Active ingredients

100 ml of solution contain: active ingredients : sodium phosphate monobasic monohydrate 16 g; sodium phosphate dibasic heptahydrate 6 g. Equivalent quantities of sodium phosphate monobasic dihydrate and sodium phosphate dibasic dodecahydrate can be used alternatively . For the full list of excipients, see section 6.1.

Excipients

Sodium methylepoxybenzoate, purified water

Therapeutic indications

– Treatment of constipation. – Clinical conditions requiring pre- and post-operative bowel emptying, in preparation for radiological examinations and endoscopic investigations of the lower intestinal tract.

Contraindications

– Hypersensitivity to the active substance or to any of the excipients. – acute abdominal pain or pain of unknown origin, – nausea or vomiting, – intestinal obstruction or stenosis, – intestinal sub-occlusion, – mechanical ileus, – paralytic ileus, – inflammatory intestinal disorders and other conditions that may increase the absorption of the medicinal product. – rectal bleeding of unknown origin, – acute haemorrhoidal crisis with pain and bleeding, – severe dehydration, – children under twelve years of age. Phosphates are contraindicated in patients with cardiac disorders, severe renal insufficiency or in the presence of hyperphosphatemia.

Dosage

Adults and adolescents (12 – 18 years): 1 bottle of 120 ml. Do not use more than one bottle per day. Each bottle must be used for a single administration; any residual medicine must be discarded. The administration can be carried out at room temperature. If lukewarm is preferred, simply place the bottle in contact with hot water (by immersion or under the tap). For a better effect, it is advisable to carry out the administration lying on the left side. For a greater cleansing action, assume the knee-chest position for a few minutes, immediately after administration. Instructions for use 1. Remove the rectal cannula included in the package from the protective sachet. 2. Remove the screw cap and screw the rectal cannula onto the bottle. 3. Hold the bottle and gently insert the cannula into the rectum, then squeeze the bottle thoroughly. It is expected that some solution residue will remain in the bottle. In children, the cannula should not penetrate more than half its length. 4. Once administration is complete, remove the cannula and throw the empty bottle into its own box according to the rules for disposing of medicines. 5. Remain lying down until an urgent need to evacuate occurs, which usually occurs within 5 minutes. In any case, it is not necessary to retain the enema for more than 10–15 minutes.

Warnings and precautions

The 120 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 with consequent loss of water, mineral salts (especially potassium) and other essential nutrients. In more serious cases, dehydration or hypokalemia may occur, which can lead to cardiac or neuromuscular dysfunction, especially in the case of simultaneous treatment with cardiac glycosides, diuretics or corticosteroids. Laxative abuse can cause dependence (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 types. Prolonged use of a laxative to treat constipation is not recommended. Pharmacological treatment of constipation should be considered an adjuvant to hygienic-dietetic treatment (e.g. increased vegetable fiber and liquids in the diet, physical activity and re-education of intestinal motility). Treatment of chronic or recurrent constipation always requires medical intervention for diagnosis, prescription of drugs and monitoring during therapy. Careful evaluation by the doctor is essential when the need for a laxative arises 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 a laxative fails to produce effects. It is advisable for elderly or unhealthy subjects to consult their doctor before using the medicine. 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 per day, in order to help soften the stool. Important information about some of the excipients: none.

Interactions

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. Concomitant use of drugs that can affect electrolyte balance (diuretics, corticosteroids, etc.) may 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. Concomitant use of calcium supplements or calcium-containing antacids may increase the risk of ectopic calcification.

Side effects

The following are the adverse reactions of sodium phosphate organized according to the MedDRA system organ classification. There are insufficient data to establish the frequency of the individual effects listed. Gastrointestinal disorders Isolated cramping pain or abdominal colic and diarrhoea, with loss of fluids and electrolytes, more frequent in cases of severe constipation, as well as irritation at the rectal level. Metabolism and nutrition disorders Hyperphosphatemia, hypocalcemia and tissue calcification may rarely occur.

Pregnancy and breastfeeding

There have been no adequate and well-controlled studies on the use of the medicine during pregnancy or breastfeeding. Although there are no obvious contraindications to the use of the medicine during pregnancy and breastfeeding, it is recommended to take the medicine only when necessary and under medical supervision.