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Composition:


active ingredient: Sodium Picosulfate;


1 tablet contains Sodium Picosulfate in terms of anhydrous substance 7.5 mg;


excipients: lactose monohydrate, potato starch, povidone, magnesium stearate.


Dosage form. Pills.


Basic physical and chemical properties: tablets of white or almost white color with a biconvex surface.


Pharmacotherapeutic group.


Contact laxatives. Sodium Picosulfate. ATX code A06A B08.


Pharmacological properties.


Pharmacodynamics.


Contact laxative of the triarylmethane group.


Sodium Picosulfate after bacterial breakdown in the colon stimulates its mucous membrane, accelerating peristalsis, promotes the accumulation of water and electrolytes in the lumen of the colon. The result is stimulation of bowel movements, reduced passage time, and softening of feces.


Pharmacokinetics.


Sodium Picosulfate is not absorbed from the digestive tract and is not subject to hepatic-intestinal circulation.


The active metabolite BIS-(P-hydroxyphenyl)-pyridyl-2-methane is formed after bacterial cleavage in the colon, the action of ENTEROLAX usually begins 6-12 hours after ingestion, depending on the release of the active metabolite. After oral administration, only a small amount of the drug can be detected in the organs and systems of the body. The laxative effect of the drug does not correlate with the level of the active metabolite in blood plasma.


Clinical characteristics.


Indications.


Constipation or cases that require easier bowel movements.


Like other laxatives, ENTEROLAX should not be used daily or for a long period of time without a full diagnostic assessment to determine the cause of constipation.


Contraindications.


- Hypersensitivity to the active substance, other triarylmethanes or to any of the excipients of the drug.


- Dynamic or mechanical intestinal obstruction or acute abdominal disease, such as appendicitis.


- Acute inflammatory bowel diseases.


- Acute abdominal pain, accompanied by nausea and vomiting and may indicate the above-mentioned acute diseases.


- Severe dehydration.


- Rare hereditary intolerance to any of the excipients of the drug, for example, there is a possibility of unidentified lactose intolerance (see the section "application features").


Interactions with other drugs and other types of interactions.


When used concomitantly with diuretics and glucocorticoids, the risk of water-electrolyte disorders, in particular hypokalemia, increases. Cardiac glycoside tolerance may worsen. Broad-spectrum antibiotics can reduce the laxative effect of Sodium Picosulfate.


Application features.


In patients suffering from chronic constipation, a full diagnosis should be made and the cause of constipation should be determined.


Prolonged and excessive use of the drug can lead to impaired fluid or electrolyte balance and hypokalemia.


Discontinuation of ENTEROLAX may lead to renewed symptoms. If ENTEROLAX has been used for chronic constipation for a long time, any resumption of symptoms may be more pronounced.


Patients taking Sodium Picosulfate have experienced cases of dizziness and/or syncope (syncope). The available information suggests that these phenomena correspond to syncope during defecation associated with Valsalva breakdown or with a vasovagal response to abdominal pain.


The drug contains lactose, so patients with rare hereditary forms of lactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome should not use the drug.


If you have an established intolerance to certain sugars, consult your doctor before taking this medicine.


Use during pregnancy or lactation.


Pregnancy


Proper clinical studies involving pregnant women have not been conducted. For safety reasons, ENTEROLAX should not be used during pregnancy if possible.


Breast-feeding period


Clinical data show that neither the active metabolite BIS-(P-hydroxyphenyl)-pyridyl-2-methane (BGPM) nor its glucuronides pass into breast milk. Thus, ENTEROLAX can be used during breast-feeding.


Fertility


Clinical studies to evaluate the effect of the drug on Human Fertility have not been conducted.


Animal studies have not demonstrated any effect of the drug on fertility.


Ability to influence the reaction rate when driving vehicles or other mechanisms.


Studies of the effect on the ability to drive a car and work with other mechanisms have not been conducted. However, patients should be warned about the possibility of developing adverse reactions such as dizziness and/or syncope due to a vasovagal reaction (in particular, abdominal spasm). If an abdominal spasm occurs, the patient should avoid potentially dangerous activities such as driving vehicles or working with other mechanisms.


Dosage and administration.


Adults Should Take 1 tablet (7.5 mg) in the evening before going to bed, so that bowel movement occurs in the morning.


ENTEROLAX should not be used daily or for a long period of time without determining the cause of constipation.


Children.


Do not use in children.


Overdose.


Symptoms: when taking large doses-intestinal spasms, diarrhea, violation of the water-electrolyte balance, in particular: hypokalemia, muscle weakness, ischemia of the mucous membrane of the large intestine.


With prolonged use of the drug in significantly increased doses, the following conditions are possible: chronic diarrhea, abdominal pain, secondary hyperaldosteronism, formation of kidney stones, damage to the renal tubules, metabolic alkalosis, muscle weakness as a result of hypokalemia.


Treatment: discontinuation of the drug, inducing vomiting, gastric lavage, taking enterosorbents (activated charcoal), symptomatic therapy aimed at normalizing the water-electrolyte balance and maintaining vital functions, according to indications – antispasmodics.


Adverse reactions.


With short-term use of the drug, side effects are rare.


With prolonged use of the drug in significantly increased doses violations are possible:


immune system disorders: hypersensitivity reactions, including angioedema, skin rash, urticaria, itching, drug-induced toxicoderma;


from the digestive system: rarely – dyspeptic phenomena, vomiting, nausea, abdominal cramps and pain, diarrhea, flatulence, pain in the stomach and anus, increased intestinal motility, which disappear with a decrease in the dose of the drug;


from the side of water-electrolyte balance: loss of fluid, potassium and other electrolytes. This, in turn, can lead to muscle weakness and impaired cardiac function, especially when the drug is co-administered with diuretics or corticosteroids.;


from the central nervous system: very rarely – headache, fatigue, drowsiness, convulsions, dizziness, syncope (the probability of dizziness and syncope is associated with a vasovagal reaction, such as abdominal spasm or defecation) (see the section "application features").


Expiration date. 3 years old.


Storage conditions.


Keep out of reach of children.


Store at a temperature not exceeding 25 °C.

Tags: Sodium picosulfate