ZETALAX CLISMA PHOSPHATE * 133ML

ZETALAX CLISMA PHOSPHATE * 133ML

Therapeutic indications

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 night before and another in the morning of the exam day.Children over 2 years:Half bottle or as advised by the physician (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 more than seven days. Use for longer periods of time requires a doctor's prescription after adequate evaluation of the individual case.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Laxatives are contraindicated in subjects with acute abdominal pain or of unknown origin, nausea or vomiting, intestinal obstruction or stenosis, rectal bleeding of unknown origin, severe dehydration.

Side effects

Occasionally: cramping pains form isolated or abdominal colic, more frequent in cases of severe constipation.Reporting of suspected adverse reactionsReporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. 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.

Special warnings

The enema should be practiced only when necessary or when advised by the doctor. The continued use of laxatives can cause addiction or damage of various kinds. 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 noticeable results, consult your doctor. The abuse of laxatives (frequent or prolonged use or with excessive doses) can cause persistent diarrhea with consequent loss of water, mineral salts (especially potassium) and other essential nutritional factors. In the most severe cases of abuse, dehydration or hypokalaemia may develop, which can lead to cardiac or neuromuscular dysfunction, especially in the case of simultaneous treatment with cardiac glycosides, diuretics or corticosteroids. The abuse of laxatives, especially contact laxatives (stimulant laxatives), can cause addiction (and, therefore, the possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony).Pediatric populationIn children under the age of 12, the medicine can only be used after consulting your doctor. The treatment of chronic or recurrent constipation always requires the intervention of the doctor for diagnosis, prescription of drugs and surveillance during the course of therapy. Consult your doctor when the need for the laxative derives from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) that has lasted for more than two weeks or when the use of the laxative fails to produce effects. It is also advisable that elderly people or those in poor health conditions consult their doctor before using the medicine. Prolonged use can induce a state of dehydration. The product should therefore be used only in occasional administrations.Important information about some of the ingredients ZETALAX enema contains phosphate: -methyl para-hydroxybeonzatewhich can cause allergic reactions (even delayed); -sodium benzoatewhich can 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 drug in pregnancy or breastfeeding. Therefore, the medicine should only be used in case of need, under the direct supervision of the doctor, after evaluating the expected benefit to the mother in relation to the possible risk to the fetus or infant.

Expiry and retention

This medicine does not require any special storage conditions.

Interactions with other drugs

No interactions with other medicaments or other types have been reported.

Overdose

Excessive doses can cause abdominal pain and diarrhea; consequent losses of fluids and electrolytes must be replaced. See also what is reported in section 4.4 - «Special warnings and precautions for use» regarding the abuse of laxatives.

Active principles

100 ml of solution contain: active ingredients: monosodium phosphate monohydrate 16 g; disodium phosphate heptahydrate 6 g. Excipients with known effect: methyl para-hydroxybenzoate and sodium benzoate. For a full list of excipients, see section 6.1.

Excipients

Methyl para-hydroxybenzoate, sodium benzoate and purified water.