CitraFleet oral solution

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Sodium picosulfate; Magnesium oxide, light ; Citric acid

Disponibil de la:

Casen-Recordati S.L.

Codul ATC:

A06AB58

INN (nume internaţional):

Sodium picosulfate; Magnesium oxide, light ; Citric acid

Forma farmaceutică:

Oral solution

Zonă Terapeutică:

sodium picosulfate, combinations

Statutul autorizaţiei:

Not marketed

Data de autorizare:

2023-03-03

Prospect

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CITRAFLEET ORAL SOLUTION
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 oral solution is and what it is used for
2.
What you need to know before you take CitraFleet oral solution
3.
How to take CitraFleet oral solution
4.
Possible side effects
5.
How to store CitraFleet oral solution
6.
Contents of the pack and other information
1.
WHAT CITRAFLEET ORAL SOLUTION IS AND WHAT IT IS USED FOR
You are taking CitraFleet oral solution 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 an oral solution that smells and
tastes of grenadine. It contains two types
of laxatives mixed in each bottle which, when 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 oral solution is indicated in adults (including the
elderly) aged 18 years and over.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CITRAFLEET ORAL SOLUTION
DO NOT TAKE CITRAFLEET ORAL SOLUTION 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

Caracteristicilor produsului

Health Products Regulatory Authority
03 March 2023
CRN00CP9P
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
CitraFleet oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each bottle (160ml) 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 bottle contains 3.4 g sodium, 0.83g sodium metabisulfite (E 223),
0.17 g sodium methyl p-hydroxybenzoate (E 219), 0.066
g ethanol, 0.02 g sodium propyl p-hydroxybenzoate (E 217) and 0.013 g
propylene glycol (E 1520).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution.
Transparent solution, colourless or slightly yellowish with grenadine
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 oral solution 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 bottle on the evening prior to the procedure and the
second bottle in the morning of the day of the
procedure.

Both bottles on the afternoon and evening prior to the procedure. This
schedule is more suitable when the
procedure is early in the morning.

Both bottles 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 bottles should be at least 5 hours.
Method of administration
_Route of administration: Oral use._
A special (low fibre food) 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.
CitraFleet oral solution should not be mixed or diluted. It is ready
to be drunk right from the