Laxygal (Drops) Instructions for Use

Marketing Authorization Holder

Teva Pharmaceutical Industries, Ltd. (Israel)

Manufactured By

Teva Czech Industries, s.r.o. (Czech Republic)

ATC Code

A06AB08 (Sodium picosulfate)

Active Substance

Sodium picosulfate (Rec.INN registered by WHO)

Dosage Form

Laxygal

Oral drops 7.5 mg/1 ml: 10 ml or 25 ml dropper bottle

Dosage Form, Packaging, and Composition

Oral drops in the form of a clear liquid from colorless to pale yellow-brown.

Excipients: sorbitol solution 70% (non-crystallizing), sodium ethylparahydroxybenzoate, hydrochloric acid 35%, purified water.

10 ml – dark glass dropper bottle (1) – cardboard boxes.
25 ml – dark glass dropper bottle (1) – cardboard boxes.

Clinical-Pharmacological Group

Laxative drug that stimulates intestinal peristalsis

Pharmacotherapeutic Group

Laxative

Pharmacological Action

Laxative. The active form of the drug, formed by hydrolysis under the influence of intestinal microorganisms, directly stimulates the nerve structures of the intestinal wall, resulting in accelerated movement of intestinal contents and reduced absorption of electrolytes and water.

The effect occurs 10-12 hours after administration.

Pharmacokinetics

After oral administration, it is not absorbed from the gastrointestinal tract and does not undergo enterohepatic circulation.

Indications

• Atonic constipation;
• Regulation of bowel movements (hemorrhoids, proctitis, anal fissures);
• Preparation for surgical operations, instrumental and radiological examinations.

ICD codes

Dosage Regimen

Administer orally with a small amount of water, before bedtime.

For adults and children over 10 years, the initial dose is 12 to 24 drops.

For children aged 4 to 10 years, the initial dose is 6 to 12 drops.

Adjust the subsequent dose based on individual response and clinical effect.

Do not exceed the maximum recommended daily dose.

For preparation for surgical operations or examinations, follow the specific regimen prescribed by the physician.

Use the provided dropper for accurate dose measurement.

Do not use for more than 10 consecutive days without medical supervision.

Discontinue use if severe abdominal pain, diarrhea, or signs of dehydration occur.

Adverse Reactions

Possible diarrhea, abdominal pain, dehydration, disturbances of water-electrolyte balance, weakness, cramps, decreased blood pressure.

Contraindications

• Intestinal obstruction;
• Incarcerated hernia;
• Acute inflammatory diseases of the abdominal organs;
• Peritonitis;
• Abdominal pain (of unclear origin);
• Gastrointestinal bleeding;
• Metrorrhagia;
• Cystitis;
• Severe dehydration;
• Spastic constipation;
• Childhood (under 4 years);
• Pregnancy (first trimester);
• Hypersensitivity.

With caution – lactation period.

Use in Pregnancy and Lactation

During pregnancy, it should be used only as prescribed by a doctor. Contraindication: pregnancy (first trimester).

With caution – lactation period.

Pediatric Use

Contraindication: childhood (under 4 years). In children aged 4 to 10 years, dose adjustment is required (see Dosage Regimen).

Special Precautions

Should not be used daily without medical supervision for more than 10 days.

Children should use it only as prescribed by a doctor.

Overdose

Symptoms: see section “Adverse Reactions”. In addition, with chronic overdose, the development of ischemia of the colon mucosa, secondary hyperaldosteronism, urolithiasis, and renal tubular damage is possible.

Treatment: gastric lavage, correction of water-electrolyte balance disorders, antispasmodics.

Drug Interactions

Increased sensitivity to cardiac glycosides is possible.

Corticosteroids and diuretics increase the risk of electrolyte disturbances.

Broad-spectrum antibiotics reduce the laxative effect.

Storage Conditions

Store at a temperature from 10°C (50°F) to 25°C (77°F), in a place protected from light and out of reach of children.

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.