Picosalax

Riik: Uus-Meremaa

keel: inglise

Allikas: Medsafe (Medicines Safety Authority)

Toimeaine:

Citric acid 12 g;  ; Light magnesium oxide 3.5 g; Sodium picosulfate 10mg

Saadav alates:

Pharmaco (NZ) Ltd

INN (Rahvusvaheline Nimetus):

Citric acid 12 g

Ravimvorm:

Powder for oral solution

Koostis:

Active: Citric acid 12 g   Light magnesium oxide 3.5 g Sodium picosulfate 10mg Excipient: Orange flavour 655280 Potassium bicarbonate Saccharin sodium

Ühikuid pakis:

Sachet, laminate, Paper/polyethylene/aluminium Surlyn, 16.1g, 2 dose units

Klass:

Restricted

Retsepti tüüp:

Restricted

Valmistatud:

Jungbunzlauer Austria AG

Näidustused:

For clearance of the bowel prior to examination by radiography, endoscopy or surgery.

Toote kokkuvõte:

Package - Contents - Shelf Life: Sachet, laminate, Paper/polyethylene/aluminium Surlyn, 16.1g - 2 dose units - 36 months from date of manufacture stored at or below 30°C

Loa andmise kuupäev:

2007-10-25

Infovoldik

PICOSALAX
1
PICOSALAX
®
_Sodium picosulfate with Magnesium citrate _
_ _
Powder for oral solution
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 YOUR PICOSALAX”.
WHAT IS IN THIS LEAFLET?
This leaflet answers some common
questions about Picosalax. 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 Picosalax
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 PICOSALAX IS USED
FOR
Picosalax is used for clearance of
the bowel before x-ray, endoscopy
or surgery.
Picosalax produces a watery stool
or bowel motion which empties and
cleans the bowel before the
procedure.
Each dose of Picosalax usually
produces a bowel movement within
2 to 3 hours, depending on your
individual response.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT
WHY THIS MEDICINE HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
BEFORE YOU TAKE
PICOSALAX
_WHEN YOU MUST NOT TAKE IT_
Picosalax is not to be used as a
routine laxative.
Picosalax is not for use in children
under 9 years of age.
DO NOT TAKE PICOSALAX IF YOU HAVE
AN ALLERGY TO:

any medicine containing
sodium picosulfate or
magnesium citrate

any of the ingredients listed at
the end of this leaflet
Some of the 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 PICOSALAX IF YOU ARE
SUFFERING FROM:

heart failure

perforation of the stomach or
stomach obstruction

delayed emptying of stomach
contents into the small int

Toote omadused

NEW ZEALAND DATA SHEET
PICOSAL006
20 Sept 2019
Page 1 of 8
PICOSALAX® POWDER FOR ORAL SOLUTION
Sodium picosulfate 10 mg, magnesium oxide 3.5g, citric acid 12 g
1 PRODUCT NAME
PICOSALAX powder for oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sachets containing 16.1g of powder for oral solution.
_Active _
_ingredients_:
sodium
picosulfate
10mg
with
magnesium
citrate
formed in
solution
from
magnesium oxide 3.5g and citric acid 12g.
Excipient(s) with known effect: Saccharin sodium, lactose
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Powder for oral solution.
White crystalline powder.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For clearance of the bowel prior to examination by radiography,
endoscopy or surgery.
4.2
DOSE AND METHOD OF ADMINISTRATION
Instructions for timing of dose and dietary and fluid restrictions
vary greatly between centres and
may over-ride the recommendations given below. Clinical studies with
PICOSALAX have shown the
following regimens to be effective.
_ADULTS (INCLUDING THE ELDERLY) AND CHILDREN AGED 9 YEARS OF AGE AND
OLDER: _
(if the procedure is scheduled for the afternoon, it is recommended
that the Split-Dose regimen be
used):
_SPLIT-DOSE REGIMEN (EVENING-BEFORE AND DAY OF THE PROCEDURE) _
The first PICOSALAX sachet is taken the night before the procedure,
and the second is taken the next
day, in the morning prior to the procedure.
_On the day before the procedure - 1 sachet:_

The first reconstituted sachet is taken in the evening (e.g. 5:00 to
9:00 pm), followed by at
least five 250mL drinks of clear liquids, spread over several hours
_On the day of the procedure - 1 sachet: _

The second reconstituted sachet is taken in the morning (5-9 hours
before the procedure),
followed by at least three 250mL drinks of clear liquids, spread over
several hours_ _

Clear liquids may be consumed until 2 hours before the time of the
procedure._ _
NEW ZEALAND DATA SHEET
PICOSAL006
20 Sept 2019
Page 2 of 8
or
_DAY-BEFORE REGIMEN (EVENING-BEFORE THE PROC