Vermox 100 mg/5 ml oral suspension

Each 5 ml of suspension contains 100 mg of mebendazole.

Excipients: Each 5 ml also contains 500 mg of sucrose, 9 mg of methyl parahydroxybenzoate (E218) and 1 mg of propyl parahydroxybenzoate (E216).

For a full list of excipients, see section 6.1

Oral suspension.

White homogeneous oral suspension.

Broad spectrum gastrointestinal anthelmintic indicated for the treatment of:

Enterobius vermicularis (threadworm/pinworm)

Oxyuris vermicularis

Trichuris trichuria (whipworm)

Ascaris lumbricoides (large roundworm)

Ancylostoma duodenale (common hookworm)

Necator americanus (American hookworm)

There is no evidence that Vermox is effective in the treatment of cysticercosis.

Method of administration.

Oral Use

Adults and children over 2 years:

Enterobiasis:

1 x 5 ml (1 dosing cup).

It is highly recommended that a second dose is taken after 2 weeks, if reinfection is suspected.

Ascariasis, trichuriasis, ancylostomiasis, necatoriasis and mixed infections:

1 x 5 ml (1 dosing cup) bd for three days.

Vermox is contraindicated in pregnancy and in patients who have shown hypersensitivity to the product or any components.

Not recommended in the treatment of children under 2 years.

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.

Vermox oral suspension contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

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).

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

As it is not known whether mebendazole is excreted in human milk, it is not advisable to breast feed following administration of Vermox.

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 using “Rule of 3”, as detailed in SmPC guideline 2009. 6276 patients exposed in clinical trials and epidemiological studies, divided by 3 (Frequency = 1/2092). Note: frequencies differ from those reported in the August 2009 CCDS, as these were not calculated using the formula detailed in the SmPC guideline 2009.

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 (see section 4.8).

Symptoms

In the event of accidental overdosage, abdominal cramps, nausea, vomiting and diarrhoea may occur.

Treatment

There is no specific antidote. Within the first hour after ingestion, gastric lavage may be performed. Activated charcoal may be given if considered appropriate.

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.

Using a tracer dose of ³H-mebendazole, the pharmacokinetics and bioavailability of a solution and IV drug have been examined. After oral administration, the half life was 0.93 hours. Absorption of this tracer dose was almost complete but low availability indicated a high first pass effect. At normal therapeutic doses, it is very hard to measure levels in the plasma.

No relevant information additional to that contained elsewhere in the Summary of Product Characteristics.

Sucrose

Microcrystalline cellulose and i carmellose sodium

Methylcellulose 15 mPa.s

Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216)Sodium laurilsulfhate

Banana flavour 1

Citric acid, monohydrate

Purified water

Not applicable.

5 years.

Shake well before use.

Keep out of reach and sight of children.

Amber glass flask containing 30 ml suspension, with either:

• Pilfer-proof screw cap. Cork insert in cap is coated on both sides with polyvinylchloride

or

• Child-resistant polypropylene screw cap, lined inside with a LDPE insert.

A 5 ml natural polypropylene (food-grade) dosing cup is also provided, graduated for 2.5 ml and 5 ml.

Not all pack sizes may be marketed.

No special requirements.

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

UK

PL 00242/0050

Date of First Authorisation: 17 November 1977

Date of Renewal of Authorisation: 15 December 2002

24/03/2011