New Zealand - English - Medsafe (Medicines Safety Authority)
Contains the active ingredient olsalazine sodium (pronounced "ole-SAL-a-zeen")
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common
questions about Dipentum.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Dipentum
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 Dipentum is
This medicine is used to treat a
disease of the bowel called ulcerative
It belongs to a group of medicines
called amino salicylates.
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.
This medicine is available only with
a doctor's prescription.
This medicine is not addictive.
Before you take
When you must not take it
Do not take Dipentum if you have
an allergy to:
olsalazine, the active ingredient in
medicines containing salicylates
any of the ingredients listed at the
end of this leaflet.
Symptoms of an allergic reaction
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue
or other parts of the body
rash, itching or hives on the skin.
Do not take Dipentum if:
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
Do not take this medicine after the
expiry date printed on the pack or
if the packaging is torn or shows
sign of tampering.
If it has expired or is damaged, return
it to your pharmacist for disposal.
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
any form of kidney disease
any problems with your liver
suffer from severe allergies or
asthma as Dipentum may worsen
Tell your doctor if you are
pregnant or plan to become
pregnant or are breast-feeding.
Do not use Dipentum if you are
pregnant or breast feeding unless
your doctor tells you to. Your doctor
will discuss with you all the risks and
benefits to help decide whether it
should be taken.
If you have not told your doctor
about any of the above, tell him/
her before you start taking
Taking other medicines
Tell your doctor or pharmacist if
you are taking other medicines,
including any that you get without
a prescription from your
pharmacy, supermarket or health
Tell your doctor if you are taking:
heparin or warfarin, which are
medicines used to prevent blood
mercaptopurine or thioguanine,
which are medicines used to treat
These medicines may cause
unwanted side effects when taken
with Dipentum. You may need
different amounts of your medicine,
or you may need to take different
Tell your doctor if you have
recently received a chickenpox
How to take Dipentum
Follow all directions given to you
by your doctor or pharmacist
They may differ from the
information contained in this leaflet.
If you do not understand the
instructions on the bottle, ask your
doctor or pharmacist for help.
How much to take
Your doctor will tell you how many
capsules or tablets you will need to
take each day. This may depend on
your condition and whether or not
you are taking any other medicines.
Your doctor may start you on a low
dose of 250 mg to 500 mg a day
before gradually increasing your dose
to 2 g to 3 g a day (given in divided
doses). A single dose should not
exceed 1 g.
Once your condition is under control
your doctor may reduce your dose to
1 g a day.
Do not switch from Dipentum
tablets to capsules or vice versa
without first talking to your
How to take it
Swallow the tablets or capsules
whole with a full glass of water.
When to take it
Take Dipentum soon after food.
Take your medicine at about the
same time each day.
Taking it at the same time each day
will have the best effect. It will also
help you remember when to take it.
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 you forget to take your
Dipentum dose, skip the dose you
missed and take your next dose
when you are meant to.
Do not take a double dose to make
up for the dose you missed.
This may increase the chance of you
getting an unwanted side effect.
If you are not sure what to do, ask
your doctor or pharmacist.
If you have trouble remembering
to take your medicine, ask your
pharmacist for some hints.
If you take too much
Immediately telephone your doctor
or the Poisons Information Centre
(telephone Australia 13 11 26 or
New Zealand 0800 POISON or
0800 764766) 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 Dipentum. Do this even if
there are no signs of discomfort or
You may need urgent medical
Symptoms of an overdose may
While you are using
Things you must do
If you are about to be started on
any new medicine, remind your
doctor and pharmacist that you
are taking Dipentum.
Tell any other doctors, dentists,
and pharmacists who treat you
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
If you become pregnant while
taking this medicine, tell your
Go to your doctor immediately if
you have a fever, sore throat,
mouth ulcers, bruising or bleeding
while using Dipentum.
These symptoms may indicate that
you have developed a blood problem.
Keep all your doctor's
appointments so that your progress
can be checked.
Your doctor may do some blood tests
and may want to check your kidney
and liver function from time to time.
Things you must not do
Do not take Dipentum to treat any
other complaints unless advised by
Do not give your medicine to
anyone else, even if they have the
same condition as you.
Do not stop taking Dipentum or
change the dose without checking
with your doctor.
Tell your doctor or pharmacist as
soon as possible if you do not feel
well while you are taking
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
list of side effects. You may not
experience any of them.
