Active ingredients

Each suppository contains: active substance : glycerol 2250 mg For the full list of excipients, see section 6.1.

Excipients

Sodium stearate, sodium carbonate anhydrous.

Therapeutic indications

Short-term treatment of occasional constipation.

Contraindications

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

Dosage

1 suppository when necessary or as prescribed by a doctor. The correct dose is the minimum sufficient to produce easy evacuation of soft stools. It is advisable to initially use the minimum doses indicated. When necessary, the dose can then be increased, but without ever exceeding the maximum indicated. A diet rich in liquids favors the effect of the medicine. 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.

Warnings and precautions

If the suppositories are less consistent than expected, immerse the containers in cold water before opening them. The continuous use of laxatives can cause addiction or damage of various types. Warnings 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 serious cases, dehydration or hypokalemia may occur which can cause 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 dependence (and, therefore, the possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony). Precautions for use In children under 12 years of age, the medicine can be used only 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 therapy. Consult your doctor when the need for a laxative arises from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) that lasts more than two weeks or when the use of a laxative fails to produce effects. It is also advisable for elderly or unhealthy subjects to consult their doctor before using the medicine.

Interactions

Milk or antacids may alter the effect of the medicine; leave an interval of at least one hour before taking the laxative. Laxatives may reduce the time spent in the intestine, and therefore the absorption, of other drugs administered orally at the same time. Therefore, avoid taking laxatives and other medicines at the same time: after taking a medicine, leave an interval of at least 2 hours before taking the laxative.

Side effects

Occasionally: isolated cramping pain or abdominal colic, more frequent in cases of severe constipation. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important, as it allows continued 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 http://www.agenziafarmaco.gov.it/it/responsabili.

Pregnancy and breastfeeding

There are no adequate and well-controlled studies on the use of the medicinal product during pregnancy or breastfeeding. Therefore, the medicinal product should be used only when necessary, under the direct supervision of a doctor, after evaluating the expected benefit for the mother in relation to the possible risk for the fetus or the infant.