxinol 100
• magnesium stearate
• simethicone emulsion (containing sorbic acid, methylcellulose)
• triethyl citrate
• purified talc
• carmellose sodium
• aspartame
• anhydrous citric acid
• vanilla custard flavour 75016-31 (containing propylene glycol)
• povidone
• titanium dioxide.

Sponsor

Orphan Australia Pty Ltd
(a member of the Aspen Australia group of companies)
34-36 Chandos Street
St Leonards NSW 2065

Australian Registration Numbers:

500 mg: AUST R 80648

1 g: AUST R 80649

1.5 g: AUST R 143611

3 g: AUST R 214810.

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

This leaflet was revised in
January 2018.