Enema

Hyperphosphataemia An association has been described between the retention time of Casinema and an increased risk of hyperphosphataemia (see section 5.2). Evacuation usually occurs approximately 5 minutes after administration of Casinema; for this reason, a retention time longer than 5 minutes is not recommended. If evacuation does not occur after use of Casinema or the retention time exceeds 10 minutes, laboratory tests should be performed to detect potential electrolyte abnormalities and to minimise the risk of severe hyperphosphataemia (see sections 4.8 and 4.9). Nausea, vomiting, or abdominal pain Do not use Casinema in the case of nausea, vomiting, or abdominal pain unless directed by a physician. Dehydration Patients should be informed to expect liquid stools and advised to drink clear fluids to prevent dehydration; this applies particularly to patients with conditions predisposing to dehydration or to patients taking medicines that may reduce glomerular filtration, such as diuretics, angiotensin-converting enzyme inhibitors (ACEIs, e.g. enalapril, ramipril, lisinopril), angiotensin receptor blockers (ARBs, e.g. losartan, candesartan, eprosartan, irbesartan, olmesartan, telmisartan, valsartan), or non-steroidal anti-inflammatory drugs (NSAIDs). Electrolyte shifts As Casinema contains sodium phosphates, there is a risk of increased serum sodium and phosphate levels and decreased calcium and potassium levels, with consequent hypernatraemia, hyperphosphataemia, hypocalcaemia, and hypokalaemia, accompanied by clinical signs such as tetany and renal failure. Electrolyte shifts are of particular concern in children with megacolon or any other condition in which the enema solution is retained, and in patients with comorbidities. For this reason, Casinema should be used with caution in the following cases: elderly or debilitated patients, patients treated with lithium, and patients with ascites, cardiac disease, or changes to the rectal mucosa (ulcers, fissures); patients with a colostomy who are taking diuretics or other medicines that may affect electrolyte levels; patients taking medicines known to prolong the QT interval (e.g. amiodarone, arsenic trioxide, astemizole, azithromycin, erythromycin, clarithromycin, chlorpromazine, cisapride, citalopram, domperidone, terfenadine, procainamide); or patients with a pre-existing electrolyte imbalance such as hypocalcaemia, hypokalaemia, hyperphosphataemia, and hypernatraemia. Caution should also be used in patients taking medicines with a known effect on renal perfusion or function or on hydration status. In cases of suspected electrolyte disturbances and in patients at risk of hyperphosphataemia, electrolyte levels should be monitored before and after administration of Casinema. Renal impairment The product should be used with caution in patients with renal impairment, and only if the expected clinical benefit outweighs the risk of hyperphosphataemia. Long-term use Repeated and long-term use of Casinema is not recommended, as it may lead to dependence. Administration of more than one enema within 24 hours may be harmful. Unless a physician decides otherwise, Casinema should not be used for more than 6 consecutive days. Casinema should be administered in accordance with the instructions for use and handling (see section 4.2). Patients should be warned to stop using the product if resistance is felt during administration, as forcing the enema may cause injury. Rectal bleeding following use of Casinema may be indicative of a serious condition. In such a case, administration must be stopped immediately and the patient's condition must be evaluated by a physician. Benzalkonium chloride This medicine may cause local irritation as it contains benzalkonium chloride.