SLABILAX-ZDOROVYA

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT SLABILAX-ZDOROVYA

Composition:

Active substance: 1 tablet contains 7.5 mg of sodium picosulfate, calculated as the anhydrous substance;

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

Pharmaceutical form. Tablets.

Main physico-chemical properties: white or almost white tablets with a biconvex surface.

Pharmacotherapeutic group. Contact laxatives. ATC code A06AB08.

Pharmacological properties.

Pharmacodynamics. Sodium picosulfate, the active substance of the medicinal product, is a locally acting laxative of the triarylmethane group. After bacterial cleavage in the colon, sodium picosulfate stimulates the mucosa, accelerating peristalsis and promoting accumulation of water and electrolytes in the lumen of the colon. As a result, defecation is stimulated, transit time is reduced, and stool is softened.

Pharmacokinetics. Absorption and distribution. After oral administration, sodium picosulfate reaches the colon without significant absorption.

Biological transformation. The active metabolite, bis-(p-hydroxyphenyl)-pyridyl-2-methane (BHPM), is formed following bacterial cleavage in the colon.

Elimination. After conversion, only a small amount of BHPM is absorbed. After oral administration of 10 mg of sodium picosulfate, 10.4% of the total dose is excreted as BHPM glucuronide in urine within 48 hours. In addition, BHPM is excreted in bile as glucuronide.

Relationship between pharmacokinetics and pharmacodynamics. The onset of action of the drug usually occurs 6–12 hours after administration, depending on the release of the active metabolite (BHPM). The laxative effect of the drug does not correlate with plasma levels of the active metabolite.

Clinical characteristics.

Indications. Constipation or conditions requiring facilitation of defecation.

Contraindications. Hypersensitivity to the active substance, other triarylmethanes, or any of the excipients of the medicinal product; intestinal obstruction; severe painful and/or febrile abdominal disorders (e.g. appendicitis), potentially associated with nausea and vomiting; acute inflammatory bowel diseases; severe dehydration; rare hereditary intolerance to any of the excipients of the medicinal product, for example, possible undiagnosed lactose intolerance (see section «Special precautions for use» ).

Interaction with other medicinal products and other forms of interaction. Concomitant use of high doses of the medicinal product Slabilax-Zdov'yata with diuretics or corticosteroids may increase the risk of electrolyte imbalance, which could lead to increased sensitivity to cardiac glycosides.

Concomitant use with antibiotics may reduce the laxative effect of the medicinal product.

Usage characteristics.

Like other laxatives, the drug should not be used daily or for prolonged periods without determining the cause of constipation. Patients suffering from chronic constipation should undergo a complete diagnostic evaluation to establish the underlying cause. Prolonged and excessive use may lead to disturbances in fluid or electrolyte balance, hypokalemia. Discontinuation of the drug may result in recurrence of symptoms. If Slabilax-Zdorovya has been used for chronic constipation over a long period, any recurrence of symptoms may be more pronounced. Dizziness and/or syncope have been observed in patients who have taken sodium picosulfate. Available data on these cases suggest that these events correspond to defecation-related syncope (associated with the Valsalva maneuver) or are related to a vasovagal response to abdominal pain. Like other laxatives, the drug should not be used daily or for prolonged periods without determining the cause of constipation.

The drug should be taken under medical supervision in conditions associated with disturbances in fluid and electrolyte balance (e.g., severe impairment of kidney function).

If a patient has known intolerance to certain sugars, consult a physician before taking this medicinal product.

Use during pregnancy or breastfeeding. There are insufficient studies on the use of sodium picosulfate in pregnant women. For safety reasons, if possible, Slabilax-Zdorovya should not be used during pregnancy.

Clinical data indicate that neither the active metabolite BHPM nor its glucuronides penetrate into breast milk. Therefore, the drug may be used during breastfeeding. Studies evaluating effects on fertility have not been conducted.

Ability to affect reaction speed when driving or operating machinery. Studies on the effect on the ability to drive or operate machinery have not been conducted. However, patients should be warned about the possible occurrence of adverse reactions such as dizziness and/or syncope due to vasovagal reactions (particularly abdominal cramps). If abdominal cramping occurs, patients should avoid potentially hazardous activities such as driving or operating machinery.

Dosage and Administration.

For adults – 1 tablet (7.5 mg) once daily. Slabilax-Health should be taken at night. Bowel movement occurs approximately 10–12 hours after taking the medication. Slabilax-Health should not be used daily or for prolonged periods without identifying the underlying cause of constipation. The maximum daily dose of 7.5 mg must not be exceeded.

Children. Do not use.

Overdose. Overdose may lead to loose stools (diarrhea), intestinal spasms, and clinically significant loss of fluid, potassium, and other electrolytes.

In acute overdose, adverse effects may be minimized or eliminated by induced vomiting or gastric lavage performed shortly after drug ingestion. Rehydration and correction of electrolyte imbalances may be required. Antispasmodic agents may be used.

There have been reports of colonic mucosal ischemia associated with the use of high doses of the drug, substantially exceeding the doses usually recommended for constipation.

Like other laxatives, prolonged overdose of Slabilax-Health may lead to chronic diarrhea and abdominal pain, hypokalemia, secondary hyperaldosteronism, and possibly kidney stone formation. With chronic abuse of laxatives, renal tubular injury, metabolic alkalosis, and muscle weakness due to hypokalemia have been reported.

Adverse reactions.

Skin and subcutaneous tissue disorders: angioneurotic edema, toxicoderma, rash, pruritus.

Immune system disorders: hypersensitivity reactions.

Nervous system disorders: dizziness, syncope. The occurrence of dizziness and syncope may be associated with a vasovagal reaction (such as abdominal spasm or defecation) (see section «Special instructions»).

Gastrointestinal disorders: diarrhea, abdominal cramps, abdominal pain, abdominal discomfort, vomiting, nausea.

Prolonged and excessive use of the drug may lead to fluid loss, potassium, and other electrolytes. This, in turn, may result in muscle weakness and impaired cardiac function, especially when the drug is used concomitantly with diuretics or corticosteroids.

Shelf life. 3 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. Tablets in packs of 10 (10×1), 20 (10×2) in blisters, in a carton.

Supply category. Over-the-counter.

Manufacturer. LIMITED LIABILITY COMPANY «CORPORATION «ZDOROV’YA».

Manufacturer's address and place of business. 22, Shevchenka Street, Kharkiv, Kharkiv region, 61013, Ukraine.