Enterolax

INSTRUCTION for medical use of the medicinal product ENTEROLAX

Composition:

Active ingredient: sodium picosulfate;

1 tablet contains sodium picosulfate, calculated as anhydrous substance, 7.5 mg;

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

Pharmaceutical form. Tablets.

Main physicochemical properties: white or almost white tablets with a biconvex surface.

Pharmacotherapeutic group.

Contact laxatives. Sodium picosulfate. ATC code A06AB08.

Pharmacological properties.

Pharmacodynamics.

A contact laxative of the triarylmethane group.

Sodium picosulfate, after bacterial cleavage in the colon, stimulates the mucosa, accelerating peristalsis and promoting accumulation of water and electrolytes in the colonic lumen. This results in stimulation of defecation, reduced transit time, and softening of stool.

Pharmacokinetics.

Sodium picosulfate is not absorbed from the gastrointestinal tract and does not undergo enterohepatic circulation.

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

Clinical characteristics.

Indications.

Constipation or conditions requiring facilitation of defecation.

Like other laxatives, ENTEROLAX should not be used daily or for prolonged periods without a full diagnostic evaluation to determine the cause of constipation.

Contraindications.

• Hypersensitivity to the active substance, other triarylmethanes, or to any of the excipients of the medicinal product.
• Dynamic or mechanical intestinal obstruction or acute abdominal conditions, such as appendicitis.
• Acute inflammatory bowel diseases.
• Acute abdominal pain accompanied by nausea and vomiting, which may indicate the aforementioned acute conditions.
• Severe dehydration.
• Rare hereditary intolerance to any of the excipients of the drug, for example, possible undiagnosed lactose intolerance (see section "Special precautions for use").

Interaction with other medicinal products and other forms of interaction.

Concomitant use with diuretics and glucocorticoids increases the risk of fluid and electrolyte disturbances, particularly hypokalemia. Tolerance to cardiac glycosides may be impaired. Broad-spectrum antibiotics may reduce the laxative effect of sodium picosulfate.

Special precautions for use.

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

Prolonged and excessive use of the medicinal product may lead to disturbances in fluid or electrolyte balance and to hypokalemia.

Discontinuation of ENTEROLAX may result in recurrence of symptoms. If ENTEROLAX has been used for chronic constipation over a long period, any recurrence of symptoms may be more pronounced.

Cases of dizziness and/or syncope (loss of consciousness) have been observed in patients taking sodium picosulfate. Available data suggest that these events correspond to defecation-related syncope associated with the Valsalva maneuver or vasovagal response to abdominal pain.

The medicinal product contains lactose; therefore, patients with rare hereditary forms of lactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome should not take this medicinal product.

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

Use during pregnancy or breastfeeding.

Pregnancy

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

Breastfeeding period

Clinical data show that neither the active metabolite, bis-(p-hydroxyphenyl)-pyridyl-2-methane (BHPM), nor its glucuronides pass into breast milk. Therefore, ENTEROLAX may be used during breastfeeding.

Fertility

Clinical studies assessing the effect of the drug on fertility in humans have not been conducted.

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

Ability to affect reaction speed when driving or operating machinery.

Studies on the influence of the drug on the ability to drive or operate machinery have not been conducted. However, patients should be warned about the possible development of adverse reactions such as dizziness and/or syncope due to vasovagal reactions (particularly abdominal cramps). If abdominal cramps occur, patients should avoid potentially hazardous activities such as driving or operating machinery.

Method of Administration and Dosage.

For adults: take 1 tablet (7.5 mg) in the evening before bedtime to ensure bowel movement in the morning.

ENTEROLAX should not be used daily or for prolonged periods without identifying the cause of constipation.

Children.

Do not use in children.

Overdose.

Symptoms: after ingestion of large doses – intestinal spasms, diarrhea, disturbances of water-electrolyte balance, particularly hypokalemia, muscle weakness, ischemia of the colonic mucosa.

With prolonged use of the drug in significantly increased doses, the following may occur: chronic diarrhea, abdominal pain, secondary hyperaldosteronism, kidney stone formation, renal tubular damage, metabolic alkalosis, muscle weakness due to hypokalemia.

Treatment: discontinue the drug, induce vomiting, gastric lavage, administration of enterosorbents (activated charcoal), symptomatic therapy aimed at restoring water-electrolyte balance and supporting vital functions; if indicated, use spasmolytic agents.

Side effects.

Side effects are rarely observed with short-term use of the medicinal product.

With prolonged use of the medicinal product at significantly increased doses, the following disturbances are possible:

Immune system: hypersensitivity reactions, including angioneurotic edema, skin rashes, urticaria, itching sensation, drug toxicoderma;

Gastrointestinal system: rarely – dyspeptic symptoms, vomiting, nausea, abdominal cramps and pain, diarrhea, flatulence, pain in the stomach area and anal area, increased intestinal motility, which resolve upon dose reduction;

Water-electrolyte balance: loss of fluid, potassium, and other electrolytes. This, in turn, may lead to muscle weakness and impaired cardiac function, especially when the medicinal product is used concomitantly with diuretics or corticosteroids;

Central nervous system: very rarely – headache, increased fatigue, drowsiness, convulsions, dizziness, syncope (the likelihood of dizziness and syncope is associated with vasovagal reactions, such as abdominal spasm or defecation) (see section "Special instructions").

Shelf life. 3 years.

Storage conditions.

Keep out of reach of children.

Store at a temperature not exceeding 25 °C.

Packaging.

10 tablets per blister. 1 blister or 3 blisters per carton.

Prescription status. Over-the-counter.

Manufacturer. JSC "STOMA".

Manufacturer's location and address of business activity.

3, Newtona Street, Kharkiv, 61105, Ukraine.