Consumer Medicine Information
What is in this leaflet
Please read this leaflet carefully before you start taking Dipentum. This leaflet answers some common questions about Dipentum (when this name is used it will refer to both the 250mg capsules and the 500mg tablets unless specified). It does not contain all the available information and does not take the place of talking to your doctor or pharmacist.
Note that Dipentum tablets and capsules should not be interchanged without your Doctor's advice.
All medicines have risks and benefits. Your Doctor has weighed the risks of your taking Dipentum against the expected benefits it will have for you.
Use Dipentum as instructed and follow the advice given in this leaflet.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with your medicine. You may need to read it again.
1. What Dipentum is used for
Dipentum is used to treat a disease of the bowel called ulcerative colitis.
Dipentum is available only with a doctor's prescription.
There is no evidence that Dipentum is addictive.
2. Before you start to use Dipentum
Some information is provided below. However, always talk to your doctor if you have concerns or questions about your treatment.
See your doctor for a check up before you start to use Dipentum.
When you must not take Dipentum
Do not take Dipentum if you have an allergy to:
salicylates e.g. aspirin
any of the ingredients of Dipentum which are listed under the heading, "Product Description", at the end of this leaflet.
Symptoms of an allergic reaction to Dipentum may include skin rash, itching and breathlessness. If you are not sure if you have or have had an allergic reaction to Dipentum, check with your doctor.
Do not take Dipentum if:
You are pregnant or trying to become pregnant.
You are breast feeding.
We do not know if it is safe for you to take Dipentum while you are pregnant or breast feeding. Ask your doctor about the risks and benefits of taking this medicine while you are pregnant or breast feeding. Do not use Dipentum if you are pregnant or breast feeding unless your doctor tells you to.
You are taking any medicine for preventing blood clotting
You have any bleeding disorder
You have any stomach diseases such as ulcers in the stomach or duodenum.
If you are not sure about any of the above, ask your doctor.
The packaging is torn or shows signs of tampering, or the Dipentum does not look as described under the heading 'Description' at the end of this leaflet.
The expiry date (Exp.) on the bottle has passed.
If you take this medicine after the expiry date has passed, it may not work as well.
Do not use Dipentum to treat any other complaints unless advised by your doctor.
Do not give this medicine to anyone else.
Use in infants under two years of age is not recommended.
Before you start taking Dipentum
Tell your doctor if you:
have any form of kidney disease.
are allergic to any other medicines or any other substances such as foods, preservatives or dyes.
suffer from severe allergy or asthma as Dipentum may worsen your condition.
3. Using Dipentum
How to take Dipentum
Your doctor will tell you how many capsules or tablets should be taken each day. The directions your doctor gives you should be strictly followed.
Dipentum should be swallowed after meals with water at regular intervals during the day.
When you first start taking Dipentum you may get some loose stools. However, this usually goes away. You should therefore begin by taking Dipentum in a small dose, then increase the dose slowly. If you are getting diarrhoea, decrease the number of capsules or tablets you are taking then build up the dose again slowly.
1. Acute treatment
If you are starting treatment with Dipentum or are having treatment for attacks of ulcerative colitis, the number of Dipentum you take per day should be increased gradually over one to two weeks, up to a dose of 2 grams per day (4 x 500mg tablets or 8 x 250mg capsules taken in divided doses over the day, e.g. twice a day or four times a day.)
2. Long term maintenance therapy
If you are on long term maintenance therapy with Dipentum for the control of ulcerative colitis, the usual dosage is 1 gram per day (1 x 500mg tablet or 2 x 250mg capsules taken twice a day after meals). This dose can be reached gradually over one to two weeks to minimise the likelihood of getting loose stools. If your colitis flares, your doctor may increase the number of Dipentum you are taking.
If you forget to take Dipentum
If you forget to take your Dipentum take your next dose at the normal time it is due.
Do not try to make up for missed doses by taking more than one dose at a time because this may increase the chance of you getting an unwanted side effect.
If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.
