Fitotranzit^® (Tablets) Instructions for Use

Marketing Authorization Holder

Evalar, CJSC (Russia)

ATC Code

A06AC (Drugs increasing stool bulk)

Active Substance

Laminaria (BP British Pharmacopoeia)

Dosage Form

Fitotranzit®

Tablets 490 mg: 20, 40, 60, or 80 pcs.

Dosage Form, Packaging, and Composition

Tablets of round cylindrical shape, with a biconvex surface; the surface is slightly rough, a layered structure is visible on the break and side; the color of the tablets ranges from greenish-gray to greenish-brown with yellowish, greenish-yellow, greenish-brown, black, rarely reddish-brown inclusions; the odor is weak, specific.

Excipients: colloidal silicon dioxide 7.5 mg, calcium stearate 2.5 mg.

20 pcs. – blister packs (1) – cardboard packs.
20 pcs. – blister packs (2) – cardboard packs.
20 pcs. – blister packs (3) – cardboard packs.
20 pcs. – blister packs (4) – cardboard packs.
40 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
80 pcs. – polymer jars (1) – cardboard packs.

Clinical-Pharmacological Group

Herbal laxative preparation

Pharmacotherapeutic Group

Laxative of plant origin

Pharmacological Action

A herbal remedy. It has a laxative effect, which is associated with the ability of high-molecular polysaccharides of seaweed to swell strongly in the gastrointestinal tract and, increasing in volume, irritate the receptors of the intestinal mucosa, promoting its emptying.

Along with other biologically active substances (vitamins, carotenoids, trace elements), laminaria contains a significant amount of iodide salts.

Indications

Use this medication for the following conditions.

• Chronic atonic constipation.
• Prevention of atherosclerosis.
• Prevention of thyroid diseases associated with iodine deficiency.

ICD codes

Dosage Regimen

Take this medication orally. Administer 1 to 2 times per day.

Swallow the tablets whole with a sufficient amount of water. Do not exceed the recommended daily dosage.

Adjust the frequency based on individual response and therapeutic need. The dosage regimen is intended for adults.

Adverse Reactions

Monitor for gastrointestinal disturbances. Possible adverse effects include intestinal atony and dyspepsia.

Observe for signs of allergic reactions. With long-term use, the risk of iodism increases.

Discontinue use immediately if any severe hypersensitivity reactions occur.

Drug Interactions

Exercise caution with concomitant use of other iodine-containing products or supplements to avoid excessive iodine intake.

Be aware that the laxative effect may influence the absorption rate of concurrently administered oral medications.

The swelling properties of the polysaccharides could potentially affect the gastrointestinal transit of other drugs.

Contraindications

Do not use this medication if any of the following conditions are present.

• Hypersensitivity to iodine or any component of the formulation.
• Severe renal impairment.
• Hemorrhagic diathesis.

Overdose

Symptoms of overdose may include severe diarrhea, abdominal pain, and cramping.

Excessive intake can lead to iodine poisoning (iodism), manifesting as metallic taste, salivary gland swelling, and gastrointestinal irritation.

Treatment is symptomatic and supportive. Ensure adequate hydration. Discontinue the medication immediately.

Use in Renal Impairment

Contraindicated in severe renal impairment.

Special Precautions

The risk of developing iodism increases with long-term use of the plant and increased sensitivity to iodine.

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.