AICARDI LAXATIVE DROPS 7.5 MG/ML ORAL DROPS, SOLUTION
Short-term treatment of occasional constipation.
Dosage and method of use
DosageAdults: 5–10 drops or more, in a little water.Pediatric populationChildren aged 3 to 12 years: 2-5 drops in a little water, after consulting your doctor. Do not exceed the recommended dose. The correct dose is the minimum sufficient to produce an easy evacuation of loose stools. 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 longer than seven days. Use for longer periods of time requires a doctor's prescription after adequate evaluation of the individual case.Method of administrationSwallow together with an adequate quantity of water (a large glass). A diet rich in liquids favors the effect of the medicine.
Aicardi Laxative Drops is contraindicated in patients with: • Hypersensitivity to the active ingredient or to any of the excipients listed in paragraph 6.1. • Acute abdominal pain or pain of unknown origin, severe and painful acute abdominal conditions (such as appendicitis). • Nausea or vomiting. • Paralytic ileus, intestinal or biliary tract obstruction or stenosis. • Rectal bleeding of unknown origin • Severe state of dehydration, abdominal colic, diarrhea, cachexia (due to the risk in such cases of excessive purgative effect). • Acute inflammation of the gastrointestinal tract. • Gallstones. • Liver failure. • Children under 3 years of age (see section 4.4). • Generally contraindicated during pregnancy and breastfeeding (see section 4.6).
Like all medicines, Aicardi Laxative Drops can cause side effects, although not everybody gets them. Adverse reactions are listed below by system organ class and frequency, according to the following categories: Very common ≥ 1/10 Common ≥ 1/100, Immune system disorders: Not known: hypersensitivity.Nervous system disorders: Not known: syncope, dizziness.Gastrointestinal disorders: Not known: diarrhoea, abdominal cramps, abdominal pain and abdominal discomfort, vomiting, nausea, isolated cramping pain or abdominal colic, more frequent in cases of severe constipation.Pathologies of the skin and subcutaneous tissueNot known: skin reactions such as angioedema, rash on taking the medicine, rash, itching.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.
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 severe cases, 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. Cases of dizziness and/or syncope have been reported in patients who have taken sodium picosulphate-based medicines. The available data on these cases suggest that the events may be related to syncope from defecation (or syncope attributable to the effort of evacuation), or to a vasovagal response to abdominal pain related to constipation, and not necessarily to the intake of sodium picosulfate itself. 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). 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.Pediatric populationDo not administer to children under 3 years of age. From 3 to 12 years old, consult your doctor before taking the product. Aicardi Laxative Drops oral drops, solution contains • sodium methyl parahydroxybenzoate: may cause allergic reactions (even delayed); • sorbitol: patients suffering from rare hereditary problems of fructose intolerance should not take this medicine.
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. The medicine is generally contraindicated during pregnancy and breastfeeding (see section 4.3 Contraindications).
Expiration and conservation
This medicine does not require any special storage conditions.
Interactions with other drugs
The association with magnesium citrate anticipates the onset of the laxative effect which can appear after 3 hours. Laxatives can reduce the residence time in the intestine, and therefore the absorption, of other drugs administered simultaneously orally. Therefore, avoid ingesting laxatives and other medicines 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; leave an interval of at least one hour before taking the laxative. Continued use of sodium picosulfate may increase patients' response to oral anticoagulants and change glucose tolerance. Concomitant intake of diuretics or adrenocorticosteroids and excessive doses of sodium picosulphate may lead to an increased risk of electrolyte imbalance. This imbalance, in turn, can lead to increased sensitivity to cardiac glycosides. Concomitant administration of antibiotics may reduce the laxative effect of sodium picosulfate.
Signs and symptomsFollowing the intake of high doses of the drug, the following may occur: watery stools (diarrhoea), abdominal cramps and a significant loss of fluids, potassium and other electrolytes. The resulting losses of fluids and electrolytes (especially potassium) must be replaced. Cases of colonic mucosal ischemia have been reported with doses of sodium picosulfate considerably higher than the recommended dosage for the treatment of occasional constipation. Sodium picosulphate, like other laxatives, in case of overdose causes chronic diarrhea, abdominal pain, hypokalemia, secondary hyperaldosteronism and kidney stones. Renal tubular injury, metabolic alkalosis, and muscle weakness secondary to hypokalemia have also been described in association with chronic laxative abuse.TreatmentIf action is taken within a short time after ingestion of sodium picosulfate, absorption can be reduced or avoided by inducing vomiting or gastric lavage. Fluid and electrolyte losses must be replaced. This is especially important in the elderly and young people. The administration of spasmolytics may be useful.
1 ml contains: Sodium picosulphate 7.5 mg Excipients with known effects: sodium methyl parahydroxybenzoate, sorbitol. For the full list of excipients, see section 6.1.
Sodium methyl parahydroxybenzoate; non-crystallizable liquid sorbitol; purified water.