CitraFleet Powder for Oral Solution in sachet

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

SODIUM PICOSULFATE, MAGNESIUM OXIDE, LIGHT, CITRIC ACID, ANHYDROUS

Available from:

Casen Recordati, S.L. Autovia de Logrono, km 13,300, 50180 Utebo, Zaragoza, Spain

ATC code:

A06AB58

INN (International Name):

SODIUM PICOSULFATE 10 mg MAGNESIUM OXIDE, LIGHT 3.5 g CITRIC ACID ANHYDROUS 10.97 g

Pharmaceutical form:

POWDER FOR ORAL SOLUTION

Composition:

SODIUM PICOSULFATE 10 mg MAGNESIUM OXIDE, LIGHT 3.5 g CITRIC ACID ANHYDROUS 10.97 g

Prescription type:

POM

Therapeutic area:

DRUGS FOR CONSTIPATION

Authorization status:

Authorised

Authorization date:

2019-03-25

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CITRAFLEET, POWDER FOR ORAL SOLUTION IN SACHET
SODIUM PICOSULFATE / LIGHT MAGNESIUM OXIDE / CITRIC ACID
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What CitraFleet is and what it is used for
2.
What you need to know before you take CitraFleet
3.
How to take CitraFleet
4.
Possible side effects
5.
How to store CitraFleet
6.
Contents of the pack and other information
1.
WHAT CITRAFLEET IS AND WHAT IT IS USED FOR
You are taking CitraFleet to clean your bowels (also known as
intestines and colon) before having any
diagnostic procedure that requires a clean bowel, for example a
colonoscopy (procedure that looks inside
your bowel using a long, flexible instrument that the doctor inserts
through your anus) or x-ray examination.
CitraFleet is a powder that smells and tastes of lemons. It contains
two types of laxatives mixed in each
sachet which, when dissolved in water and drunk, wash-out and clean
the bowels. It is important to have an
empty, clean bowel so that your doctor or surgeon can see it clearly.
CitraFleet is indicated in adults (including the elderly) aged 18
years and over.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CITRAFLEET
DO NOT TAKE CITRAFLEET IF YOU:
-
are ALLERGIC
to sodium picosulfate, magnesium oxide, citric acid or any of the
other ingredients of this
medicine (listed in section 6).
-
have CONGESTIVE HEART FAILURE
(your heart is unable to properly pump blood round the body).
-
have a condition called GASTRIC RETENTION
(your sto

Summary of Product characteristics

1
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
10.97 g
Excipients with known effect: each sachet also contains 5 mmol (or 195
mg) potassium and sodium
(see section 4.4).
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.
•
Both sachets on the afternoon and evening prior to the procedure. This
schedule is more
suitable when the procedure is early in the morning.
•
Both sachets in the morning of the day of the procedure. This regimen
is only suitable when
the procedure is planned in the afternoon/evening.
The time elapsed between the two sachets should be at least 5 hours.
Method of administration
_Route of administration: Oral use. _
For instructions on reconstitution of the medicinal product before
administration, see section 6.6.
_ _
2
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 liq