PHOSPHO-SODA oral solution bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

dibasic sodium phosphate, Quantity: 4.3 g; monobasic sodium phosphate, Quantity: 18.8 g

Available from:

Chiesi Australia Pty Ltd

INN (International Name):

dibasic sodium phosphate,monobasic sodium phosphate

Pharmaceutical form:

Oral Liquid

Composition:

Excipient Ingredients: glycerol; saccharin sodium; sodium benzoate; purified water; Flavour

Administration route:

Oral

Units in package:

45 mL

Prescription type:

(S3) Pharmacist Only Medicine

Therapeutic indications:

For use as part of a bowel cleansing regimen in preparing adult patients for colon surgery or for preparing the colon for x-ray or endoscopic examination.

Product summary:

Visual Identification: PHOSPHO-SODA is a clear colourless solution with ginger lemon odour.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2016-12-13

Patient Information leaflet

PHOSPHO
®
-SODA CMI v3.0
1
PHOSPHO
®
-SODA
_ORAL SOLUTION _
_monobasic sodium phosphate dihydrate and dibasic sodium phosphate
dodecahydrate _
CONSUMER MEDICINE INFORMATION
WARNING: LIFE THREATENING
DEHYDRATION AND/OR ELECTROLYTE
DISTURBANCES MAY OCCUR IN SOME
PEOPLE. READ THE SECTION WITH
THE HEADING ‘BEFORE YOU TAKE
PHOSPHO-SODA’ (BELOW)
AND, IF YOU THINK YOU _COULD_ BE
AT RISK, DISCUSS WITH YOUR DOCTOR
AND DO NOT TAKE THIS PRODUCT
WITHOUT HIS/HER APPROVAL.
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PHOSPHO-SODA.
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 PHOSPHO-
SODA against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
READ THIS LEAFLET CAREFULLY BEFORE
YOU TAKE THIS MEDICINE.
If you are having an operation or x-
ray of the bowel or colonoscopy,
read all of these instructions at least
two days before your examination.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT PHOSPHO-
SODA IS USED FOR
This medicine is used as part of a
bowel cleansing procedure before
x-ray of the bowel, colonoscopy
(looking into the bowel with an
instrument) or before a bowel
operation.
PHOSPHO-SODA is for use in
adults.
It works by producing bowel motions
which cleanse the bowel. It usually
works within 30 minutes, although it
may take as long as 6 hours. Expect
frequent liquid stools.
STOP USING THIS PRODUCT AND CONSULT
A DOCTOR IF YOU DO NOT HAVE A BOWEL
MOVEMENT WITHIN 6 HOURS.
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.
Do not drive, use machinery or tools
if you feel tired or dizzy, or think you
may be dehydrated, after taking
PHOSPHO-SODA. You should also
stay within easy reach of toilet
facilities after taking this medi

Summary of Product characteristics

Phospho-Soda PI v3.0
Page 1 of 12
AUSTRALIAN PRODUCT INFORMATION - PHOSPHO
®
-SODA (MONOBASIC SODIUM
PHOSPHATE AND DIBASIC SODIUM PHOSPHATE)
_WARNING: _
_LIFE THREATENING DEHYDRATION AND/OR ELECTROLYTE DISTURBANCES MAY
OCCUR IN ‘AT RISK’ _
_GROUPS – SEE SECTION 4.3 CONTRAINDICATIONS AND SECTION 4.4 SPECIAL
_
_WARNINGS AND PRECAUTIONS FOR USE. _
1
NAME OF THE MEDICINE
PHOSPHO
®
-SODA (monobasic sodium phosphate and dibasic sodium phosphate)
_ _
_ _
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active Ingredients: _18.8 g monobasic sodium phosphate (as 24.4 g
monobasic sodium
phosphate dihydrate) and 4.3 g dibasic sodium phosphate (as 10.8 g
dibasic sodium
phosphate dodecahydrate) per 45 mL bottle.
_Excipients with known effect: _Each 45 mL of bottle contains
saccharin, benzoates and
5.0 g sodium.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS._
_
3
PHARMACEUTICAL FORM
PHOSPHO-SODA is a clear, colourless, ginger-lemon odour and flavour
oral solution, free
from precipitation and turbidity.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For use as part of a bowel cleansing regimen in preparing adult
patients for colon surgery or
for preparing the colon for x-ray or endoscopic examination.
4.2
DOSE AND METHOD OF ADMINISTRATION:_ _
Refer to Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE and
Section 4.3
CONTRAINDICATIONS.
For use as part of a bowel cleansing regimen in preparing the patient
for surgery or for
preparing the colon for x-ray or endoscopic examination.
This product normally produces a bowel movement within ½ to 6 hours.
Patients should be
warned to expect frequent liquid stools.
PHOSPHO-SODA should not be taken by children under 18 years of age
(see Section 4.3
CONTRAINDICATIONS).
Phospho-Soda PI v3.0
Page 2 of 12
ADULTS:
The recommended dosage for adults is 45 mL (one full bottle) and
repeated 10 to 12 hours
later. The intake of clear liquids is an essential part of this
regimen.
Please note that for:

Early morning procedures, on the day before the procedure, the p