INDICATIONS Short-term treatment of occasional constipation.
CONTRAINDICATIONS / SECONDARY EFFECT Hypersensitivity 'to the active ingredients or to any of the excipients. Mechanical obstruction of the biliary tract. Acute and chronic liver diseases. Gallstone disease. Hepatic insufficiency. 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, inflammatory bowel conditions (Chron's disease-Ulcerative Colitis). Contraindicated during pregnancy and lactation. Contraindicated in pediatric age.
DOSAGE Adults: a teaspoon in a little water, twice a day before meals. Children: a teaspoon a day, before the evening meal. The correct dose is the minimum sufficient to produce an easy evacuation of soft faeces. It is advisable to initially use the minimum doses provided. 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. Ingesting together with an adequate quantity of water (a large glass). A diet rich in liquids favors the effect of the medicine.
STORAGE This medicinal product does not require any special storage conditions.
WARNINGS Use for short periods only. Do not use laxatives if abdominal pain, nausea and vomiting are present. The continued use of laxatives can cause addiction or damage of various kinds. If constipation is persistent, 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 the onset of dehydration or hypokalemia is possible which can cause cardiac or neuromuscular dysfunctions, 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, 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 the medicine can 'be used only 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 lasted 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.
INTERACTIONS Laxatives can reduce the time spent in the intestine, and therefore the absorption, of other drugs administered simultaneously orally. Therefore, avoid ingesting laxatives and other drugs at the same time: after taking a medicine, leave an interval of at least 2 hours before taking the laxative. Milk or antacids can change the effect of the medicine; allow an interval of at least one hour to elapse before taking the laxative. Caution should be exercised in case of concomitant treatment with cardiac glycosides, diuretics or corticosteroids.
SIDE EFFECTS Gastrointestinal disorders. Occasionally: abdominal cramping pains, abdominal colic, more frequent in cases of severe constipation. Report any suspected adverse reactions via the national reporting system.
PREGNANCY AND BREASTFEEDING There are no adequate and well-controlled studies on the use of the medicinal product in pregnancy or breastfeeding. The use during pregnancy and during breastfeeding must be avoided because anthraquinones are partly excreted with breast milk giving it purgative properties.
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