Dipentum

Ülke: Yeni Zelanda

Dil: İngilizce

Kaynak: Medsafe (Medicines Safety Authority)

Aktif bileşen:

Olsalazine sodium 250mg

Mevcut itibaren:

Clinect NZ Pty Limited

INN (International Adı):

Olsalazine sodium 250 mg

Doz:

250 mg

Farmasötik formu:

Capsule

Kompozisyon:

Active: Olsalazine sodium 250mg Excipient: Gelatin Magnesium stearate Opacode black S-1-17822 Opacode black S-1-17823

Paketteki üniteler:

Bottle, plastic, 100 capsules

Sınıf:

Prescription

Reçete türü:

Prescription

Tarafından üretildi:

Dottikon Exclusive Synthesis AG

Terapötik endikasyonlar:

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.

Ürün özeti:

Package - Contents - Shelf Life: Bottle, plastic, - 100 capsules - 60 months from date of manufacture stored at or below 30°C

Yetkilendirme tarihi:

1987-09-24

Bilgilendirme broşürü

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

Ürün özellikleri

1
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