CLISMALAX * 1 ENCLISM 133ML

CLISMALAX * 1 ENCLISM 133ML

Therapeutic indications

Short-term treatment of occasional constipation.

Dosage and method of use

DosageAdults and adolescents (12-18 years): the full dose of the bottle.Method of administrationDo not exceed the recommended dose. Laxatives should be used as infrequently as possible and for no more than seven days. Use for longer periods of time requires a doctor's prescription after adequate evaluation of the individual case. Take preferably in the evening.

Contraindications

- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. - acute abdominal pain or of unknown origin - nausea or vomiting - intestinal obstruction or stricture or anorectal stenosis - sub intestinal obstruction - mechanical ileus - paralytic ileus - inflammatory intestinal disorders and other conditions that may increase the absorption of the drug - anal perforation - congenital or acquired megacolon - Hirschsprung's disease - rectal bleeding of unknown origin - acute haemorrhoidal crisis with pain and bleeding - severe dehydration - children under the age of twelve. Phosphates are contraindicated in patients with heart disease, 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 at the same time (see section 4.5).

Side effects

The following are sodium phosphate side effects organized according to the MedDRA system organ class. Insufficient data are available to establish the frequency of the individual effects listed.Disorders of the immune systemHypersensitivity reactions (e.g. hives)Skin and subcutaneous tissue disordersBlisters, itching, burningGastrointestinal disordersIsolated cramping pains 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 disordersHyperphosphataemia, hypokalaemia, 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 ratio 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.

Special warnings

Pediatric population: The 133ml bottle is not for use in children under 12 years of age. The 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 severe cases, the onset of dehydration or hypokalemia is possible, which can lead to cardiac or neuromuscular dysfunctions, especially in the 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 them to dehydration, or those taking medications that can decrease glomerular filtration rate, such as diuretics, enzyme inhibitors converting angiotensin (ACE inhibitors), angiotensin receptor blockers (sartans) or non-steroidal anti-inflammatory drugs (NSAIDs). Since Enema lax 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 may occur with clinical signs such as tetany and kidney failure. The abuse of laxatives can cause addiction (and, therefore, the possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony). Repeated use of laxatives can give rise to addiction or damage of various kinds. Prolonged use of a laxative for the treatment of constipation is not recommended. The pharmacological treatment of constipation must be considered an adjuvant to the hygienic-dietetic treatment (eg increase of vegetable fibers and fluids in the diet, physical activity and re-education of intestinal motility). The treatment of chronic or recurrent constipation always requires the intervention of the doctor for the diagnosis, the prescription of drugs and the surveillance during the course of therapy. A careful evaluation of the doctor is essential when the need for the laxative derives from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) that has lasted for more than two weeks or when the use of the laxative fails to produce effects. It is advisable that elderly people or those in poor health and patients with uncontrolled arterial hypertension, ascites, heart disease, changes in the rectal mucosa (ulcers, cracks), consult their doctor before using the medicine. Patients should be advised to discontinue administration if resistance is encountered, as forceful administration of the enema may cause injury. In episodes of constipation, it is advisable 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 per day, in order to facilitate the softening of the stool.

Pregnancy and breastfeeding

There are no adequate and well-controlled studies on the use of the drug in pregnancy or breastfeeding. Therefore, the medicine should only be used in case of need, under the direct supervision of the doctor, after evaluating the expected benefit to the mother in relation to the possible risk to the fetus or infant.

Expiration and retention

This medicine does not require any special storage conditions.

Interactions with other drugs

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 concomitant intake of drugs that may have effects on the electrolyte balance (such as diuretics, steroids, calcium channel blockers, lithium) can facilitate the onset of hyperphosphatemia, hypercalcemia and hypernatremia. Patients taking drugs capable of prolonging the QT interval may be more at risk of developing this adverse reaction when treated concomitantly with sodium phosphate. Since hypernatremia is associated with low lithium levels, concomitant use of lax enema and lithium may cause a decrease in serum lithium levels, with decreased 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 at the same time (see section 4.3).

Overdose

The most frequently observed effect following ingestion or rectal administration is gastrointestinal irritation (abdominal pain, nausea, vomiting, diarrhea). Persistent diarrhea results in loss of water, mineral salts (especially potassium) and other essential nutritional factors. Leaks of fluids and electrolytes must be replaced. Electrolyte imbalances are characterized by the following symptoms: thirst, weakening vomiting, edema, bone pain (osteomalacia) and hypoalbuminemia. In severe cases, the onset of dehydration or hypokalaemia is possible, which can cause cardiac or neuromuscular dysfunctions, especially in the case of simultaneous treatment with cardiac glycosides, diuretics or corticosteroids. Leaks of fluids and electrolytes must be replaced. Conservative measures are generally sufficient; you should be given plenty of fluids, especially fruit juices. See also what is reported in section 4.4 about laxative abuse. Hyperphosphataemia, hypocalcemia, and hypomagnesaemia may occur if a significant amount of phosphate is absorbed. Alterations in water and electrolyte balance have been observed following oral, rectal and intravenous exposure. Severe hyperphosphataemia and hypocalcemia can cause tetany, seizures, bradycardia, QT prolongation, arrhythmia, coma and cardiac arrest. Severe dehydration, hypernatremia, hypotension, metabolic acidosis and tachycardia can also occur. The elderly, children and patients with renal insufficiency are at increased risk of toxic effects.

Active principles

100 ml contain 13.91 g of anhydrous monobasic sodium phosphate (NaH₂BIT₄); 3.18 g dibasic sodium phosphate (Na₂HPO₄). Excipients with known effects: sodium benzoate (100mg per 100ml) and methyl parahydroxybenzoate (50mg per 100ml). For the full list of excipients, see section 6.1.

Excipients

Sodium hydroxide, sodium benzoate, methyl parahydroxybenzoate, purified water.