CitraFleet oral powder 16.11g sachets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sodium picosulfate; Citric acid monohydrate; Magnesium oxide light

Available from:

Casen Recordati S.L.

ATC code:

A06AB58

INN (International Name):

Sodium picosulfate; Citric acid monohydrate; Magnesium oxide light

Dosage:

10mg ; 12gram ; 3.5gram

Pharmaceutical form:

Oral powder

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 01060500

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CITRAFLEET, POWDER FOR ORAL SOLUTION IN SACHET
SODIUM PICOSULFATE, LIGHT MAGNESIUM OXIDE, CITRIC ACID ANHYDROUS.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told
you. However, you still need to take CitraFleet carefully to get the
best results from it.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
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 cal

Summary of Product characteristics

OBJECT 1
CITRAFLEET POWDER FOR ORAL SOLUTION
Summary of Product Characteristics Updated 18-Aug-2017 | Casen
Recordati S.L.
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(s) with known effect: each sachet also contains 5 mmol (or
195 mg) potassium (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.
• 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._
For instructions on reconstitution of the medicinal product before
administration, see section 6.6
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