Properties
What is it?
LEGKOLAX Composition: Active substance: Macrogol; 1 sachet contains polyethylene glycol (macrogol) 4000, calculated on 100% substance, 4.0 g or 10.0 g. Dosage form. Powder for oral solution. Main physical-chemical properties: White or almost white powder. Pharmacotherapeutic group. Laxatives. Osmotic laxatives. Macrogol. Pharmacological properties. Pharmacodynamics. By forming hydrogen bonds with water molecules, the preparation retains water in the intestines. This increases the water content in the intestinal lumen, which improves the defecation process. Pharmacokinetics. The laxative effect of the preparation begins 24-28 hours after administration. The preparation is not absorbed and not metabolized. It is excreted unchanged from the body. Clinical features. Indications. Symptomatic treatment of constipation. Contraindications. Hypersensitivity to macrogol. Inflammatory bowel diseases (non-specific ulcerative colitis, Crohn's disease, toxic megacolon). Intestinal obstruction or suspicion of intestinal obstruction. Gastrointestinal perforation or risk thereof. Abdominal pain of unknown origin. Interactions with other medicinal products and other types of interactions. The absorption of medicinal products taken together with LEGKOLAX may be slowed down. Therefore, it is recommended to take the preparation separately from other medicinal products, with an interval of at least 2 hours. Special precautions for use. Before starting treatment, it is necessary to exclude an organic cause of constipation. Treatment of constipation with any medicinal product is only adjunctive therapy, provided that a healthy lifestyle and proper nutrition are maintained, specifically: intake of large amounts of fluids and fiber, corresponding to physical activity and restoration of intestinal function. Maximum duration of use in children - no more than 3 months. The fact that symptoms do not disappear even after using the preparation and following the appropriate diet may indicate other pathologies that require diagnosis and treatment. Cases of aspiration have been reported when administering large volumes of polyethylene glycol with electrolytes via a nasogastric tube. A particular risk of aspiration is observed in children with neurological disorders of the swallowing reflex. Use with caution in patients prone to water-electrolyte balance disorders, specifically: elderly patients, patients with liver and kidney disorders; when taking diuretics simultaneously, considering the possibility of developing diarrhea. Electrolyte balance control is also recommended. The preparation does not contain sugar, so it can be prescribed to patients with diabetes mellitus, as well as individuals whose diet excludes galactose. Since the preparation contains macrogol, symptoms of hypersensitivity to the active substance may occur (see section "Adverse reactions"). Use during pregnancy or breastfeeding. The preparation can be prescribed during pregnancy or breastfeeding. Ability to influence reaction speed when driving vehicles or operating machinery. Not established. Dosage and administration. The preparation is intended for oral use. Treatment normalizes colonic motility, provided that proper dietary habits are maintained. For adults and children over 8 years of age, 10-20 g per day is usually prescribed. The daily dose for children from 6 months to 1 year is 4 g, from 1 year to 4 years - 8 g, from 4 to 8 years - 16 g. The contents of the sachet should be dissolved in advance in 1 glass of water, clear juice (e.g., apple) or cold tea; for children under 1 year of age - in 50 ml of water. It is advisable to take LEGKOLAX in the morning with meals, in one dose. The first effect of the preparation occurs 24-48 hours after administration. The daily dose is determined according to the clinical effect and can range from 4 g every other day (for children) to 20 g per day. The duration of treatment is determined by the doctor based on the nature and course of the disease, and the effectiveness of the treatment. The duration of treatment should not exceed 3 months, as there are no clinical trial data regarding the use of the preparation for longer than this period. Children. The preparation can be used in children from 6 months of age. Overdose. Due to the absence of systemic absorption, overdose is unlikely. Overdose causes diarrhea, which subsides when the use of the preparation is stopped or the dose is reduced. Due to the loss of excess fluid as a result of vomiting or diarrhea, correction of the disturbed water-electrolyte balance may be necessary. Adverse reactions. In isolated cases, bloating and/or abdominal pain, nausea, vomiting, urge to defecate, and involuntary defecation may occur. When taking very large doses, diarrhea may develop, which stops 1-2 days after discontinuation of the preparation; after that, the preparation can be taken in lower doses. In children, diarrhea can cause painful sensations in the perianal area. Water-electrolyte imbalance (hyponatremia, hypokalemia) and/or dehydration may occur, especially in elderly patients. Very rarely, hypersensitivity reactions may occur, including itching, urticaria, rash, facial swelling, angioedema, anaphylactic shock, bronchospasm. 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. 4.0 g or 10.0 g in a sachet. 4, 10 or 20 sachets are placed in a carton. Dispensing category. Pharmaceutical product group III, available without a prescription.
