FLEET ENEMA READY TO USE 4FLAC

CLISMA FLEET 21,4 G/9,4 G RECOVERNMENT

active ingredients

Each dose of 118 ml contains the equivalent of 21,4 g (18.1% p/v) of hydrogen phosphate dihydrate and 9.4 g (8.0% p/v) of hydrogen phosphate dodecahydrate. Contains 4,4 g sodium for 118 ml dose delivered. This medicine contains 0.0006 g/ml of benzalconio chloride. For the full list of excipients, see paragraph 6.1.

Excellent

Benzalconio chloride Denorated distilled water q.s.

Therapeutic indications

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

Contraindications

Clisma Fleet is contraindicated in patients with: • Hypersensitivity to active ingredients or any of the excipients listed in the paragraph 6.1. • Conditions that cause an increase in absorption capacity, a decrease in elimination capacity or a decrease in gastric motility, for example: or suspected intestinal obstruction or paralytic ileo or anorettale stenosis or perforated anus or congenital megacolon or acquired or Hirschsprung disease. • Undiagnosed gastrointestinal pathologies, for example: or indicative symptoms of appendicitis, intestinal perforation or active intestinal inflammatory disease or undiagnosed rectal bleeding. • Congestive heart failure. • Dehydration. • Children under 3 years of age. • clinically significant kidney failure. Other preparations with sodium phosphates should not be administered simultaneously, including oral solutions or sodium phosphates (see paragraph 4.5).

Population

Population Adults and children over the age of 12: 1 bottle (118 ml dose delivered) no more than once a day or according to instructions of the doctor (see paragraph 4.4). Children between 3 and 12 years: Dose halved no more than once a day or according to medical instructions (see paragraphs 4.4 and 4.9). Clisma Fleet is contraindicated in children under the age of 3 (see paragraph 4.3). Laxatives must be used as frequently as possible and for no more than seven days. Use for longer periods of time requires the doctor’s prescription after adequate assessment of the case. Renal insufficiency: Do not administer patients with clinically significant impairment of kidney function (see paragraph 4.3). The product must be used with caution in patients with compromised kidney function, when the clinical benefit is expected to exceed the risk of hyperphosphateemia (see paragraph 4.4). Method of administration For only rectal use: Shake on the left side with both knees bent, arms resting. Remove the orange protector cap. With constant pressure, gently insert the Comfortip of the enema in the anus with the reed to the navel. Press the bottle until almost all the liquid is out. Stop use if you encounter resistance. Force the enema may cause injuries. It takes 2 to 5 minutes to achieve the desired effect. For occasional constipation, rectal enemaries are used to provide relief and only short-term.

Conservation

Do not store at temperature above 25°C.

