Fleet Enema Ready To Use

Occasional Constipation Treatment

Composition

Each 118 mL dose contains the equivalent of 21.4 g (18.1% w / v) disodium hydrogen phosphate dihydrate and 9.4 g (8.0% w / v) disodium phosphate dodecahydrate. Contains 4.4 g of sodium per 118 ml delivered dose. Excipients with known effect: This medicinal product contains 0.0006 g / ml of benzalkonium chloride. For the full list of excipients, see section 6.1.

Excipients

Benzalkonium chloride Disodium edetate Distilled water qs

Therapeutic indications

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

Contraindications

Fleet enema is contraindicated in patients with: • Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. • Conditions that cause an increase in absorption capacity, a decrease in the ability to eliminate or a decrease in gastric motility, for example, - suspected intestinal obstruction - paralytic ileus - anorectal stenosis - perforated anus - congenital or acquired megacolon - Hirschsprung's disease • Undiagnosed gastrointestinal disorders, eg - symptoms suggestive of appendicitis, bowel perforation or active inflammatory bowel disease - undiagnosed rectal bleeding • Congestive heart failure. • Dehydration. • Children under the age of 3. • Clinically significant renal insufficiency. Other preparations with sodium phosphates, including oral solutions or sodium phosphate tablets, should not be administered concurrently (see section 4.5).

Dosage

Posology Adults and children over 12 years of age: 1 bottle (118 ml delivered dose) no more than once a day or as directed by the physician (see section 4.4). Children 3 years of age and under 12 years: Dose halved no more than once daily or as directed by the physician (see sections 4.4 and 4.9). Fleet enema is contraindicated in children less than 3 years of age (see section 4.3). In occasional constipation, laxatives should be used as infrequently as possible and for no more than seven days. The use of longer periods of time requires a doctor's prescription after adequate evaluation of the case. Renal impairment Do not administer to patients with clinically significant renal impairment (see section 4.3). The product should be used with caution in patients with abnormal renal function when the clinical benefit is expected to outweigh the risk of hyperphosphataemia (see section 4.4). Method of administration For rectal use only: • Lie on your left side with both knees bent, arms at rest. • remove the orange protective shield. • with constant pressure, gently insert Comfortip of the enema into the anus with the cannula facing the navel. • press the bottle until the liquid is almost completely expelled. • Discontinue use if resistance is encountered. Forcing the enema can cause injury. 2 to 5 minutes are enough to achieve the desired effect. For occasional constipation, rectal enemas are used to provide relief and only in the short term.

Warnings and Precautions

Do not use ClismaFleet in case of nausea, vomiting or pain. Patients should be advised to expect liquid stools and encouraged to drink fluids to help prevent dehydration, particularly patients with conditions that may predispose them to dehydration or those taking medications that can decrease glomerular filtration rate, such as diuretics, angiotensin converting enzyme inhibitors (ACE inhibitors), angiotensin receptor blockers (sartans) or non-steroidal 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, hyperphosphataemia, hypocalcaemia and hypokalaemia which can occur with clinical signs such as tetany and insufficiency. renal. Fluid and electrolyte changes are of particular concern in children with megacolon or any other condition in which enema solution retention occurs, and in patients with co-morbidities. This is why Fleet Enema 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, cracks), • subjects with colostomy, patients who are taking diuretics or other medicines that can affect fluid and electrolyte levels, • people who are taking medicines known to prolong the QT interval (eg amiodarone, arsenic trioxide, astemizole, azithromycin, erythromycin, clarithromycin, chlorpromazine, cisapride, citalopram, domperidone, terfenadine, procainamide), or with known hydroelectrolytic imbalance, such as hypocalcemia, hypokalaemia, hyperphosphatemia, hypernatremia. Also use with caution in patients taking medicinal products known to affect perfusion, renal function, or hydration status. Where there is a suspicion of electrolyte disorders and risk of hyperphosphataemia, hydroelectrolyte levels should be monitored before and after 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 hyperphosphataemia. Repeated and prolonged use of Fleet Enema is not recommended as it can be addictive. Giving more than one enema in a 24 hour period can be harmful. Fleet enema should not be used for more than one week. Fleet enema should be administered according to the instructions for use (see section 4.2). Patients should be advised to discontinue administration if resistance is encountered, as forceful administration of the enema may cause injury. Rectal bleeding after using Fleet enema can indicate a serious condition. In this case the administration must be stopped immediately. In general, evacuation occurs approximately 5 minutes after the administration of Fleet Enema, therefore, retention times of more than 5 minutes are not recommended. In case evacuation does not occur after using Fleet Enema or if the retention time lasts more than 10 minutes, serious side effects can occur. No other administrations should be used and the patient's condition should be evaluated in order to identify any hydroelectrolytic alterations and to minimize the risk of severe hyperphosphataemia (see sections 4.8 and 4.9). Important information about some of the excipients Due to the presence of benzalkonium chloride the product is irritating and can cause skin reactions.

Interactions

Use with caution in patients who are on 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 sodium phosphate preparations including oral solutions or sodium phosphate tablets should not be administered at the same time (see section 4.3). Since hypernatremia is associated with low lithium levels, concomitant use of Fleet Enema and lithium may cause a decrease in serum lithium levels with a decrease in efficacy.

Side effects

Fleet enema is well tolerated when used as directed. However, adverse events associated with the use of Fleet Enema have frequently been reported. In some cases, adverse events can occur, especially if the enema is used inappropriately. Within each frequency group, undesirable effects are reported in order of decreasing severity. Organized by the MedDRA Organ Classification System undesirable effects are listed below, using the following frequency: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1 / 1. 000 to <1/100), rare (≥ 1/10. 000 to <1/1. 000), very rare (<1/10. 000), not known (cannot be estimated from available data): Immune system disorders Very rare: hypersensitivity e.g. urticaria. Skin and subcutaneous tissue disorders Very rare: blisters, itching, burning. Metabolism and nutrition disorders Very rare: dehydration, hyperphosphataemia, hypocalcemia, hypokalaemia, hypernatremia, metabolic acidosis. Gastrointestinal disorders Very rare: nausea, vomiting, abdominal pain, abdominal distension, diarrhea, gastrointestinal pain, anal discomfort and proctalgia. General disorders and administration site conditions Very rare: rectal irritation, pain, burning, chills.

Pregnancy and breastfeeding

As there are no relevant data available to evaluate the potential for fetal malformation or other foetotoxic effects when administered during pregnancy Fleet enema should be used under direct medical supervision only at the time of delivery or postpartum. Since sodium phosphate can pass into breast milk, it is recommended that breast milk be expressed and discarded for at least 24 hours after administering the Fleet Enema.