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AICARDI LAXATIVE DROPS * FL15ML

  • SIT LABORATORIO FARMAC. Srl
  • 022015022
Features:


Indicated in case of constipation.


Based on sodium picosulfate.


Deductible over-the-counter drug.


















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AICARDI LAXATIVE DROPS * FL15ML

Therapeutic indications

Short-term treatment of occasional constipation.

Dosage and method of use

Dosage Adults: 5-10 drops and more, in a little water. Pediatric population Children from 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 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. Method of administration Swallow with an adequate amount of water (a large glass). A diet rich in liquids favors the effect of the medicine.

Contraindications

Aicardi Laxative Drops is contraindicated in patients with: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. • Acute abdominal pain or of unknown origin, severe and painful acute abdominal conditions (such as appendicitis). • Nausea or vomiting. • Paralytic ileus, intestinal or biliary obstruction or stricture. • 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. • Hepatic insufficiency. • Children under the age of 3 (see section 4.4). • Generally contraindicated during pregnancy and lactation (see section 4.6).

Side effects

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: diarrhea, abdominal cramps, abdominal pain and abdominal discomfort, vomiting, nausea, isolated cramping pain or abdominal colic, more frequent in cases of severe constipation. Skin and subcutaneous tissue disorders Not known: skin reactions such as angioedema, rash on taking the medicine, rash, pruritus. Reporting of suspected adverse reactions Reporting 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.

Special warnings

The abuse of laxatives (frequent or prolonged use or with excessive doses) can cause persistent diarrhea with consequent loss of water, minerals (especially potassium) and other essential nutritional factors. In severe cases, the onset of dehydration or hypokalaemia is possible, which can lead to cardiac or neuromuscular dysfunctions, especially in the case of simultaneous treatment with cardiac glycosides, diuretics or corticosteroids. Cases of dizziness and / or syncope have been reported in patients taking sodium picosulfate medicines. Available data on these cases suggest that the events may be related to defecation syncope (or syncope attributable to evacuative effort), or a vasovagal response to abdominal pain related to constipation, and not necessarily to the intake of sodium picosulfate itself. 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). The treatment of chronic or recurrent constipation always requires the intervention of the doctor for the diagnosis, the prescription of drugs and the 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) lasting 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 population Do not administer to children under 3 years of age. From 3 to 12 years, consult your doctor before taking the product. Laxative drops Aicardi oral drops, solution contains • sodium methyl parahydroxybenzoate: can cause allergic reactions (even delayed); • sorbitol: patients with 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 in pregnancy or breastfeeding. Therefore, the medicinal product 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. The medicinal product is generally contraindicated in pregnancy and lactation (see section 4.3 Contraindications).

Expiration and retention

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 manifest itself after 3 hours. 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; leave an interval of at least an hour before taking the laxative. Continued use of sodium picosulfate may increase patient response to oral anticoagulants and alter glucose tolerance. Concomitant intake of diuretics or adrenocorticosteroids and excessive doses of sodium picosulfate may lead to an increased risk of electrolyte imbalance. This imbalance, in turn, can lead to an increase in sensitivity to cardiac glycosides. Concomitant administration of antibiotics may reduce the laxative effect of sodium picosulfate.

Overdose

Signs and symptoms Following high doses of the drug, watery stools (diarrhea), abdominal cramps and significant loss of fluids, potassium and other electrolytes may occur. The resulting loss of fluids and electrolytes (especially potassium) must be replaced. Cases of colonic mucosal ischaemia have been reported with significantly higher doses of sodium picosulfate than the recommended dosage for the treatment of occasional constipation. Sodium picosulfate, like other laxatives, causes chronic diarrhea, abdominal pain, hypokalemia, secondary aldosteronism and kidney stones in case of overdose. In association with chronic laxative abuse, renal tubular injury, metabolic alkalosis and muscle weakness secondary to hypokalaemia have also been described. Treatment If action is taken within a short time after ingestion of sodium picosulfate, absorption can be reduced or avoided by induction of vomiting or gastric lavage. Fluid and electrolyte leaks must be replaced. This is particularly important in the elderly and young people. The administration of spasmolytics may be useful.

Active principles

1 ml contains: Sodium picosulfate 7.5 mg Excipients with known effects: sodium methyl parahydroxybenzoate, sorbitol. For the full list of excipients, see section 6.1.

Excipients

Sodium methyl parahydroxybenzoate; non crystallizable liquid sorbitol; purified water.

022015022
6 Items