CITRAFLEET

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CITRIC ACID ANHYDROUS; LIGHT MAGNESIUM OXIDE; SODIUM PICOSULFATE

Available from:

TRADIS GAT LTD

ATC code:

A06AB58

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

CITRIC ACID ANHYDROUS 10.97 G; LIGHT MAGNESIUM OXIDE 3.5 G; SODIUM PICOSULFATE 10 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

CASEN RECORDATI S.L., SPAIN

Therapeutic area:

SODIUM PICOSULFATE, COMBINATIONS

Therapeutic indications:

For bowel cleansing prior to any diagnostic procedures requiring a clean bowel e.g. colonoscopy or x-ray examination.

Authorization date:

2019-02-28

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor's prescription only
CITRAFLEET
POWDER FOR ORAL SOLUTION
ACTIVE INGREDIENTS
Each sachet contains the following active ingredients:
sodium picosulfate 10 mg
light magnesium oxide 3.5 g
citric acid anhydrous 10.97 g
Inactive ingredients and allergens: see section 2 under ‘Important
information about some of this
medicine’s ingredients’, and section 6 ‘Additional
information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains concise
information about this medicine. If you have any further questions,
consult your doctor or
pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if it
seems to you that their medical condition is similar to yours.
1) WHAT IS THIS MEDICINE INTENDED FOR?
This medicine is intended to empty/clean your bowels prior to a
diagnostic procedure such as an x-
ray, surgery or colonoscopy (a procedure for viewing the inside of
your bowel cavity by inserting an
instrument through your anus).
The emptying of the bowel is possible thanks to two types of laxatives
mixed in each sachet.
THERAPEUTIC GROUP: Laxative.
CitraFleet contains two laxatives in each sachet which, when dissolved
in water and drunk, flush and
clean the bowels. It is very important to empty and clean the bowels
so that your doctor/surgeon
can see them clearly.
CitraFleet is intended for adults aged 18 years and older.
2) BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredients or to any of
the other ingredients in
this medicine (see section 6).
•
You have CONGESTIVE HEART FAILURE (a condition in which your heart is
unable to properly
pump blood round the body).
•
YOUR STOMACH DOES NOT EMPTY PROPERLY (gastric retention).
•
You have stomach or duodenal ULCERS.
•
You have BLOCKAGE OF THE GUT OR FAILURE OF NORMAL BOWEL MOVEMENTS
(ileus).
•
Y

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
CitraFleet, Powder for oral solution in sachet
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet (15.08 g) contains the following active ingredients:
Sodium picosulfate
10.0 mg
Light magnesium oxide
3.5 g
Citric acid anhydrous
10.97 g
Excipient with known effect: each sachet also contains 5 mmol (or 195
mg) potassium (see
section 4.4) and sodium.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Powder for oral solution, in sachet.
White crystalline powder with a lemon flavour.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For bowel cleansing prior to any diagnostic procedures requiring a
clean bowel e.g.
colonoscopy or x-ray examination.
CitraFleet is indicated in adults (including the elderly) aged 18
years and over.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults (including the elderly) aged 18 years and over _
The treatment can be administered in one of the following ways:
•
Usually, one sachet on the evening prior to the procedure and the
second sachet in the
morning of the day of the procedure.
•
Alternatively, both sachets on the afternoon and evening prior to the
procedure. This
schedule is more suitable when the procedure is early in the morning.
The time elapsed between the two sachets should be at least 5 hours.
Method of administration
_Route of administration: Oral use._
_ _
A low residue diet or only clear liquids on the day before the
procedure is recommended. No
solid food should be taken from the start of the course of treatment
until after the procedure.
Because the osmolarity of the product needs to be maintained in order
to obtain the desired effect,
each sachet should be reconstituted in a cup of water. Do not further
dilute the product by drinking
liquid immediately after the intake of each sachet.
After a period of ten minutes following the administration of each
reconstituted sachet, it is
recommended to drink approximately 1.5-2 litres of a variety of clear
fluids at a rate of