Descrizione Clinica
SODIUM PHOSPHATE SELLA 16% / 6% RECTIVE DEAL
active ingredients
100 ml of solution contain: Active ingredients: monobasic phosphate sodium dihydrate 18,08 g equal to monobasic phosphate sodium monohydrate 16 g, phosphate bibasic phosphate dodecaidrate 8,03 g, equal to phosphate sodium bibasic eptahydrate 6 g. Known effect excipients: Parahydroxybenzoate (E218) propile parahydroxybenzoate (E216) For the complete list of excipients see paragraph 6.1.Excellent
Parahydroxybenzoate, propile parahydroxybenzoate, purified water.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; - acute or unknown abdominal pain; - nausea or vomiting; - obstruction, intestinal stenosis or anorettale 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.Non 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 warm, 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: 1. Remove the hood from the cannula. 2. Handle the bottle, lubricate the cannula with a few drops of solution and gently introduce the cannula into the rectum, then squeeze the bottle thoroughly until the complete release of the solution. A solution residue is expected to remain in the bottle. 3. When finished, remove the cannula by holding the bottle. Throw the product, after placing the empty bottle in its box, according to the rules of disposal of medicines 4. Stay tucked for a few minutes, possibly belly down, before sitting down. Get into the bathroom as soon as you feel the urge to evacuate, which usually manifests within 5 minutes. In any case it is not necessary to retain the solution over 10-15 minutes.Conservation
Keep the bottle closed in the original packaging to protect the medicine from light.Warnings
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 (sartans). Since Sodium Phosphate Sella contains sodium phosphates, there is the risk of high serum 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 kind. 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 facilitate the softening of stools. Important information about some excipients: Sodium phosphate Sella contains methyl parahydroxybenzoate (E218) and propile parahydroxybenzoate (E216) which can cause allergic reactions (also delayed).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 range Q.T. can be more at risk of developing this adverse reaction if treated concomitantly with phosphate sodium. Since hypernatriemia is associated with low lithium levels, simultaneous use of Sella and Lithium phosphate sodium 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. Nausea, vomit. 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
