What is the active ingredient in CITRAFLEET 10MG/3.5G/10.97G Powder for oral solution in sachet?

Natrii picosulfas + Magnesii oxidum leve + Acidum citricum

What pharmaceutical form is CITRAFLEET 10MG/3.5G/10.97G Powder for oral solution in sachet available in?

CITRAFLEET 10MG/3.5G/10.97G Powder for oral solution in sachet: Proszek do sporządzania roztworu doustnego (0,01 g + 3,5 g + 10,97 g)/sasz.

What are the side effects of CITRAFLEET 10MG/3.5G/10.97G Powder for oral solution in sachet?

The most commonly reported adverse reactions in clinical studies with the combination of sodium picosulfate and magnesium citrate were related to direct effects on the bowel (abdominal pain and nausea) and to the consequences of diarrhoea and dehydration (sleep disturbances, dry mouth, thirst, headache, and fatigue). Adverse reactions are listed below by MedDRA system organ class and preferred terms. The following convention is used to express frequency of occurrence: very common (≥ 1/10); commo

Who should NOT take CITRAFLEET 10MG/3.5G/10.97G Powder for oral solution in sachet?

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, congestive heart failure, severe dehydration, hypermagnesaemia, gastric retention, gastrointestinal ulceration, toxic colitis, toxic megacolon, ileus, nausea and vomiting, ascites, acute surgical abdominal conditions such as acute appendicitis, and known or suspected gastrointestinal obstruction or perforation. Do not use in patients with rhabdomyolysis, as laxatives may trigger rhabdomyolysis and thereb

Does CITRAFLEET 10MG/3.5G/10.97G Powder for oral solution in sachet interact with other medications?

Citrafleet, as a purgative, increases the rate of gastrointestinal transit. During treatment, the absorption of other orally administered medicinal products (e.g. antiepileptics, contraceptives, antidiabetics, antibiotics) may therefore be altered (see section 4.4). Tetracycline and fluoroquinolone antibiotics and penicillamine should be taken at least 2 hours before and no earlier than 6 hours after administration of Citrafleet, to prevent chelation with magnesium. Bulk-forming laxatives reduce

Can CITRAFLEET 10MG/3.5G/10.97G Powder for oral solution in sachet be used during pregnancy?

Pregnancy No clinical data are available regarding exposure to Citrafleet during pregnancy or its reproductive toxicity. Since picosulfate is a stimulant laxative, the use of Citrafleet during pregnancy is not recommended as a safety precaution. Breastfeeding There is no experience with the use of Citrafleet in breastfeeding mothers. However, given the pharmacokinetic properties of the active substances, treatment with Citrafleet may be considered in breastfeeding women.

CITRAFLEET 10MG/3.5G/10.97G Powder for oral solution in sachet

This information is for educational purposes only. It is not intended as medical advice. Always consult a qualified healthcare professional.

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 prior to radiological examination, colonoscopy, or surgical intervention. The product is not intended for use as a routine laxative. In a randomised, multicentre, blinded study in adults, bowel preparation 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). Treatment groups were: CitraFleet administered the day before the procedure (2 sachets 5 hours apart during the afternoon and evening the day before colonoscopy, n=229); Klean-Prep administered the day before the procedure (4 sachets administered during the afternoon and evening the day before colonoscopy, n=227); and CitraFleet administered on the morning of the procedure day (2 sachets 3 hours apart in 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 to Klean-Prep), while significantly higher proportions of patients had good/excellent cleansing with the CitraFleet morning-of-procedure regimen compared to 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 reporting adverse events with the CitraFleet day-before regimen. No serious adverse events occurred. In a randomised, multicentre, blinded study in adults, bowel preparation before colonoscopy was compared using two different regimens with CitraFleet: split dosing (1 sachet in the evening the day before colonoscopy and the second sachet in the morning before colonoscopy, n=159) and morning-before-the-procedure 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). A significantly higher proportion of patients achieved good/excellent bowel cleansing with the split-dose regimen (79.9% vs. 30.8% with the morning-before-the-procedure 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 events in the split-dose and morning-before-the-procedure groups, respectively. More patients in the split-dose group than in the morning-before-the-procedure group experienced nausea (23.3% vs. 13.5%) and overall physical discomfort (29.6% vs. 17.3%), whereas more patients in the morning-before-the-procedure group experienced hunger (46.2% vs. 32.1% with the split-dose regimen). No serious adverse events occurred. Overall, mean changes in electrolyte values 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 serious and potentially fatal electrolyte imbalances or renal impairment in frail or debilitated patients. Therefore, a careful assessment of the benefit/risk ratio of Citrafleet must be made in this at-risk population before initiating treatment. Particular attention should be paid when prescribing Citrafleet to any patients with regard to the known contraindications. In addition, special attention should be given to the importance of adequate hydration and, in at-risk patients (as specified below), to the importance of determining electrolyte levels at the start and after completion of treatment. Elderly and debilitated patients, as well as patients at risk of developing hypokalaemia or hyponatraemia, may require exceptional care. Citrafleet should be used with caution in patients with diagnosed disturbances of fluid and/or electrolyte balance or in patients taking medicinal products that may affect fluid and/or electrolyte balance, such as diuretics, corticosteroids, lithium (see section 4.5). Caution should also be exercised 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 preparation should not exceed 24 hours, as longer preparation may increase the risk of fluid and electrolyte imbalance. Diarrhoea caused by the evacuant action of Citrafleet may result in fluid and electrolyte loss, hypovolaemia, and hypotension. In addition, a vasovagal reflex may be triggered through abdominal stimuli, e.g. pain, which may lead to low blood pressure and loss of consciousness. Adequate intake of clear fluids is necessary, 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 in whom epilepsy had previously been controlled (see sections 4.5 and 4.8). Citrafleet may cause aphthoid ulcers on 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 should be taken into account in patients with reduced renal function and in patients on a low-potassium diet. This medicinal product contains less than 1 mmol (23 mg) of sodium per sachet, i.e. it is essentially sodium-free. This medicine contains sulfites including disulfites and hydrogen sulfites, which are generated from the maltodextrin present in the lemon flavouring. Rarely, this may cause severe hypersensitivity reactions and bronchospasm.

CITRAFLEET 10MG/3.5G/10.97G Powder for oral solution in sachet

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