Euchessina CM Sodium picosulfate Constipation 18 Chewable Tablets

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022941076
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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 the most severe cases the onset of dehydration or hypokalaemia is possible which can cause cardiac or neuromuscular dysfunction, 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, 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. Pay attention 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. 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.
PHARMACOTHERAPEUTIC CATEGORY
Constipation medications.
STORAGE
This medicinal product does not require any special storage conditions.
CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active substance or to any of the excipients; laxatives are contraindicated in subjects 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 pediatric age; contraindicated during pregnancy and lactation; the medicine is not contraindicated for people with celiac disease.
NAME
EUCHESSINA CM
EXCIPIENTS
Tablets: sorbitol, cocoa, gum arabic, magnesium stearate. Oral drops: methyl p-hydroxybenzoate, sorbitol, distilled water.
SIDE EFFECTS
Like all medicines, the product can cause side effects, although not all people experience them. Adverse reactions are listed below by system organ class and frequency, according to the following categories: very common (> = 1/10); common (> = 1/100, <1/10); uncommon (> = 1 / 1,000, <1/100); rare (> = 1 / 10,000, <1 / 1,000); very rare (<1 / 10,000); not known. Disorders of the immune system. Not known: hypersensitivity ', angioneurotic edema and skin reactions. Nervous system disorders. Uncommon: dizziness; nonnote: syncope. The phenomena of dizziness and syncope that occur after the intake of sodium picosulfate appear to be attributable to a vasovagal response (resulting, for example, from abdominal pain or stool evacuation). 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.
PREGNANCY AND BREASTFEEDING
There are no adequate and well-controlled studies on the use of the medicinal product in pregnancy or breastfeeding. Therefore, the medicine should be used only in case of need ', 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. The risk to the infant cannot be excluded. The decision to continue / discontinue breastfeeding or to continue / discontinue drug therapy, it must be taken after taking into account the benefit of breastfeeding for the child and the benefit of drug therapy for the woman.
INDICATIONS
Short-term treatment of occasional constipation.
INTERACTIONS
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 the drug may increase patient response to oral anticoagulants and change glucose tolerance. Concomitant intake of diuretics or adrenocorticosteroids and excessive doses of the drug can 'lead to an increased risk of electrolyte imbalance. This imbalance, in turn, can lead to an increase in sensitivity to cardioactive glycosides. Concomitant administration of antibiotics can reduce the laxative effect of the drug.
DOSAGE
>> Tablets. Adults: 1 to 2 tablets. Children (over 3 years old): from half to 1 tablet. The tablets are divisible 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. Ingest together with an adequate quantity of water (a large glass). A diet rich in liquids favors the effect of the medicine.
ACTIVE PRINCIPLES
Sodium picosulfate.
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