ZETALAX PHOSPHATE ENEMATIC*133ML
Short-term treatment of occasional constipation. The product is also indicated before radiological or rectoscopic examinations.
Dosage and method of use
Adults and children over 12 years:The entire dose contained in the bottle (133 ml). In stubborn cases and for particular clinical-diagnostic needs: two bottles instilled consecutively.Before radiological or rectoscopic examinations: 1 enema the evening before and another in the morning of the day of the exam.Children over 2 years:Half a bottle or as directed by the doctor (see section 4.4). DO NOT EXCEED THE RECOMMENDED DOSES. Take preferably in the evening. Laxatives should be used as infrequently as possible and for no longer than seven days. Use for longer periods of time requires a doctor's prescription after adequate evaluation of the individual case.
Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1. Laxatives are contraindicated in subjects with acute abdominal pain or pain of unknown origin, nausea or vomiting, intestinal obstruction or stenosis, rectal bleeding of unknown origin, severe dehydration.
Occasionally: isolated cramping pain or abdominal colic, more frequent in cases of severe constipation.Reporting of suspected adverse reactionsReporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
The enema should be performed only when necessary or when recommended by the doctor. The continuous use of laxatives can cause addiction or damage of various types. Do not use laxatives if abdominal pain, nausea and vomiting are present. If constipation is stubborn, see your doctor. After a short period of treatment without appreciable results, consult your doctor. Abuse of laxatives (frequent or prolonged use or with excessive doses) can cause persistent diarrhea resulting in loss of water, mineral salts (especially potassium) and other essential nutritional factors. In more serious cases of abuse, the onset of dehydration or hypokalemia is possible, which can cause cardiac or neuromuscular dysfunction, especially in case of simultaneous treatment with cardiac glycosides, diuretics or corticosteroids. Abuse of laxatives, especially contact laxatives (stimulant laxatives), can cause dependence (and, therefore, possible need to progressively increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony).Pediatric populationIn children under 12 years of age the medicine can only be used after consulting a doctor. The treatment of chronic or recurrent constipation always requires the intervention of a doctor for diagnosis, prescription of drugs and monitoring during the course of therapy. Consult your doctor when the need for the laxative derives from a sudden change in previous intestinal habits (frequency and characteristics of bowel movements) that lasts for more than two weeks or when the use of the laxative fails to produce effects. It is also advisable for elderly people or those in poor health to consult their doctor before using the medicine. Prolonged use can induce a state of dehydration. The product should therefore only be used occasionally.Important information about some excipients ZETALAX phosphate enema contains: –methyl para-hydroxybeonzatewhich can cause allergic reactions (even delayed); –sodium benzoatewhich may be mildly irritating to the skin, eyes and mucous membranes.
Pregnancy and breastfeeding
There are no adequate and well-controlled studies on the use of the medicine during pregnancy or breastfeeding. Therefore the medicine must be used only if necessary, under the direct supervision of the doctor, after having evaluated the expected benefit for the mother in relation to the possible risk for the fetus or infant.
Expiration and conservation
This medicine does not require any special storage conditions.
Interactions with other drugs
No interactions with other medications or of any other nature have been reported.
Excessive doses can cause abdominal pain and diarrhea; the resulting losses of fluids and electrolytes must be replaced. See also what is reported in paragraph 4.4 – «Special warnings and precautions for use» regarding the abuse of laxatives.
100 ml of solution contains: active ingredients: monosodium phosphate monohydrate 16 g; disodium phosphate heptahydrate 6 g. Excipients with known effect: methyl para-hydroxybenzoate and sodium benzoate. For full list of excipients, see section 6.1.
Methyl para-hydroxybenzoate, sodium benzoate and purified water.