ZETALAX FOSFATE CLIS 133ML

ZETALAX ENZYME PHOSPHATE

active ingredients

100 ml of solution contain: active ingredients: monosodium phosphate monohydrate 16 g; phosphate bisodic eptahydrate 6 g. Excipients with known effect: methyl para–hydroxybenzoate and benzoate sodium. For full list of excipients, see paragraph 6.1.

Excellent

Para-hydroxybenzoate, benzoate sodium and purified water.

Therapeutic indications

Short-term treatment of occasional constipation. The product is also indicated before radiological or rectographic examinations.

Contraindications

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

Population

Adults and children over 12 years: The whole dose contained in the bottle (133 ml). In stubborn cases and for particular clinical–diagnostic needs: two consecutively instilled bottles. Before radiological or rectographic examinations: 1 enema in the previous evening and another in the morning of the exam. Children over 2 years: Half bottle or according to the doctor's opinion (see paragraph 4.4). Do not overtake the dosing preferably in the evening. Laxatives must be used as frequently as possible and for no more than seven days. Use for longer periods of time requires the doctor’s prescription after adequate evaluation of the individual case.

Conservation

This medicine does not require any special condition of conservation.

Warnings

The clisma should be practiced only when it is necessary or when advised by the doctor. Continuous use of laxatives can result in a different type of addiction or damage. Do not use laxatives if there are abdominal pain, nausea and vomiting. If constipation is stubborn, consult your doctor. After a short period of treatment without appreciable results, consult your doctor. 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 severe cases of abuse, dehydration or hypopotassiemia may occur, which may result in cardiac or neuromuscular dysfunctions, especially in the case of contemporary treatment with cardiac, diuretic or corticosteroid glycosides. The abuse of laxatives, especially those of contact (stimulating laxatives), can cause dependence (and, therefore, possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atonia). Pediatric population In children under 12 years, the medicine can only be used after consulting the doctor. Treatment of chronic or recurring constipation always requires medical intervention for diagnosis, prescription of drugs and surveillance during therapy. Consult your doctor when the need for laxative comes from a sudden change of previous intestinal habits (frequency and evacuation characteristics) that lasts for more than two weeks or when the use of laxative fails to produce effects. You should also consult your doctor before using the medicine. Prolonged use can induce dehydration. The product should therefore be used only in occasional administrations. Important information about some excipients ZETALAX clisma phosphate contains: – methyl para–hydroxybeonza which can cause allergic reaction (also delayed); – sodium benzoate which can be slightly irritating to the skin, eyes and mucosa.

Interactions

Interactions with other medicines or other types have not been reported.

Effects

Occasionally: pains in isolated formes or abdominal colic, more frequent in cases of severe constipation. 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. Reporting the side effects you may contribute to providing more information on the safety of this medicine.

Overdosing

Excessive doses can cause abdominal pain and diarrhea; the consequent losses of liquids and electrolytes must be replaced. See also in paragraph 4.4 – ‘Special warnings and precautions of use’ about the abuse of laxatives.

There are no adequate and well-controlled studies on the use of pregnant or nursing medicine. Therefore the medicinal product must be used only in case of need, under the direct control of the doctor, after evaluating the expected benefit for the mother in relation to the possible risk for the fetus or for the infant.

Source: Farmadati