In patients treated at dosages substantially higher than recommended or for prolonged periods of time, the following adverse reactions have been reported rarely: alopecia, reversible liver function disturbances, hepatitis, agranulocytosis, neutropenia and glomerulonephritis. With the exception of agranulocytosis and glomerulonephritis, these also have been reported in patients who were treated with mebendazole at standard dosages.
Signs and symptoms
In the event of accidental overdosage, abdominal cramps, nausea, vomiting and diarrhoea may occur.
Treatment
There is no specific antidote. Activated charcoal may be given if considered appropriate.
3 years.
Not applicable.
Microcrystalline cellulose
Sodium starch glycolate
Talc
Maize starch
Sodium saccharin
Magnesium stearate
Cottonseed oil hydrogenated
Orange flavour
Colloidal anhydrous silica
Sodium lauril sulfate
Sunset yellow (E110)
Purified water*
2-propanol*
* Not present in the final product.
No relevant information additional to that contained elsewhere in the Summary of Product Characteristics.
Pharmacotherapeutic group: anthelmintic for oral administration, benzimidazole derivatives; ATC code: P02CA01.
In vitro and in vivo work suggests that mebendazole blocks the uptake of glucose by adult and larval forms of helminths, in a selective and irreversible manner. Inhibition of glucose uptake appears to lead to endogenous depletion of glycogen stores within the helminth. Lack of glycogen leads to decreased formation of ATP and ultrastructural changes in the cells.
There is no evidence that Vermox is effective in the treatment of cysticercosis.
Absorption
Following oral administration, < 10% of the dose reaches the systemic circulation, due to incomplete absorption and to extensive pre-systemic metabolism (first-pass effect). Maximum plasma concentrations are generally seen 2 to 4 hours after administration. Dosing with a high fat meal leads to a modest increase in the bioavailability of mebendazole.
Distribution
The plasma protein binding of mebendazole is 90 to 95%. The volume of distribution is 1 to 2 L/kg, indicating that mebendazole penetrates areas outside the vascular space. This is supported by data in patients on chronic mebendazole therapy (e.g., 40 mg/kg/day for 3-21 months) that show drug levels in tissue.
Metabolism
Orally administered mebendazole is extensively metabolised primarily by the liver. Plasma concentrations of its major metabolites (amino and hydroxylated amino forms of mebendazole) are substantially higher than those of mebendazole. Impaired hepatic function, impaired metabolism, or impaired biliary elimination may lead to higher plasma levels of mebendazole.
Elimination
Mebendazole, the conjugated forms of mebendazole, and its metabolites likely undergo some degree of enterohepatic recirculation and are excreted in the urine and bile. The apparent elimination half-life after an oral dose ranges from 3 to 6 hours in most patients.
Steady-state pharmacokinetics
During chronic dosing (e.g., 40 mg/kg/day for 3-21 months), plasma concentrations of mebendazole and its major metabolites increase, resulting in approximately 3-fold higher exposure at steady-state compared to single dosing.
19 November 2014
Janssen-Cilag Ltd
50-100 Holmers Farm Way
High Wycombe
Buckinghamshire
HP12 4EG
UK
This medicinal product does not require any special storage conditions..
Blister strips of PVC genotherm glass clear aluminium foil coated on the inside with a heat seal lacquer.
Pack sizes: 1 and 6 tablet packs.
Not all pack sizes may be marketed.
PL 00242/0011
No special requirements.
Date of First Authorisation: 9 April 1975
Date of Renewal of Authorisation: 30 September 2003
