Instructions Vermox tablets 100 mg No. 6
Composition
active ingredient: mebendazole;
1 tablet contains 100 mg of mebendazole;
excipients: microcrystalline cellulose, sodium starch glycolate (type A), talc, corn starch, sodium saccharin, magnesium stearate, hydrogenated cottonseed oil, orange flavor, colloidal anhydrous silicon dioxide, sodium lauryl sulfate, orange yellow S (E 110).
Dosage form
Pills.
Main physicochemical properties: round, flat tablet with beveled edges, pale orange in color, engraved with “Me” and “100” separated by a break line on one side and engraved with “JANSSEN” on the other.
Pharmacotherapeutic group
Anthelmintics. Antinematode agents. Benzimidazole derivatives. ATC code P02C A01.
Pharmacological properties
Pharmacodynamics.
Mebendazole acts locally in the intestinal lumen, preventing the formation of cellular tubulin in helminths, which causes disruption of glucose utilization and digestion processes and autolysis of the parasite.
There is no evidence of the effectiveness of Vermox® in the treatment of cysticercosis.
Pharmacokinetics.
Absorption: After oral administration, <10% of the dose reaches the systemic circulation due to incomplete absorption and extensive first-pass metabolism. Peak plasma concentrations are achieved 2–4 hours after administration. Concomitant administration with a high-calorie meal slightly increases the bioavailability of mebendazole.
Distribution. 90–95% of the dose of the drug binds to plasma proteins. The volume of distribution is from 1 to 2 l/kg, which indicates the ability of mebendazole to penetrate the walls of blood vessels. This is confirmed by data on patients who took mebendazole for a long time (40 mg/kg/day for 3–21 months).
Metabolism: After oral administration, mebendazole is metabolized primarily in the liver. Plasma concentrations of its major metabolites are significantly higher than those of mebendazole. Impaired liver function, impaired metabolism, or biliary elimination may lead to increased plasma levels of mebendazole.
Elimination: Mebendazole, conjugated forms of mebendazole and its metabolites undergo partial enterohepatic recirculation and are excreted in urine and bile. The apparent half-life after oral administration in most patients is 3–6 hours.
Steady-state pharmacokinetics.
With prolonged therapy (40 mg/kg/day for 3–21 months), the concentration of mebendazole and its main metabolites in the blood plasma increases, resulting in an approximately 3-fold increase in its exposure at steady state compared to a single dose.
Indication
Treatment of infestations such as: enterobiasis, ascariasis, hookworm, trichocephalosis, necatoriasis.
Contraindication
Hypersensitivity to mebendazole or to any of the excipients.
Pregnancy, breastfeeding period.
Interaction with other medicinal products and other types of interactions
Concomitant use with cimetidine may lead to an increase in the effect of Vermox® due to inhibition of its metabolism in the liver and an increase in the concentration of mebendazole in the blood plasma.
The simultaneous use of mebendazole and metronidazole should be avoided (see section "Special warnings and precautions for use").
Application features
Not recommended for the treatment of children under 2 years of age.
Rare cases of reversible liver dysfunction, hepatitis and neutropenia have been reported in patients receiving mebendazole at standard doses for the indicated indications (see section "Adverse reactions"). There have been reports of the development of glomerulonephritis and agranulocytosis associated with doses that significantly exceed the recommended ones and with treatment for a long period of time.
Clinical trial results suggest a possible association between the use of mebendazole and metronidazole and the occurrence of Stevens-Johnson syndrome/toxic epidermal necrolysis. Concomitant use of mebendazole and metronidazole should be avoided.
Due to insufficient experience with the use of the drug in children under 2 years of age, as well as the fact that there are isolated reports of seizures when using the drug in children of this age group, Vermox® should only be prescribed if the existing helminthic invasion seriously affects their nutritional status and physical development.
When treating with the drug, there is no need to prescribe a diet or use laxatives.
Orange Yellow S dye (E 110) may cause allergic reactions.
This medicinal product contains 48 mg/dose of sodium. Caution should be exercised when used in patients on a salt-free diet.
Use during pregnancy or breastfeeding
Vermox® is contraindicated during pregnancy, therefore pregnant patients or those who suspect pregnancy should not use the drug.
