CITRAFLEET

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.

• One sachet in the afternoon and the second sachet in the evening prior to the procedure. This schedule is more suitable when the procedure is early in the morning. • Both sachets in the morning of the day of the procedure. This regimen is only suitable when the procedure is planned in the afternoon/evening.

The time elapsed between the two sachets should be at least 5 hours.

Method of administration Route of administration:

Oral use. 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. 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.

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 to < 1/10); uncommon (≥ 1/1,000 to < 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 (cannot be estimated from the available data)’.

Immune system disorders Not known:

Anaphylactoid reaction, hypersensitivity.

Metabolism and nutrition disorders Not known:

Hyponatraemia.

Not known:

Hypokalaemia.

Psychiatric disorders Common:

Sleep disorder.

Nervous system disorders Common:

Headache.

Uncommon:

Dizziness.

Not known:

Epilepsy, grand mal convulsion, convulsion, confusional state.

Vascular disorders Uncommon:

Orthostatic hypotension.

CitraFleet should not be used as a routine laxative. CitraFleet could rarely lead to severe and potentially fatal cases of electrolyte disorders or impaired renal function in frail or debilitated 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. g. 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. Diarrhoea due to the evacuating effect of CitraFleet may result in fluid and electrolyte losses, hypovolemia and hypotension.

g. pain, which may lead to low blood pressure and loss of consciousness . 2. g. 8). CitraFleet may induce aphtoid ulcers of the colonic mucosa and there have been reports of serious cases of colitis (including ischaemic colitis) requiring hospitalisation.

As a result, this diagnosis should be considered in case of severe and/or persistent abdominal pain, with or without rectal bleeding, after the administration of CitraFleet. This medicine contains 5 mmol (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. This medicine contains less than 1 mmol sodium (23 mg) per sachet, that is to say essentially ‘sodium-free’.

1, 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. 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.