400 mg, 800 mg and 1600 mg Enteric Coated Tablets
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about ASACOL. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking ASACOL against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
What ASACOL is used for
This medicine is used to treat and prevent further episodes of ulcerative colitis.
ASACOL contains the active ingredient mesalazine. This is an anti-inflammatory agent used to treat ulcerative colitis. Ulcerative colitis is a disease of the large bowel (colon) or back passage (rectum), in which the lining of the bowel becomes inflamed (red and swollen).
ASACOL acts locally at the site of inflammation (colon, rectum and terminal ileum) to reduce this inflammation.
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.
ASACOL is not addictive.
It is available only with a doctor`s prescription.
ASACOL is not expected to affect your ability to drive a car or operate machinery.
Before you take ASACOL
When you must not take it
Do not take ASACOL if:
- you are allergic to mesalazine or any of the other ingredients of this medicine listed at the end of this leaflet.
- Patients who are intolerant to lactose should note that ASACOL 400 mg and 800 mg tablets contain a small amount of lactose. If your doctor has told you that you have intolerance to some sugars, contact your doctor before taking this medicine
- you are allergic to salicylates (e.g. Aspirin)
- you have severe liver problems
- you have severe kidney problems.
Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.
Children and adolescents
The safety and effectiveness of ASACOL in this age group have not been established.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
- any lung problems, e.g. asthma.
- a liver disease.
- a kidney disease.
- suffered an allergy to sulphasalazine in the past.
- ever had any heart problems such as inflammation of the heart muscle or heart sac. If you have had previous suspected mesalazine-induced allergic reactions, then ASACOL must not be taken.
- an ulcer of the stomach or intestine, you should take ASACOL with care.
- If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after using 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.
Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding. Your doctor can discuss with you the risks and benefits involved.
If you have not told your doctor about any of the above, tell him/her before you start taking ASACOL.
Taking other medicinces
Tell your doctor or pharmacist if you are taking any other medicines including any that you get without a prescription from your pharmacy, supermarket or health food shop.
ASACOL may interfere with the following types of medicines:
- medicines affecting the immune system or anticancer drugs (e.g. azathioprine, or 6-mercaptopurine or thioguanine)
- medicines that prevent the formation of blood clots (anticoagulants, e.g. warfarin).
- Non-steroidal anti-inflammatory drugs (e.g. medicines containing aspirin, ibuprofen or diclofenac)
How to take ASACOL
Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.
If you do not understand the instructions on the packaging, ask your doctor or pharmacist for help.
How much to take
Usual dose: Adults (including the elderly)
To treat a current episode of ulcerative colitis your daily dose is 2.4 g to 4.8 g taken once daily or in divided doses. The dosage may be adjusted by your doctor.
To prevent an episode of ulcerative colitis your daily dose is 1.6 g to 2.4 g taken once daily or in divided doses.
How to take it
This medicine must be swallowed whole preferably with some liquid. Do not chew, crush or break the tablets before swallowing them.
When to take it
The tablets can be taken with or without food.
How long to take it
Continue taking your medicine for as long as your doctor tells you. This medicine helps to control your condition, but does not cure it. It is important to keep taking your medicine even if you feel well.
If you forget to take it
If it is almost time for your next dose, skip the dose you missed and take the next dose as normal.
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 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 ASACOL. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
While you are taking ASACOL
Things you must do
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking ASACOL.
Before and while you are taking ASACOL, your doctor may want to monitor you from time to time to check that your liver, kidneys, blood and lungs are all right.
Tell any other doctors, dentists, and pharmacist that you are taking this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine. It may affect other medicines used during surgery.
If you become pregnant while taking this medicine, tell your doctor immediately.
Things you must not do
Do not take ASACOL to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as you.
Do not stop taking your medicine or lower the dosage without checking with your doctor. If you stop taking it suddenly, your condition may worsen.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking ASACOL.
