SODIUM PHOSPHATE MV RETT 120ML

SODIUM PHOSPHATE MARCO VITI 16% / 6% RECTAL SOLUTION

active ingredients

100 ml of solution contain: active ingredients: Sodium phosphate monobasic dihydrate 18.088 g equivalent to sodium phosphate monobasic monohydrate 16 g Sodium phosphate dibasic dodecahydrate 8.016 g equivalent to sodium phosphate dibasic heptahydrate 6 g Excipient with known effect: bronopol.For the full list of excipients, see section 6.1.

Excellent

Purified water, bronopol.

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 listed in section 6.1;– acute or unknown abdominal pain; – nausea or vomiting;– intestinal obstruction or stenosis or anorectal stenosis;– intestinal sub-occlusion;– mechanical ileus;– paralytic ileus;– inflammatory intestinal disorders and other conditions that may increase the absorption of the medicinal product;– 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 12 years of age.Phosphates are contraindicated in patients with cardiac disorders, severe renal insufficiency or in the presence of hyperphosphatemia.Other preparations containing sodium phosphates, including oral solutions or tablets of sodium phosphates, should not be administered concomitantly (see section 4.5).

Population

Adults and teenagers (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 in a lying position on the left side.For a greater cleansing action, assume the knee-chest position for a few minutes, immediately after the administration. Instructions for use Before using the product, push the cannula cover down until the safety seal on the bottle breaks.1. Remove the protective cap from the rectal cannula.2. 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.3. Once administration is complete, remove the cannula and throw the empty bottle into its box according to the rules for disposing of medicines.4. Remain lying down until you urgently need to evacuate, which usually occurs within 5 minutes.In any case, it is not necessary to retain the enema for more than 10–15 minutes.

Conservation

Keep this medicine tightly closed in the original package in order to protect from light.

Warnings

Pediatric population The 120 ml bottle should not be used in children under 12 years of age.Laxative abuse (frequent or prolonged use or excessive doses) may cause persistent diarrhoea with consequent loss of water, mineral salts (especially potassium) and other essential nutrients.In more severe cases, dehydration or hypokalaemia may occur, which may lead to cardiac or neuromuscular dysfunction, especially in case of concomitant treatment with cardiac glycosides, diuretics or corticosteroids.Patients should be encouraged to drink fluids to help prevent dehydration, especially 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 non-steroidal anti-inflammatory drugs (NSAIDs).Since Sodio fosfato Marco Viti contains sodium phosphates, there is a risk of high serum sodium and phosphate levels and decreased calcium and potassium levels, and consequently hypernatremia, hyperphosphatemia, hypocalcemia and hypokalemia, which may occur with clinical signs such as tetany and renal failure.Laxative abuse may cause dependence (and, therefore, possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony).Repeated use of laxatives may give rise to addiction or damage of various types.Prolonged use of a laxative for the treatment of 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).The treatment of chronic or recurrent constipation always requires the intervention of a doctor for diagnosis, prescription of drugs and monitoring during therapy.A careful evaluation by a doctor is essential when the need for a laxative arises from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) that lasts more than two weeks or when the use of a laxative fails to produce effects.It is advisable that elderly or unhealthy subjects and patients with uncontrolled arterial hypertension, ascites, heart disease, changes in the rectal mucosa (ulcers, fissures), consult their doctor before using the medicine.Patients should be advised to stop administration if resistance is encountered, since the forced administration of the enema can cause lesions.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. Important information about some excipients Sodium phosphate Marco Viti 16% / 6% rectal solution contains: – bronopol which can cause local skin reactions (e.g. contact dermatitis).

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 (such as diuretics, corticosteroids, calcium antagonists, lithium) 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.Since hypernatremia is associated with low lithium levels, concomitant use of Sodium phosphate Marco Viti 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 containing sodium phosphates, including oral solutions or sodium phosphate tablets, should not be administered concomitantly (see section 4.3).

Effects

The following are adverse reactions of sodium phosphate organized according to the MedDRA system organ classification.There are insufficient data to determine the frequency of the individual effects listed. Immune system disorders Hypersensitivity reactions (e.g. urticaria) Pathologies of skin and subcutaneous tissue Blisters, 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. Metabolism and nutrition disorders Hyperphosphatemia, hypokalemia, hypernatremia, hypocalcemia and tissue calcification may rarely occur. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur 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.agenziafarmaco.gov.it/it/responsabili.

Overdosing

The most frequently observed effect following ingestion or rectal administration is gastrointestinal irritation (abdominal pain, nausea, vomiting, diarrhoea).Persistent diarrhoea results in loss of water, mineral salts (especially potassium) and other essential nutrients.Fluid and electrolyte losses must be replaced.Electrolyte imbalances are characterised by the following symptoms: thirst, vomiting, weakness, edema, bone pain (osteomalacia) and hypoalbuminemia.In more severe cases, dehydration or hypokalaemia may occur, which may lead to cardiac or neuromuscular dysfunction, especially in the case of concomitant treatment with cardiac glycosides, diuretics or corticosteroids.Fluid and electrolyte losses must be replaced.Conservative measures are generally sufficient;plenty of fluids should be administered, especially fruit juices.See also section 4.4 regarding laxative abuse.If a significant amount of phosphate is absorbed, hyperphosphatemia, hypocalcemia, and hypomagnesemia may occur.Alterations in fluid and electrolyte balance have been observed following oral, rectal, and intravenous exposure.Severe hyperphosphatemia and hypocalcemia may cause tetany, convulsions, bradycardia, QT prolongation, arrhythmia, coma, and cardiac arrest.Severe dehydration, hypernatremia, hypotension, metabolic acidosis, and tachycardia may also occur.The elderly, children, and patients with renal insufficiency are at increased risk of toxic effects.

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.

Source: Farmadati