VERMOX anthelmintic tablet & susp

Properties

Pharmacodynamics

Vermox interferes with the cellular tubulin formation in the worm, thus disturbing the glucose uptake and the normal digestive functions of the worm to such an extent that an autolytic process occurs.

Pharmacokinetics

Mebendazole is poorly absorbed after oral administration. At the normal anthelmintic dosage, the bioavailability is poor, because of the combination of high first-pass metabo lism and the very low solubility of the drug.

90% of the small absorbed fraction is bound to plasma proteins.

Indications

Vermox is indicated for the treatment of single or mixed infestations by Enterobius vermicularis (threadworm/ pinworm); Trichuris trichiura (whipworm); Ascaris lumbri coides (large roundworm); Ancylostoma duodenale, Necator americanus (hookworm); Strongyloides stercoralis; Taenia spp. (tapeworm).

Contraindications

Vermox is contraindicated in persons who have shown hypersensitivity to the drug.

Warnings and Precautions

Use in infants below 1 year of age: as well-documented experience in children below 1 year of age is scarce and as there have been very exceptional reports of convulsions in this age group. Vermox should only be given to very young children if their worm infection interferes significantly with the nutritional status and the physical development.

Interactions

  • Concomitant treatment with cimetidine may inhibit the metabolism of mebendazole in the liver, resulting in increased plasma concentrations of the drug especially during prolonged treatment.
  • In the latter case, determination of plasma concentrations are recommended in order to allow dose adjustments.

Pregnancy and lactation

  • Vermox has shown embryotoxic and teratogenic activity in rats and in mice at oral doses.
  • No such findings have been reported in the rabbit, dog, sheep or horse.
  • Although until now, experience in humans has shown that the use of Vermox during pregnancy entails no risks, possible risks of prescribing Vermox during pregnancy should be weighed against the expected therapeutic benefits, particularly during the first trimester.
  • It is not known wheterh Vermox is excreted in human milk.
  • Therefore caution should be exercised when Vermox is administered to nursing women.

Effects on driving ability and use of machinery

Vermox does not affect the mental alertness or driving ability.

Dosage and administration

Enterobiasis: 1 tablet or 5 ml drinkable suspension given as a single dose. Since reinfections by Enterobius vermicularis are known to be very frequent, it is recommended that the treatment may be repeated after 2 and 4 weeks, particularly in eradication programmes.

Ascariasis, trichuriasis, hookworm and mixed infections: 1 tablet b.i.d. or 5 ml drinkable suspension in the morning and in the evening for 3 consecutive days. The dosages above apply to children as well as adults.

Taeniasis and strongyloidiasis:

  • Adults: although favourable results have been obtained with lower dosages, it is suggested that 2 tablets b.i.d. or 2 x 5 ml be prescribed in the morning and the evening for 3 consecutive days, to obtain complete cure.
  • Even at this higher dosage side-effects are rare. The dosage for children is kept at 1 tablet b.i.d. or 1 x 5 ml b.i.d. for 3 consecutive days.
  • No special procedures, such as diet or use of laxatives, are required.
  • The suspension should be shaken before use.
  • For infants < 1 year, see under Warnings and Precautions.

Adverse reactions

  • Adverse reactions to Vermox have been minor in most cases.
  • Transient abdominal pain and diarrhoea have only occa sionally been reported, in cases of massive infestation and expulsion of worms.
  • Hypersensitivity reactions such as exanthema, rash, urti caria and angio-oedema have rarely been observed.

Overdosage

Symptoms

In the event of accidental overdosage, abdominal cramps, nausea, vomiting and diarrhoea may occur. Although the maximum recommended treatment duration of Vermox is limited to three days there have been rare reports of reversible liver function disturbances, hepatitis and neutropenia described in patients who were treated for hydatid disease with massive doses for prolonged periods of time.

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.

How supplied

  • Blister packs with 100 mg tablets.
  • Vermox drinkable suspension is supplied in bottles of 30 ml with a measuring cap of 5 ml.

Description

  • Vermox is a synthetic broad-anthelmintic.
  • Vermox is available as oral tablets and as a drinkable suspension.
  • Each tablet contains 100 mg mebendazole and the suspension contains 20 mg mebendazole per ml.
  • The other ingredients in the tablet are microcrystalline cellulose, sodium starch glycolate, talc, maize starch, sodium saccharin, magnesium stearate, hydrogenated vegetable oil, orange flavour, colloidal anhydrous silica, sodium lauryl sulphate and orange yellow S (formulation F84).
  • The other ingredients in the suspension are sucrose, microcrystalline cellulose, sodium carmellose, methylcellulose, methylparahydroxybenzoate, sodium lauryl sulphate, propyl parahydroxybenzoate, banana flavour 1, citric acid monohy drate and purified water (formulation F4).

Storage conditions

Store between 15 and 30°C.

Instructions for use

The bottle comes with a child-proof cap, and should be opened as follows: push the plastic screw cap down, while turning it counter clockwise.

This is medicine

  • Medicine is a product that influences your health and it is dangerous not to follow the directions for treatment.
  • Strictly abide by your doctor’s prescription and his directions for use.
  • Take your pharmacist’s advice.
  • Your doctor and pharmacist are familiar with the medicine and its contra-indications.
  • Do not take the initiative to prematurely stop the treatment.
  • Always consult your doctor before increasing the dosage or repeating the treatment.
  • Keep all medicines out of reach of children.

For Arabic Imformation: فيرموكس شراب طارد للديدان

vermox tablet& suspension patient information leaflet

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