MV RETT 4FL

SODIUM PHOSPHATE MARCO VITI 16% / 6% RECTIVE DEAL

active ingredients

100 ml of solution contain: active ingredients: Sodium phosphate monobasic bihydrate 18,088 g equal to sodium phosphate monobasic monohydrate 16 g Sodium phosphate bibasic dodecaidrate 8,016 g equal to phosphate bibasic eptaidrate 6 g Excipient with known effect: bronopol. For the full list of excipients see paragraph 6.1.

Excellent

Purified water, bronopol.

Therapeutic indications

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

Contraindications

– Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1; – acute or unknown abdominal pain; – nausea or vomiting; – obstruction or intestinal stenosis or ananorectal stenosis; – intestinal subocclusion; – mechanical ileo; – paralytical ileo; – inflammatory bowel disorders and other conditions that may increase the absorption of the medicinal product; – anal drilling; – congenital or acquired megacolons; – Hirschsprung disease; – rectal bleeding of unknown origin; – acute hemorrhoid crisis with pain and bleeding; – severe dehydration; – children under 12 years of age. Phosphates are contraindicated in patients with heart disorders, severe kidney failure or in the presence of hyperphosphateemia. Other preparations with sodium phosphates should not be administered simultaneously, including oral solutions or sodium phosphates (see paragraph 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 should be used for one administration; any remaining medicinal product must be eliminated. The administration can be performed at room temperature. If preferred lukewarm, just put the bottle in contact with hot water (for dive or under the tap). For a better effect, it is advisable to perform the administration in a coricated position on the left flank. For greater cleaning action, take the genupettoral position for a few minutes, immediately after administration. Instructions for use Before using the product push the cover down to the break of the safety seal of the bottle. 1. Remove the protective cap from the rectal cannula. 2. Handle the bottle and gently introduce the cannula into the rectum, then squeeze the bottle thoroughly. A solution residue is expected to remain in the bottle. 3. When finished administration, extract the cannula and throw the empty bottle in its same box according to the rules of elimination of medicines. 4. Remain coricated until urgent need to evacuate, which usually manifests within 5 minutes. In any case it is not necessary to hold the enema over 10–15 minutes.

Conservation

Keep this medicine closed in the original packaging to protect it 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) can cause persistent diarrhea resulting in water loss, mineral salts (especially potassium) and other essential nutrients. In the most serious cases, dehydration or hypopotassiemia may occur, which may result in cardiac or neuromuscular dysfunctions, especially in the case of contemporary treatment with cardiac glycosides, diuretics or corticosteroids. Patients should be encouraged to drink liquids to help prevent dehydration, especially patients with conditions that may predispose to dehydration, or those taking medicines that may decrease glomerular filtration speed, such as diuretics, angiotensin conversion enzyme inhibitors (ACE inhibitors), angiotensin receptor blockers– non-steroidal inflammations). Since Sodium phosphate Marco Viti contains sodium phosphates, there is the risk of high levels of sodium and phosphate and decreased levels of calcium and potassium, and consequently hypernatriemia, hyperphosphateemia, hypocalcemia and hypopotassiemia, which can occur with clinical signs such as tetania and kidney failure. Laxative abuse can cause dependence (and, therefore, possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony). The repeated use of laxatives can give rise to addiction or damage of different types. The prolonged use of a laxative for the treatment of stypsis is not recommended. The pharmacological treatment of stypsis must be considered an adjuvant to hygienic–diethetic treatment (e.g. increased plant fibers and liquids in feeding, physical activity and re-education of intestinal motility). Treatment of chronic or recurring constipation always requires medical intervention for diagnosis, prescription of drugs and surveillance during therapy. A careful evaluation of the doctor is indispensable when the need for laxative comes from a sudden change of previous intestinal habits (frequency and characteristics of evacuations) that lasts for more than two weeks or when the use of laxative fails to produce effects. It is appropriate that elderly or in poor health conditions and patients with uncontrolled arterial hypertension, ascites, heart diseases, changes of the rectal mucosa (ulcere, cracks), consult the doctor before using the medicine. Patients should be advised to stop administration if they encounter resistance, as forced enema administration may cause injury. In episodes of constipation, it is recommended first of all to correct food habits by integrating the daily diet with an adequate supply of fiber and water. When using laxatives it is appropriate to drink at least 6–8 glasses of water per day, or other liquids, so as to encourage the softening of feces. 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 phosphate sodium rectal solution is limited; however in some conditions it may be increased and predispose to possible interactions with other drugs. The contemporary intake of drugs that can have effects on electrolytic balance (such as diuretics, cortisonics, calcium–antagonists, lithium) can facilitate the occurrence of hyperphosphateemia, hypercalcemia and hypernatriemia. Patients taking medications that can prolong the QT range can be more at risk of developing this adverse reaction if treated concomitantly with phosphate sodium. Since hypernatriemia is associated with low lithium levels, the concomitant use of Marco Viti phosphate Sodium and lithium can cause a reduction in serum lithium levels, with a decrease in effectiveness. Concurrent use of calcium or antacid supplements containing calcium can increase the risk of ectopic calcification. Other preparations with sodium phosphates should not be administered simultaneously, including oral solutions or sodium phosphates (see paragraph 4.3).

Effects

Below are the undesirable effects of phosphate sodium organized according to the MedDRA organic systemic classification. No sufficient data is available to determine the frequency of the individual effects listed. Immune system disorders Hypersensitivity reactions (e.g. hives) Pathologies of skin and subcutaneous tissue Vesicles, 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. Disorders of metabolism and nutrition Hyperphosphateemia, hypopotassiemia, hypernatriemia, 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, diarrhea). Persistent diarrhea results in water loss, mineral salts (especially potassium) and other essential nutrients. Liquid and electrolyte losses must be replaced. Electrolytic imbalances are characterized by the following symptoms: thirst, vomiting, weakening, edema, bone pain (osteomalacia) and hypoalbuminemia. In the most serious cases, dehydration or hypopotassiemia may occur, which may result in cardiac or neuromuscular dysfunctions, especially in the case of contemporary treatment with cardiac glycosides, diuretics or corticosteroids. Liquid and electrolyte losses must be replaced. Generally enough conservative measures; many liquids must be administered, especially fruit juices. See also in paragraph 4.4 about the abuse of laxatives. If a significant amount of phosphate is absorbed, hyperphosphateemia, hypocalcemia, and hypomagnesemia may occur. Alterations of hydroelectronic balance were observed following oral, rectal and intravenous exposure. Severe hyperphosphateemia and hypocalcemia can cause tetania, convulsions, bradycardia, extension of the QT range, arrhythmia, coma and cardiac arrest. There may also be severe dehydration, hypernatriemia, hypotension, metabolic acidosis and tachycardia. The elderly, children and patients with kidney failure are at greater risk of toxic effects.

No adequate and well-controlled studies have been carried out on the use of the medicinal product during pregnancy or breastfeeding. Although there are no obvious contraindications of the use of the medicinal product in pregnancy and during breastfeeding, it is recommended to take the medicine only if necessary and under medical supervision.

Source: Farmadati