Regisol is

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT REGISOL® IS

Composition:

Active substances: sodium chloride, potassium chloride, sodium citrate, glucose;

1 sachet contains sodium chloride 3.5 g, potassium chloride 2.5 g, sodium citrate 2.9 g, glucose 10.0 g.

Pharmaceutical form. Powder for oral solution.

Main physicochemical properties: white crystalline powder.

Pharmacotherapeutic group.

Electrolyte preparations with carbohydrates. Oral rehydration salts.

ATC code A07CA.

Pharmacological properties.

Pharmacodynamics.

Glucose promotes salt absorption; citrates help correct the balance in metabolic acidosis. The osmolarity of the Regisol® IS medicinal product solution is 235–255 mOsm/L; pH is weakly alkaline – 8.2.

The medicinal product solution contains (per 1 L of solution):

Pharmacokinetics.

The pharmacokinetics of water, electrolytes, and glucose contained in the medicinal product correspond to the natural pharmacokinetics of these substances in the body.

Clinical characteristics.

Indications.

Restoration of water-electrolyte balance, correction of acidosis in acute diarrhea with mild to moderate dehydration (e.g., loss of 3–9% body weight in children), and in heat-related conditions accompanied by disturbances in water-electrolyte metabolism.

For prophylactic use: during heat exposure or physical exertion leading to excessive sweating.

Contraindications.

Hypersensitivity to any component of the medicinal product, severe dehydration, hemodynamic shock, intractable vomiting, loss of consciousness, intestinal obstruction, ileus.

Interaction with other medicinal products and other types of interactions.

There is no information available on interactions between Regisol® IS and other medicinal products. The pH of the medicinal product solution is slightly alkaline; therefore, it may affect medicinal products whose absorption depends on the pH of intestinal contents. Additionally, drug absorption may be altered during diarrhea, particularly for medicinal products absorbed in the small or large intestine, or those undergoing enterohepatic circulation.

Special precautions for use.

Severe dehydration (loss of more than 9% of body weight in children, anuria) must first be treated with intravenous rehydration agents. After this, Regisol® IS may be prescribed for continuation of therapy.

Recommended doses of the medicinal product should not be exceeded unless the patient's need for additional electrolyte supplementation is confirmed by laboratory tests.

Exceeding the dose may lead to development of hypernatremia in the patient.

The medicinal product should be administered orally, using water for its dissolution. The contents of 1 sachet of Regisol® IS should be dissolved in 1 L of water. Sugar must not be added to the solution. Food intake is possible immediately after rehydration. In case of vomiting, wait 10 minutes and then drink the solution slowly, in small sips.

Patients in whom dehydration has developed against a background of renal insufficiency, diabetes mellitus, or other chronic diseases affecting acid-base, electrolyte, or carbohydrate balance require careful monitoring during therapy with Regisol® IS and may require hospitalization.

Diarrhea can significantly affect fluid and glucose balance in patients with diabetes mellitus, renal insufficiency, or certain other chronic diseases. Therefore, while diarrhea symptoms persist, such patients require more careful monitoring with laboratory assessments and hospital-based rehydration therapy.

Caution should be exercised when using Regisol® IS in patients with liver disease.

The medicinal product should be used with caution in patients with renal insufficiency during periods of oliguria or anuria, or during parenteral rehydration therapy.

The medicinal product should not be used in children under 6 months of age without consulting a physician.

In infants, acute diarrhea may cause dehydration and electrolyte disturbances, leading to rapid deterioration of the patient's condition. All cases of diarrhea and dehydration in infants must be reported to a physician as quickly as possible.

Situations during use of Regisol® IS requiring medical intervention:

• change in the patient's mental status (irritability, apathy, lethargy);
• the patient develops slowed speech, drowsiness, rapid fatigue, and does not respond to questions;
• persistent vomiting;
• temperature rises above 39 °C;
• urine output stops;
• watery bloody stools occur;
• diarrhea lasts more than 2 days;
• severe abdominal pain;
• diarrhea suddenly stops and severe pain appears;
• home treatment is unsuccessful or impossible.

