PREDSOL prednisolone 5mg (as sodium phosphate) suppository blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

prednisolone sodium phosphate, Quantity: 6.72 mg (Equivalent: prednisolone, Qty 5 mg)

Available from:

Aspen Pharma Pty Ltd

Pharmaceutical form:

Suppository, moulded

Composition:

Excipient Ingredients: Hard fat

Administration route:

Rectal

Units in package:

10 suppositories

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 01 JAN 1991 : PREDSOL SUPPOSITORIES are indicated for the treatment of haemorrhagic and granular proctitis, post-radiation proctitis and rectal complication of Crohn's disease.

Product summary:

Visual Identification: White to off-white suppositories of regular shape with no defects, air occulsion or dirt present.; Container Type: Strip Pack; Container Material: PVC/PVDC/PE; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1996-09-17

Patient Information leaflet

PREDSOL suppository and enema – Consumer Medicine Information
Page 1 of 4
PREDSOL SUPPOSITORY AND RETENTION ENEMA
_prednisolone (as sodium phosphate) _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS THIS LEAFLET
This leaflet answers some
common questions about
PREDSOL Suppositories
and PREDSOL retention
enemas.
It does not contain all of 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
using PREDSOL against the
benefits they expect it will
have for you.
IF YOU HAVE ANY CONCERNS
ABOUT USING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it
again.
WHAT PREDSOL IS
USED FOR
The active ingredient in
PREDSOL is prednisolone
(as sodium phosphate),
which is a type of
glucocorticoid belonging to a
group of medicines called
corticosteroids.
PREDSOL suppositories are
used in the treatment of
many different conditions
such as:
•
haemorrhagic and
granular proctitis
(a type of inflammation in
the rectum)
•
post radiation proctitis
(inflammation in the
rectum following
radiation therapy)
•
rectal complications of
Crohn’s disease
(inflammation of the
intestine).
PREDSOL retention
enemas are used in the
treatment of ulcerative colitis
and Crohn’s disease.
PREDSOL suppositories
and PREDSOL retention
enemas are for use in the
rectum only. They should
not be taken by mouth.
ASK YOUR DOCTOR IF YOU
HAVE ANY QUESTIONS ABOUT
WHY PREDSOL HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have
prescribed it for another
reason, for example,
haemorrhoids.
This medicine is only
available with a doctor’s
prescription.
BEFORE YOU USE IT
_WHEN YOU MUST NOT USE IT _
_ _
DO NOT USE PREDSOL IF
YOU ARE ALLERGIC TO
PREDNISOLONE OR ANY OF THE
INGREDIENTS LISTED AT THE
END OF THIS LEAFLET.
DO NOT USE PREDSOL IF
YOU HAVE:
•
tuberculous and fungal
infections (such as tinea,
thrush or ringworm) of
the skin
•
acute herpes simplex
(such as cold sores,
shingles or chic

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
PREDSOL AND PREDSOL RETENTION ENEMA
(PREDNISOLONE (AS SODIUM PHOSPHATE))
SUPPOSITORY AND ENEMA
1
NAME OF THE MEDICINE
Prednisolone (as sodium phosphate).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
PREDSOL SUPPOSITORY contains prednisolone 5 mg (as sodium phosphate).
PREDSOL RETENTION ENEMA contains prednisolone 20 mg/100 mL (as sodium
phosphate).
List of excipients with known effect: Nipastat GL75 which contains
methyl hydroxybenzoate,
ethyl
hydroxybenzoate,
propyl
hydroxybenzoate,
butyl
hydroxybenzoate
and
isobutyl
hydroxybenzoate.
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
PREDSOL SUPPOSITORY is a white to off white suppository of regular
shape with no defects,
air occlusion or dirt present.
PREDSOL RETENTION ENEMA is a clear, colourless liquid free from haze
and substantially free
from particulate matter.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
PREDSOL SUPPOSITORY is indicated for the treatment of haemorrhagic and
granular proctitis,
post-radiation proctitis and rectal complication of Crohn’s disease.
PREDSOL
RETENTION
ENEMA
provides
local
corticosteroid
treatment
for
rectal
and
rectosigmoidal disease in ulcerative colitis and Crohn’s disease.
4.2
D
OSE AND METHOD OF ADMINISTRATION
PREDSOL SUPPOSITORY:
Administer twice daily, one at bedtime and the other after morning
defecation. When response
is good treatment should be continued for some months, or ideally,
until sigmoidoscopic or
protoscopic appearances are normal. If symptoms recur, treatment
should at once be
resumed.
2
PREDSOL RETENTION ENEMA:
Use one enema nightly on retiring, for two to four weeks. Treatment
may be continued in
patients showing progressive improvement but it should not be
persisted with if the response
has been inadequate. Some patients may relapse after an interval but
are likely to respond
equally well to a repeated course of treatment. THE ENEMA, AS PACKED,
IS NOT SUITABLE FOR
USE IN CHILDREN.
It may be warmed before administration by pl