DIPENTUM olsalazine sodium 500mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

olsalazine sodium, Quantity: 500 mg

Available from:

Atnahs Pharma Australia Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: povidone; crospovidone; colloidal anhydrous silica; magnesium stearate; ethanol

Administration route:

Oral

Units in package:

100 tablets, 50 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS: Treatment of ulcerative colitis in patients intolerant of sulphasalazine.

Product summary:

Visual Identification: yellow capsule-shaped tablets, debossed with "D500" on one side and score line on the other.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 4 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1995-09-28

Patient Information leaflet

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

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – DIPENTUM
®
(OLSALAZINE SODIUM)
1. NAME OF THE MEDICINE
olsalazine sodium
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 250 mg of olsalazine sodium.
Each tablet contains 500 mg of olsalazine sodium.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
Capsules, 250 mg (beige, opaque, hard gelatin capsule shells, size 1,
radially printed "DIPENTUM 250mg" in
black).
Tablets 500 mg (yellow, capsule-shaped tablets, debossed with "D500"
on one side and score line on the
other).
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of ulcerative colitis in patients intolerant of
sulphasalazine.
4.2 DOSE AND METHOD OF ADMINISTRATION
Dipentum should be taken at regular intervals during the day, after
meals.
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.
For maximum compliance titration of the dose is recommended. If taking
the capsules, commence treatment
with 250 mg on the first day, gradually increasing the dose each day
by 250 mg to 2 g/day in divided doses.
If taking the tablets, commence treatment with 500mg on the first day,
gradually increasing the dose each
day by 500 mg to 2 g/day 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
250mg 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 medicine is well tolerated
the total dose may be increased to
3 g/day. A single dose should not exceed 1g.
Should a patient experience a medicine related watery diarrhoea during
escalation of the dose, reduce the
dose to a previously tolerated level for three days and then increase