SLABILAX-ZDOROVYA

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SLABILAX-ZDOROV'YA

Composition:

Active ingredient: 1 ml (15 drops) contains sodium picosulfate 7.5 mg;

Excipients: sodium benzoate (E 211), sorbitol (E 420), citric acid, sodium citrate, purified water.

Pharmaceutical form. Oral drops.

Main physico-chemical properties: clear solution, colorless to slightly greenish-yellow.

Pharmacotherapeutic group. Stimulant laxatives. ATC code A06AB08.

Pharmacological Properties

Pharmacodynamics. Sodium picosulfate, the active ingredient of the drug Slabilax-Zdorovya, is a locally acting laxative of the triarylmethane group. After bacterial cleavage in the colon, sodium picosulfate stimulates the mucosa, promoting increased colonic peristalsis and accumulation of water and electrolytes in the colonic lumen. This results in stimulation of defecation, reduced intestinal transit time, and softening of stool.

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

Biotransformation. 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. Following oral administration of 10 mg of sodium picosulfate, 10.4% of the total dose is excreted as BHPM glucuronide in urine within 48 hours. Additionally, BHPM is excreted in bile as glucuronide.

Relationship between pharmacokinetics and pharmacodynamics. The onset of action of the drug typically 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.

Like other laxatives, Slabilax-Zdorovya should not be used daily or for prolonged periods without establishing the cause of constipation.

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 diseases (e.g., appendicitis), potentially associated with nausea and vomiting.

• 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 medicinal product; for example, suspected undiagnosed fructose intolerance (see section «Special precautions for use»).

Slabilax-Zdorovya should be taken under medical supervision in conditions associated with disturbances in water and electrolyte balance (e.g., severe renal function impairment).

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

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

Special precautions for use

Patients suffering from chronic constipation should undergo a full diagnosis to determine the cause of constipation.

Prolonged use of the drug may lead to disturbances in fluid and electrolyte balance and to hypokalemia.

Discontinuation of the drug may result in recurrence of symptoms. If Slabilax-Zdorovya is used for chronic constipation over a prolonged period, any recurrence of symptoms may be more pronounced.

Cases of dizziness and/or syncope temporally associated with the use of sodium picosulfate have been reported. Available data suggest that these events correspond to defecation syncope (associated with the Valsalva maneuver) or are related to a vasovagal response to abdominal pain.

1 ml of drops contains 0.45 g of sorbitol, i.e., 0.6 g of sorbitol in each maximum recommended daily dose. If a patient has been diagnosed with intolerance to certain sugars, medical advice should be sought before taking this medicinal product.

Use during pregnancy or breastfeeding. There are insufficient studies in pregnant women. As a precaution, the drug should not be used during pregnancy, if possible.

Clinical data indicate that neither the active metabolite BHPM nor its glucuronides penetrate into breast milk. Therefore, the drug may be used during breastfeeding.

Fertility studies have not been conducted.

Ability to affect reaction speed when driving or operating machinery. Studies on the influence on the ability to drive vehicles 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 a vasovagal response (particularly abdominal cramps). If abdominal cramps occur, patients should avoid potentially hazardous activities such as driving vehicles or operating machinery.

Method of Administration and Dosage

For adults: 10-20 drops (corresponding to 5-10 mg of sodium picosulfate);

For children aged 4 years and older (only on a doctor's prescription): 5-10 drops (corresponding to 2.5-5 mg of sodium picosulfate).

It is recommended to start with the lowest dose. The dose may be adjusted up to the maximum recommended dose for regular bowel movements. The maximum daily dose of 20 drops (for adults) or 10 drops (for children aged 4 years and older) must not be exceeded.

Slabilax-Zdorovya should be taken at night. After administration, bowel movement occurs within 10-12 hours. The medication can be taken either with liquid or without.

Slabilax-Zdorovya should not be used daily or for prolonged periods without determining the cause of constipation.

Children. The medication should be used in children aged 4 years and older only on a doctor's prescription.

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

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

Cases of colonic mucosal ischemia have been reported following administration of large doses of the drug, significantly exceeding the usual recommended doses for constipation.

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

Side effects.

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 is likely related to a vasovagal reaction (such as abdominal spasm or defecation) (see section «Special instructions»).

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

Prolonged and excessive use of the drug may lead to loss of fluid, 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. 15 ml or 30 ml in a bottle, in a carton.

Supply category. Over-the-counter.

Manufacturer. LIMITED LIABILITY COMPANY «CORPORATION «ZDOROVIYA».

Manufacturer's address. 22, Shevchenka Street, Kharkiv, Kharkiv region, 61013, Ukraine.