Fleet Enema 21.4g/9.4g Rectal Solution Ready to Use 133ml

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

Short-term treatment of occasional constipation in adults and children over 3 years of age; pre- and post-operative intestinal emptying, in obstetrics, in preparation for radioscopic examinations and endoscopic investigations of the last intestinal tract.

CONTRAINDICATIONS

Enema Fleet is contraindicated in patients with: • Hypersensitivity to the active ingredients or to any of the excipients listed in paragraph 6.1. • Conditions causing increased absorptive capacity, decreased elimination capacity, or decreased gastric motility, for example: o   suspected intestinal obstruction o   paralytic ileus o   anorectal stenosis o   perforated anus o   congenital or acquired megacolon o   Hirschsprung's disease. • Undiagnosed gastrointestinal disorders, for example: o   symptoms suggestive of appendicitis, intestinal perforation or active inflammatory bowel disease o   undiagnosed rectal bleeding. • Congestive heart failure. • Dehydration. • Children under 3 years of age. • Clinically significant renal insufficiency. Other preparations with sodium phosphates, including oral solutions or sodium phosphate tablets, should not be administered simultaneously (see section 4.5).

WARNINGS AND PRECAUTIONS FOR USE

Do not use Clisma Fleet in case of nausea, vomiting or pain. Patients should be advised to expect loose stools and should be encouraged to drink fluids to help prevent dehydration, particularly patients with conditions that may predispose to dehydration or those taking medications that may decrease the glomerular filtration rate, such as diuretics, angiotensin-converting enzyme inhibitors (ACE inhibitors), angiotensin receptor blockers (sartans) or nonsteroidal anti-inflammatory drugs (NSAIDs). Since Enema Fleet contains sodium phosphates, there is a risk of elevated serum sodium and phosphate levels and decreased calcium and potassium levels and consequently hypernatremia, hyperphosphatemia, hypocalcemia and hypokalemia which may occur with clinical signs such as tetany and renal failure. Fluid and electrolyte changes are of particular concern in children with megacolon or any other condition in which there is retention of enema solution, and in patients with comorbidities. This is why Enema Fleet should be used with caution in: • elderly or weakened patients and in patients with uncontrolled arterial hypertension, ascites, heart disease, changes in the rectal mucosa (ulcers, fissures); • subjects with colostomy, patients taking diuretics or other medicines that can modify fluid and electrolyte levels; • subjects who are taking medicines known to prolong the QT interval (for example amiodarone, arsenic trioxide, astemizole, azithromycin, erythromycin, clarithromycin, chlorpromazine, cisapride, citalopram, domperidone, terfenadine, procainamide), or with known fluid and electrolyte imbalance, such as hypocalcemia, hypokalemia, hyperphosphatemia, hypernatremia. Also use with caution in patients taking medications known to affect perfusion, renal function, or hydration status. Where there is suspicion of hydroelectrolyte disorders and risk of hyperphosphatemia, hydroelectrolyte levels must be monitored before and after the administration of Fleet Enema. The product should be used with caution in patients with impaired renal function, when the clinical benefit is expected to outweigh the risk of hyperphosphatemia. Repeated and prolonged use of Clisma Fleet is not recommended as it may cause habituation. Administering more than one enema in a 24-hour period may be harmful. Enema Fleet should not be used for more than a week. Clisma Fleet must be administered according to the instructions for use (see paragraph 4.2). Patients should be advised to discontinue administration if resistance is encountered, as forcible administration of the enema may cause injury. Rectal bleeding after using Fleet Enema may indicate a serious condition. In this case the administration must be stopped immediately. In general, evacuation occurs approximately 5 minutes after administration of Fleet Enema, therefore, retention times of more than 5 minutes are not recommended. If evacuation does not occur after using Clisma Fleet or if the retention time lasts more than 10 minutes, serious side effects may occur. No other administrations must be used and the patient's condition must be evaluated in order to identify any hydroelectrolyte alterations and to minimize the risk of severe hyperphosphatemia (see sections 4.8 and 4.9). Important information about some excipients Due to the presence of benzalkonium chloride, the product is irritating and can cause local skin reactions.

INTERACTIONS

Use with caution in patients who are receiving calcium channel blockers, diuretics, lithium or other medicinal products that may affect fluid and electrolyte levels as hyperphosphataemia, hypocalcaemia, hypokalaemia, acidosis and hypernatremic dehydration may occur (see section 4.4). Other preparations with sodium phosphates including oral solutions or sodium phosphate tablets should not be administered simultaneously (see section 4.3). Since hypernatremia is associated with low lithium levels, concomitant use of Fleet Enema and lithium may cause a reduction in serum lithium levels with decreased efficacy.

SIDE EFFECTS

Enema Fleet is well tolerated if used as indicated. However, adverse events associated with the use of Enema Fleet have frequently been reported. In some cases, adverse events may occur, especially if the enema is used inappropriately. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Undesirable effects are listed below, by MedDRA system organ class and using the following frequency: very common (≥ 1/10), common (≥ 1/100, <1/10), uncommon (≥ 1/1,000, <1/100), rare (≥ 1/10,000, <1/1,000), very rare (<1/10,000), not known (frequency cannot be estimated from the available data): Immune system disorders: Very rare: hypersensitivity e.g. urticaria. Pathologies of the skin and subcutaneous tissue: Very rare: blisters, itching, burning. Metabolism and nutrition disorders: Very rare: dehydration, hyperphosphatemia, hypocalcaemia, hypokalaemia, hypernatraemia, metabolic acidosis. Gastrointestinal disorders: Very rare: nausea, vomiting, abdominal pain, abdominal distension, diarrhoea, gastrointestinal pain, anal discomfort and proctalgia. Systemic pathologies and conditions relating to the administration site: Very rare: rectal irritation, pain, burning, chills. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.