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

Logo VERMOX® suspension
SCHEDULING STATUS
Schedule 1.

PROPRIETARY NAME
(and dosage form)

VERMOX® suspension

COMPOSITION
Each medicine measure (5 mL) contains 100 mg of the active substance, mebendazole polymorph C and methylparaben 0,18% m/v and propylparaben 0,02% m/v as preservatives.

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 a transport blocking of secretory vesicles. This may lead to impaired coating of the membranes followed by a decreased digestion and absorption of nutrients, e.g. glucose, thereby depleting the energy level until it is inadequate for survival.

INDICATIONS
VERMOX is indicated for the treatment of single and mixed helminth infestations caused by:
– nematodes such as:
– Trichuris trichiura (whipworm)
– Ancylostoma duodenale (hookworm)
– Necator americanus (hookworm)
– Ascaris lumbricoides (large roundworm)
– Ternidens deminutus
– Enterobius vermicularis (pinworm)
– Strongyloides stercoralis (threadworm)
– cestodes such as:
– Taenia spp (tapeworm)
– infestations by Moniliformis moniliformis

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

DOSAGE AND DIRECTIONS FOR USE
Whipworm; Hookworm; Large Roundworm; Pinworm; Ternidens deminutus; Infestations by Moniliformis moniliformis:
One medicine measure (5 mL) twice daily (morning and evening) for three consecutive days. The standard dosage applies to adults, children and infants.
Tapeworm (Taenia spp):
One medicine measure (5 mL) twice daily (morning and evening) for six consecutive days. The standard dosage applies to adults, children and infants.
Threadworm (Strongyloides stercoralis):
Adults: Two medicine measures (10 mL) twice daily (morning and evening) for three consecutive days.
Children: One medicine measure (5 mL) twice daily (morning and evening) for three consecutive days.
VERMOX has a banana flavour that is easily accepted by children and adults alike and may be used as a substitute for tablets.
A second course of treatment should be given to those patients who are still infected three to four weeks after the first course.
In worm-eradication campaigns the standard course should be administered every quarter during the first year.
If a helminth is not susceptible to the standard dosage, a treatment course of longer than three days and/or involving higher doses than 5 mL for suspension is recommended.
The efficacy of VERMOX is dependent upon the duration of physical contact between drug and parasite. When gastro-intestinal transit time is accelerated, e.g. in diarrhoea, it is necessary to repeat the dose at more frequent intervals daily.
For infants under 2 years, see "Side-effects and Special Precautions".
Instructions for use:
The bottle comes with a child-proof cap, and should be opened as follows:
1. Push the plastic screw-cap down
2. While pressing down, turn the cap counter clockwise.
{illustrated}

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
In doses exceeding the recommended dosages, VERMOX can cause vomiting, fever, transient neutropenia, alopecia, bone marrow suppression, raised hepatic enzymes, hepatitis and glomerular nephritis. Agranulocytosis can occur.
In cases of massive infestation expulsion of worms may occasionally cause transient symptoms such as abdominal pain and diarrhoea.
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 should only be given to very young children if their worm infections interfere significantly with their nutritional status and 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
Banana-flavoured, beige suspension.

PRESENTATION
Amber glass bottles containing 30 mL VERMOX suspension.

STORAGE INSTRUCTIONS
Store below 25°C.
Keep out of reach of children.

REGISTRATION NUMBER
K/12/206

NAME AND BUSINESS ADDRESS OF THE APPLICANT
JANSSEN–CILAG
Janssen Pharmaceutica (Pty)Ltd.
(Reg. No. 1980/11122/07)
15th Road,
Halfway House 1685
© JPh (Pty) Ltd SA
www.janssencilag.co.za

DATE OF PUBLICATION OF THIS PACKAGE INSERT
24 January 1992

                Code No.: 024369
                2003F
        Britepak
®= TRADEMARK

Updated on this site: May 2005
Source: Pharmaceutical Industry

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2005