Clisma Lax rectal solution 133ml

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

Short-term treatment of occasional constipation.

CONTRAINDICATIONS

-Hypersensitivity to the active substances or to any of the excipients listed in paragraph 6.1. - acute abdominal pain or of unknown origin - nausea or vomiting - intestinal obstruction or stenosis or anorectal stenosis - intestinal sub-occlusion - mechanical ileus - paralytic ileus - inflammatory intestinal disorders and other conditions that can increase the absorption of the medicine - anal perforation - congenital or acquired megacolon - Hirschsprung's disease - rectal bleeding of unknown origin - acute haemorrhoidal crisis with pain and bleeding - severe state of dehydration - children under the age of twelve. Phosphates are contraindicated in patients with cardiac disorders, severe renal insufficiency or in the presence of hyperphosphatemia. Other preparations with sodium phosphates, including oral solutions or sodium phosphate tablets, should not be administered simultaneously (see section 4.5).

WARNINGS AND PRECAUTIONS FOR USE

Pediatric population: The 133 ml bottle should not be used in children under 12 years of age. Abuse of laxatives (frequent or prolonged use or with excessive doses) can cause persistent diarrhea with consequent loss of water, mineral salts (especially potassium) and other essential nutritional factors. In more severe cases, the onset of dehydration or hypokalemia is possible which can cause cardiac or neuromuscular dysfunction, especially in case of simultaneous treatment with cardiac glycosides, diuretics or corticosteroids. Patients should be 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 (sartans), or nonsteroidal anti-inflammatory drugs (NSAIDs). Since Clisma lax contains sodium phosphates, there is a risk of elevated serum sodium and phosphate levels and decreased calcium and potassium levels, and consequently hypernatraemia, hyperphosphataemia, hypocalcaemia and hypokalaemia, which may occur with clinical signs such as tetany and renal failure. Abuse of laxatives can cause dependence (and, therefore, possible need to progressively increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony). Repeated use of laxatives can give rise to addiction or various types of damage. Prolonged use of a laxative to treat constipation is not recommended. The pharmacological treatment of constipation must be considered an adjuvant to the hygienic-dietary treatment (e.g. increase in vegetable fibers and liquids in the diet, physical activity and re-education of intestinal motility). The treatment of chronic or recurrent constipation always requires the intervention of a doctor for diagnosis, prescription of drugs and monitoring during the course of therapy. A careful evaluation by the doctor is essential when the need for the laxative derives from a sudden change in previous intestinal habits (frequency and characteristics of evacuations) that lasts for more than two weeks or when the use of the laxative fails to produce effects. Elderly people or those in poor health and patients with uncontrolled arterial hypertension, ascites, heart disease, changes in the rectal mucosa (ulcers, fissures) should consult their doctor before using the medicine. Patients should be advised to discontinue administration if resistance is encountered, as forcible administration of the enema may cause injury. In episodes of constipation, it is recommended first of all to correct eating habits by integrating the daily diet with an adequate intake of fiber and water. When using laxatives it is advisable to drink at least 6-8 glasses of water or other liquids a day to help soften the stool.

INTERACTIONS

The systemic absorption of sodium phosphate rectal solution is limited, however in some conditions it may be increased and predispose to possible interactions with other drugs. The simultaneous intake of drugs that can have effects on electrolyte balance (such as diuretics, cortisone, calcium channel blockers, lithium) can facilitate the onset of hyperphosphatemia, hypercalcemia and hypernatremia. Patients taking drugs that can prolong the QT interval may be at greater risk of developing this adverse reaction if treated concomitantly with sodium phosphate. Since hypernatremia is associated with low lithium levels, the concomitant use of Enema lax and lithium may cause a reduction in serum lithium levels, with a decrease in efficacy. Concomitant use of calcium supplements or calcium-containing antacids may increase the risk of ectopic calcification. Other preparations with sodium phosphates, including oral solutions or sodium phosphate tablets, should not be administered simultaneously (see section 4.3).

SIDE EFFECTS

Below are the side effects of sodium phosphate organized according to the MedDRA system organic classification. There is insufficient data to establish the frequency of the individual effects listed. Immune system disorders Hypersensitivity reactions (e.g. urticaria) Pathologies of the skin and subcutaneous tissue Blisters, itching, burning Gastrointestinal disorders Isolated crampy pain or abdominal colic and diarrhea, with loss of fluids and electrolytes, more frequent in cases of severe constipation, as well as rectal irritation. Nausea, vomiting. Metabolism and nutrition disorders Hyperphosphatemia, hypokalemia, hypernatremia, hypocalcemia, and tissue calcification may rarely occur. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.