Dipentum

New Zealand - English - Medsafe (Medicines Safety Authority)

Buy It Now

Active ingredient:
Olsalazine sodium 250 mg
Available from:
Clinect NZ Pty Limited
INN (International Name):
Olsalazine sodium 250 mg
Dosage:
250 mg
Pharmaceutical form:
Capsule
Composition:
Active: Olsalazine sodium 250 mg Excipient: Gelatin Magnesium stearate Opacode black S-1-17822 Opacode black S-1-17823
Units in package:
Bottle, plastic, 100 capsules
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Dottikon Exclusive Synthesis AG
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 steroids.
Product summary:
Package - Contents - Shelf Life: Bottle, plastic, - 100 capsules - 60 months from date of manufacture stored at or below 30°C
Authorization number:
TT50-4341
Authorization date:
1987-09-24

DIPENTUM

®

(pronounced "dye-PENT-um")

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

pharmacist.

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

used for

This medicine is used to treat a

disease of the bowel called ulcerative

colitis.

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

Dipentum

When you must not take it

Do not take Dipentum if you have

an allergy to:

olsalazine, the active ingredient in

Dipentum

medicines containing salicylates

e.g. aspirin

any of the ingredients listed at the

end of this leaflet.

Symptoms of an allergic reaction

may include:

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

duodenum.

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

medical conditions:

any form of kidney disease

any problems with your liver

suffer from severe allergies or

asthma as Dipentum may worsen

your condition.

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

Dipentum.

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

food shop.

Tell your doctor if you are taking:

heparin or warfarin, which are

medicines used to prevent blood

clots

mercaptopurine or thioguanine,

which are medicines used to treat

leukaemia.

DIPENTUM

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

medicines.

Tell your doctor if you have

recently received a chickenpox

vaccination.

How to take Dipentum

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 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

doctor.

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

poisoning.

You may need urgent medical

attention.

Symptoms of an overdose may

include:

nausea

vomiting

diarrhoea.

While you are using

Dipentum

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

during surgery.

If you become pregnant while

taking this medicine, tell your

doctor immediately.

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

your doctor.

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.

Side Effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

Dipentum,

DIPENTUM

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

have.

Tell your doctor if you notice any

of the following and they worry

you:

diarrhoea

nausea or vomiting

stomach pain or upset stomach

watery diarrhoea

headache or dizziness

rash, itching or sensitivity to

sunlight

fever or chills

joint or muscle pain

hair loss

Tell your doctor as soon as possible

if you notice any of the following:

increased heart rate or awareness

of your heart beat

blurred vision

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

nearest hospital:

fever, sore throat, mouth ulcers,

bruising or bleeding

shortness of breath, wheezing or

difficulty breathing

swelling of the face, lips, mouth,

throat or tongue or other parts of

the body

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

Storage

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

well.

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

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.

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

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 250 mg capsules are

available in plastic bottles containing

100 capsules.

Dipentum 500mg tablets are

available in plastic bottles containing

100 tablets.

Ingredients

Dipentum capsules contain 250 mg

of olsalazine sodium as the active

ingredient.

The capsules also contain:

magnesium stearate

gelatin

caramel (E150)

titanium dioxide (E171)

iron oxide (E172).

Dipentum tablets contain 500 mg of

olsalazine sodium as the active

ingredient.

The tablets also contain:

magnesium stearate

silica-colloidal anhydrous

povidone

crospovidone.

Dipentum tablets and capsules do not

contain gluten, lactose, sucrose,

tartrazine or other azo dyes.

Supplier

Dipentum is supplied by:

Clinect Pty Ltd

120 - 132 Atlantic Drive

Keysborough VIC 3173

Australia

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

November 2016.

DIPENTUM

NEW ZEALAND DATA SHEET

1.

DIPENTUM

®

250 mg capsules and 500 mg tablets

DIPENTUM 250 mg capsules and 500 mg tablets.

2.

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.

3.

PHARMACEUTICAL FORM

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.

CLINICAL PARTICULARS

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

steroids.

4.2 Dosage and method of administration

Dose

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

beneficial.

Concomitant oral or rectal steroids may be used.

Paediatric

Safety and efficacy in children have not been established. See 'Section 4.4 Special warnings and precautions

for use’.

Method of Administration

Dipentum should be taken at regular intervals during the day, after meals.

4.3 Contraindications

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

bleeding develop.

Paediatric Use

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

Pregnancy

Category B2

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.

Breast-feeding

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.

Fertility

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

a.

Summary of the safety profile

The most common side effect is diarrhoea, which is usually transient.

b.

Tabulated list of adverse reactions

In addition, the following undesirable effects have been reported:

General disorders and administration site conditions

headache, pyrexia

Blood and lymphatic system disorders

aplastic anaemia, eosinophilia, haemolytic anemia,

leukopenia, neutropenia, pancytopenia,

thrombocytopenia

Gastrointestinal disorders

abdominal pain upper, diarrhoea, dyspepsia,

nausea, pancreatitis, vomiting

Hepatobiliary disorders

hepatic enzyme increased, hepatitis, increased

bilirubin

Skin and subcutaneous tissue disorders

alopecia, angioneurotic oedema, photosensitivity

reaction, pruritus, rash, urticaria

Cardiac disorders

myocarditis, palpitations, pericarditis, tachycardia

Renal and urinary disorders

interstitial nephritis

Respiratory, thoracic and mediastinal disorders

dyspnoea, interstitial lung disease

Musculoskeletal and connective tissue disorders

arthralgia, myalgia

Nervous system disorders

dizziness, paraesthesia, peripheral neuropathy

Psychiatric disorders

depression

Eye disorders

vision blurred

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/

4.9 Overdose

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

(0800 764766).

5.

PHARMACOLOGICAL PROPERTIES

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

Absorption

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.

Distribution

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

Toxicology

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.

Carcinogenicity/Genotoxicity

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.

PHARMACEUTICAL PARTICULARS

6.1 List of excipients

250 mg capsule - magnesium stearate, gelatin capsule shells

500 mg tablet - magnesium stearate, colloidal silicon dioxide, povidone, crospovidone.

6.2 Incompatibilities

6.3 Not applicable.Shelf life

60 months.

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.

7.

MEDICINE SCHEDULE

Prescription medicine.

8.

SPONSOR

Clinect NZ Pty Limited

C/- Ebos Group Limited

108 Wrights Road

Christchurch 8024

NEW ZEALAND

Telephone: 0800 138 803

9.

DATE OF FIRST APPROVAL

24 September 1987

10.

DATE OF REVISION OF THE TEXT

21 February 2019

Summary Table of Changes

Section Changed

Summary of New Information

Movement and addition of text to align with Medsafe Data Sheet

guidance

Similar products

Search alerts related to this product

Share this information