Fleet Enema Ready To Use 1 Bottle 133 ml

WARNINGS
Do not use the product 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 the drug contains sodium phosphates, there is a risk of elevated serum sodium and phosphate levels and decreased calcium and potassium levels and consequently hypernatremia, hyperphosphataemia, hypocalcemia and hypokalaemia which can occur with clinical signs such as tetany and kidney failure. 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. Use with caution in: elderly or weakened patients and in patients with uncontrolled arterial hypertension, ascites, heart disease, changes in the rectal mucosa (ulcers, cracks); people with colostomy, patients who are taking diuretics or other medicines that can change fluid and electrolyte levels; people who are taking medicines known to prolong the QT interval (e.g. amiodarone, arsenic trioxide, astemizole, azithromycin, erythromycin, clarithromycin, chlorpromazine, cisapride, citalopram, domperidone, terfenadine, procainamide), or with known water and electrocalcemic imbalance, , 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 disturbances and risk of hyperphosphatemia, hydroelectrolyte levels should be monitored before and after administration. Use with caution in patients with impaired renal function, when clinical benefit is expected to outweigh the risk of hyperphosphataemia. Repeated and prolonged use is not recommended as it can cause addiction. Administering more than one enema in a 24 hour period can be harmful. It should not be used for more than a week. Administer to according to instructions for use. Patients should be advised to discontinue administration if resistance is encountered, as forced administration of the enema can cause injury. Rectal bleeding after use may indicate a serious condition. In this case the administration must be stopped immediately. In general, evacuation occurs approximately 5 minutes after administration, therefore retention times of more than 5 minutes are not recommended. In the event that evacuation does not occur after using the drug or if the retention time lasts more than 10 minutes, serious side effects may 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. Due to the presence of benzalkonium chloride, the product is irritating and can cause skin reactions.
PHARMACOTHERAPEUTIC CATEGORY
Constipation medications.
STORAGE
Store at a temperature not exceeding 25 degrees C.
CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active ingredients or to any of the excipients. Conditions that cause increased absorption capacity, decreased elimination capacity or decreased gastric motility, for example: suspected intestinal obstruction, paralytic ileus, anorectal stenosis, perforated anus, congenital or acquired megacolon, Hirschsprung's disease . Undiagnosed gastrointestinal disorders, for example, symptoms suggestive of appendicitis, intestinal perforation or active inflammatory bowel disease, 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 at the same time.
NAME
CLISMA FLEET
EXCIPIENTS
Benzalkonium chloride, disodium edetate, distilled water qs.
SIDE EFFECTS
It is well tolerated when used as directed. However, adverse events associated with the use of the medicinal product have frequently been reported. In some cases, adverse events may occur, especially if the enema is used inappropriately. Disorders of the immune system. Very rare (<1 / 10,000): hypersensitivity 'eg urticaria. Skin and subcutaneous tissue disorders. Very rare (<1 / 10,000): blisters, itching, burning. Metabolism and nutrition disorders. Very rare (<1 / 10,000): dehydration, hyperphosphataemia, hypocalcemia, hypokalaemia, hypernatremia, metabolic acidosis. Gastrointestinal disorders. Very rare (<1 / 10,000): nausea, vomiting, abdominal pain, abdominal distension, diarrhea, gastrointestinal pain, anal discomfort and proctalgia. General disorders and administration site conditions. Very rare (<1 / 10,000): rectal irritation, pain, burning, chills.
PREGNANCY AND BREASTFEEDING
As there are no relevant data available to evaluate the potential for fetal malformation or other fetotoxic effects when administered during pregnancy it 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 feeding.
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.
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. Other sodium phosphate preparations including oral solutions or sodium phosphate tablets should not be administered at the same time. Since hypernatremia is associated with low lithium levels, concomitant use with lithium may cause a decrease in serum lithium levels with a decrease in efficacy.
DOSAGE
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. Children of 3 years of age and children of 12 years: halved dose not more than once a day. The medicine is contraindicated in children younger than 3 years. 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 insufficiency: do not administer to patients with clinically significant disturbance of renal function. Use with caution in patients with abnormal renal function when the clinical benefit is expected to outweigh the risk of hyperphosphataemia. 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 all 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.
ACTIVE PRINCIPLES
Disodium hydrogen phosphate dihydrate 21.4 g / 118 ml and disodium phosphate dodecahydrate 9.4 g / 118 ml.