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About This Product
Manufacturer
Delfarma Sp. z o.o.
Composition
Magnesii oxidum leve 10,97 g, Natrii picosulfas 0,01 g
ATC Code
A06AB58
Source
URPL · 17/19
Pharmacotherapeutic group: sodium picosulfate, combinations, ATC code: A06AB58. The active ingredients of Citrafleet are sodium picosulfate, a stimulant laxative acting locally in the colon, and magnesium citrate, which acts as an osmotic laxative by retaining moisture in the colon. These substances produce a powerful "washout" effect combined with stimulation of peristalsis, aimed at bowel cleansing before radiological examination, colonoscopy, or surgery. The product is not intended for use as a routine laxative.
In a randomized, multicenter, blinded study in adults, bowel cleansing before colonoscopy was compared using two different regimens with CitraFleet versus Klean-Prep (one sachet containing 59 g polyethylene glycol 3350, 5.685 g 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: CitraFleet administered the day before the procedure (2 sachets 5 hours apart during the afternoon and evening before colonoscopy, n=229); Klean-Prep administered the day before the procedure (4 sachets administered during the afternoon and evening before colonoscopy, n=227); and CitraFleet administered on the morning of the procedure (2 sachets 3 hours apart on the morning before colonoscopy, n=56). Bowel cleansing was assessed using a categorical scale (excellent, good, acceptable, and poor). Good/excellent cleansing was observed in 68.1% of patients with the CitraFleet day-before regimen (statistically non-significant difference compared with Klean-Prep), while significantly higher proportions of patients achieved good/excellent cleansing with the CitraFleet morning-of-procedure regimen compared with both day-before regimens (p<0.05). Both CitraFleet regimens were rated by patients as substantially easier to complete than Klean-Prep (p<0.001). All regimens were well tolerated, with only 2.2% of patients experiencing adverse effects with the CitraFleet day-before regimen. No serious adverse events occurred.
In a randomized, multicenter, blinded study in adults, bowel cleansing before colonoscopy was compared using two different regimens with CitraFleet: split dosing (1 sachet the evening before colonoscopy and the second sachet on the morning before colonoscopy, n=159) and day-before morning regimen (1 sachet before 8:00 AM the day before colonoscopy and the second sachet 6–8 hours later, n=156). Bowel cleansing was assessed using a categorical scale (excellent, good, acceptable, and poor). Good/excellent bowel cleansing was achieved by a significantly higher proportion of patients in the split-dose regimen (79.9% vs. 30.8% in the day-before morning regimen, 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 experiencing adverse effects in the split-dose and day-before morning groups, respectively. More patients in the split-dose group than in the day-before morning group experienced nausea (23.3% vs. 13.5%) and overall physical discomfort (29.6% vs. 17.3%), while more patients in the day-before morning group experienced hunger (46.2% vs. 32.1% with the split-dose regimen). No serious adverse events occurred. Overall, mean changes in electrolyte levels and other laboratory parameters were small in both groups.
⚠️ Warnings
Citrafleet should not be used as a routine laxative.
Citrafleet could in rare cases lead to severe and potentially fatal electrolyte disturbances or renal impairment in frail or debilitated patients. Therefore, the benefit/risk balance of Citrafleet must be carefully evaluated in this at-risk population before initiating treatment.
Special attention is required when prescribing Citrafleet to any patients with regard to known contraindications. Furthermore, special attention should be given to the importance of adequate hydration and, in at-risk patients (as listed below), to the importance of determining electrolyte levels at the start and after completion of treatment.
Extraordinary care may be required in elderly and debilitated patients, and in patients at risk of developing hypokalaemia or hyponatraemia.
Citrafleet should be used with caution in patients with diagnosed disturbances of water and/or electrolyte balance or in patients taking medicinal products that may affect water and/or electrolyte balance, such as diuretics, corticosteroids, lithium (see section 4.5).
Caution is also advised in patients who have recently undergone gastrointestinal surgery or who have renal impairment, mild to moderate dehydration, hypotension, or cardiac disease.
The duration of bowel cleansing should not exceed 24 hours, as prolonged preparation may increase the risk of water and electrolyte imbalance.
Diarrhoea caused by the evacuant effect of Citrafleet may result in loss of fluid and electrolytes, hypovolaemia, and hypotension. In addition, a vasovagal reflex may be triggered by abdominal stimuli, e.g. pain, which may lead to low blood pressure and loss of consciousness. Adequate intake of clear fluids is required, see section 4.2.
Citrafleet may alter the absorption of regularly prescribed oral medications and should therefore be used with caution. For example, isolated cases of seizures have been reported in patients taking antiepileptic drugs whose epilepsy was previously well controlled (see sections 4.5 and 4.8).
Citrafleet may induce aphthoid ulcers in the colonic mucosa and serious cases of colitis (including ischaemic colitis) requiring hospitalisation have been reported. Consequently, this diagnosis should be considered in the event of severe and/or persistent abdominal pain, with or without rectal bleeding, following administration of Citrafleet.
This product contains 5 mmol (or 195 mg) of potassium per sachet. This must be taken into consideration in patients with reduced renal function and in patients on a low-potassium diet.
This medicinal product contains less than 1 mmol (23 mg) sodium per sachet, i.e. it is essentially sodium-free.
This medicine contains sulfites including disulfites and hydrogen sulfites, which originate from the maltodextrin present in the lemon flavouring. Rarely, it may cause severe hypersensitivity reactions and bronchospasm.
