Extension of shelf-life to 36 months.

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 approximately 250-400 ml/h. Clear soups and/or balanced electrolyte solutions would be recommended. It is advisable not to drink clear or demineralised water alone.

The patient should be nil-by-mouth prior to the procedure (usually for at least 2 hours) in accordance with anaesthesia requirements.

5.1     Pharmacodynamic properties

Pharmacotherapeutic group: Sodium picosulfate, combinations, ATC code: A06A B58.

The active components of CitraFleet are sodium picosulfate, a stimulant cathartic, active locally in the colon, and magnesium citrate which acts as an osmotic laxative by retaining moisture in the colon. The action is of a potent 'washing out' effect combined with peristaltic stimulation to clear the bowel prior to radiography, colonoscopy or surgery. The product is not intended for use as a routine laxative.

In a randomized, multicentre, rater-blinded study in adults, bowel cleansing prior to colonoscopy using two different regimens of CitraFleet was compared with that following Klean-Prep (each sachet containing 59 g polyethylene glycol 3350, 5.685 g anhydrous sodium sulfate, 1.685 g sodium bicarbonate, 1.465 g sodium chloride and 0.7425 g potassium chloride; to be dissolved in 1 litre of water) The treatment groups were: late prior-day CitraFleet (2 sachets, 5 hours apart during the afternoon and evening the day before colonoscopy, n=229); late prior-day Klean-Prep (4 sachets administered during the afternoon and evening the day before colonoscopy, n=227); same-morning CitraFleet (2 sachets, 3 hours apart on the morning before colonoscopy, n=56). Bowel cleansing was assessed using a categorical scale (excellent, good, fair and poor). Good/excellent cleansing was reported in 68.1% of patients on the late prior-day CitraFleet regimen (not statistically different from  Klean-Prep), while a significantly higher proportion of patients had good/excellent cleansing with same-morning CitraFleet  compared with either late prior-day regimen (p<0.05). Both CitraFleet regimens were rated as significantly easier to complete by patients than Klean-Prep (p<0.001). All regimens were well tolerated, with only 2.2% of patients on the late prior-day CitraFleet regimen having adverse drug reactions. There were no serious adverse drug reactions.

In a randomized, multicentre, rater-blinded study in adults, bowel cleansing prior to colonoscopy was compared using two different regimens of CitraFleet: split-dose (1 sachet in the evening the day before colonoscopy, and another sachet on the morning before colonoscopy, n=159); early prior-day regimen (1 sachet before 0800h the day before colonoscopy and another sachet 6-8 hours later, n=156). Bowel cleansing was assessed using a categorical scale (excellent, good, fair and poor). A significantly higher proportion of patients on the split-dose regimen had good/excellent cleansing (79.9% vs 30.8% for early prior-day,  p<0.0001). Over 93% of patients in both groups rated the regimens as ‘easy’ or ‘very easy’ to take. Both regimens were well tolerated, with 1.9% and 2.5% of patients having adverse drug reactions in the split-dose and early prior-day groups, respectively. More patients in the split-dose group than in the early prior-day group reported nausea (23.3% vs 13.5%) and overall physical discomfort (29.6% vs 17.3%), while more patients in the early prior-day group  reported hunger (46.2% vs 32.1% with split-dose). There were no serious adverse drug reactions. Overall, changes in electrolyte levels and other laboratory parameters were minor in both groups.

10      DATE OF REVISION OF THE TEXT

            February 2016