NEW F FL 120ML

SODIUM PHOSPHATE NEW.FA.DEM.16% + 6% RECTIVE DEAL

active ingredients

100 ml of solution contain: active ingredients: monobasic phosphate sodium 16 g; phosphate bibasic sodium eptahydrate 6 g. Can be used alternatively equivalent amounts of phosphate sodium bihydrate monobasic and sodium phosphate bibasic dodecaidrate. For the full list of excipients see paragraph 6.1.

Excellent

Metilep–sodium oxidised, purified water

Therapeutic indications

– Treatment of constipation. – Clinical conditions requiring a pre and post-operative intestinal emptiness, 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 or intestinal stenosis, – intestinal subocclusion, – mechanical ileo, – paralytic ileo, – inflammatory bowel disorders and other conditions that can increase the absorption of the drug. – rectal bleeding of unknown origin, – acute hemorrhoid crisis with pain and bleeding, – severe state of dehydration, – children under the age of twelve. Phosphates are contraindicated in patients with heart disorders, severe kidney failure or in the presence of hyperphosphateemia.

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 1. Remove the rectal cannula acclusa to the package from the protective bag. 2. Remove the screw cap and screw the rectal cannula on the bottle. 3. 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. In children the cannula should not penetrate beyond half of its length. 4. When finished administration, extract the cannula and throw the empty bottle in its same box according to the rules of elimination of medicines. 5. 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

Store in the package well closed, at a temperature not exceeding 30° C.

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. 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. You should consult your doctor before using the medicine. 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: none.

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 (diuretics, cortisonists, etc.) 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. Concurrent use of calcium or antacid supplements containing calcium can increase the risk of ectopic calcification.

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. 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, hypocalcemia, and tissue calcification may rarely occur.

Overdosing

The most frequently observed effects following ingestion or rectal administration are 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