1 sachet of Regisol® IS contains 10.0 g of glucose. Before taking this medicinal product, patients with diagnosed intolerance to certain sugars should consult a physician. Regisol® IS should not be taken by patients with the rare hereditary condition glucose-galactose malabsorption.

1 sachet of Regisol® IS contains 89.5 mmol (or 2059 mg) of sodium. The medicinal product should be used with caution in patients on a sodium-controlled diet.

1 sachet of Regisol® IS contains 33.5 mmol (or 1307 mg) of potassium. Caution is required when administering the medicinal product to patients with impaired renal function or those on a potassium-controlled diet.

Use during pregnancy or breastfeeding.

The medicinal product is permitted for use at recommended doses during pregnancy or breastfeeding. Breastfeeding may continue as long as necessary, even during oral rehydration, or may be resumed immediately after rehydration.

Effect on the ability to drive or operate machinery.

No effect.

Method of Administration and Dosage

Dissolve the contents of 1 sachet of Regisol® IS medicinal product in 1 liter of boiled, cooled to room temperature water. No other components should be added to the solution in order not to interfere with the action of the medicinal product. The solution should be taken orally or administered under medical supervision via a nasogastric tube.

Before starting treatment, the patient must be weighed to determine body weight loss and degree of dehydration.

During treatment, fatty foods and foods high in simple sugars should be avoided.

Therapy with the medicinal product Regisol® IS should be initiated after the onset of diarrhea. The prepared solution of Regisol® IS should be taken in small sips after each episode of liquid stool. Within 6–10 hours, the dose of solution may amount to 30–60 mL/kg body weight. Usually, the medicinal product should not be taken for longer than 3–4 days; treatment should be discontinued after diarrhea resolves. In cases of nausea or vomiting, it is advisable to take the cooled solution in small amounts.

Rehydration: to correct dehydration, the medicinal product should be taken during the first 6–10 hours in an amount twice exceeding the body weight loss due to diarrhea; for example, if losses are 400 g, the amount of medicinal product should be 800 mL. During therapy with Regisol® IS, there is no need to use other fluids.

Subsequent use: if diarrhea persists, after correction of dehydration, during the following 24 hours, administration of the medicinal product Regisol® IS and other fluids may continue according to the data in the table:

Children.

Regisol® IS can be used in children. There are no age restrictions regarding when this medicinal product can be administered to children.

In children under 6 months of age, the medicinal product should be administered under medical supervision.

Overdose.

Administration of a very large amount or a highly concentrated solution of Regisol® IS may lead to hypernatremia. Symptoms of hypernatremia include weakness, neuromuscular excitability, drowsiness, confusion, coma, and sometimes even respiratory arrest.

In patients with impaired renal function, metabolic alkalosis and hyperkalemia may occur. Metabolic alkalosis may manifest as decreased lung ventilation, neuromuscular excitability, and tetanic seizures.

In case of severe overdose with pronounced adverse effects following administration of Regisol® IS, the administration of the medicinal product must be discontinued immediately. Medical consultation is required. Electrolyte and fluid balance correction should be performed based on laboratory test results.

Adverse reactions.

When following the recommended doses, the development of adverse reactions is unlikely.

Potential development of allergic reactions is possible.

Vomiting may occur, which indicates too rapid administration of the medicinal product.

In patients with normal kidney function, the risk of developing hypernatremia or hyperhydration when using Regisol® IS is low.

Shelf life. 3 years.

Storage conditions.

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

Keep out of reach of children.

The prepared solution should be stored in a refrigerator at a temperature from +2 °C to +8 °C for 24 hours.

Packaging.

Powder for oral solution 18.9 g in sachets; 10 sachets in a cardboard box.

Pharmaceutical category. Over-the-counter (without prescription).

Manufacturer.

Limited liability company "INTERKHIM".

Manufacturer's address and location of business activity.

40-A, 21st km, Starokyivska Road, Odesa, Ukraine, 65025.