In case of overdose
Contact your doctor or go to the Casualty Department at your nearest hospital immediately if you think that you or anyone else may have taken too much Dipentum, even if there are no signs of discomfort or poisoning. Ensure that you have the Dipentum bottle or this leaflet available to give details if needed.
Advice may also be obtained from the Poisons Information Centre. The telephone number for your regional centre can be found in the telephone directory.
4. While taking Dipentum
Things you must do
Advise your doctor immediately if you notice any unusual symptoms.
Ensure you drink plenty of fluids.
Tell your doctor if you become pregnant.
If you are about to start taking any new medicines, tell your doctor or pharmacist that you are taking Dipentum.
Tell all doctors, dentists and pharmacists who are treating you that you are taking Dipentum.
Ensure that you keep all doctor's appointments for check-ups and any tests that your doctor may order for you.
Things you must not do
Do not stop taking Dipentum or change the dose without first checking with your doctor.
Do not give Dipentum to anyone else even if they have the same condition as you.
5. Side Effects
Check with your doctor as soon as possible if you have any concerns while taking Dipentum, even if you do not think the concerns are connected with the medicine or are not listed in this leaflet. Dipentum, like all other medicines, may cause unwanted side-effects in some people. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects. Do not be alarmed by this list of possible side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
Less commonly, Dipentum can cause the following: nausea, stomach pain, upset stomach, rash, hives, headache and joint pain.
There have been rare reports of the following side effects:- vomiting, rectal bleeding, inflammation of the liver, tremors, sleeplessness, mood swings, irritability, fevers, chills, loss of hair, sensitivity to sunlight, hot flushes, redness of skin, dizziness, lightheadedness, muscle cramps, chest pain, irregular heart beat, shortness of breath, frequent urination, difficulty achieving erections, dry mouth, dry eyes, watery eyes, blurred vision.
If these effects do not go away or they are worrying to you, tell your doctor.
Some people may get other side-effects while taking Dipentum.
Tell your doctor if you notice any side-effects while taking Dipentum.
6. After using Dipentum
Keep your Dipentum where children cannot reach them
Your Dipentum capsules or tablets should be stored in their original container in a place where the temperature stays below 30°C. Make sure the container is well closed after use.
Do not store Dipentum or any other medicine in the bathroom or near the sink. Heat and dampness can destroy medicines.
If your doctor tells you to stop taking Dipentum, or it has passed its expiry date, ask your pharmacist what to do with any left over medicine.
7. Product Description
a. What it looks like
There are two different strengths of Dipentum:- 250 mg and 500 mg.
The 250 mg strength is a capsule and is beige in colour and marked 'DIPENTUM 250mg' at one end.
The 500 mg strength is a tablet and is yellow in colour and capsule-shaped. The tablets are debossed with "D500" on one side and scored line on the other side.
Dipentum 250mg capsules are available in plastic bottles containing 100 capsules.
Dipentum 500mg tablets are available in plastic bottles containing 100 tablets.
Dipentum capsules and tablets can be identified by an Australian Register number which is found on the bottle label:
250 mg capsules: AUST R 14466
500 mg tablets: AUST R 53582
Dipentum 250mg Capsules The active ingredient in Dipentum is olsalazine sodium. The capsules contain 250mg olsalazine sodium.
The inactive ingredients are magnesium stearate, gelatin, caramel (E150), titanium dioxide (E171), iron oxide (E172).
Dipentum 500mg Tablets The active ingredient in Dipentum is olsalazine sodium. The tablets contain 500mg olsalazine sodium.
The inactive ingredients are magnesium stearate, silica-colloidal anhydrous, povidone and crospovidone.
Dipentum tablets and capsules do not contain gluten, lactose, sucrose, tartrazine or other azo dyes.
d. Manufacturer and Supplier
Dipentum is supplied in Australia by:-
A division of UCB Australia Pty Ltd
Level 1, 1155 Malvern Road
Victoria 3144, Australia
For medical enquiries call (03) 9828 1800
This leaflet was updated in August 2007