COMPOSITION: Each bottle (10 mL suspension) contains 500 mg of the active substance mebendazole polymorph C. Preservatives: methylparaben 0,18% m/v and propylparaben 0,02% m/v. Ethyl alcohol content: 0,48% v/v.
PHARMACOLOGICAL CLASSIFICATION: A.12 Anthelmintics, Bilharzia medicines, Filariacides, 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 SD suspension is indicated for the treatment of single and mixed helminth infestations caused by nematodes such as:
- Trichuris trichiura
- Ancylostoma duodenale
- Necator americanus
- Ascaris lumbricoides
- Enterobius vermicularis
CONTRA-INDICATIONS: In persons who have shown sensitivity to mebendazole. VERMOX SD suspension should not be given during pregnancy or lactation.
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: Whipworm; Hookworm; Large Roundworm; Pinworm; 10 mL given as a single dose. This dosage applies only to adults and children older than 2 years.
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. The efficacy of VERMOX SD suspension is dependent upon the duration of physical contact between drug and parasite.
For infants under 2 years, see "Side-Effects and Special Precautions".
SIDE-EFFECTS AND SPECIAL PRECAUTIONS: In doses exceeding the recommended dosages, VERMOX SD suspension 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 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. INTERACTIONS: Concomitant treatment with cimetidine may inhibit the metabolism of the mebendazole in the liver, resulting in increased plasma concentrations of the medicine especially during prolonged treatment. In the latter case, determination of plasma concentrations are 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: White to off-white suspension with a chocolate flavour.
PRESENTATION: 15 mL amber glass bottles containing 10 mL VERMOX SD suspension.
STORAGE INSTRUCTIONS: Store below 25°C. Keep well closed.
Keep out of reach of children.
REGISTRATION NUMBER: 34/12/0058
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
JANSSEN-CILAG JANSSEN PHARMACEUTICA (PTY) LTD.
(Reg. No. 1980/011122/07)
15th Road, HALFWAY HOUSE, 1685
DATE OF PUBLICATION OF THIS PACKAGE INSERT: 20 December 1999
Code No.: 024372
Updated on this site: March 2004
Current: May 2005
Source: Pharmaceutical Industry