Clisma fleet - against the occasional constipation bottle 133 ml

Product Description

Laxative for the treatment of occasional constipation in adults and children.

Indications

Fleet Enema is a rectal solution (enema) with laxative action indicated in case of occasional constipation that acts in 2-5 minutes.
Indicated for the short-term treatment of occasional constipation in adults and children over 3 years of age.
It is also used for pre- and post-operative intestinal emptying, for preparation for radioscopic examinations and endoscopic investigations of the upper intestinal tract and in obstetrics.

Ingredients

Active ingredients
Each 118 ml dose contains the equivalent of 21.4 g (18.1% w/v) disodium hydrogen phosphate dihydrate and 9.4 g (18.1% w/v) disodium hydrogen phosphate dihydrate and 9.4 g (18.1% w/v) disodium hydrogen phosphate dihydrate. g (8.0% w/v) disodium phosphate dodecahydrate.
Contains 4.4 g of sodium per 118 ml delivered dose.

Excipients
Benzalkonium chloride Disodium edetate Distilled water q.s.

Directions for use and Dosage

Adults and children over 12 years: 1 bottle (118 ml delivered dose) no more than once a day or as directed by your doctor.
Children aged 3 years and under 12 years: Half the dose no more than once a day or as directed by your doctor. once a day or as directed by your doctor.
Fleet enema is contraindicated in children under 3 years of age.
In occasional constipation, laxatives should be used as infrequently as possible and for no more than 1 hour. 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 renal function impairment.
The product should be used with caution in patients with abnormal renal function when the clinical benefit is expected to outweigh the risk of hyperphosphatemia.
Method of administration
For rectal use only:

• Lie on the left side with both knees bent, arms at rest.
• Remove the orange protective shield.
• Using constant pressure, gently insert Comfortip enema into the anus with the cannula pointing towards the navel.
• Squeeze the bottle until it clicks into place. the liquid is almost all expelled.

Discontinue use if resistance is encountered.
Forcing the enema may cause sores.
2 to 5 minutes are sufficient to achieve the desired effect.
For occasional constipation, rectal enemas are used to provide relief and only for the short term.

Warnings

Do not use Fleet Enema if you experience nausea, vomiting, or pain.
Patients should be advised to expect loose stools and 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 (ARBs), or nonsteroidal anti-inflammatory drugs (NSAIDs).
Since Fleet Enema 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 the enema solution, and in patients with co-morbidities.
This is why Fleet Enema should be used with caution in:

• Elderly or debilitated patients and in patients with uncontrolled arterial hypertension, ascites, cardiac disease, changes in the rectal mucosa (ulcers, fissures),
• Subjects with a colostomy, patients taking diuretics or other medicinal products that may alter fluid and electrolyte levels,
• Subjects taking medicinal products known to prolong the QT interval (e.g. 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 fluid and electrolyte disorders are suspected, risk of hyperphosphatemia, fluid and electrolyte levels must 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 hyperphosphatemia.
Repeated and prolonged use of Fleet Enema is not recommended as it may cause habituation.
Administration of multiple doses may cause increased risk of hyperphosphatemia. of an enema in a 24-hour period may be harmful.
Fleet Enema should not be used for more than one week. Fleet Enema should be administered according to the instructions for use.
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, administration should be discontinued immediately.
In general, bowel movements occur approximately 5 minutes after administration of Fleet Enema, therefore, retention times longer than 5 minutes are not recommended.
If bowel movements do not occur after using Fleet Enema or if the retention time is longer than 5 minutes, the patient should be advised to discontinue administration. If the drug is administered within 10 minutes, serious adverse effects may occur.
No further administration should be performed and the patient's condition should be evaluated to identify any hydroelectrolytic alterations and to minimize the risk of severe hyperphosphatemia.
Important information about some excipients
Due to the presence of benzalkonium chloride, the product is irritating and may cause allergic reactions. cause skin reactions.

Contraindications

Fleet enema is contraindicated in patients with:

• Hypersensitivity to the active substances or to any of the excipients.
• Conditions causing an increase in the capacity for absorption, a decrease in the capacity for elimination 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, for example:
  
  • symptoms suggestive of appendicitis, intestinal perforation or intestinal disease active inflammatory bowel disease;
  • undiagnosed rectal bleeding.
• Congestive heart failure.
• Dehydration.
• Children under 3 years of age.
• Clinically significant renal insufficiency.
• Other preparations containing sodium phosphates, including oral solutions or sodium phosphate tablets, should not be administered concomitantly.

Interactions

Use with caution in patients receiving calcium channel blockers, diuretics, lithium or other medicinal products that may affect fluid and electrolyte levels as hyperphosphatemia, hypocalcemia, hypokalemia, acidosis and hypernatremic dehydration may occur.
Other preparations containing sodium phosphates, including oral solutions or sodium phosphate tablets, should not be administered concomitantly. sodium.
Since hypernatremia is associated with low lithium levels, the concomitant use of Fleet Enema and lithium may cause a reduction in serum lithium levels with a decrease in efficacy.

Undesirable effects

Fleet enema is well tolerated when used as directed.
However, adverse events associated with the use of Fleet enema have been reported frequently.
In some cases, adverse events may occur, especially if the enema is used inappropriately.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Organized by the MedDRA System Organ Class, adverse reactions 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 ... 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.
Skin and subcutaneous tissue disorders
Very rare: blister, pruritus, 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.
General disorders and administration site conditions
Very rare: irritation rectal irritation, pain, burning, chills.

Overdose

Fatal cases have been reported after administration of excessive doses, after retention, when administered to pediatric patients or in obstructed patients.
In case of overdose or retention, hyperphosphatemia, hypocalcemia, hypernatremia, hypernatremic dehydration, hypokalemia, hypovolemia, acidosis and tetany may occur.
Recovery from toxic effects can usually be achieved by rehydration.
Treatment of electrolyte imbalances may require immediate medical intervention with the administration of adequate electrolytes and fluid therapy.

Pregnancy and Breastfeeding

Since the use of this medicine is contraindicated, the following symptoms may occur: There are no relevant data available to evaluate the potential for fetal malformation or other fetotoxic effects when administered during pregnancy. Fleet Enema should be used under the direct supervision of a physician 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 Fleet Enema.

Storage

Store at a temperature not exceeding 25°C.

Format

133 ml single-dose bottle