SALOFALK® GRANULES modified release granules
mesalazine
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about SALOFALK GRANULES 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 GRANULES.
Keep this leaflet with the medicine. You may want to read it again.
What SALOFALK GRANULES modified release granules is used for
SALOFALK 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 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 GRANULES 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 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
– you have kidney problems
– you have liver problems
– phenylketonuria. - You have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after using mesalazine.
SALOFALK GRANULES contain aspartame. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Kidney stones may develop with use of mesalazine. Symptoms may include pain in sides of abdomen and blood in urine. Take care to drink sufficient amount of liquid during treatment with mesalazine.
Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis have been reported in association with mesalazine treatment. Stop using mesalazine 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 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 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 GRANULES modified release granules once a day or in 2-3 divided doses.
For long term treatment of ulcerative colitis, take 1.5 g SALOFALK GRANULES modified release granules once a day or in 2-3 divided doses.
Children over 6 years old:
The dose of SALOFALK 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 GRANULES 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 GRANULES 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
- Tear open the sachet along the end with the triangular mark.
- Pour contents of sachet onto tongue.
- Swallow the modified release granules whole without chewing or crushing.
- Drink some water to wash down the medicine.
When to take it
Take SALOFALK GRANULES the same time each day. This will help you remember when to take it.
How long to take it
SALOFALK 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 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 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 GRANULES 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 GRANULES 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 GRANULES modified release granules.
Like all medicines, SALOFALK 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
- diarrhoea
- 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 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 in swallowing or breathing
- Marked worsening 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.
- 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. These serious skin rashes can be preceded by fever and flu-like symptoms.
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
- 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)
- severe diarrhoea and abdominal pain due to an allergic reaction to this medicine (pancolitis).
Other events with unknown frequency, include:
- kidney stones and associated kidney pain
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 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 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 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 GRANULES 500 mg modified release granules are available in packs of 100 sachets.
SALOFALK GRANULES 1 g modified release granules are available in packs of 100 sachets.
SALOFALK GRANULES 1.5 g modified release granules are available in packs of 60 sachets.
SALOFALK GRANULES 3 g modified release granules are available in packs of 30 sachets.
Ingredients
Each SALOFALK GRANULES 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 (500 mg, 1 g, 1.5 g only)
- magnesium stearate
- simethicone
- sorbic acid (1.5 g, 3 g only)
- methylcellulose (1.5 g, 3 g only)
- triethyl citrate
- purified talc
- carmellose sodium
- aspartame
- citric acid
- vanilla custard flavour 75016-31 (PI 2187)
- povidone
- titanium dioxide.
Sponsor
Dr Falk Pharma Australia Pty
Ltd, 815 Pacific Highway,
Chatswood, NSW 2067
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.
This leaflet was revised in December 2020.
Published by MIMS March 2021
