Gelmindazol (Tablets) Instructions for Use

Marketing Authorization Holder

Avva Rus, JSC (Russia)

ATC Code

P02CA01 (Mebendazole)

Active Substance

Mebendazole (Rec.INN registered by WHO)

Dosage Form

Gelmindazol

Tablets 100 mg: 6, 10, 12, 18 or 24 pcs.

Dosage Form, Packaging, and Composition

Tablets from white to light yellow in color, round, flat-cylindrical, with a bevel and a score line.

Excipients: corn starch – 30 mg, crospovidone (XL) – 12 mg, hypromellose – 6 mg, sodium stearyl fumarate – 6 mg, talc – 6 mg, lactose monohydrate* – 140 mg.

*The mass of lactose monohydrate may vary depending on the quantitative content of mebendazole and the water content in the mebendazole pharmaceutical substance.

6 pcs. – contour cell packaging (1) – cardboard packs.
6 pcs. – contour cell packaging (2) – cardboard packs.
6 pcs. – contour cell packaging (3) – cardboard packs.
6 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (1) – cardboard packs.

Clinical-Pharmacological Group

Anthelmintic drug

Pharmacotherapeutic Group

Anthelmintic agent

Pharmacological Action

Anthelmintic drug of broad-spectrum action; most effective in enterobiasis. It causes irreversible disruption of glucose utilization in the helminth’s body and inhibits ATP synthesis.

Pharmacokinetics

It is practically not absorbed from the gastrointestinal tract. Plasma protein binding is 90%. It is unevenly distributed in the organs, accumulates in adipose tissue, liver, and helminth larvae. In the liver, it is metabolized to a 2-amino derivative.

T_1/2 is 2.5-5.5 hours. More than 90% of the dose is excreted in the feces unchanged. The absorbed part (5-10%) is excreted by the kidneys.

Indications

Enterobiasis, ascariasis, ancylostomiasis, strongyloidiasis, trichuriasis, trichinellosis, taeniasis, echinococcosis, alveolar echinococcosis, intestinal capillariasis, gnathostomiasis, mixed helminthiases.

ICD codes

Dosage Regimen

For adults and children over 10 years of age with enterobiasis – in a dose of 100 mg once.

For children aged 2 to 10 years – in a dose of 25-50 mg once. In case of a high probability of reinvasion, the dose is repeated after 2-4 weeks in the same dose.

Simultaneous treatment of all family members is recommended.

For ascariasis, trichuriasis, ancylostomiasis, taeniasis, strongyloidiasis, and mixed helminthiases – 100 mg in the morning and evening for 3 days. For trichinellosis – 200-400 mg 3 times/day for 3 days, and from the 4th to the 10th day – 400-500 mg 3 times/day. For echinococcosis – 500 mg 2 times/day for the first 3 days, then in the same dose 3 times/day for the next 3 days. Subsequently, it is used in a dose of 25-30 mg/kg/day in 3-4 divided doses.

Adverse Reactions

From the digestive system rarely – nausea, abdominal pain; with long-term use in high doses, vomiting, diarrhea, transient increase in the activity of liver transaminases in the blood serum are possible.

From the CNS rarely – dizziness; with long-term use in high doses – headache.

From the hematopoietic system with long-term use in high doses, leukopenia, anemia, eosinophilia are possible.

From the urinary system with long-term use in high doses – hematuria, cylindruria.

Other with long-term use in high doses – allergic reactions, hair loss.

Contraindications

Severe liver dysfunction, pregnancy, lactation (breastfeeding), children under 2 years of age, hypersensitivity to mebendazole.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and during lactation (breastfeeding).

Use in Hepatic Impairment

Contraindicated in severe liver dysfunction.

Pediatric Use

Contraindicated in children under 2 years of age.

Special Precautions

With long-term use, it is necessary to monitor the peripheral blood picture, liver and kidney function.

Avoid alcohol consumption for 24 hours after taking mebendazole.

Do not use a laxative after taking mebendazole.

Periodic examination of smears from the anal area and feces after the end of treatment is mandatory (therapy is considered effective in the absence of helminths or their eggs for the next 7 days).

Drug Interactions

Mebendazole reduces the need for insulin in patients with diabetes mellitus.

Concomitant administration of mebendazole with lipophilic substances should be avoided. With simultaneous use, cimetidine may increase, and carbamazepine and other metabolism inducers may decrease the concentration of mebendazole in the blood.

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

Rx Only

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.