Sodium Phosphate Nova Argentia Adults 16%-6% Rectal Solution 120 ml

Therapeutic indications

- Treatment of constipation. - Clinical conditions that require pre and post-operative intestinal emptying, in preparation for radiological examinations and endoscopic investigations of the last intestinal tract.

Dosage

Adults and adolescents (12 - 18 years): 1 bottle of 120 ml. Do not use more than one bottle per day. Each bottle is to be used for one administration only; any remaining medicine must be discarded. Administration can be practiced at room temperature. If you prefer lukewarm, just put the bottle in contact with hot water (by immersion or under the tap). For a better effect it is advisable to practice the administration in a lying position on the left side. For a greater cleaning action, assume the genupectoral position for a few minutes, immediately after administration. Instructions for use 1. Warm the enema by immersing it in warm water for about five minutes. 2. Break the seal and screw the cannula on. 3. Grasp the bottle and gently introduce the cannula into the rectum, then squeeze the bottle thoroughly. A residue of solution is expected to remain in the bottle. In children, the cannula should not penetrate more than half of its length. 4. At the end of the administration, remove the container keeping it pressed and discard the empty bottle in its own box according to the rules of disposal of medicines. 5. Remain lying down until urgent need to evacuate, usually within 5 minutes. In any case it is not necessary to withhold the enema beyond 10-15 minutes.

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. Leaking fluids and electrolytes must be replaced. Electrolyte imbalances are characterized by the following symptoms: thirst, vomiting, weakness, edema, bone pain (osteomalacia) and hypoalbuminemia. In the most severe cases, dehydration or hypokalaemia may develop, which can lead to cardiac or neuromuscular dysfunctions, especially in the case of simultaneous treatment with cardiac glycosides, diuretics or corticosteroids. Leaking 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.

Contraindications

- Hypersensitivity to the active substance or to any of the excipients, - acute abdominal pain or 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 medicine, - rectal bleeding of unknown origin, - acute haemorrhoidal crisis with pain and bleeding, - severe dehydration, - children under 12 years of age. Phosphates are contraindicated in patients with heart disease, severe renal insufficiency or in the presence of hyperphosphatemia.

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. Gastrointestinal disorders Isolated 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. Metabolism and nutrition disorders Hyperphosphataemia, hypocalcaemia and calcification of the tissues 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 in case of need and under medical supervision.

Special warnings

The 120 ml 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 the most severe cases, dehydration or hypokalaemia may develop, which can lead to cardiac or neuromuscular dysfunctions, especially in the case of simultaneous treatment with cardiac glycosides, diuretics or corticosteroids. 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 by 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 lasted for more than two weeks or when the use of the laxative fails to produce effects. Elderly subjects or those in poor health conditions should consult their doctor before using the medicine.In episodes of constipation, it is advisable first of all to correct their 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 to help soften the stool. Important information about some of the excipients : the medicinal product contains methyl p-hydroxybenzoate and propyl p-hydroxybenzoate which may cause allergic reactions, even if delayed.

Expiry and Retention

Store in ordinary environmental conditions.

Active principles

100 ml of solution contain: Active ingredients: monobasic sodium phosphate monohydrate 16 g; dibasic sodium phosphate heptahydrate 6 g. For the full list of excipients see section 6.1.

Excipients

Excipients: purified water, methyl p – hydroxybenzoate, propyl – p hydroxybenzoate.