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EUCHESSINA CM * 18CPR MAST DIV

  • Chiesi Farmaceutici S.p.A
  • 022941076

Laxative drug with sodium picosulfate indicated for occasional constipation.

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EUCHESSINA CM * 18CPR MAST DIV

Therapeutic indications

Short-term treatment of occasional constipation.

Dosage and method of use

• Tablets: Adults: 1 to 2 tablets. Children (over 3 years old): from half to 1 tablet. Euchessina CM tablets are breakable to facilitate the intake of refracted doses. • Oral drops: Adults: 5 to 10 drops. Children (over 3 years old): 2 to 5 drops. The correct dose of the laxative is the minimum sufficient to produce an easy evacuation of soft stools. It is advisable to use the lowest recommended dose initially. When necessary, the dose can then be increased, but without ever exceeding the maximum indicated. 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. Swallow with an adequate amount of water (a large glass). A diet rich in liquids favors the effect of the medicine.

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Laxatives are contraindicated in people with acute abdominal pain or of unknown origin, nausea or vomiting, intestinal or biliary tract obstruction or stenosis, paralytic ileus, acute inflammation of the gastrointestinal tract, rectal bleeding of unknown origin, severe dehydration, gallstones , liver failure, in patients with acute abdominal conditions such as appendicitis and severe abdominal pain associated with nausea and vomiting which may be indicative of a serious condition. Contraindicated in children under 3 years of age. Contraindicated during pregnancy and lactation (see section 4.6). The medicine is not contraindicated for people with celiac disease.

Side effects

Like all medicines, Euchessina CM 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, Gastrointestinal disorders: Very common: diarrhea. Common: abdominal cramps, abdominal pain and abdominal discomfort. Uncommon: vomiting, nausea. Occasionally: isolated cramping pains or abdominal colic, more frequent in cases of severe constipation.

Special warnings

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 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, 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) that has lasted for more than two weeks or when the use of the laxative fails to produce effects. Patients with rare hereditary problems of fructose intolerance should not take the medicine due to the presence of sorbitol. It is also advisable that elderly people or those in poor health conditions consult their doctor before using the medicine. Cases of dizziness and / or syncope have been reported in patients taking sodium picosulfate. The available data on these cases suggest that the events could be related to defecation syncope (or syncope attributable to evacuative effort), or to a vasovagal response to abdominal pain related to constipation, and not necessarily to the intake of sodium picosulfate itself. children between 3 and 12 years of age the medicine can only be used after consulting your doctor.

Pregnancy and breastfeeding

There are no adequate and well-controlled studies on the use of the drug in pregnancy or breastfeeding. Therefore, the medicine 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. There is insufficient information on the excretion of sodium picosulfate in human or animal milk. A risk to the infant cannot be excluded. A decision to continue / discontinue breastfeeding or to continue / discontinue Euchessin CM therapy must be made after taking into account the benefit of breastfeeding for the child and the benefit of Euchessin CM therapy for the woman. .

Expiration and retention

Store at a temperature below 25 ° C

Interactions with other drugs

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 Euchessin CM may increase patient response to oral anticoagulants and alter glucose tolerance. Concomitant use of diuretics or adrenocorticosteroids and excessive doses of Euchessin CM 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 Euchessin CM

Overdose

Excessive doses can cause abdominal pain and diarrhea; consequent losses of fluids and electrolytes 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. Euchessina CM, 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. (see section 4.4)TreatmentIf action is taken within a short time after ingestion of Euchessin CM, absorption can be reduced or avoided by induction of vomiting or gastric lavage. Leaks of fluids and electrolytes must be replaced. This is particularly important in the elderly and young people. The administration of spasmolytics may be useful. See also the information in the paragraph “Special warnings and appropriate precautions for use” regarding the abuse of laxatives.

Active principles

Tablets: one tablet contains:active principle: sodium picosulfate 3.5 mg; excipients: sorbitol, cocoa, gum arabic, magnesium stearate. Oral drops: 100 ml of solution contain:active principle: sodium picosulfate 750 mg; excipients: sorbitol, methyl p-hydroxybenzoate, purified water.

Excipients

Tablets: Sorbitol, cocoa, gum arabic, magnesium stearate. •Oral drops:Methyl p-hydroxybenzoate, sorbitol, purified water.

022941076

Data sheet

Packaging
3 -5 mg (2x9) chewable tablets
3,5 mg (2x9) compresse masticabili
Product Type
HUMAN DRUG
ATC code
A06AB08
ATC description
Sodium picosulfate
Therapeutic Group
Laxatives
Active principle
sodium picosulfate (DC.IT) (FU)
Class
C.
Pharmaceutical form
chewable tablet
Type of Administration
oral
Container
blister
Quantity
18 chewable tablet
Quantity of the Active Ingredient
3 -5MG
3,5MG
Recipe required
OTC - self-medication medicine
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