FOR THE PURPOSES OF THIS REGULATION, THE FOLLOWING DEFINITIONS SHALL APPLY:

GOCCE LASSATIVE AICARDI 7,5 MG/ML GOCCE ORALI, SOLUTION

active ingredients

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

Excellent

Sodium parahydroxybenzoate; liquid sorbitol not crystallized; purified water.

Therapeutic indications

Short-term treatment of occasional constipation.

Contraindications

Lassative Drops Aicardi is contraindicated in patients with:• Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. • Acute or unknown abdominal pain, severe and painful acute abdominal conditions (such as appendicitis). • Nausea or vomiting. • Paralytic ileum, obstruction or intestinal stenosis or bile routes. • Rectal bleeding of unknown origin • Severe dehydration, abdominal colics, diarrhee, cachesia (for risk in such cases of excessive purgative effect). • Acute inflammation of the gastrointestinal tract. • Calculosis biliare. • Hepatic insufficiency. • Children under 3 years (see paragraph 4.4). • Generally contraindicated during pregnancy and nursing (see paragraph 4.6).

Population

Population Adults: 5–10 drops and more, in little water. Pediatric population Children from 3 to 12 years: 2–5 drops in little water, after consulting the doctor. Do not exceed the recommended doses. The correct dose is sufficient to produce an easy evacuation of soft feces. It is advisable to initially use the minimum doses provided. 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. Method of administration Eating together with an adequate amount of water (a plentiful glass). A fluid-rich diet promotes the effect of the medicine.

Conservation

This medicine does not require any special condition of conservation.

Warnings

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 the most serious cases, dehydration or hypopotassiemia may occur, which may result in cardiac or neuromuscular dysfunctions, especially in the case of contemporary treatment with cardiac glycosides, diuretics or corticosteroids. Cases of capogiri and/or syncope have been reported in patients who have taken picosophite sodium medicines. The data available on these cases suggest that events may be related to defecation syncops (or syncope attributable to evacuative effort), or a vasovagal response to abdominal pain related to constipation, and not necessarily to the taking of picosophite sodium itself. 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). 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. Pediatric population Do not administer children under 3 years. From 3 to 12 years consult your doctor before taking the product. Laxative Drops Oral Drops, solution contains • sodium parahydroxybenzoate methyl: it can cause allergic reactions (also delayed); • sorbitol: patients suffering from rare hereditary problems of fructose intolerance, should not take this medicine.

Interactions

The association with magnesium citrate anticipates the occurrence of the laxative effect that can be manifested after 3 hours. Laxatives can reduce the time of stay in the intestine, and therefore the absorption, of other drugs administered simultaneously orally. Avoid ingesting laxatives and other drugs at the same time: after taking a medicine let spend a range of at least 2 hours before taking laxative. Milk or antacids may change the effect of the medicinal product; let spend a range of at least an hour before taking the laxative. Continued use of picosophate sodium could increase patient response to oral anticoagulants and change glucose tolerance. Concurrent intake of diuretics or adrenocorticosteroids and excessive doses of picosophite sodium may result in an increase in the risk of electrolytic imbalance. This imbalance, in turn, can lead to increased sensitivity to cardioactive glycosides. Concurrent administration of antibiotics can reduce the laxative effect of picosophate sodium.

Effects

Like all medicines, Laxative Drops Aicardi can cause unwanted effects though not all people manifest them. Adverse reactions are listed below by classification for systems and organs and by frequency, according to the following categories: Very common ≥ 1/10 Municipality ≥ 1/100, Immune system disorders: Not known: hypersensitivity. Diseases of the nervous system: Don't note: syncope, dizziness. Gastrointestinal diseases: Notable: diarrhea, abdominal cramps, abdominal pain and abdominal discomfort, vomiting, nausea, isolated crampiform pain or abdominal colic, more frequent in cases of severe constipation. Pathologies of skin and subcutaneous tissue Not known: skin reactions such as angioedema, eruption for taking the medicine, rash, itching. 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: www.agenziafarmaco.gov.it/it/responsabili.

Overdosing

Signs and symptoms After taking high doses of the drug, aqueous feces (diarrhea), abdominal cramps and a significant loss of liquids, potassium and other electrolytes may occur. The resulting losses of liquids and electrolytes (especially potassium) must be replaced. Casi di ischemia alla mucosa del colon have been reported with doses of picosophate sodium considerably higher than the recommended dosage for the treatment of occasional constipation. Picosophate sodium, like other laxatives, in case of overdose causes chronic diarrhea, abdominal pain, hypokaliemia, secondary hyperaldosteronism and kidney stones. In association with chronic laxative abuse they were also described: renal piping injury, metabolic alkalosis and secondary muscle weakness to hypokaliemia. Treatment If the ingestion of picosophate sodium occurs within a short time, absorption can be reduced or avoided by induction of vomiting or gastric lavender. Liquid and electrolyte losses must be replaced. This is particularly important in the elderly and young people. Spasmolytic administration may be useful.

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. The medicinal product is generally contraindicated in pregnancy and nursing (see paragraph 4.3 Contraindications).

Source: Farmadati