CLISMALAX 1CLISMA 133ML

CLISMA LAX FLACONS

active ingredients

100 ml contain 13,91 g sodium phosphate monobasic anidro (NaH₂OPINION₄); 3,18 g of bibasic sodium phosphate (Na₂HPO₄). Excipients with known effects: benzoate sodium (100mg per 100ml) and methylparahydroxybenzoate (50mg per 100ml). For the full list of excipients, see paragraph 6.1.

Excellent

Sodium hydroxide, benzoate sodium, methylparahydroxybenzoate, purified water.

Therapeutic indications

Short-term treatment of occasional constipation.

Contraindications

-Hypersensitivity to active ingredients or any of the excipients listed in paragraph 6.1. - acute or unknown abdominal pain - nausea or vomiting - obstruction or intestinal stenosis or anorectal stenosis - intestinal sub occlusion - mechanical ileo - paralytic ileum - intestinal disorders of inflammatory type and other conditions that can increase the absorption of the medicinal product - anal perforation - megacolon congenital or acquired - Hirschsprung disease. Phosphates are contraindicated in patients with heart disorders, severe kidney failure or in the presence of hyperphosphateemia. Other preparations with sodium phosphates should not be administered simultaneously, including oral solutions or sodium phosphates (see paragraph 4.5).

Population

Population Adults and teenagers (12-18 years): the whole bottle dose. Method of administration Do not exceed the recommended doses. 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 evaluation of the individual case. Preferably in the evening.

Conservation

This medicine does not require any special condition of conservation.

Warnings

Pediatric population: The 133 ml bottle should not be used in children under 12 years of age. Laxative abuse (frequent or prolonged use or excessive doses) can cause persistent diarrhea resulting in water loss, mineral salts (especially potassium) and other essential nutrients. In the most serious cases, dehydration or hypopotassiemia may occur, which may result in cardiac or neuromuscular dysfunctions, especially in the case of contemporary treatment with cardiac glycosides, diuretics or corticosteroids. Patients should be encouraged to drink liquids to help prevent dehydration, especially patients with conditions that may predispose to dehydration, or those taking medicines that may decrease glomerular filtration speed, such as diuretics, angiotensin conversion enzyme inhibitors (ACE inhibitors), angiotensin receptor blockers (sartans). Since Clisma lax 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 hypopotassiemia, which can occur with clinical signs such as tetania and kidney failure. Laxative abuse can cause dependence (and, therefore, possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony). The repeated use of laxatives can give rise to addiction or damage of different types. The prolonged use of a laxative for the treatment of stypsis is not recommended. The pharmacological treatment of stypsis must be considered an adjuvant to hygienic-diethetic treatment (e.g. increased plant fibers and liquids in feeding, physical activity and re-education of intestinal motility). Treatment of chronic or recurring constipation always requires medical intervention for diagnosis, prescription of drugs and surveillance during therapy. A careful evaluation of the doctor is indispensable when the need for laxative comes from a sudden change of previous intestinal habits (frequency and characteristics of evacuations) that lasts for more than two weeks or when the use of laxative fails to produce effects. It is appropriate that elderly or in poor health conditions and patients with uncontrolled arterial hypertension, ascites, heart diseases, changes of the rectal mucosa (ulcere, cracks), consult the doctor before using the medicine. Patients should be advised to stop administration if they encounter resistance, as forced enema administration may cause injury. In episodes of constipation, it is recommended first of all to correct food habits by integrating the daily diet with an adequate supply of fiber and water. When using laxatives it is appropriate to drink at least 6-8 glasses of water per day, or other liquids, so as to facilitate the softening of stools.

Interactions

Systemic absorption of the phosphate solution is limited, however in some conditions it can be increased and predispose to possible interactions with other drugs. The contemporary intake of drugs that can have effects on electrolytic balance (such as diuretics, cortisonics, calcium-antagonists, lithium) can facilitate the occurrence of hyperphosphateemia, hypercalcemia and hypernatriemia. Patients taking medications that can prolong the QT range can be more at risk of developing this adverse reaction if treated concomitantly with phosphate sodium. Since hypernatriemia is associated with low lithium levels, the concomitant use of Clisma lax and lithium can cause a reduction in serum levels of lithium, with a decrease in effectiveness. Concurrent use of calcium or antacid supplements containing calcium can increase the risk of ectopic calcification. Other preparations with sodium phosphates should not be administered simultaneously, including oral solutions or sodium phosphates (see paragraph 4.3).

Effects

Below are the undesirable effects of phosphate sodium organized according to the MedDRA organic systemic classification. No sufficient data is available to determine the frequency of the individual effects listed. Immune system disorders Hypersensitivity reactions (e.g. hives) Pathologies of skin and subcutaneous tissue Vesicles, itching, burning Gastrointestinal diseases Insulated cramping pains or abdominal colic and diarrhea, with loss of liquids and electrolytes, more frequent in cases of severe constipation, as well as rectal irritation. Nausea, vomit. Disorders of metabolism and nutrition Hyperphosphateemia, hypopotassiemia, hypernatriemia, hypocalcemia and tissue calcification may rarely occur. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions occurring 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.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

The most frequently observed effect following ingestion or rectal administration is gastrointestinal irritation (abdominal pain, nausea, vomiting, diarrhea). Persistent diarrhea results in water loss, mineral salts (especially potassium) and other essential nutrients. Liquid and electrolyte losses must be replaced. Electrolytic imbalances are characterized by the following symptoms: thirst, vomiting weakening, edema, bone pain (osteomalacia) and hypoalbuminemia. In the most serious cases, dehydration or hypopotassemia may occur, which may result in cardiac or neuromuscular dysfunctions, especially in the case of a contemporary treatment with cardiac glycosides, diuretics or corticosteroids. Liquid and electrolyte losses must be replaced. Generally enough conservative measures; many liquids must be administered, especially fruit juices. See also paragraph 4.4 of the abuse of laxatives. If a significant amount of phosphate is absorbed, hyperphosphateemia, hypocalcemia, and hypomagnesemia may occur. Alterations of hydroelectronic balance were observed following oral, rectal and intravenous exposure. Severe hyperphosphateemia and hypocalcemia can cause tetania, convulsions, bradycardia, extension of the QT range, arrhythmia, coma and cardiac arrest. There may also be severe dehydration, hypernatriemia, hypotension, metabolic acidosis and tachycardia. The elderly, children and patients with kidney failure are at greater risk of toxic effects.

There are no adequate and well-controlled studies on the use of pregnant or nursing medicine. Therefore the medicinal product must be used only in case of need, under the direct control of the doctor, after evaluating the expected benefit for the mother in relation to the possible risk for the fetus or for the infant.

Source: Farmadati