Vermox Tablet& Suspension Patient Information Leaflet

CJ'C
pharmacia
2002
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 a er-o
. istra ion.
At the normal anthelmintic dosage, the bioavailability is
poor, because of the combination of high first-pass metabolism 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 lumbricoides
(large roundworm);
Ancylostoma
duodena/e,
Necator americanus (hookworm); Strongyloides stercora/is;
Taenia spp. (tapeworm).
Contraindications
Vermox is contraindicated in persons who ha e shown
hypersensitivity to e drug.
Warnings and Precautions
Use in infants below 1 year 0 age: as ell-documented
experience in children below 1 year of age tS scarce and as
there have been very exceptional reports of convulsions in
this age group. Vermox should only be given 0 very young
children if their worm infection interferes
nificantly with
the nutritional status and the physical deve opmenl
Interactions
Concomitant treatment with cimetidine may
ibit the
metabolism of mebendazole in the liver, resu ing n
increased plasma concentrations of the drug especially
during prolonged treatment.
In the latter case, determination of plasma concentra ions
are recommended in order to allow dose adjus e ts.
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 ental Is 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
Therefore caution should be exercised when Vermox
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

1) 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.
2) 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.
3) 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 occasionally been reported, in cases of massive infestation and
expulsion of worms.
Hypersensitivity reactions such as exanthema, rash, urticaria and angio-oedema have rarely been observed.
Overdosage
Symptoms
In the event of accidental overdosage, abdomlnal cramps,
nausea, vomiting and diarrhoea may occur. A~hough the
maximum recommended trea ent duration of Vermox is
limited to three days there
e been rare reports of reversible liver function disturbances.
epatitJs and neutropenia
described in patients who ere treated or hydatid disease
with massive doses for prolOnged penods of time.
Treatment
ere .
an .
IlIn tne first hour after
ingestion, ga
avage may be performed.
Activated charcoa may be given if considered appropriate.
How supplied
Blister packs
100 mg tablets.
Vermox drinkable suspension is supplied in bo
w
a easuring
Storage conditions
Store between 15 a:
30C.
es of 30 ml
pharmacia
Instructions for use

The bottle comes w
a child-proof cap,
and should be openea as follows: push the
plastic sere cap down, whO turn ng
~<D
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 pharrrracist's advice.
- Your doc or and pharmacist are familiar with he medicine
and
contra-indicatIOnS.
- 00 not take the initia
to
stop usa men .
- />Jways consult your ooc:or before ncreaSill9
e dosage
or repeating the trea
Keep all medicines out of reach of children.
This preparation can only be kept for a limited period.
Check the expiry date on the package .
JANSSEN-CILAG
Manufactured
by: see outer pack
for Janssen Pharmaceutica
N.V., Turnhoutseweg
pharmacia
pharmacia
Vermox
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, methyl cellulose,
methylparahydroxybenzoate, sodium lauryl sulphate, propyl
parahydroxybenzoate, banana flavour 1, citric acid monohydrate and purified water (formulation F4).
SA . 2425BON1
pharmacia
30, B-2340
Beerse, Belgium

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CJ'C

Effects on driving ability and use of machinery

Dosage and administration

Since reinfections by Enterobius vermicularis are known to

Instructions for use

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