Vermox tablets

Each tablet contains mebendazole 100 mg.

Tablet.

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.

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.

Method of Administration

Oral use.

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.

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 contra-indicated in pregnancy, patients who think they are, or may be, pregnant should not take this preparation.

Lactation

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

None stated.

At the recommended dose, Vermox is generally well tolerated. However, patients with high parasitic burdens when treated with Vermox have manifested diarrhoea and abdominal pain.

Post-marketing experience

Within each system organ class, the adverse drug reactions are ranked under the headings of reporting frequency, using the following convention:

Very common (1/10) Common ( 1/100, < 1/10) Uncommon ( 1/1000, < 1/100) Rare ( 1/10000, < 1/1,000) Very rare (< 1/10,000) including isolated reports.

Immune system disorders

Very rare: hypersensitivity reactions such as anaphylactic and anaphylactoid reactions.

Nervous system disorders

Very rare: convulsions in infants.

Gastrointestinal disorders

Very rare: abdominal pain, diarrhoea (these symptoms can also be the result of the worm infestation itself).

Skin and subcutaneous tissue disorders

Very rare: toxic epidermal necrolysis, Stevens-Johnson syndrome (see also section 4.4), exanthema, angio-edema, urticaria, rash.

Adverse drug reactions reported with prolonged use at dosages substantially above those recommended

Liver function disturbances, hepatitis, glomerulonephritis and neutropenia.

Symptoms

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

See also section 4.8. subheading 'Adverse drug reactions reported with prolonged use at dosages substantially above those recommended'.

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.

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.

Microcrystalline cellulose

Sodium starch glycolate

Talc

Maize starch

Sodium saccharin

Magnesium stearate

Hydrogenated vegetable oil

Orange flavour

Colloidal anhydrous silica

Sodium lauryl sulphate

Orange yellow S

Purified water*

2-propanol*

* Not present in the final product.

Not applicable.

36 months.

None.

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 applicable

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

UK

PL 0242/0011

Date of First Authorisation: 9 April 1975

Date of Renewal of Authorisation: 30 September 2003

01 May 2009

LEGAL CATEGORY POM