Breast-feeding.
Some data indicate that small amounts of mebendazole are present in human milk after oral administration. Therefore, breastfeeding is not recommended while using Vermox®.
Mebendazole is known to have no effect on fertility at doses up to 10 mg/kg/day. Reproductive studies have shown that mebendazole has no effect on male fertility at doses up to and including 40 mg/kg/day.
Ability to influence reaction speed when driving vehicles or other mechanisms
Vermox® does not affect the ability to drive or use machines, but the possibility of developing undesirable reactions from the nervous system should be taken into account (see the section "Adverse reactions").
Method of administration and doses
For oral use.
For enterobiasis, adults and children over 2 years of age should be prescribed 1 tablet (100 mg) of the drug Vermox® once. To prevent re-invasion, 1 tablet (100 mg) of the drug should be repeated after 2 weeks.
For ascariasis, trichocephalosis, hookworm, and necatoriasis, adults and children over 2 years of age should be prescribed 1 tablet (100 mg) 2 times a day (morning and evening) for 3 days.
The tablet can be chewed or swallowed whole. The tablet should be crushed before giving it to a child. Children should be supervised when taking the medicine.
Children
Use for the treatment of children aged 2 years and over.
Overdose
Alopecia, reversible liver dysfunction, hepatitis, agranulocytosis, neutropenia and glomerulonephritis have been reported rarely in patients receiving higher than recommended doses or for prolonged periods. In addition to agranulocytosis and glomerulonephritis, these adverse reactions have also been observed in patients receiving standard doses of mebendazole (see section 4.8).
Symptoms: In case of accidental overdose, abdominal cramps, nausea, vomiting and diarrhea may occur.
Treatment. There is no specific antidote. Gastric lavage can be performed immediately after oral administration of mebendazole. Activated charcoal can be administered if warranted.
Side effects
At recommended doses, Vermox® is generally well tolerated. Diarrhea and abdominal pain have been observed in patients with significant parasite burdens during the use of Vermox®.
The safety of Vermox® was determined in 6276 patients who participated in 39 clinical trials of the drug for the treatment of single or mixed parasitic infestations of the gastrointestinal tract. During these clinical trials, adverse reactions were observed in less than 1% of patients treated with Vermox®.
Adverse reactions identified during clinical trials and in the post-marketing period are listed in Table 1.
Table 1.
| Organ systems | Adverse reactions |
| Reaction frequency |
common (≥ 1/100 — < 1/10) | uncommon (≥ 1/1000 - < 1/100) | rare (≥ 1/10,000 - <1/1,000) |
Blood and lymphatic system disorders | | | neutropeniab agranulocytosis b* |
| On the part of the immune system | | | hypersensitivity, including anaphylactic and anaphylactoid reactionsb |
| Central nervous system | | | Convulsionsb, dizzinessa |
| Gastrointestinal tract | stomach ache | abdominal discomfort, diarrhea, flatulence, nausea, vomiting | |
| Liver and biliary tract disorders | | | Uncommon: hepatitisb, increased liver enzymesb |
| Skin and subcutaneous tissue disorders | | | rasha, toxic epidermal necrolysisb, angioedema, Stevens-Johnson syndromeb, exanthemab, angioedemab, urticariab, alopeciab |
| Renal and urinary system disorders | | | Glomerulonephritis b* |
a Data on the frequency of adverse reactions were obtained from clinical and epidemiological studies.
b Adverse reactions not observed in clinical trials, frequency determined using the “rule of 3” (frequency = 1/2092).
*Observed with high doses and long-term treatment.
Expiration date
3 years.
Storage conditions
Store in original packaging at a temperature not exceeding 30 ° C. Keep out of the reach of children.
Packaging
6 tablets in a blister made of PVC film and aluminum foil; 1 blister in a cardboard pack.
Vacation category
According to the recipe.
Producer
Lusomedicamenta Sociedade Tecnica Farmaceutica, SA/Lusomedicamenta Sociedade Tecnica Farmaceutica, SA
Address
Estrada Consiglieri Pedroso, 66, 69 – B, Queluz de Baixo, 2730-055 Barcarena, Portugal.
