VERMOX Tablet Ref.[8055] Active ingredients: Mebendazole

Not recommended in the treatment of children under 2 years.

There have been rare reports of reversible liver function disturbances, hepatitis and neutropenia described in patients who were treated with mebendazole at standard dosages for indicated conditions (see section 4.8 ‘Undesirable effects’). These events, along with glomerulonephritis and agranulocytosis, have also been reported with dosages substantially above those recommended and with treatment for prolonged periods of time.

A case-control study of a single outbreak of Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) suggested a possible association with the concomitant use of metronidazole with mebendazole. Although there are no additional data on this potential interaction, concomitant use of mebendazole and metronidazole should be avoided.

Convulsions in children, including in infants below 1 year of age, have been reported very rarely during post-marketing experience (see section 4.8 ‘Undesirable effects’). Vermox has not been extensively studied in children below the age of 2 years. Therefore, Vermox should be used in children aged 1-2 years only if the potential benefit justifies the potential risk.

Because of the lack of sufficient safety data, Vermox should not be used in children below the age of 1 year.

Vermox should only be given to very young children if their worm infestation interferes significantly with their nutritional status and physical development.

This medicinal product contains 3.8 mg sodium per tablet, equivalent to 0.19% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

Concomitant treatment with cimetidine may inhibit the metabolism of mebendazole in the liver, resulting in increased plasma concentrations of the drug.

Concomitant use of mebendazole and metronidazole should be avoided (see section 4.4).

Pregnancy

Since Vermox is contraindicated in pregnancy, patients who think they are, or may be, pregnant should not take this preparation.

Breast-feeding

Limited data from case reports demonstrate that a small amount of mebendazole is present in human milk following oral administration. Therefore, caution should be exercised when Vermox is administered to breast-feeding women.

Vermox has no influence on the ability to drive and use machines.

Throughout this section adverse reactions are reported. Adverse reactions are adverse events that were considered to be reasonably associated with the use of Vermox based on the comprehensive assessment of the available adverse event information. A causal relationship with Vermox cannot be reliably established in individual cases. Further, because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The safety of Vermox was evaluated in 6276 subjects who participated in 39 clinical trials for the treatment of single or mixed parasitic infestations of the gastrointestinal tract. In these 39 clinical trials, no adverse drug reactions (ADRs) occurred in ≥1% of Vermox-treated subjects.

ADRs identified from clinical trials and post-marketing experience with Vermox are included in Table 1. The displayed frequency categories use the following convention:

Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1000 to <1/100); Rare (≥1/10,000 to <1/1000); Very rare (<1/10,000), Not known (cannot be estimated from the available data).

Table 1. Adverse Drug Reactions Reported in Clinical Trials and Post-marketing Experience for Vermox:

^a ADR frequency data derived from Clinical Trials or Epidemiological Studies
^b ADRs not observed in clinical trials and frequency calculated based on 6276 patients exposed in clinical trials and epidemiological studies, divided by 3 (Frequency = 1/2092).
* Observed in higher and prolonged doses

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via: Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Not applicable.