INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo VERMOX® 500 mg tablets

SCHEDULING STATUS:
Schedule 1

PROPRIETARY NAME
(and dosage form):

VERMOX® 500 mg tablets

COMPOSITION
Each tablet contains 500 mg of the active substance,
mebendazole polymorph C.

PHARMACOLOGICAL CLASSIFICATION
A.12 Anthelmintics, Bilharzia medicines, Filaricides, etc.

PHARMACOLOGICAL ACTION
Mebendazole is a broad-spectrum anthelmintic. It appears to affect the cytoplasmic microtubules of the tegumental or intestinal cells of parasitic worms resulting in transport blocking of secretory vesicles. This may lead to impaired coating of the membranes followed by a decreased digestion and absorption of nutrients (eg. glucose), thereby depleting the energy level until it is inadequate for survival.

INDICATIONS
VERMOX 500 mg is indicated for the treatment of single and mixed helminth infestations caused by:
        nematodes such as
        Ascaris lumbricoides (large roundworm)
        Trichuris trichiura (whipworm)
        Ancylostoma duodenale (hookworm)
        Necator americanus (hookworm)
        Enterobius vermicularis (pinworm)

CONTRA-INDICATIONS
In persons who have shown sensitivity to mebendazole.
VERMOX should not be given during pregnancy.

WARNINGS
There have been reports of reversible liver function disturbances, hepatitis and neutropenia described in patients treated with massive doses for prolonged periods of time. Therefore, haematological parameters and liver function tests should be monitored in patients receiving VERMOX for prolonged periods of time.

DOSAGE AND DIRECTIONS FOR USE
Large Roundworm; Whipworm; Hookworm; Pinworm:
Adults and children older than 2 years:
One tablet (500 mg) given as a single dose.
A single dose of VERMOX 500 mg may not be sufficient to cure infestations with hookworm and whipworm (Trichuris) although a substantial reduction in egg count can be expected.
VERMOX is easily accepted even by children. The tablets may be crushed and given with some liquid.
A second dose should be given to those patients who are still infected three to four weeks after the first dose.
In worm-eradication campaigns the standard dose should be administered every 3 months during the first year.
The efficacy of VERMOX is dependent upon the duration of physical contact between drug and parasite. When gastro-intestinal transit time is accelerated (eg. in diarrhoea) it may be necessary to repeat the dose.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
In cases of massive infestation, expulsion of worms may occasionally cause transient symptoms such as abdominal pain, diarrhoea and vomiting.
Headache has been reported. Agranulocytosis can occur.

ADVERSE REACTIONS
Hypersensitivity reactions such as exanthema, rash, urticaria and angio-oedema have been observed.

PRECAUTIONS
Usage in children below 2 years is not well documented and as there have been very rare reports of convulsions in this age group, VERMOX 500 mg should not be used and VERMOX 100 mg tablets or VERMOX 20 mg/mL suspension should only be given to very young children if their worm infection interferes significantly with the nutritional status and the physical development.

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

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
In the event of accidental overdosage, abdominal cramps, nausea, vomiting and diarrhoea may occur. If poisoning or excessive overdosage is suspected it is recommended, on general principles, that vomiting be induced or gastric lavage be performed, and such symptomatic supportive therapy be administered as appears indicated.
Activated charcoal may be given.

IDENTIFICATION
A white to faintly cream-coloured, bevel-edged tablet with "Me" above "500" inscription the one side and "JANSSEN" on the other side.

PRESENTATION
Carton containing one or more blister packs of 1 tablet.

STORAGE INSTRUCTIONS
Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER
W/12/42

NAME AND BUSINESS ADDRESS OF THE APPLICANT
JANSSEN–CILAG logo
JANSSEN PHARMACEUTICA (PTY) LTD.
(Reg. No. 1980/011122/07)
15th Road, HALFWAY HOUSE, 1685
© Copyright Janssen Pharmaceutica (Pty) Ltd, S.A.

www.janssencilag.co.za

DATE OF PUBLICATION OF THIS PACKAGE INSERT
24 January 1992

                        Code No.: 024406
                        2003H

Updated on this site: March 2004
Current: May 2005
Source: Pharmaceutical Industry

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