Warnings

Do not use Clisma Fleet in case of nausea, vomiting or pain. Patients should be advised to expect liquid feces and should be encouraged to drink liquids to help prevent dehydration, particularly patients with conditions that may predispose to dehydration or those taking medicines that may decrease the rate of glomerular filtration, such as diuretics, angiotensin conversion enzyme inhibitors (ACE inhibitors), non-inflammatory steroid receptor blockers). Since Clisma Fleet contains sodium phosphates, there is the risk of high levels of sodium and phosphate and decreased levels of calcium and potassium and consequently hypernatriemia, hyperphosphateemia, hypocalcemia and hypokaliemia that can occur with clinical signs such as tetania and kidney failure. Hydroelectrolytic changes are of particular interest in children with megacolons or any other condition in which you have retention of the enema solution, and in patients with co-morbidity. This is why Clisma Fleet should be used with caution in: • elderly or weakened patients and in patients with uncontrolled arterial hypertension, ascites, heart diseases, kidney mucosa changes (ulcere, cracks); • subjects with choleostomy, patients who are taking diuretics or other medicines that may change hydroelectrolytic levels; • subjects that are taking known medicines to prolong the QT range (e.g. amiodarone, arsenic trioxide, astemizole, azithromycin, erythromycin, clarithromycin, chlorromazine, cisapride, citalopram, domperidone, terphenadine, procainamide), or with known hydroelectrophilic imbalance, such as hypochlorochocymiaemia. Use with caution also in patients taking medications known to affect perfusion, kidney function, or hydration status. Where suspects of hydroelectrolysis disorders and the risk of hyperphosphateemia, hydroelectrolyte levels must be monitored before and after administration of Clisma Fleet. The product must be used with caution in patients with compromised kidney function, when the clinical benefit is expected to exceed the risk of hyperphosphateemia. The repeated and prolonged use of Clisma Fleet is not recommended as it can cause addiction. The administration of more than one enema in a period of 24 hours may be harmful. Clisma 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 stop administration if resistance occurs, as forced enema administration may cause injury. The rectal bleeding after the use of Clisma Fleet can indicate a serious condition. In this case the administration must be stopped immediately. In general, evacuation occurs about 5 minutes after administration of Clisma Fleet, so retention times of more than 5 minutes are not recommended. If you do not experience evacuation after using Clisma Fleet or if retention time lasts more than 10 minutes, you may experience serious side effects. You should not resort to other administrations and the condition of the patient must be evaluated in order to detect any hydroelectrolytic alterations and to minimize the risk of severe hyperphosphateemia (see paragraphs 4.8 and 4.9). Important information about some excipients For the presence of benzalconio chloride the product is irritating and can cause local skin reactions.

Interactions

Carefully use in patients who are in therapy with calcium–antagonists, diuretics, lithium or other medicines that may affect hydroelectrolytic levels as hyperphosphateemia, hypocalcemia, hypokaliemia, acidosis and hypernatriemic dehydration (see paragraph 4.4). Other preparations must not be administered simultaneously with sodium phosphates including oral solutions or sodium phosphates (see paragraph 4.3). Since hypernatriemia is associated with low lithium levels, the concomitant use of Clisma Fleet and lithium can cause a reduction in serum lithium levels with a decrease in effectiveness.

Effects

Clisma Fleet is well tolerated if used as indicated. However, adverse events associated with the use of Clisma Fleet have frequently been reported. In some cases, adverse events may occur, especially if the enema is used inappropriately. Within each frequency group, unwanted effects are reported in decreasing order of gravity. The side effects are listed below, according to the classification for systems and organs according to MedDRA and using the following frequency: very common (≥ 1/10), common (≥ 1/100, immune system disorders: Very rare: hypersensitivity for example hives. Pathologies of skin and subcutaneous tissue: Very rare: vesicles, itching, burning. Disorders of metabolism and nutrition: Very rare: dehydration, hyperphosphateemia, hypocalcemia, hypokaliemia, hypernatriemia, metabolic acidosis. Gastrointestinal diseases: Very rare: nausea, vomiting, abdominal pain, abdominal distension, diarrhea, gastrointestinal pain, anal discomfort and proctalgia. Systemic pathologies and conditions for administration: Very rare: rectal irritation, pain, burning, shivers. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address www.agenziafarmaco.gov.it/it/responsabili.

Overdosing

Fatal cases were reported after administration of excessive doses, after retention, in case of administration to patients in pediatric age or in obstructed patients. In case of overdose or retention, hyperphosphateemia, hypocalcemia, hypernatriemia, hyperphosphateemia, hypernatriemic dehydration, hypokaliemia, hypovolemia, acidosis and tetania may occur. Recovery from toxic effects can normally be obtained by rehydration. Treatment of electrolytic imbalances may require immediate medical intervention by the administration of adequate electrolytes and fluid therapy.

Since there are no relevant data available to evaluate the potential of fetus malformation or other fetotoxic effects when administered during pregnancy, Clisma Fleet must be used under direct medical control only at the time of childbirth or postpartum. Since sodium phosphate can pass into breast milk, it is recommended that breast milk be extracted and discarded for at least 24 hours after administering Clisma Fleet.

Source: Farmadati