Prolaksanit^® (Tablets) Instructions for Use

Marketing Authorization Holder

Vifitech, CJSC (Russia)

ATC Code

A06A (Laxatives)

Active Substance

Frangula bark

Dosage Form

Prolaksanit®

Film-coated tablets, 200 mg: 20, 40, or 50 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets blue in color, round, biconvex.

Excipients : potato starch – 0.00625 g, calcium stearate – 0.00125 g, talc – 0.00125 g, sugar (sucrose) – 0.001 g, sodium bicarbonate – 0.00025 g.

Shell composition sugar (sucrose) – 0.09431 g, basic magnesium carbonate (magnesium hydroxycarbonate) – 0.01908 g, talc – 0.00161 g, colloidal silicon dioxide (aerosil) – 0.0016 g, low molecular weight medical polyvinylpyrrolidone (povidone) – 0.0016 g, titanium dioxide – 0.0016 g, vaseline oil (liquid paraffin) – 0.0001 g, beeswax – 0.0001 g.

10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
20 pcs. – contour cell packs (1) – cardboard packs.
20 pcs. – contour cell packs (2) – cardboard packs.

Clinical-Pharmacological Group

Herbal laxative preparation

Pharmacotherapeutic Group

Laxative of plant origin

Pharmacological Action

A laxative of plant origin. The main pharmacological action is due to the content of anthraglycosides in the bark, which have an irritating effect on the intestinal mucosa, enhance reflex stimulation of peristalsis, and have a laxative effect. The laxative effect develops after 8-10 hours.

Indications

• Chronic constipation.

Use only for the symptomatic relief of chronic constipation after excluding serious underlying pathology.

Do not use in cases of sudden, acute change in bowel habits lasting more than two weeks, or in the presence of rectal bleeding.

ICD codes

Dosage Regimen

Administer orally, usually once daily in the evening before bedtime.

The typical adult and pediatric dose for individuals 12 years and older is one to two film-coated tablets (200-400 mg).

Swallow the tablets whole with a sufficient amount of water; do not chew or crush.

Adjust the dose individually to achieve the desired therapeutic effect, using the lowest effective dose for the shortest possible duration.

Adverse Reactions

Gastrointestinal disorders are common and include spastic abdominal pain, nausea, and diarrhea, particularly with prolonged use or high doses.

Immune system reactions such as hypersensitivity and skin rashes may occur.

Long-term use can lead to electrolyte disturbances, including hypokalemia, and the development of habituation and melanosis coli.

Discoloration of urine to yellow-brown is a known, harmless effect due to chrysophanic acid metabolites.

Drug Interactions

Concurrent use with thiazide diuretics, corticosteroids, or licorice root increases the risk of potassium depletion (hypokalemia).

May reduce the absorption and bioavailability of other concurrently administered oral medications due to accelerated gastrointestinal transit time.

Exercise caution with antiarrhythmic drugs like digoxin and quinidine, as hypokalemia can potentiate their toxic effects.

Monitor for reduced effects of anticoagulants like warfarin, as chronic use may induce vitamin K deficiency.

Contraindications

• Hypersensitivity to frangula bark, anthranoids, or any excipient of the formulation.
• All cases of intestinal obstruction, acute inflammatory diseases of the colon, rectum, or anus, such as appendicitis, Crohn’s disease, ulcerative colitis, and severe abdominal pain of unknown origin ( acute abdomen).
• Severe dehydration states and conditions with electrolyte imbalances.
• Pregnancy and lactation; the agent may stimulate uterine activity and is excreted in breast milk.
• Children under 12 years of age due to lack of safety and efficacy data in this population.

Overdose

Symptoms of overdose include severe abdominal cramps, watery diarrhea, and consequent fluid and electrolyte loss, which can lead to weakness, cardiac arrhythmias, and renal dysfunction.

Initiate supportive measures; discontinue the medication immediately.

Treat fluid and electrolyte imbalances appropriately; monitor potassium levels and correct hypokalemia if present.

Do not administer additional laxatives or antiperistaltic agents. Severe dehydration may require intravenous fluid replacement.

Use in Pregnancy and Lactation

Use is contraindicated during pregnancy and breastfeeding.

Pediatric Use

Use is contraindicated in children under 12 years of age.

Special Precautions

Long-term use without medical consultation is not recommended.

With prolonged use of the drugs, habituation and weakening or loss of the laxative effect may develop, so it is recommended to alternate this remedy with laxative drugs that have a different mechanism of action.

Urine may turn yellow (due to the presence of chrysophanic acid, discontinuation is not required).

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.