CitraFleet, Powder for oral solution in sachet

Each sachet (15.08 g) contains the following active ingredients:

Each sachet also contains 5 mmol (or 195 mg) potassium (see section 4.4)

For a full list of excipients, see section 6.1.

Powder for oral solution, in sachet.

White crystalline powder with a lemon flavour.

For bowel cleansing prior to any diagnostic procedures requiring a clean bowel e.g. colonoscopy or x-ray examination.

Route of administration: Oral

A low residue diet is recommended on the day prior to the hospital procedure. To avoid dehydration during treatment with CitraFleet, it is recommended to drink approximately 250 ml per hour, of water or other clear fluid while the washout effect persists.

Directions for reconstitution:

Refer to section 6.6.

Adults (including the elderly) aged 18 years and over:

One sachet reconstituted in water as directed, taken before 8 am on the day before the procedure. Second sachet 6 to 8 hours later.

Hypersensitivity to any of the ingredients of the product, congestive cardiac failure, severe dehydration, hypermagnesaemia, gastric retention, gastro-intestinal ulceration, toxic colitis, toxic megacolon, ileus, nausea and vomiting, ascites, acute surgical abdominal conditions such as acute appendicitis and known or suspected gastro-intestinal obstruction or perforation.

Do not use in patients with rhabdomyolysis as laxatives may induce rhabdomyolysis and may therefore exacerbate the condition.

Do not use in patients with active inflammatory bowel disease e.g. Crohn's disease, ulcerative colitis.

In patients with severely reduced renal function, accumulation of magnesium in plasma may occur. Another preparation should be used in such cases.

CitraFleet should not be used as a routine laxative.

CitraFleet could rarely lead to severe and potentially fatal cases of electrolyte disorders in fragile or debilitated elderly patients. Therefore, the benefit/risk ratio of CitraFleet needs to be carefully considered before initiating treatment in this at-risk population.

Special attention should be taken when prescribing CitraFleet to any patient with regard to known contra-indications and special attention made to the importance of adequate hydration and, in at-risk populations (as defined below), to the importance of also obtaining baseline and post-treatment electrolyte levels.

Elderly and debilitated patients, and patients at risk of hypokalaemia or hyponatraemia, may need particular attention.

CitraFleet should be used with caution in patients with known disorders of water and/or electrolyte balance or on drugs that might affect water and/or electrolyte balance e.g. diuretics, corticosteroids, lithium (see 4.5).

Care should also be taken in patients who have recently undergone gastrointestinal surgery or who have renal impairment, mild to moderate dehydration, hypotension or heart disease.

The period of bowel cleansing should not exceed 24 hours because longer preparation may increase the risk of water and electrolyte imbalance.

CitraFleet may modify the absorption of regularly prescribed oral medication and should be used with caution e.g. there have been isolated reports of seizures in patients on antiepileptics, with previously controlled epilepsy (see 4.5 and 4.8).

This medicine contains 5mmol (or 195 mg) potassium per sachet. This should be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.

As a purgative, CitraFleet increases the gastrointestinal transit rate. Absorption of other orally administered medicines (e.g. anti-epileptics, contraceptives, anti-diabetics, antibiotics) may therefore be modified during the treatment period (see 4.4). Tetracycline and fluoroquinolone antibiotics, and pencillamine, should be taken at least 2 hours before and not less than 6 hours after administration of CitraFleet to avoid chelation with magnesium.

The efficacy of CitraFleet is lowered by bulk-forming laxatives.

Care should be taken with patients already receiving drugs which may be associated with hypokalaemia (such as diuretics or corticosteroids, or drugs where hypokalaemia is a particular risk i.e. cardiac glycosides). Caution is also advised when CitraFleet is used in patients on NSAIDs or drugs known to induce SIADH e.g. tricyclic antidepressants, selective serotonin re-uptake inhibitors, antipsychotic drugs and carbamazepine as these drugs may increase the risk of water retention and/or electrolyte imbalance.

For CitraFleet neither clinical data on exposed pregnancy nor reproductive toxicity are available. As picosulfate is a stimulant laxative, for safety measure, it is preferable to avoid the use of CitraFleet during pregnancy.

There is no experience with the use of CitraFleet in nursing mothers. However, due to the pharmacokinetic properties of the active ingredients, treatment with CitraFleet may be considered for females who are breastfeeding.

CitraFleet may cause fatigue or dizziness, probably as a result of dehydration, and this may have a mild to moderate effect on the ability to drive or use machinery.

The most common adverse events reported in clinical trials using the combination of sodium picosulfate and magnesium citrate were related to direct effects on the bowel (abdominal pain and nausea) and the consequences of diarrhoea and dehydration (sleep disturbance, dry mouth, thirst, headache and fatigue).

Undesirable effects are presented below by MedDRA System Organ Class and Preferred Term, using the following frequency convention: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100). The frequency calculations are based on data derived from an analysis of clinical studies. Undesirable effects that were not reported in these clinical trials are described as 'Frequency not known'.

Hyponatraemia has been reported with or without associated convulsions (see 4.4). In epileptic patients, there have been reports of seizure/grand mal convulsion without associated hyponatraemia (see 4.4 and 4.5).

No cases of overdose with CitraFleet, or similar combinations of sodium picosulfate and magnesium citrate, have been reported. However, because of its modes of action, an overdose of CitraFleet would be expected to cause profuse diarrhoea with dehydration and electrolyte loss. Dehydration could also lead to orthostatic hypotension and dizziness. Dehydration and electrolyte imbalances should be corrected with fluid and electrolytes as necessary.

A06A B58 - Sodium picosulfate, combinations.

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.

Both active components are locally active in the colon, and neither is absorbed in any detectable amounts.

In patients with severely reduced renal function, accumulation of magnesium in plasma may occur.

Prenatal developmental studies in rats and rabbits did not reveal any teratogenic potential after oral dosing of sodium picosulfate up to 100 mg/kg/d, but embryotoxicity had been observed in both species at this dose level. In rats daily doses of 10mg/kg during late gestation (fetal development) and lactation reduced body weights and survival of the offspring. Male and female fertility was not affected by oral doses of sodium picosulfate up to 100 mg/kg.

Potassium hydrogen carbonate

Saccharin sodium

Lemon Flavour (lemon flavour, maltodextrin, tocopherol E307).

Not applicable

Unopened sachets: 30 months

Use immediately after reconstitution.

Do not store above 25°C.

The powder is supplied in unit dose sachets containing 15.08 g. Sachets are packaged in cartons of 2, 50, 100, 200, 500 and 1000 sachets or 50 sachets (hospital pack). The sachet is a complex formed by a polyester layer, an intermediate aluminium layer and an internal polyethylene layer.

Not all pack sizes may be marketed.

Directions for reconstitution:

Reconstitute the contents of one sachet in a cup of water (approximately 150 ml). The resulting solution appears turbid. Stir for 2-3 minutes and drink the solution. If it becomes hot, wait until it cools sufficiently to drink.

Laboratorios Casen-Fleet S.L.U.

Autovía de Logroňo Km 13,300

50180 UTEBO

Zaragoza

Spain

PL 12695/0007

8^th June 2005

20/12/2010

(IF APPLICABLE)

(IF APPLICABLE)