EUCHESSINA CM OS GTT 20ML

EUCHESSINA C.M

active ingredients

Tablets: a tablet contains: active ingredient: picosophate sodium 3.5 mg; excipients: sorbitol, cocoa, arabic rubber, magnesium stearate. Oral drops: 100 ml of solution contain: active ingredient: picosophate sodium 750 mg; excipients: sorbitol, p-hydroxybenzoate methyl, purified water.

Excellent

• Tables: Sorbitol, cocoa, arabic rubber, magnesium stearate. • Oral drops: P-hydroxybenzoate, sorbitol, purified water.

Therapeutic indications

Short-term treatment of occasional constipation.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients. Laxatives are contraindicated in subjects with acute abdominal pain or unknown origin, nausea or vomiting, obstruction or intestinal stenosis or biliary pathways, paralytic ileum, acute inflammation of the gastrointestinal tract, rectal bleeding of unknown origin, severe state of dehydration, biliary calculus, liver failure, in patients with abdominal conditions. Contraindicated in children under 3 years of age. Contraindicated during pregnancy and nursing (see paragraph 4.6). The medicinal product is not contraindicated for persons suffering from celiac disease.

Population

• Tablets: Adults: 1 to 2 tablets. Children (over 3 years): from half to 1 tablet. The tablets of Euchessina C.M. are divisible to facilitate the intake of refracted doses. • Oral drops: Adults: 5 to 10 drops. Children (over 3 years): 2 to 5 drops. The correct dose of laxative is sufficient to produce an easy evacuation of soft feces. It is advisable to use the minimum dose initially. When necessary, the dose may be increased, but never exceed the maximum indicated. Preferably in the evening. Laxatives must be used as frequently as possible and for no more than seven days. Use for longer periods requires the doctor’s prescription after adequate evaluation of the individual case. Eating together with an adequate amount of water (a plentiful glass). A fluid-rich diet promotes the effect of the medicine.

Conservation

Store at a temperature below 25°C

Warnings

The abuse of laxatives (frequent or prolonged use or excessive doses), may 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. 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. Patients with rare problems of hereditary origin of fructose intolerance should not take the medicine because of the presence of sorbitol. You should also consult your doctor before using the medicine. Cases of capogiri and/or syncope have been reported in patients who have taken picosophate sodium. 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. In children aged between 3 and 12 years, the medicine can only be used after consulting the doctor.

Interactions

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. The continued use of Euchessina C.M. could increase patient response to oral anticoagulants and change glucose tolerance. Concurrent intake of diuretics or adrenocorticosteroids and excessive doses of Euchessina C.M. 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 Euchessina C.M.

Effects

Like all medicines, Euchessina C.M. can cause side 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, Gastrointestinal pathologies: Very common: diarrhea. Common: abdominal cramps, abdominal pain and abdominal discomfort. Not common: vomiting, nausea. Occasionally: isolated crampiform pain or abdominal colic pain, more frequent in cases of severe constipation.

Overdosing

Excessive doses can cause abdominal pain and diarrhea; the consequent losses of liquids and electrolytes 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. Euchess C.M., like other laxatives, in case of overdose causes chronic diarrhea, abdominal pain, hypocalyemia, 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 hypopotassemia. (see paragraph 4.4) Treatment If you intervene within a short time from the ingestion of Euchessina C.M., 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. See also the paragraph “Special warnings and appropriate precautions of use” about the abuse of laxatives.

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 the infant. Information on the excretion of picosophite sodium in human or animal milk is insufficient. The risk for the infant cannot be excluded. The decision to continue/interrupt breastfeeding or to continue/interrupt therapy with Euchessina CM, must be taken after taking into account the benefit of breastfeeding for the child and the benefit of therapy with Euchessina CM for the woman.

Source: Farmadati