Ask your doctor or pharmacist to
answer any questions you may
Tell your doctor if you notice any
of the following and they worry
nausea or vomiting
stomach pain or upset stomach
headache or dizziness
rash, itching or sensitivity to
fever or chills
joint or muscle pain
Tell your doctor as soon as possible
if you notice any of the following:
increased heart rate or awareness
of your heart beat
pins and needles
pain in passing urine
blood in the urine.
If any of the following happen, tell
your doctor immediately or go to
Accident and Emergency at your
fever, sore throat, mouth ulcers,
bruising or bleeding
shortness of breath, wheezing or
swelling of the face, lips, mouth,
throat or tongue or other parts of
rash, itching or hives on the skin
Tell your doctor or pharmacist if
you notice anything that is making
you feel unwell.
Other side effects not listed above
may also occur in some people.
After using Dipentum
Keep your Dipentum tablets or
capsules in the bottle until it is time
to take them.
If you take your tablets or capsules
out of the bottle they may not keep
Keep your tablets or capsules in a
cool dry place where the
temperature stays below 30°C.
Do not store Dipentum or any
other medicine in the bathroom or
near a sink. Do not leave it on a
window sill or car.
Heat and dampness can destroy some
Keep it where children cannot
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
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
Dipentum 250 mg capsules are
available in plastic bottles containing
Dipentum 500mg tablets are
available in plastic bottles containing
Dipentum capsules contain 250 mg
of olsalazine sodium as the active
The capsules also contain:
titanium dioxide (E171)
iron oxide (E172).
Dipentum tablets contain 500 mg of
olsalazine sodium as the active
The tablets also contain:
Dipentum tablets and capsules do not
contain gluten, lactose, sucrose,
tartrazine or other azo dyes.
Dipentum is supplied by:
Clinect Pty Ltd
120 - 132 Atlantic Drive
Keysborough VIC 3173
Free Call Australia:
1800 899 005
Free Call New Zealand:
0800 138 803
Dipentum 250 mg capsules:
- AUST R 14466
Dipentum 500 mg tablets:
- AUST R 53582
This leaflet was prepared in
NEW ZEALAND DATA SHEET
250 mg capsules and 500 mg tablets
DIPENTUM 250 mg capsules and 500 mg tablets.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DIPENTUM capsules contain 250 mg olsalazine sodium.
DIPENTUM tablets contain 500 mg olsalazine sodium.
For the full list of excipients, see section 6.1.
250 mg capsules: Beige, opaque, hard, gelatin capsules size 1, filled with yellow powder and without print or
radially printed "DIPENTUM 250mg".
500 mg tablets: Yellow, capsule-shaped tablets, with the letters 'KPh' on one side and the product code '110'
and a score line on the other. The tablets are 16mm long and 7mm wide.
4.1 Therapeutic indications
Maintenance of patients with ulcerative colitis in remission.
Treatment of acute ulcerative colitis of mild to moderate severity with or without the concomitant use of
4.2 Dosage and method of administration
Adults: Long Term Maintenance of Remission
Adults including the elderly: 1 g/day (2 capsules or 1 tablet, twice daily), to be continued indefinitely.
Adults: Acute Ulcerative Colitis
Adults including the elderly: Normal dose 2 g/day, in divided doses.
To ensure maximum tolerability, commence treatment with 0.5g the first day and increase the dose each day
by 0.5 g to 2 g daily in divided doses.
As bioequivalence between the 250 mg capsule and 500 mg tablet has not been established, care should be
taken when changing from one dosage form to the other to ensure an equivalent clinical effect. A dose of 250
mg should be given as the 250 mg capsule; the 500 mg tablet should not be divided.
If no response is achieved with 2 g and the drug is well tolerated the total dose may be increased to 3 g/day.
A single dose should not exceed 1 g.
Should a patient experience a drug related watery diarrhoea during escalation of the dose, reduce the dose to
a previously tolerated level for three days and then increase again. Further subdivision of the dose may be
Concomitant oral or rectal steroids may be used.
Safety and efficacy in children have not been established. See 'Section 4.4 Special warnings and precautions
Method of Administration
Dipentum should be taken at regular intervals during the day, after meals.
Known hypersensitivity to salicylates or to any other constituents in Dipentum.
