VERMOX Tablet Ref.[8055] Active ingredients: Mebendazole

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Janssen-Cilag Ltd, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK

Therapeutic indications

For the treatment of Trichuris trichuria (whipworm), Enterobius vermicularis (pinworm or threadworm), Ascaris lumbricoides (roundworm), Ancylostoma duodenale (common hookworm), Necator americanus (American hookworm) in single or mixed gastrointestinal infestations.

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

Posology and method of administration

Adults and children over 2 years

For the control of trichuriasis, ascariasis and hookworm infections, one tablet twice a day for three consecutive days.

For the control of enterobiasis a single tablet is administered. It is highly recommended that a second tablet is taken after two weeks, if re-infection is suspected.

Tablets may be chewed or swallowed whole. Crush the tablet before giving it to a young child. Always supervise a child while they are taking this medicine.

Vermox oral suspension should be considered for patients such as young children who are unable to swallow the tablet.

Children under 2 years

Vermox has not been extensively studied in children below the age of 2 years.

Currently available data are described in section 4.4, 4.8 and 5.2, but no recommendations on a posology can be made.

Because of the lack of sufficient safety data, Vermox should not be used in children below the age of 1 year (see section 4.4, 4.8 and 5.2).

Method of Administration

Oral use.

Vermox oral suspension should be considered for patients such as young children who are unable to swallow the tablet.

Overdose

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).

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.

Shelf life

3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

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.

Special precautions for disposal and other handling

No special requirements.

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