This medicine helps most people, with ulcerative colitis, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Stop taking ASACOL immediately and seek urgent medical advice
- If you develop unexplained bruising (without injury), bleeding under your skin, purple spots or patches under your skin, anaemia (feeling tired, weak and looking pale, especially on lips, nails and inside of eyelids), fever (high temperature), sore throat or unusual bleeding (e.g. nose bleeds).
- There have been a few reports of intact tablets in the stool (400 mg and 800 mg tablets only). What appear to be intact tablets may sometimes be the remains of the tablet coating. If you often observe tablets or tablet shells in the stool, you should consult your doctor.
- There have been a few reports of kidney stones. Drink plenty of water during treatment.
- If you notice 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.
If you notice any of the following, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
- sudden signs of allergic reactions such as rash, itching or hives, shortness of breath, wheezing, coughing, or swelling of limbs, face, lips, mouth, tongue or throat which may cause difficulty swallowing or breathing
- severe stomach cramps and/or pain, bloody diarrhoea, fever, severe headache, skin rash and increased sensitivity of the skin to sun
- rash with severe blisters and bleeding of the eyes, mouth, lips, nose and genitals.
Other rare side effects might include:
- Changes in kidney function
- Kidney stones
- Changes in liver function
- Changes in blood
- Hair loss
As a precaution, your doctor may do blood tests to check if there are any changes in your blood, kidney or liver function.
Other side effects not listed above may also occur in some people.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
After taking ASACOL
Keep your tablets in the packaging until it is time to take them. If you take the tablets out of the packaging they may not keep well.
Store below 25°C.
Do not store ASACOL 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 damage some medicines.
Keep it 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.
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.
What it looks like
ASACOL 400 mg, and 800 mg tablets are coated, reddish to brownish oblong tablets with a glossy to matt finish.
The dimensions of the 400 mg tablet are:
- Thickness: 7 mm
- Length: 15 mm
- Width: 6 mm
The dimensions of the 800mg tablet are:
- Thickness: 8 mm
- Length: 17 mm
- Width: 8 mm
Asacol 1600 mg tablets are coated, dark orange oblong tablets with a glossy to matte finish. The dimensions of this tablet are:
- Thickness: 9 mm
- Length: 23 mm
- Width: 11 mm
The 400 mg and 800 mg tablets are supplied in packs of 30, 60, 90 or 180 tablets.
The 1600 mg tablets are supplied in packs of 30, 60 or 90 tablets. Not all pack sizes are marketed.
Each ASACOL 400 mg tablet contains 400 mg of the active ingredient, mesalazine.
Each ASACOL 800 mg tablet contains 800 mg of the active ingredient, mesalazine.
Each ASACOL 1600 mg tablet contains 1600 mg of the active ingredient, mesalazine.
ASACOL 400 mg and 800 mg tablets also contain the following inactive ingredients:
- sugars as lactose (lactose monohydrate)
- sodium starch glycollate type A
- magnesium stearate
- purified talc
- methacrylic acid copolymer
- triethyl citrate
- iron oxide yellow
- iron oxide red
- macrogol 6000
ASACOL 1600 mg tablets also contain the following inactive ingredients:
- magnesium stearate
- methacrylic acid copolymer
- iron oxide yellow
- iron oxide red
- macrogol 6000
- microcrystalline cellulose
- glycerol monostearate
- maize starch
- polysorbate 80
- monobasic potassium phosphate
- colloidal anhydrous silica
- sodium starch glycolate (type A)
- sodium hydroxide
ASACOL Tablets are supplied in Australia by:
Chiesi Australia Pty Ltd
Suite 3, 22 Gillman Street
Hawthorn East, VIC. 3123
ASACOL 400 mg:
AUST R 261419
ASACOL 800 mg:
AUST R 261420
ASACOL 1600 mg:
AUST R 322671
This leaflet was prepared in December 2021.
ASACOL® is a registered trademark of Tillotts Pharma AG, Switzerland
Published by MIMS May 2022