Pathological bleeding tendency, peptic ulcer, erosive gastritis and concomitant anticoagulants.
4.4 Special warnings and precautions for use
Patients suffering from severe allergy or asthma should be observed for signs of worsening of these conditions.
Although rare, blood dyscrasias may develop during therapy. Practitioners should be aware of the possibility
of this occurring and be prepared to cease treatment immediately.
Use in renal impairment
Caution should be exercised in patients with compromised renal function or impaired renal reserve. These
patients should be monitored.
Regular monitoring of renal function in the elderly is advisable as renal function deteriorates with age.
Although clinical trials with olsalazine have not shown any renal adverse effects, the possibility of renal tubular
damage due to absorbed 5-ASA or its n-acetylated metabolite as noted in the Animal Toxicology section, must
be kept in mind particularly for patients with pre-existing renal disease. In these patients, monitoring with
urinalysis, blood urea nitrogen (BUN) and creatinine determinations is advised.
It is recommended to monitor patients with impaired kidney function.
It is recommended to monitor renal function in patients receiving olsalazine, by estimating serum creatinine
before treatment, every 3 months for the first year, every 6 months for the next 4 years, and annually after 5
years of treatment.
Use in hepatic impairment
It is recommended to monitor patients with impaired liver function.
Patients or their carers should be instructed how to recognize signs of haematotoxicity and should be advised
to contact their physicians immediately if symptoms such as fever, sore throat, mouth ulcers, bruising, or
Safety and efficacy in children have not been established. Therefore, use in infants 2 years of age and under
is not recommended.
4.5 Interactions with other medicines and other forms of interaction
The coadministration of salicylates and low molecular weight heparins or haparinoids may result in an
increased risk of bleeding, more specifically haematomas following neuraxial anaesthesia. Salicylates should
be discontinued prior to the initiation of a low molecular weight heparin or heparinoid. If this is not possible, it
is recommended to monitor patients closely for bleeding.
Increased prothrombin time in patients taking concomitant warfarin has been reported.
The coadministration of olsalazine and 6-mercaptopurine or thioguanine may result in an increased risk of
myelosuppression. If coadministered with 6-mecaptopurine, it is recommended to use the lowest possible
doses of each drug and to monitor the patient, especially for leucopenia. In case of coadministration with
thioguanine, careful monitoring of blood counts is recommended.
It is recommended not to give salicylates for six weeks after the varicella vaccine to avoid a possible increased
risk of developing Reye's syndrome.
4.6 Fertility, pregnancy and lactation
Olsalazine has been shown to produce foetal developmental toxicity as indicated by reduced foetal weights,
retarded ossifications and immaturity of the foetal visceral organs when given during organogenesis to
pregnant rats in doses 5 to 20 times the human dose (100 to 400 mg/Kg).
There are no adequate and well controlled studies in pregnant women. Olsalazine should be used during
pregnancy only if the potential benefit justifies the potential risk to the foetus.
Small amounts of the active metabolite of olsalazine (5-ASA) may pass into breast milk. There have been
reports of infants developing diarrhoea when 5-ASA was used during breastfeeding. Unless the benefit of the
treatment outweighs the risks, olsalazine should not be taken by breast-feeding women, or patients should be
advised to discontinue breasfeeding if using olsalazine.
No Data Available.
4.7 Effects on ability to drive and use machines
On the basis of the pharmacodynamic profile and reported adverse events, olsalazine does not appear to
produce any effects on ability to drive and use machines.
4.8 Undesirable effects
Summary of the safety profile
The most common side effect is diarrhoea, which is usually transient.
Tabulated list of adverse reactions
In addition, the following undesirable effects have been reported:
General disorders and administration site conditions
Blood and lymphatic system disorders
aplastic anaemia, eosinophilia, haemolytic anemia,
leukopenia, neutropenia, pancytopenia,
abdominal pain upper, diarrhoea, dyspepsia,
nausea, pancreatitis, vomiting
hepatic enzyme increased, hepatitis, increased
Skin and subcutaneous tissue disorders
alopecia, angioneurotic oedema, photosensitivity
reaction, pruritus, rash, urticaria
myocarditis, palpitations, pericarditis, tachycardia
Renal and urinary disorders
Respiratory, thoracic and mediastinal disorders
dyspnoea, interstitial lung disease
Musculoskeletal and connective tissue disorders
Nervous system disorders
dizziness, paraesthesia, peripheral neuropathy
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued
monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any
suspected adverse reactions https://nzphvc.otago.ac.nz/reporting/
The knowledge of overdosage with Dipentum is limited. Possible symptoms are nausea, vomiting, diarrhoea.
It is recommended to check haematology, the status of the acid-base balance, electrolyte levels and the liver
and kidney. There is no specific antidote to Dipentum.
For advice on the management of overdose please contact the National Poisons Centre on 0800 POISON
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Intestinal anti-inflammatory agents, ATC code: A07EC03
Olsalazine sodium is a fine crystalline powder. The pH of an aqueous solution is in the range of 7 to 8. Solubility
is poor in most solvents except water. Solubility is low at low pH.
Mechanism of action
Olsalazine consists of two molecules of 5-amino-salicylic acid (5-ASA) covalently bound through an azo-bond.
Olsalazine is activated exclusively in the colon. Colonic bacterial azoreductases split the azo-bond converting
olsalazine into 5-ASA, the clinically active moiety. The mechanism of action of 5-ASA in the treatment of
ulcerative colitis remains unknown.
5.2 Pharmacokinetic properties
The parent molecule is poorly absorbed from the gastrointestinal tract (approximately 2% of a 1g oral dose)
and its action is neither pH nor time-release dependent. Thus there is no absorption of 5-ASA from the small
bowel, and more than 95% of an oral dose will consistently reach the colon where it is completely transformed
into 5-ASA. The 5-ASA formed is partially acetylated to acetyl-5-ASA (Ac-5-ASA). Partial colonic absorption of
the resulting 5-ASA and acetyl-5-ASA thus explains the appearance of approximately 20% of the dose in urine.
The concentration of 5-ASA in the colon approaches 1000 times that found in the serum.
Olsalazine sulphate is formed as a minor metabolite following a single oral dose of olsalazine. However, with
repeat dosing, this metabolite accumulates and becomes the major circulating metabolite at steady state.
In clinical studies Dipentum has been well tolerated and shows clinical efficacy similar to sulphasalazine.
5.3 Preclinical safety data
Repeat dose toxicity studies in the rat have shown the kidney to be the major target organ. In a four week oral
gavage study the 800 mg/kg/day dose level produced interstitial nephritis and tubular necrosis. In a six month
oral gavage study the highest dose (400 mg/kg/day) caused no appreciable toxic changes. In a 12 month study
using diet admixture the 400 mg/kg dose caused no appreciable toxic changes whilst at higher doses (800 and
1600 mg/kg) pelvic dilatation, focal mineral deposition, transitional cell hyperplasia, congestion and/or
haemorrhage and fibrosis were seen.
In male rats, a low incidence of transitional cell carcinomas of the urinary bladder was observed following
dietary administration of olsalazine sodium at 800 mg/kg/day for 2 years. These tumours appear to have
developed as a result of irritating effects of urinary calculi, that were also observed at this dose level. No drug-
related tumours were observed in male rats treated with 400 mg/kg/day, in female rats treated with doses up
to 800 mg/kg/day, or in mice treated with dietary doses up to 2000 mg/kg/day. There was no clear evidence
of genotoxic activity in gene mutation assays in bacterial or cultured mammalian cells, or in chromosomal
aberration studies in human lymphocytes in vitro or in rat bone marrow in vivo.
6.1 List of excipients
250 mg capsule - magnesium stearate, gelatin capsule shells
500 mg tablet - magnesium stearate, colloidal silicon dioxide, povidone, crospovidone.
6.3 Not applicable.Shelf life
6.4 Special precautions for storage
Store below 30ºC in a dry place. Keep container tightly closed
6.5 Nature and contents of container
250mg capsules are available in polyethylene bottles: 100's
500mg tablets are available in polyethylene bottles: 100's
6.6 Special precautions for disposal and other handling
No special requirements.
Any unused medicine or waste material should be disposed of in accordance with local requirements.
Clinect NZ Pty Limited
C/- Ebos Group Limited
108 Wrights Road
Telephone: 0800 138 803
DATE OF FIRST APPROVAL
24 September 1987
DATE OF REVISION OF THE TEXT
21 February 2019
Summary Table of Changes
Summary of New Information
Movement and addition of text to align with Medsafe Data Sheet